AU2009203046A1

AU2009203046A1 - Method and system for obtaining consent

Info

Publication number: AU2009203046A1
Application number: AU2009203046A
Authority: AU
Inventors: Mohamed Hassan Khadra; Mitchell Edward Robert Read; Stephen James Robson
Original assignee: MEDICAL CONSENT SYSTEMS Pty Ltd
Current assignee: MEDICAL CONSENT SYSTEMS Pty Ltd
Priority date: 2008-07-28
Filing date: 2009-07-27
Publication date: 2010-02-11

Description

S&F Ref: 910270 AUSTRALIA PATENTS ACT 1990 COMPLETE SPECIFICATION FOR A STANDARD PATENT Name and Address Medical Consent Systems Pty Ltd, of Applicant: an Australian company, ACN 108 388 405, of 55 Berry Street, Wagga Wagga, New South Wales, 2650, Australia Actual Inventor(s): Mitchell Edward Robert Read, Stephen James Robson, Mohamed Hassan Khadra Address for Service: Spruson & Ferguson St Martins Tower Level 35 31 Market Street Sydney NSW 2000 (CCN 3710000177) Invention Title: Method and system for obtaining consent Associated Provisional Application Details: [33] Country: [31] Appl'n No(s): [32] Application Date: AU 2008903841 28 Jul 2008 The following statement is a full description of this invention, including the best method of performing it known to me/us: 5845c(2220007_1) - 1 - 2217063_1 METHOD AND SYSTEM FOR OBTAINING CONSENT Technical Field The present invention relates to the provision of professional services such as 5 medical procedures and more particularly to methods, systems and computer program products for obtaining consent prior to performing such procedures. Background An obvious enquiry following treatment or a medical procedure having an io adverse outcome is whether the treatment or procedure performed was appropriate for the diagnosed condition. As a general rule, a doctor or other practitioner who acts in accordance with a practice accepted as proper by a responsible body of medical opinion will not likely be guilty of negligence in their choice of treatment or a medical procedure, regardless of whether another body of practitioners has a different practice. 15 Notwithstanding the foregoing, it is uncontroversial that doctors should obtain a patient's consent prior to treatment or performance of a medical procedure. Such consent may be implied or express, oral or written. However, the advantages of obtaining a patient's express written consent are considerable, particularly for 20 purposes of defending a negligence claim. The phrase "informed consent" refers to consent that is given by an individual competent to do so, after having been provided with and understanding the necessary information under the circumstances. Many doctors have a standard method of 25 delivering information relating to risks associated with a particular treatment or medical procedure. However, it is important to take into account a patient's particular needs and circumstances so that the appropriate information can be tailored and delivered in a manner that ensures understanding by the patient. 30 In a joint judgment of the majority of the High Court of Australia in the case of Rogers v Whitaker, the Court stated (at 490): -2- 2217063_1 "The law should recognize that a doctor has a duty to warn a patient of a material risk inherent in the proposed treatment; a risk is material if in the circumstances of the particular case, a reasonable person in the patient's position, if warned of the risk, would be likely to attach 5 significance to it or if the medical practitioner is or should reasonably be aware that the patient, if warned of the risk, would be likely to attach significance to it." (emphasis added) The Court appeared to recognize that individual patients may have special io concerns different from those of the so-called 'reasonable' person, which implies that all risks that would be considered material by a patient should be disclosed to the patient. Reasonable implementation of this requires that the doctor or practitioner have knowledge of individual circumstances and character of the patient, even beyond the subject matter relating to the presenting complaint. However, it can be difficult, is particularly in a busy clinical practice, to assess a patient's temperament, personality, and lifestyle to determine what level of information the patient would want to know. A recognized problem with obtaining informed consent stems from the environment in which the doctor/patient consultation takes place. In many cases, after 20 the doctor has informed the patient of his or her diagnosis, the patient simply does not fully comprehend the information which follows dealing with pros and cons of the suggested treatment or procedure, including risks, complications and alternatives. A number of factors may contribute to or exacerbate this, including: - The patient may be nervous or distracted in the strange environment ('white 25 coat anxiety'); - The patient may be hesitant to ask questions; - The patient may only have heard the diagnosis (e.g. "you have cancer") and have fixed their attention on that; - The doctor may not know the patient well, or even at all, and thus cannot 30 adequately assess what information, including risks, is/are material to that individual patient over and above that which would be important to the average person; - 3 - 2217063_1 - A failure to fully communicate the necessary information on account of the communication style of the doctor or the literary, numeracy and comprehension levels of the patient; - In some hospital settings, the diagnosis is made by a senior doctor or specialist, 5 but the task of conveying the information to the patient and obtaining informed consent is left to a junior doctor; - A language barrier can reduce effectiveness of communication if one of the participants (i.e., either the patient or the doctor) is not speaking in their first language or 'native tongue'. 10 Nevertheless, failure to adequately warn patients of potential risks or complications forms the basis of a significant proportion of negligence claims against doctors and other practitioners. Accordingly, a need exists for methods and systems that enable improved delivery of such information and/or that ameliorate such claims. 15 Summary An aspect of the present invention provides a computer-implemented method for obtaining consent from a patient prior to performing a proposed procedure involving the patient. The method comprises the steps of: retrieving a proposed procedure 20 relating to the patient from a data repository; determining a level of risk acceptable to the patient; identifying one or more potential complications relating to the proposed procedure based on the patient's acceptable level of risk; visually displaying a first description of each of the identified potential complications to the patient; evaluating the patient's understanding of each of the identified potential complications; and 25 generating a consent form subject to obtaining the patient's confirmation of acceptance of risk of each of the identified potential complications. The patient's understanding of each of the identified potential complications may be evaluated by measuring elapsed time from visual display of the first description to said patient. If the elapsed time exceeds a predetermined maximum 30 period, an alternative description of the identified potential complication is visually displayed to the patient. Similarly, if a response to visual display of the first description is detected and the elapsed time is less than a predetermined minimum - 4 - 2217063_1 period, the alternative description of the identified potential complication is visually displayed to the patient. If the patient still does not understand the identified potential complication after display of the alternative description, the patient is required to discuss the identified potential complication with a doctor. An alert message may be 5 output to the doctor (e.g., an email message) to advise that discussion of the identified potential complication with the patient is required. An alert message may be output to the doctor (e.g., an email message) if the consent form cannot be generated a predetermined period before a scheduled time for performing the proposed procedure. 10 The time taken by the patient to understand each of the potential complications is preferably recorded for later defending a claim or an allegation of failure to inform in relation to one or more potential complications. The method may comprise the further steps of: retrieving a diagnosis relating to IS the patient from a data repository; determining appropriateness of the proposed procedure by assessing the proposed procedure against one or more procedures preselected by a competent body in response to a substantially similar diagnosed condition; and outputting a warning message and enabling justification of the proposed procedure to be stored in the data repository if the proposed procedure is 20 deemed inappropriate. The one or more procedures preselected by the competent body may be retrieved from a database that comprises a plurality of procedures each indexed against one or more diagnosed conditions. 25 Computer systems and computer program products for performing the foregoing methods are also provided. Brief Description of the Drawings A small number of embodiments are described hereinafter, by way of example 30 only, with reference to the accompanying drawings in which: - 5 - 2217063_1 Fig. 1 is a schematic flow diagram of a computer-assisted method for validating a proposed procedure in response to a diagnosis in accordance with an embodiment of the present invention; Fig. 2 is a schematic flow diagram of a computer-assisted method for obtaining 5 informed consent from a patient for a procedure in accordance with an embodiment of the present invention; Fig. 3 is a schematic flow diagram of a computer-implemented method for performing a "pre-emptive Bolam Test" in accordance with an embodiment of the present invention; 10 Fig. 4 shows a graphical user interface for obtaining a patient's acceptable level of risk in accordance with an embodiment of the present invention; Fig. 5 is a schematic flow diagram of a method for determining understanding of a visually displayed passage of text in accordance with an embodiment of the present invention; is Fig. 6 is an example of a consent form generated in accordance with an embodiment of the present invention; and Fig. 7 is a schematic block diagram of a computer system with which embodiments of the present invention may be practised. 20 Detailed Description Embodiments of methods, systems and computer program products for obtaining consent are described hereinafter. The embodiments described hereinafter are described with specific reference to a doctor obtaining consent from a patient prior to performing a procedure involving the patient. However, it is not intended that the 25 present invention be limited in this manner as the principles of the present invention have application for other medical specialities and healthcare professionals, including (but not limited to) psychologists, psychiatrists and dentists. Furthermore, the principles of the present invention may have application to other professions, including law, architecture, engineering, accountancy, etc. 30 Embodiments of the present invention described hereinafter include performance of the so-called Bolam Test, which is a familiar concept to most doctors.

