CA2683169A1 - A method for diagnosing psoriatic arthritis in patients with skin psoriasis - Google Patents
A method for diagnosing psoriatic arthritis in patients with skin psoriasis Download PDFInfo
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Abstract
A computer-implemented method and system for detecting and diagnosing psoriatic arthritis in patients with skin psoriasis is provided. More specifically, the invention uses information entered by a patient into a self-administered electronic questionnaire to construct a score that provides a probability of having or detecting psoriatic arthritis in patients with skin psoriasis using a combination of algorithms and empirical data. The electronic questionnaire can be used to set an etiology-based diagnosis of psoriatic arthritis for targeting of treatment and preventative interventions. The present invention is also useful for ruling out one or more diseases or disorders that present with psoriasis like symptoms and ruling out psoriasis and/or PsA.
Description
A METHOD FOR DIAGNOSING PSORIATIC ARTHRITIS IN PATIENTS WITH SKIN
PSORIASIS
FIELD OF THE INVENTION
The present invention relates to the field of medical diagnostic screening.
BACKGROUND OF THE INVENTION
Psoriatic arthritis (PsA) is a serious chronic condition that affects 10-35%
of patients with skin psoriasis and is associated with increased patient morbidity and mortality (Reference 1). It is often described as a chronic inflammatory arthropathy affecting the distal interphalangeal joints of the hands (DIPs), feet and spine associated with psoriasis (PSO) (Reference 2). The Norfolk Arthritis Registry (NOAR) cohort study recently demonstrated that 5-year outcomes for psoriasis-associated inflammatory arthritis are very similar to those of inflammatory arthritis without PSO (Reference 3). Results of this study suggested 36.7 % of PsA patients had radiographic erosions at 5 years compared to 33.8%
of those without PSO, and 47% of PsA patients in early synovitis clinics, providing evidence this is neither a benign nor infrequent disease, as previously perceived (References 4-7). Most patients develop PsA years after the onset of their PSO (References 8-9).
Early diagnosis and intervention of PsA plays an important role in preventing the progression of inflammatory joint damage, reducing pain and improving quality of life (QoL) (Reference 10). Traditional therapies have provided inadequate control of the inflammation associated with PsA, but the introduction of the biologic agents (e.g. tumour necrosis factor antagonists) offer a new option.
There has been considerable variation in how rheumatologists have diagnosed PsA, and international groups such as GRAPPA are attempting to more precisely define PsA
patients for clinical trials (References 5, 11-18). The differential diagnosis of PsA can be challenging since many of its features overlap with those of rheumatoid arthritis, reactive inflammatory bowel disease and ankylosing spondylitis. Furthermore, osteoarthritis, soft tissue rheumatism, septic arthritis and true RA can coexist with PSO.
Preliminary efforts to develop screening tools for the identification of PsA
patients have met with limited success (Reference 19). The Psoriatic and Arthritis Questionnaire (PAQ), a 12-item questionnaire, was developed by Peloso and colleagues to identify psoriatic patients with arthritis (Reference 20). An evaluation using this questionnaire in 202 hospital- and community-based patients, in Sweden, demonstrated a score of 4 (scale 0-8) was the best cut off value for detecting arthritis. This cut off, however, yielded sensitivity of 60% and specificity of 62%, indicating the PAQ did not effectively discriminate for arthritis (Reference 20). The Psoriatic Arthritis Screening and Evaluation (PASE) is a 15 item questionnaire with symptom and function sub-scales. The questionnaire, evaluated in 69 patients, showed an optimal cut off point of 47, and was able to distinguish PsA from non-PsA patients with sensitivity and specificity of 82% and 73% respectively (Reference 6).
The Toronto Psoriatic Arthritis Screen (ToPAS), which supplements the questionnaire with photos to aid the patients, showed a sensitivity of 91.9%, and a specificity of 95.2% in a dermatology practice (Reference 21). In 2006 the Classification Criteria for PsA
(CASPAR) was introduced as a research tool for classifying PsA (Reference 22).
The CASPAR criteria are defined as follows: A patient must have presented with inflammatory articular disease and must satisfy three or more of the following: (1) evidence of current PSO, (2) a personal history of PSO, or (3) a family history of PSO, (4) typical psoriatic nail dystrophy, (5) a negative test result for the presence of rheumatoid factor, (6) current dactylitis or a history of dactylitis, and (7) radiographic evidence of juxta-articular new bone formation, appearing as ill-defined ossification near joint margins.22 The CASPAR criteria have demonstrated high sensitivity and specificity of 91.4% and 98.7%, respectively.