- 6 - 2217063_1 The test provides a measure of whether an appropriate standard of care has been exercised in the management or treatment of a patient. The test does not apply only to doctors, but generally to all professionals. This test was developed through a series of English legal cases, culminating in the case of Bolam v Friern Hospital Management 5 Committee (1957) 1 WLR 582. It has since also been refined in subsequent cases. The test is the standard of the ordinary skilled man exercising and professing to have the particular special skill - he does not have to be the best doctor. The Bolam test is generally performed as an ex-post facto analysis, that is, after complications have arisen and in the face of an allegation of failure to fully inform of one or more 1o potential risks or complications. Defending such an allegation typically involves calling expert evidence to show what other doctors, of similar standing and exercising that particular skill, would have done for the patient under the particular circumstances. is Fig. I shows a schematic flow diagram of a computer-assisted method for validating a proposed procedure in response to a diagnosis. Typically, the procedure is proposed by a doctor or other practitioner for treating a diagnosed condition. Referring to Fig. 1, patient information is retrieved at step 110. The information includes the diagnosis and the proposed procedure. Other information may also be 20 retrieved. The retrieved information may include multiple diagnoses and/or multiple proposed procedures. A pre-emptive Bolam test is performed at step 120 to determine the appropriateness of the proposed procedure for treating the diagnosed condition. The test is pre-emptive in that it is performed prior to performing the procedure. 25 If the outcome of the Bolam test is a fail, at step 130, a warning message is generated and an option is provided for inputting a justification for the proposed procedure at step 140. The method then continues at step 150. On the other hand, if the outcome of the Bolam test is a pass at step 130, the method proceeds directly to step 150. 30 At step 150, information relating to the proposed procedure is made available to the patient.

- 7 - 2217063_1 Fig. 2 shows a schematic flow diagram of a computer-assisted method for obtaining informed consent for a proposed procedure from a patient. The method of Fig. 2 typically follows the method of Fig. 1 and may be appended to the method of Fig. 1. s Referring to Fig. 2, at step 210, a patient is enabled to retrieve information based on validation of a unique identifier input by the patient. The information includes information relating to the proposed procedure. A level of risk that is acceptable to the patient is determined at step 220. At step 230, potential complications that may occur in relation to the proposed to procedure are determined based on the patient's acceptable level of risk. Determination of potential complications that may occur in relation to the proposed procedure may also be determined based on the patient's particular circumstances. For example, the patient may be requested to input information that may be relevant to the proposed procedure. Non-limiting examples of such 15 information may, for example, include height and weight (to assess Body Mass Index (BMI)), relevant illnesses or injuries other than the presenting condition, current medication and whether the patient is a smoker. A description of a selected potential complication is presented to the patient and the patient's level of understanding of the description is assessed at step 240. If 20 insufficient understanding by the patient of the selected potential complication is detected (NO), at step 250, an alternative description (e.g., a simpler description) of the selected potential complication is presented to the patient at step 255. The patient is asked, at step 260, whether he or she now understands the selected potential complication. If so (YES), the method continues at step 270. If not (NO), at step 260, 25 the patient is required to consult the doctor to obtain a better understanding of the selected potential complication at step 265 and the method then proceeds to step 270. An alert message may be output to the doctor (e.g., an email message) to advise that discussion of the identified potential complication with the patient is required. If sufficient understanding by the patient of the selected potential complication is 30 detected (YES), at step 250, the method proceeds directly to step 270. At step 270, a determination is made whether there are any more potential complications that need to be disclosed to the patient. If so (YES), the next potential - 8 - 2217063_1 complication is selected at step 275 and the method returns to step 240. If there are no more potential complications to be disclosed to the patient (NO), at step 270, the method proceeds to step 280. The patient's confirmation of acceptance of risk of potential complications is 5 requested at step 280. If the patient's confirmation is obtained, a consent form is generated at step 290. If the patient was requested to consult the doctor to obtain a better understanding of a selected potential complication at step 265, generation of the consent form may optionally be further subject to confirmation from the doctor that patient consulted the doctor and obtained a better understanding of the selected 1o potential complication. The patient may also be asked at step 280 whether they require any additional information. If so (YES), an alert message (e.g., an email message) may be sent to the doctor to provide such information. As is evident from the foregoing, failure of the patient to properly understand a is particular, potential complication does not cause the method to terminate. That is, the patient may continue with other potential complications and later deal with the particular potential complication that was not fully understood. Furthermore, the patient may participate in the method of Fig. 2 on a multi-session basis. For example, the patient may log-on to a computer system multiple times to review the potential 20 complications without having to again review information that has already been reviewed. An alert message may be sent to the doctor (e.g., an email message) if the consent form cannot be generated a predetermined period before a scheduled time for performing the proposed procedure. 25 Fig. 3 shows a schematic flow diagram of computer-implemented method for performing a "pre-emptive Bolam Test" in accordance with an embodiment of the present invention. Specifically, the method of Fig. 3 may be used to perform the "pre emptive Bolam Test" of step 120 of Fig. 1. 30 Referring to Fig. 3, data representative of a diagnosis and a proposed procedure for treating the diagnosed condition is retrieved from a data repository at step 310. With reference to the computer system 700 described hereinafter with reference to -9- 2217063 1 Fig. 7, the data repository may comprise the internal storage device 709. Alternatively, the data repository may comprise an external data storage device (not shown in Fig. 7). At step 320, a list of procedures deemed appropriate for treating the patient 5 based on the diagnosis (or a similar diagnosis) is retrieved from a database at step 310. The database typically comprises procedures indexed against one or more diagnoses and reflects the opinion of a competent body such as a panel of learned specialists or medical experts at a particular point in time. The competent body preferably reviews the contents of the database from time-to-time and modifies or adds to the contents as 1o needed (e.g., as new relevant medical information comes to light), in the interest of keeping the database current. The dates for which each version of a diagnosis and corresponding list of procedures is extant is recorded for later use, such as in defending a doctor against a claim. At step 330, the proposed procedure is compared to the list of appropriate is procedures retrieved in step 320. A determination is made, at step 340, whether the proposed procedure matches a procedure on the retrieved list. If so (YES), the method proceeds to step 350, which corresponds to step 150 in Fig. 1. If not (NO), at step 330, a warning message is generated and the doctor is provided with an opportunity to input justification for the 20 proposed procedure at step 345, which corresponds to step 140 in Fig. 1. Fig. 4 shows a graphical image for obtaining a patient's acceptable level of risk. Referring to Fig. 4, a graded scale of risk probabilities 410 is presented to the patient. The patient may indicate an acceptable level of risk by moving an arrow 430 along an 25 increasing/decreasing scale 420. The arrow 430 may be moved to select a different level of risk by using a pointing device (e.g., a mouse) to select (click) and drag the arrow 430. As a particular level of risk is selected, an example of that risk level may optionally be provided. For example, selection of a risk level of I in 100 may cause the following text box to be displayed: - 10 - 22170631 A risk of 1 in 100 This is the average woman's risk of developing ovarian cancer in her lifetime. It is the risk that a man will develop a melanoma in his lifetime. Once the patient has indicated or selected an acceptable level of risk, the list of material potential complications is generated with reference to the patient's acceptable level of risk. Only potential complications with risks at the selected frequency or 5 higher will be presented to the patient. Numerous potential complications are common to multiple procedures. For example, thrombosis can occur in most operations. Accordingly, complications may be given identification codes and risk codes (to identify the probability of occurrence). 10 Fig. 5 is a schematic flow diagram of a method for determining understanding of a visually displayed passage of text in accordance with an embodiment of the present invention. Specifically, the method of Fig. 5 may be used to determine whether a patient has sufficient understanding of a visually displayed passage of text relating to a potential complication. For example, the method of Fig. 5 may be used to perform 15 step 240 of the method of Fig. 2. Referring to Fig. 5, at step 510, the passage of text is visually displayed to the patient (i.e., on a video display such as the video display of the computer system 700 described hereinafter with reference to Fig. 7) and the elapsed time from first display of the passage of text is measured. The patient is requested to respond by confirming 20 their understanding of the passage of text. If a patient response is detected and the elapsed time (teiapsed) is less than a predetermined minimum period (tmin) (YES), at step 520, the patient is deemed to have an insufficient understanding of the potential complication at step 525. In the case of the method of Fig. 2, the method then continues at step 255. If a patient 25 response is detected and the elapsed time (teiapsed) is not less than a predetermined minimum period (tmin) (NO), at step 520, the method proceeds to step 530.