Although the CASPAR criteria provide a sensitive tool for confirmation of the diagnosis of PsA, it is still a research instrument and its use in the clinical settings has not been widely utilized. Furthermore, it requires proficiency in joint examination and it may be difficult to implement by other health care providers such as dermatologists and family physicians.
It is believed that screening PSO patients likely to develop PsA with an easy to administer tool with good sensitivity and specificity will facilitate early identification, prevention of disease progression and destruction of joints and efficient referral for optimal treatment. In order to achieve this objective, a simple, self-administered questionnaire -the PSO and Arthritis Screening Questionnaire (PASQ) - was developed which can be utilized for screening patients who meet the CASPAR criteria for PsA. It has been demonstrated that the PASQ is highly sensitive and specific in detecting patients with PsA
(whether in early-stages or established stages of the disorder) who fulfill the CASPAR criteria (Reference 23).
The PASQ, shown in FIG. 1, comprises a simple, self-administered questionnaire containing ten questions for which a positive and negative response are assigned a score of 1 and 0, respectively, with a maximum score of 10. Patients are also requested to indicate, on a diagram where they experienced joint swelling or pain (at present or in the past). The PASQ diagram for patient assessment of painful and swollen sites is shown in FIG. 2. The diagram is scored 0, 1, 3 or 5 depending on the distribution of markings, as show in FIG. 3. The points are weighted consistent with the different presentations and joints affected in PsA (Reference 12), and other forms of arthritis (e.g.
osteoarthritis and rheumatoid arthritis). The scores of the questionnaire and diagram are then tabulated by the physician or assistant.
The receiver operating curve (ROC) is a known statistical method which may be used determine the optimal cut off score that will best discriminate between those patients having or not having PsA. The optimal score will provide the best sensitivity, meaning the proportion of actual positives which are correctly identified as such (i.e.
the percentage of affected patients who are correctly identified as having PsA) and specificity, meaning the proportion of negatives which are correctly identified (i.e. the percentage of well people who are correctly identified as not having the condition).
Using the ROC, the PASQ has been shown to yield an optimal cut-off of 9, with 86.27%
sensitivity and 88.89% specificity, although a score of 8 increases the sensitivity to 92.78%
while maintaining a specificity of 77.16% specificity. An analysis of the PASQ
diagram score indicate an optimal total score of 1 (out of maximum 5 for the diagram) with 100%
sensitivity and 55.56% specificity.
The PASQ has the advantage of being a wholly patient administered tool with no physical examination needed to complete its score, which makes it an ideal screening tool to utilize by non-rheumatologists. The PASQ is of particular benefit to dermatologists and family physicians who may benefit from the use of this tool for rapid diagnosis of patients that require referral to a rheumatologist for their management in order to avoid potentially irreversible destruction of the involved joints, leading to more timely and optimal selection of systemic treatments, particularly for moderate-severe PSO. Optimal and timely treatment of this population with the most efficacious systemic therapies is important as it may yield improved clinical outcomes and enhanced quality of life for these patients. The positive outcomes may also be reflected in more efficient utilization of health care resources and ultimately in cost savings to the health care system.
A further advantage of the PASQ is that it can be completed and scored in an efficient manner, offers little difficulty to the patient and the scorer, requires minimal intervention by the physician and adds very little burden to the clinical routine.
Notwithstanding the foregoing, although the PASQ provides a sensitive, simple and easy to administer questionnaire that can be used to screen for PsA, it is a paper-based method requiring a physician or trained assistant to physically mark and score the questionnaire and, therefore, is subject to human error in calculating the scores of both the questionnaire and, in particular, the diagram. Accordingly, there exists a need for a version of the PASQ
which limits or eliminates the possibility of human errors in analysing the test data.
SUMMARY OF THE INVENTION
The following presents a simplified summary of the invention in order to provide a basic understanding of some aspects of the invention. This summary is not an extensive overview of the invention. It is not intended to identify key/critical elements of the invention or to delineate the scope of the invention. Its sole purpose is to present some concepts of the invention in a simplified form as a prelude to the more detailed description that is presented later.
It is an object of the present invention to provide a self-administered, electronic version of the PASQ which may be widely distributed and which will automatically score the questionnaire, thereby eliminating possible inaccuracies of the diagram scoring, as well as provide useful information when self-administered to an untrained user.