-11 - 22170631 If the elapsed time (teiapsed) exceeds a predetermined maximum period (tmax) (YES), at step 530, the patient is deemed to have an insufficient understanding of the potential complication. In the case of the method of Fig. 2, the method then continues at step 255. If the elapsed time (telapsed) does not exceed a predetermined maximum 5 period (tmax) (NO), at step 530, the method proceeds to step 540. If a patient response is detected and the elapsed time (teiapsed) is greater than or equal to a predetermined minimum period (tmin) and the elapsed time (telapsed) is less than or equal to a predetermined maximum period (tmax) (YES), at step 540, the 1o patient is deemed to have sufficient understanding of the potential complication at step 545. In the case of the method of Fig. 2, the method then proceeds to step 270. If a patient response is detected and the elapsed time (teiapsed) is not greater than or equal to a predetermined minimum period (tmin) and the elapsed time (teiapsed) is not less than or equal to a predetermined maximum period (tma) (NO), at step 540, the method reverts is to step 520. The values for the predetermined minimum period (tmin) and the predetermined maximum period (tmax) are determined based on a word count (Wpass) of the passage of text displayed to the patient. In one embodiment, formulae used for determining the 20 values (tmin) and (tmax) are as follows: tmin = (Wpass /100 * M) - (Wpass /50 * SD) tmax = (Wpass /100 * M) + (Wpass /50 * SD) 25 where: Wpass is the word count of the passage of text displayed to the patient; M is a mean time to read and understand 100 words; and SD is a standard deviation of the mean time to read and understand 100 words. 30 In one embodiment, the passage of text visually displayed to the patient is written at a basic reading level of a person of age 10-12 years and the mean (M) and - 12 - 22170631 standard deviation (SD) values used are determined based on the average time for a group of 12 year old English-speaking children to read and understand a similar passage of displayed text. Key medical terms used in the passage of text may be hyperlinked to related descriptions. 5 The information displayed to the patient and the time duration spent by the patient on each displayed screen are preferably recorded to form a record that may be used to defend a claim based on an allegation of a failure to warn of one or more potential complications. 10 The embodiments described hereinbefore are computer-implemented and may be performed in an online environment. That is, both the doctor and the patient may interact with an online (e.g., Internet-based) computer system to obtain informed consent. In an example scenario, the doctor inputs information relating to the patient, is including a diagnosis and a proposed procedure. An online version of the Bolam test is performed to validate the doctor's diagnosis. Thereafter, the patient may access his/her information, including the diagnosis and the proposed procedure. The patient may access his/her information and proceed with generating a consent form by logging on to an Internet-based website using a unique identifier. The patient may log 20 on multiple times and continue where they left off the last time they were logged on. Alternatively, the embodiments described hereinbefore may be performed on a computer system located in the doctor's surgery or a clinic. That is, both doctor and patient may interact with the same computer system during a consultation. 25 Fig. 6 shows an example of a consent form 600 such as may be generated in step 290 of the method of Fig. 2. As can be seen from Fig. 6, the consent form identifies the proposed procedure/s and lists the potential complications. By signing the consent form 600, the patient gives his/her consent to performance of the proposed procedure/s, notwithstanding the listed potential complication/s. The educational 30 consent process of the method/s described hereinbefore and the stored history thereof provide substantial evidence that the consent given by the patient is an informed consent.

- 13 - 22170631 The methods described hereinbefore may be implemented using a computer system such as the computer system 700 shown in Fig. 7. Specifically, the methods may be implemented as software, such as one or more application programs 5 executable within the computer system 700. More specifically, the steps of the methods described hereinbefore may be effected by instructions in the software that are carried out within the computer system 700. The instructions may be formed as one or more code modules, each for performing one or more particular tasks. The software may also be divided into two or more separate parts. For example, a first part 1o and the corresponding code modules may perform the methods described herein and a second part and the corresponding code modules may manage a user interface between the first part and a user (e.g., a patient and/or a doctor). Such an arrangement facilitates a network-based or online implementation of the methods described herein, whereby a host computer system may be remotely accessed by a patient and/or a 15 doctor using a remote computer system via a network such as an intranet or the Internet. Both the host computer system and the remote computer system may comprise a computer system such as the computer system 700. The software may be stored in a computer readable medium, including the storage devices described below, for example. The software is loaded into the 20 computer system 700 from the computer readable medium, and then executed by the computer system 700. A computer readable medium having such software or computer program recorded on it is a computer program product. The use of the computer program product in the computer system 700 preferably effects an advantageous apparatus for implementing or performing the methods described 25 herein. As seen in Fig. 7, the computer system 700 comprises a computer module 701, input devices such as a keyboard 702 and a mouse pointer device 703, and output devices including a printer 715, a display device 714 and loudspeakers 717. An external Modulator-Demodulator (Modem) transceiver device 716 may be used by the 30 computer module 701 for communicating to and from a communications network 1020 via a connection 1021. The network 720 may be a wide-area network (WAN), such as the Internet or a private WAN. Where the connection 721 is a - 14 - 2217063 1 telephone line, the modem 716 may be a traditional "dial-up" modem. Alternatively, where the connection 721 is a high capacity (e.g., cable) connection, the modem 716 may be a broadband modem. A wireless modem may also be used for wireless connection to the network 720. 5 The computer module 701 typically includes at least one processor unit 705, and a memory unit 706 for example formed from semiconductor random access memory (RAM) and/or read only memory (ROM). The module 701 also includes an number of input/output (1/0) interfaces including an audio-video interface 707 that couples to the video display 714 and loudspeakers 717, an I/O interface 713 for the keyboard 702 10 and mouse 703 and optionally a joystick (not illustrated), and an interface 708 for the external modem 716 and printer 715. In some implementations, the modem 716 may be incorporated within the computer module 701, for example within the 1/O interface 708. The computer module 701 also has a local network interface 711 which, via a connection 723, permits coupling of the computer system 700 to a local 15 computer network 722, known as a Local Area Network (LAN). As also illustrated, the local network 722 may also couple to the wide network 720 via a connection 1024, which would typically include a so-called "firewall" device or similar functionality. The interface 711 may, for example, be formed by an Ethernet T circuit card, a wireless BluetoothTM or an IEEE 802.11 wireless arrangement. 20 The interfaces 708 and 713 may afford either or both of serial and parallel connectivity, the former typically being implemented according to the Universal Serial Bus (USB) standards and having corresponding USB connectors (not illustrated). Storage devices 709 are provided and typically include a hard disk drive (HDD) 710. Other devices such as a floppy disk drive and a magnetic tape drive (not 25 illustrated) may also be used. An optical disk drive 712 is typically provided to act as a non-volatile source of data. Portable memory devices, such optical disks (eg: CD ROM, DVD), USB-RAM, and floppy disks for example may then be used as appropriate sources of data to the system 700. The components 705 to 713 of the computer module 701 typically communicate 30 via an interconnection bus 704 and in a manner which results in a conventional mode of operation of the computer system 700 known to those skilled in the relevant art. Examples of computer systems with which the described arrangements can be - 15 - 2217063_1 practised include IBM-PC's and compatibles, Sun Sparcstations, Apple Mac T or similar computer systems evolved therefrom. Typically, the application programs discussed above are resident on the hard disk drive 710 and read and controlled in execution by the processor 705. 5 Intermediate storage of such programs and any data fetched from the networks 720 and 722 may be accomplished using the semiconductor memory 706, possibly in concert with the hard disk drive 710. In some instances, the application programs may be supplied to the user encoded on one or more CD-ROM and read via the corresponding drive 712, or alternatively may be read by the user from the networks io 720 or 722. Still further, the software can also be loaded into the computer system 700 from other computer readable media. Computer readable media refers to any storage medium that participates in providing instructions and/or data to the computer system 700 for execution and/or processing. Examples of such media include floppy disks, magnetic tape, CD-ROM, a hard disk drive, a ROM or integrated is circuit, a magneto-optical disk, or a computer readable card such as a PCMCIA card and the like, whether or not such devices are internal or external of the computer module 701. Examples of computer readable transmission media that may also participate in the provision of instructions and/or data include radio or infra-red transmission channels as well as a network connection to another computer or 20 networked device, and the Internet or Intranets including e-mail transmissions and information recorded on Websites and the like. The computer system 700 has been described for illustrative purposes. Accordingly, the foregoing description relates to an example of a particular type of computer system suitable for practicing the methods and computer program products 25 described hereinbefore. Those skilled in the computer arts would readily appreciate that alternative configurations or types of computer systems such as portable computers, Personal Digital Assistants (PDAs) and mobile telephones may be used to practice the methods and computer program products described hereinbefore. 30 Appendix 1, hereinafter, comprises an example of step-by-step operation of a computer-implemented Medical Consent System (MCS) in accordance with a particular embodiment of the present invention.

- 16 - 22170631 Embodiments of the present invention advantageously assist in defending an allegation made against a doctor or other practitioner for failing to adequately inform a patient of potential complications associated with a proposed procedure. 5 Embodiments of the present invention advantageously avoid interrogating or testing a patient's comprehension after visual displaying information to the patient. Rather, a positive indication is sought from the patient that he/she understands the visually displayed information. If the patient responds that he/she does not understand the visually displayed information, or a likely lack of understanding on the patient's part 10 is identified (notwithstanding a response that he/she does understand the visually displayed information), the need for additional information is identified. The additional information (e.g., simpler and/or more detailed information) may be visually presented to the patient or a consultation may be arranged. is The foregoing description provides exemplary embodiments only, and is not intended to limit the scope, applicability or configurations of the present invention. Rather, the description of the exemplary embodiments provides those skilled in the art with enabling descriptions for implementing an embodiment of the invention. Various changes may be made in the function and arrangement of elements without departing 20 from the spirit and scope of the invention as set forth in the claims hereinafter. Where specific features, elements and steps referred to herein have known equivalents in the art to which the invention relates, such known equivalents are deemed to be incorporated herein as if individually set forth. Furthermore, features, 25 elements and steps referred to in respect of particular embodiments may optionally form part of any of the other embodiments unless stated to the contrary. (Australia Only) In the context of this specification, the word "comprising" means "including principally but not necessarily solely" or "having" or "including", 30 and not "consisting only of'. Variations of the word "comprising", such as "comprise" and "comprises" have correspondingly varied meanings.

- 17 - 2217063_1 Appendix I Appendix 1 comprises an example of step-by-step operation of a computer implemented Medical Consent System (MCS) in accordance with a particular 5 embodiment of the present invention. Step I INITIAL REGISTRATION A doctor or doctors' practice registers with the system via a web page on the Internet. Doctors are able to add or remove specific complications or comments about 10 procedures they may perform (e.g., customised procedure descriptions). Doctors are able to input information about costs relating to the procedure. Doctors are able to input information about specific equipment requirements for a particular procedure. A default option provides complications and costs in the absence of specific is inputs in these areas by a doctor. Step 2 CONSULTATION A typical doctor/patient interaction occurs at the doctor's consulting rooms. As a result of a diagnosis, the doctor suggests the patient has one or more 20 specific operations or procedures. The doctor accesses the Medical Consent System (MCS) website on-line and inputs information relating to the patient, the diagnosis and the proposed procedures. The information is stored in a database or data repository. Such information may, for example, include: 25 * The patients name and date of birth 0 A patient identifying number (e.g., Medicare number) * A patient-specified password . The major diagnosis being addressed * The proposed date of the proposed operations/procedures 30 e The hospital at which the operations/procedures is/are to be carried out * Whether the procedures will be under local or general anaesthetic e A description of procedure (most likely, Medicare Benefit Schedule (MBS) number/s) - 18 - 2217063_1 At this stage, a PRE-EMPTIVE BOLAM TEST is applied. In performing the Bolam Test, the system accesses a database. The database comprises, for each major diagnosis, a list of procedures that would be considered appropriate for that diagnosis. For example: 5 Major Diagnosis: Ovarian cyst Acceptable procedures: MBS item number 30320 MBS item number 35637 MBS item number 35638 The database of major diagnoses and acceptable procedures is generated by 1o a body of learned experts who consult the literature. A record of the list, which is time specific and date specific, is maintained. The list of diagnoses and corresponding procedure/s is regularly updated and modified as new information comes to hand and as the body of medical opinion changes. Proper records of the list over time enables determination of whether a is particular procedure was considered appropriate for a diagnosis at the time the procedure was booked. When a conflict occurs (e.g., a procedure is selected by the doctor that is not on the list of acceptable procedures for the diagnosis) the doctor is alerted and provision is made for the doctor to input remarks (e.g., justification for the 20 procedure selected for the particular diagnosis). An example of such an alert follows: ALERT The procedure you have selected for this patient may not be appropriate for the condition. If this is not a mistake, please make a note about the reasons for your 25 choice of procedure: TEXT BOX - PLEASE TYPE HERE 30 This enables the doctor's justification comments to be stored for future reference.

- 19 - 2217063_1 Step 3 PATIENT CONSENT PROCEDURE In the patient consent procedure, the patient accesses the Medical Consent System (MCS) via an Internet website. Access is granted to the patient after 5 successful entry and validation of one or more of the patient's name, identifier (e.g., Medicare number), and password. The patient is presented with a welcome screen, similar to the following: Welcome. You are scheduled to have the following procedures: io < Procedure 1 > < Procedure 2 > At < Hospital name > On is < Date > Performed by < Doctor name > Confirm (yes/no) Once the patient confirms, he/she is given a description of the procedure. For 20 example: LAPAROSCOPY This is a procedure where a telescope is passed through a small incision (cut) in the wall of the abdomen, to see the organs within the abdomen. The patient may select one of the following options: 25 or If is selected, the patient is taken to step 4, described hereinafter, to determine the patient's acceptable level of risk.