The present invention describes a computer-implemented method and system to provide an electronic Psoriatic Arthritis Screening Questionnaire (the "EPASQ") used as a tool for reliable diagnosis of PsA in patients with PSO. The subject matter described herein is implemented as a computer program product comprising computer executable instructions embodied in a computer readable medium. For greater clarity, any references herein to the "EPASQ" or to "electronic questionnaire and diagram" refers to the present invention, which includes a computer implemented method and system for the detection and diagnosis of PsA in patients with PSO.
The present invention provides a simple, self-administered and automatically scored electronic program with a high sensitivity and specificity and is an effective tool to screen for early and established PsA patients. It is hoped that the present invention will assist dermatologists and family physicians in the identification of PSO patients at risk of developing PsA, resulting in timely referrals to and treatment by a rheumatologist, and, additionally, will assist dermatologists in selecting appropriate systemic treatments for moderate-to-severe PSO. In addition, the present invention, in one embodiment, is intended to be self-administered by a patient. The present invention may also be used to collect and aggregate data relating to the prevalence of PsA in PSO patient populations.
Broadly, the invention features a method of identifying PsA in PSO patients by determining a symptom profile, wherein the symptom profile is determined by identifying the presence or severity certain symptoms in the patient and classifying the symptom profile as identifying PsA using an algorithm based on the symptom profile. The method includes obtaining clinical data from a patent including various physical and demographic factors.
In the preferred embodiment, a questionnaire in computer-readable medium is used to produce the symptom profile. The questionnaire, shown in FIG. 1, comprises a standardized set of questions and answers for the purposes of gathering information from patients regarding their current and/or recent PsA-related symptoms. The preferred embodiment also comprises a diagram in computer-readable medium upon which patients indicate where they experienced joint swelling or pain.
PSORIASIS
FIELD OF THE INVENTION
The present invention relates to the field of medical diagnostic screening.
BACKGROUND OF THE INVENTION
Psoriatic arthritis (PsA) is a serious chronic condition that affects 10-35%
of patients with skin psoriasis and is associated with increased patient morbidity and mortality (Reference 1). It is often described as a chronic inflammatory arthropathy affecting the distal interphalangeal joints of the hands (DIPs), feet and spine associated with psoriasis (PSO) (Reference 2). The Norfolk Arthritis Registry (NOAR) cohort study recently demonstrated that 5-year outcomes for psoriasis-associated inflammatory arthritis are very similar to those of inflammatory arthritis without PSO (Reference 3). Results of this study suggested 36.7 % of PsA patients had radiographic erosions at 5 years compared to 33.8%
of those without PSO, and 47% of PsA patients in early synovitis clinics, providing evidence this is neither a benign nor infrequent disease, as previously perceived (References 4-7). Most patients develop PsA years after the onset of their PSO (References 8-9).
Early diagnosis and intervention of PsA plays an important role in preventing the progression of inflammatory joint damage, reducing pain and improving quality of life (QoL) (Reference 10). Traditional therapies have provided inadequate control of the inflammation associated with PsA, but the introduction of the biologic agents (e.g. tumour necrosis factor antagonists) offer a new option.
There has been considerable variation in how rheumatologists have diagnosed PsA, and international groups such as GRAPPA are attempting to more precisely define PsA
patients for clinical trials (References 5, 11-18). The differential diagnosis of PsA can be challenging since many of its features overlap with those of rheumatoid arthritis, reactive inflammatory bowel disease and ankylosing spondylitis. Furthermore, osteoarthritis, soft tissue rheumatism, septic arthritis and true RA can coexist with PSO.
Preliminary efforts to develop screening tools for the identification of PsA
patients have met with limited success (Reference 19). The Psoriatic and Arthritis Questionnaire (PAQ), a 12-item questionnaire, was developed by Peloso and colleagues to identify psoriatic patients with arthritis (Reference 20). An evaluation using this questionnaire in 202 hospital- and community-based patients, in Sweden, demonstrated a score of 4 (scale 0-8) was the best cut off value for detecting arthritis. This cut off, however, yielded sensitivity of 60% and specificity of 62%, indicating the PAQ did not effectively discriminate for arthritis (Reference 20). The Psoriatic Arthritis Screening and Evaluation (PASE) is a 15 item questionnaire with symptom and function sub-scales. The questionnaire, evaluated in 69 patients, showed an optimal cut off point of 47, and was able to distinguish PsA from non-PsA patients with sensitivity and specificity of 82% and 73% respectively (Reference 6).