- 20 - 2217063_1 If is selected, a simpler description of the procedure is displayed. For example: LAPAROSCOPY This is a procedure where the doctor wishes to look at the organs inside your 5 abdomen (for example, the gall bladder, bowel or appendix). Firstly, a small cut is made through the skin of your abdomen. Some gas is passed into your abdomen to allow a good view. Then a long instrument with lenses, like a telescope, is carefully passed through the hole. The surgeon can then see the organs in your abdomen. 10 Step 4 DETERMINATION OF PATIENT'S ACCEPTABLE RISK LEVEL The patient is requested to input their acceptable level of risk. One technique for performing this step is display of a risk level selection meter ("Risk-o Meter") that allows the patient to graphically select the level of risk they wish is to be informed about. An example of such a meter follows: Less than 1 in 1 000 000 - chance of a regular lotto entry winning the main prize E 20 1 in 100 - the chance of you having a major car accident in your life. 25 The level at which the patient sets and confirms the risk-o-meter arrow dictates the potential complications that are presented to the patient. 30 Complications are each coded according to risk. For example, a bowel injury at laparoscopy occurs in about 1 in 100 cases. However, a stomach injury -21 - 2217063_1 occurs in about 1 in 1000 cases. Each potential complication is presented as a script in sequence. An example follows: Injury to the bowel If the bowel is injured, it may be necessary to repair this. In some cases, s small injuries can be sutured (stitched) at the time of your laparoscopy. Other injuries may require an open operation (making a large cut on you abdomen) to repair. This can substantially delay healing and recovery. You may need treatment with antibiotics. In severe injuries, a portion of the bowel may need to be removed, or a diversion of the bowel to the skin (colostomy) may be 1o required, either permanently or for a short time while the bowel recovers. At the completion of each complication script, the patient must select either: or, The time a person spends reading and understanding a passage of text 15 (words-per-minute) may be calculated using an algorithm based on average and standard deviation values for a class of people (e.g., 10-12 year olds) to read and understand a passage of a particular number of words. If the patient spends less than the average less 2 standard deviations before selecting the option, the following 20 message is presented: < You read that very quickly. Are you sure that you read and understood it? > If the patient takes more than the average plus 2 standard deviations, then the following message is presented: 25 < You're taking a little while to read this. Would you like a more simple description? > If the patient selects the option, then a simpler explanation is presented. If the patient still doesn't understand, then the following message is presented: 30 < You need to discuss this complication with your doctor. Let's continue with the other possible complications > The remainder of the potential complications is presented. However, if there are any outstanding potential complications (i.e., potential complications that are not understood by the patient), the procedure remains incomplete and the 35 following warning message is presented: - 22 - 2217063_1 < One or more sections of the consent remain incomplete. Before this consent if finalised, you must discuss your concerns with your doctor.> If all the potential complications are presented and accepted by the patient, the patient is presented with the following message: 5 < It is time to sign your consent document. Would you like to print this document now, or have your doctor print it? > OPTIONS < Print the consent form now. I will sign it and return it to my doctor. > < Please have the doctor print it. I will go to the doctor's office and sign 10 it there. > DOCUMENTATION The system stores data on ALL interactions with the medical consent system (MCS), to provide medico-legal defence for the doctor. This includes the is screens viewed by the patient, the time spent on each, and the fact that confirmations were selected. DOCTOR'S CAPABILITY Typical system capability available to a doctor includes the following: 20 Alerts These typically include the following: " Patient has not completed the consent procedure 7 days before the scheduled date. * Patient has indicated they would like more information about one of 25 more complications. In this instance, the doctor can select the option <1 confirm that I have discussed this complication to the patient's satisfaction>, which will enable generation of the consent form. " Consent forms to be printed. This occurs when a patient wants the practice staff to print the form, so that the patient can attend to sign the 30 printed consent form.

-23 - 22170631 Inbox * Routine administrative messages or notations from the medical consent system (MCS) to the doctor. s Input patient * This capability allows the doctor or administrative staff to input patient and/or procedure information. Running sheets 1o0 This capability takes into account the fact that staff will not be on-line at all times. Running sheets may be printed for manual (e.g., handwritten) recording of patient information, as required, and later entry into the medical consent system. 15 Patient documents e This typically comprises the website address and access information for the patient. Administrative entry 20 e This enables a doctor or staff to input, access and/or modify information such as financial information and information relating to proposed procedures and potential complications. For example, if access of potential complications relating to 25 Laparoscopy MBS item number 35637 is requested by the doctor, a list of the potential complications is displayed. If the doctor selects a replace text option, a text box is opened for replacement text to be input. 30

Claims

1. A computer-implemented method for obtaining consent from a patient prior to performing a procedure involving the patient, said method comprising the steps of: s retrieving a proposed procedure relating to said patient from a data repository; determining a level of risk acceptable to said patient; identifying one or more potential complications relating to said proposed procedure based on said patient's acceptable level of risk; visually displaying a first description of each of said identified potential io complications to said patient; evaluating said patient's understanding of each of said identified potential complications; and generating a consent form subject to obtaining said patient's confirmation of acceptance of risk of each of said identified potential complications. 15

2. The method of claim 1, wherein said step of evaluating said patient's understanding of a potential complication comprises the sub-steps of: measuring elapsed time from presentation of said first description to said patient; 20 visually displaying an alternative description of said identified potential complication to said patient if said elapsed time exceeds a predetermined maximum period, wherein said predetermined maximum period is a function of a word count of said first description; and requiring said patient to discuss said identified potential complication with a 25 doctor if said patient still does not understand said identified potential complication after visual display of said alternative description.

3. The method of claim 2, wherein said predetermined maximum period (tmax) is determined in accordance with the formula: 30 tmax = (Wpass /100 * M) + (Wpass /50 * SD) wherein: Wpass is the word count of said first description; - 25 - 22170631 M is a mean time to read and understand 100 words; and SD is a standard deviation of the mean time to read and understand 100 words. 5

4. The method of claim 1, wherein said step of evaluating said patient's understanding of a potential complication comprises the sub-steps of: measuring elapsed time from display of said first description to said patient; visually displaying an alternative description of said identified potential complication to said patient if a response to display of said first description is detected 10 and said elapsed time is less than a predetermined minimum period, wherein said predetermined minimum period is a function of a word count of said first description; and requiring said patient to discuss said identified potential complication with a doctor if said patient still does not understand said identified potential complication 15 after visual display of said alternative description.

5. The method of claim 4, wherein said predetermined minimum period (tmin) is determined in accordance with the formula: tmin = (Wpass /100 * M) - (Wpass /50 * SD) 20 wherein: Wpass is the word count of said first description; M is a mean time to read and understand 100 words; and SD is a standard deviation of the mean time to read and understand 100 words. 25

6. The method of claim 2 or claim 4, comprising the further step of outputting an alert message to said doctor that discussion of said identified potential complication with said patient is required. 30

7. The method of any one of claims 2, 4 and 6 wherein said step of generating a consent form is further subject to said doctor confirming said patient's understanding of said identified potential complication. - 26 - 2217063_1

8. The method of claim I comprising the further step of outputting an alert message to said doctor if said consent form cannot be generated a predetermined period before a scheduled time for performing said procedure. 5

9. The method of any one of claims 1, 2, 4 and 6, comprising the further step of recording time taken by said patient to understand each of said potential complications.

10 10. The method of claim I comprising the further steps of: retrieving a diagnosis relating to said proposed procedure from a data repository; determining appropriateness of said proposed procedure by assessing said proposed procedure against one or more procedures preselected by a competent body in response to a substantially similar diagnosed condition; and is outputting a warning message and enabling justification of said proposed procedure to be stored in said data repository if said proposed procedure is deemed inappropriate.

11. The method of claim 10, comprising the further step of retrieving said one or 20 more procedures preselected by said competent body from a database, said database comprising a plurality of procedures each indexed against one or more diagnosed conditions.

12. The method of claim 10, wherein said competent body comprises a plurality of 25 medical experts.

13. A computer-assisted method for validating a proposed procedure relating to a diagnosis, said method comprising the steps of: retrieving said diagnosis and proposed procedure from a data repository; 30 determining appropriateness of said proposed procedure by assessing said proposed procedure against one or more procedures preselected by a competent body in response to a substantially similar diagnosed condition; and - 27 - 22170631 outputting a warning message and enabling justification of said proposed procedure to be stored in said data repository if said proposed procedure is deemed inappropriate. s

14. The method of claim 13, comprising the further step of retrieving said one or more procedures preselected by said competent body from a database, said database comprising a plurality of procedures each indexed against one or more diagnosed conditions. io

15. The method of claim 13, wherein said competent body comprises a plurality of medical experts.

16. A computer system for obtaining consent from a patient prior to performing a procedure involving the patient, said computer system comprising at least one 15 processor programmed to: retrieve a proposed procedure relating to said patient from a data repository; determine a level of risk acceptable to said patient; identify one or more potential complications relating to said proposed procedure based on said patient's acceptable level of risk; 20 output a first description of each of said identified potential complications for display to said patient; evaluate said patient's understanding of each of said identified potential complications; and generate a consent form subject to obtaining said patient's confirmation of 25 acceptance of risk of each of said identified potential complications.

17. The computer system of claim 15, wherein to evaluate said patient's understanding of a potential complication, said at least one processor is programmed to: 30 measure elapsed time from presentation of said first description to said patient; output an alternative description of said identified potential complication for display to said patient if said elapsed time exceeds a predetermined maximum period, -28 - 2217063_1 wherein said predetermined maximum period is a function of a word count of said first description; and output, for display to said patient, a requirement for said patient to discuss said identified potential complication with a doctor if said patient still does not understand 5 said identified potential complication after display of said alternative description.

18. The computer system of claim 17, wherein said at least one processor is programmed to determine said predetermined maximum period (tmax) in accordance with the formula: 10 tmax = (Wpass /100 * M) + (Wpass /50 * SD) wherein: Wpass is the word count of said first description; M is a mean time to read and understand 100 words; and SD is a standard deviation of the mean time to read and understand 100 is words.

19. The computer system of claim 16, wherein to evaluate said patient's understanding of a potential complication, said at least one processor is programmed to: 20 measure elapsed time from display of said first description to said patient; output an alternative description of said identified potential complication for display to said patient if a response to display of said first description is detected and said elapsed time is less than a predetermined minimum period, wherein said predetermined minimum period is a function of a word count of said first description; 25 and output, for display to said patient, a requirement for said patient to discuss said identified potential complication with a doctor if said patient still does not understand said identified potential complication after display of said alternative description. 30

20. The computer system of claim 19, wherein said at least one processor is programmed to determine said predetermined minimum period (tmin) in accordance with the formula: - 29 - 2217063_1 tmin = (Wpass /100 * M) - (Wpass /50 * SD) wherein: Wpa, is the word count of said first description; M is a mean time to read and understand 100 words; and 5 SD is a standard deviation of the mean time to read and understand 100 words.

21. The computer system of claim 17 or claim 19, wherein said at least one processor is programmed to output an alert message to said doctor that discussion of io said identified potential complication with said patient is required.

22. The computer system of any one of claims 17, 19 and 21, wherein said at least one processor is programmed to generate said consent form subject to said doctor confirming said patient's understanding of said identified potential complication. 15

23. The computer system of claim 16, wherein said at least one processor is programmed to output an alert message to said doctor if said consent form cannot be generated a predetermined period before a scheduled time for performing said procedure. 20

24. The computer system of any one of claims 16, 17, 19 and 21, wherein said at least one processor is programmed to record time taken by said patient to understand each of said potential complications.