The Toronto Psoriatic Arthritis Screen (ToPAS), which supplements the questionnaire with photos to aid the patients, showed a sensitivity of 91.9%, and a specificity of 95.2% in a dermatology practice (Reference 21). In 2006 the Classification Criteria for PsA
(CASPAR) was introduced as a research tool for classifying PsA (Reference 22).
The CASPAR criteria are defined as follows: A patient must have presented with inflammatory articular disease and must satisfy three or more of the following: (1) evidence of current PSO, (2) a personal history of PSO, or (3) a family history of PSO, (4) typical psoriatic nail dystrophy, (5) a negative test result for the presence of rheumatoid factor, (6) current dactylitis or a history of dactylitis, and (7) radiographic evidence of juxta-articular new bone formation, appearing as ill-defined ossification near joint margins.22 The CASPAR criteria have demonstrated high sensitivity and specificity of 91.4% and 98.7%, respectively.
Although the CASPAR criteria provide a sensitive tool for confirmation of the diagnosis of PsA, it is still a research instrument and its use in the clinical settings has not been widely utilized. Furthermore, it requires proficiency in joint examination and it may be difficult to implement by other health care providers such as dermatologists and family physicians.
It is believed that screening PSO patients likely to develop PsA with an easy to administer tool with good sensitivity and specificity will facilitate early identification, prevention of disease progression and destruction of joints and efficient referral for optimal treatment. In order to achieve this objective, a simple, self-administered questionnaire -the PSO and Arthritis Screening Questionnaire (PASQ) - was developed which can be utilized for screening patients who meet the CASPAR criteria for PsA. It has been demonstrated that the PASQ is highly sensitive and specific in detecting patients with PsA
(whether in early-stages or established stages of the disorder) who fulfill the CASPAR criteria (Reference 23).
The PASQ, shown in FIG. 1, comprises a simple, self-administered questionnaire containing ten questions for which a positive and negative response are assigned a score of 1 and 0, respectively, with a maximum score of 10. Patients are also requested to indicate, on a diagram where they experienced joint swelling or pain (at present or in the past). The PASQ diagram for patient assessment of painful and swollen sites is shown in FIG. 2. The diagram is scored 0, 1, 3 or 5 depending on the distribution of markings, as show in FIG. 3. The points are weighted consistent with the different presentations and joints affected in PsA (Reference 12), and other forms of arthritis (e.g.
osteoarthritis and rheumatoid arthritis). The scores of the questionnaire and diagram are then tabulated by the physician or assistant.
The receiver operating curve (ROC) is a known statistical method which may be used determine the optimal cut off score that will best discriminate between those patients having or not having PsA. The optimal score will provide the best sensitivity, meaning the proportion of actual positives which are correctly identified as such (i.e.
the percentage of affected patients who are correctly identified as having PsA) and specificity, meaning the proportion of negatives which are correctly identified (i.e. the percentage of well people who are correctly identified as not having the condition).
Using the ROC, the PASQ has been shown to yield an optimal cut-off of 9, with 86.27%
sensitivity and 88.89% specificity, although a score of 8 increases the sensitivity to 92.78%
while maintaining a specificity of 77.16% specificity. An analysis of the PASQ
diagram score indicate an optimal total score of 1 (out of maximum 5 for the diagram) with 100%
sensitivity and 55.56% specificity.
The PASQ has the advantage of being a wholly patient administered tool with no physical examination needed to complete its score, which makes it an ideal screening tool to utilize by non-rheumatologists. The PASQ is of particular benefit to dermatologists and family physicians who may benefit from the use of this tool for rapid diagnosis of patients that require referral to a rheumatologist for their management in order to avoid potentially irreversible destruction of the involved joints, leading to more timely and optimal selection of systemic treatments, particularly for moderate-severe PSO. Optimal and timely treatment of this population with the most efficacious systemic therapies is important as it may yield improved clinical outcomes and enhanced quality of life for these patients. The positive outcomes may also be reflected in more efficient utilization of health care resources and ultimately in cost savings to the health care system.
A further advantage of the PASQ is that it can be completed and scored in an efficient manner, offers little difficulty to the patient and the scorer, requires minimal intervention by the physician and adds very little burden to the clinical routine.
Notwithstanding the foregoing, although the PASQ provides a sensitive, simple and easy to administer questionnaire that can be used to screen for PsA, it is a paper-based method requiring a physician or trained assistant to physically mark and score the questionnaire and, therefore, is subject to human error in calculating the scores of both the questionnaire and, in particular, the diagram. Accordingly, there exists a need for a version of the PASQ
which limits or eliminates the possibility of human errors in analysing the test data.