25 25. The computer system of claim 16, wherein said at least one processor is programmed to: retrieve a diagnosis relating to said proposed procedure from a data repository; determine appropriateness of said proposed procedure by assessing said proposed procedure against one or more procedures preselected by a competent body 30 in response to a substantially similar diagnosed condition; and - 30 - 2217063_1 output a warning message and enable a justification of said proposed procedure to be stored in said data repository if said proposed procedure is deemed inappropriate. 5

26. The computer system of claim 25, wherein said at least one processor is programmed to retrieve said one or more procedures preselected by said competent body from a database, said database comprising a plurality of procedures each indexed against one or more diagnosed conditions. 10

27. A computer system for validating a proposed procedure relating to a diagnosis, said computer system comprising at least one processor programmed to: retrieve said diagnosis and proposed procedure from a data repository; determine appropriateness of said proposed procedure by assessing said proposed procedure against one or more procedures preselected by a competent body is in response to a substantially similar diagnosed condition; and output a warning message and enable a justification of said proposed procedure to be stored in said data repository if said proposed procedure is deemed inappropriate. 20

28. The computer system of claim 28, wherein said at least one processor is further programmed to retrieve said one or more procedures preselected by said competent body from a database, said database comprising a plurality of procedures each indexed against one or more diagnosed conditions. 25

29. A computer program product comprising a computer readable medium having a computer program recorded thereon for obtaining consent from a patient prior to performing a procedure involving the patient, the computer program comprising: computer program code means for retrieving a proposed procedure relating to said patient from a data repository; 30 computer program code means for determining a level of risk acceptable to said patient; -31 - 2217063_1 computer program code means for identifying one or more potential complications relating to said proposed procedure based on said patient's acceptable level of risk; computer program code means for outputting a first description of each of said 5 identified potential complications for display to said patient; computer program code means for evaluating said patient's understanding of each of said identified potential complications; and computer program code means for generating a consent form subject to obtaining said patient's confirmation of acceptance of risk of each of said identified io potential complications.

30. The computer program product of claim 29, wherein said computer program code means for evaluating said patient's understanding of a potential complication comprises: 15 computer program code means for measuring elapsed time from presentation of said first description to said patient; computer program code means for outputting an alternative description of said identified potential complication for display to said patient if said elapsed time exceeds a predetermined maximum period, wherein said predetermined maximum 20 period is a function of a word count of said first description; and computer program code means for outputting a message requiring said patient to discuss said identified potential complication with a doctor if said patient still does not understand said identified potential complication after display of said alternative description. 25

31. The computer program product of claim 30, wherein said predetermined maximum period (tmax) is determined in accordance with the formula: tmax = (Wpas /100 * M) + (Wpas /50 * SD) wherein: 30 Wpass is the word count of said first description; M is a mean time to read and understand 100 words; and -32- 2217063_1 SD is a standard deviation of the mean time to read and understand 100 words.

32. The computer program product of claim 29, wherein said computer program 5 code means for evaluating said patient's understanding of a potential complication comprises: computer program code means for measuring elapsed time from display of said first description to said patient; computer program code means for outputting an alternative description of said to identified potential complication for display to said patient if a response to display of said first description is detected and said elapsed time is less than a predetermined minimum period, wherein said predetermined minimum period is a function of a word count of said first description; and computer program code means for outputting a message requiring said patient to is discuss said identified potential complication with a doctor if said patient still does not understand said identified potential complication after display of said alternative description.

33. The computer program product of claim 32, wherein said predetermined 20 minimum period (tmin) is determined in accordance with the formula: tmin = (Wpass /100 * M) - (Wpass /50 * SD) wherein: Wpass is the word count of said first description; M is a mean time to read and understand 100 words; and 25 SD is a standard deviation of the mean time to read and understand 100 words.

34. The computer program product of claim 30 or claim 32, further comprising computer program code means for outputting an alert message to said doctor that 30 discussion of said identified potential complication with said patient is required. - 33 - 22170631

35. The computer program product of any one of claims 30, 32 and 34 wherein said computer program code means for generating a consent form is further subject to said doctor confirming said patient's understanding of said identified potential complication. 5

36. The computer program product of claim 29 further comprising computer program code means for outputting an alert message to said doctor if said consent form cannot be generated a predetermined period before a scheduled time for performing said procedure. 10

37. The computer program product of any one of claims 29, 30, 32 and 34, further comprising computer program code means for recording time taken by said patient to understand each of said potential complications. 15

38. The computer program product of claim 29, further comprising: computer program code means for retrieving a diagnosis relating to said proposed procedure from a data repository; computer program code means for determining appropriateness of said proposed procedure by assessing said proposed procedure against one or more procedures 20 preselected by a competent body in response to a substantially similar diagnosed condition; and computer program code means for outputting a warning message and enabling a justification of said proposed procedure to be stored in said data repository if said proposed procedure is deemed inappropriate. 25

39. The computer program product of claim 38, further comprising computer program code means for retrieving said one or more procedures preselected by said competent body from a database, said database comprising a plurality of procedures each indexed against one or more diagnosed conditions. 30 - 34 - 2217063_1

40. A computer program product comprising a computer readable medium having a computer program recorded thereon for validating a proposed procedure relating to a diagnosis, the computer program comprising: computer program code means for retrieving said diagnosis and proposed 5 procedure from a data repository; computer program code means for determining appropriateness of said proposed procedure by assessing said proposed procedure against one or more procedures preselected by a competent body in response to a substantially similar diagnosed condition; and 1o computer program code means for outputting a warning message and enabling a justification of said proposed procedure to be stored in said data repository if said proposed procedure is deemed inappropriate.

41. The computer program product of claim 40, further comprising computer 15 program code means for retrieving said one or more procedures preselected by said competent body from a database, said database comprising a plurality of procedures each indexed against one or more diagnosed conditions.

42. A computer-implemented method for obtaining consent from a patient prior to 20 performing a procedure involving the patient, said method substantially as described hereinbefore with reference to an embodiment as shown in the accompanying drawings.

43. A computer-assisted method for validating a proposed procedure relating to a 25 diagnosis, said method substantially as described hereinbefore with reference to an embodiment as shown in the accompanying drawings.

44. A computer system for obtaining consent from a patient prior to performing a procedure involving the patient, said computer system substantially as described 30 hereinbefore with reference to an embodiment as shown in the accompanying drawings. -35 - 2217063_1

45. A computer system for validating a proposed procedure relating to a diagnosis, said computer system substantially as described hereinbefore with reference to an embodiment as shown in the accompanying drawings. 5

46. A computer program product comprising a computer readable medium having a computer program recorded thereon for obtaining consent from a patient prior to performing a procedure involving the patient, said computer program substantially as described hereinbefore with reference to an embodiment as shown in the accompanying drawings. 10

47. A computer program product comprising a computer readable medium having a computer program recorded thereon for validating a proposed procedure relating to a diagnosis, said computer program substantially as described hereinbefore with reference to an embodiment as shown in the accompanying drawings. 15 Dated 23 July, 2009 Medical Consent Systems Pty Ltd Patent Attorneys for the Applicant/Nominated Person SPRUSON & FERGUSON 20