SUMMARY OF THE INVENTION
The following presents a simplified summary of the invention in order to provide a basic understanding of some aspects of the invention. This summary is not an extensive overview of the invention. It is not intended to identify key/critical elements of the invention or to delineate the scope of the invention. Its sole purpose is to present some concepts of the invention in a simplified form as a prelude to the more detailed description that is presented later.
It is an object of the present invention to provide a self-administered, electronic version of the PASQ which may be widely distributed and which will automatically score the questionnaire, thereby eliminating possible inaccuracies of the diagram scoring, as well as provide useful information when self-administered to an untrained user.
The present invention describes a computer-implemented method and system to provide an electronic Psoriatic Arthritis Screening Questionnaire (the "EPASQ") used as a tool for reliable diagnosis of PsA in patients with PSO. The subject matter described herein is implemented as a computer program product comprising computer executable instructions embodied in a computer readable medium. For greater clarity, any references herein to the "EPASQ" or to "electronic questionnaire and diagram" refers to the present invention, which includes a computer implemented method and system for the detection and diagnosis of PsA in patients with PSO.
The present invention provides a simple, self-administered and automatically scored electronic program with a high sensitivity and specificity and is an effective tool to screen for early and established PsA patients. It is hoped that the present invention will assist dermatologists and family physicians in the identification of PSO patients at risk of developing PsA, resulting in timely referrals to and treatment by a rheumatologist, and, additionally, will assist dermatologists in selecting appropriate systemic treatments for moderate-to-severe PSO. In addition, the present invention, in one embodiment, is intended to be self-administered by a patient. The present invention may also be used to collect and aggregate data relating to the prevalence of PsA in PSO patient populations.
Broadly, the invention features a method of identifying PsA in PSO patients by determining a symptom profile, wherein the symptom profile is determined by identifying the presence or severity certain symptoms in the patient and classifying the symptom profile as identifying PsA using an algorithm based on the symptom profile. The method includes obtaining clinical data from a patent including various physical and demographic factors.
In the preferred embodiment, a questionnaire in computer-readable medium is used to produce the symptom profile. The questionnaire, shown in FIG. 1, comprises a standardized set of questions and answers for the purposes of gathering information from patients regarding their current and/or recent PsA-related symptoms. The preferred embodiment also comprises a diagram in computer-readable medium upon which patients indicate where they experienced joint swelling or pain.
In the preferred embodiment, the patient completes the electronic questionnaire and indicates, on the electronic diagram, the locations at which they experience or experienced joint swelling or pain. The symptom profile is produced by compiling and analyzing all of the answers to the questions set forth in the questionnaire and is used in combination with the diagram profile in the algorithmic-based methods described herein to improve the accuracy of identifying or predicting PsA.
In the preferred embodiment, the answers to the questions in the questionnaire and the number of areas marked on the diagram are automatically assigned a score. The scores of the questionnaire and diagram are automatically tabulated to generate a cumulative score useful for predicting or identifying PsA in patients with PSO.
The methods of the invention allow the accurate diagnosis of PsA in patients with skin PSO who are likely to develop PsA, at or before disease onset, thus reducing or minimizing the debilitating and often morbid effects of PsA. The method can be applied in persons with PSO who are free from clinical symptoms of PsA, in those who already have clinical PsA, those who have a family history of PsA or in those who have an elevated level or levels of risk factors of PsA.
The major application of the current invention involves the identification PsA
or the risk of developing PsA in those patients who have been diagnosed with PSO.
A key aspect of the present invention is that it may be self-administered by a patient without requiring the patient to attend at a health clinic or doctor's office.
After taking the test, the patient receives an indication as to whether PsA or a risk of PsA
was identified and whether further treatment by a physician or specialist is required.
In another application, the present invention may be used as a part of a comprehensive evaluation and diagnosis of PsA by a rheumatologist by serving as an indicator of patients at risk that should receive further follow-up by a specialist and as a means to assist that specialist in choosing appropriate treatment choices. Better means of identifying those individuals having or an risk of developing PsA should lead to better preventative and treatment regimens. For example, dermatologists tend to treat mild and moderate PSO
without arthritis with creams and/or UV therapy. If these patients have a diagnosis of PsA, then the treatment in these patients may change and include medications that work on both the skin and the joints such as methotrexate and biologics such as etanercept (Enbrel(D) or infliximab (Remicade ). These more effective therapies can induce significant clinical improvement in both the arthritis and the skin components of the diseases).
In a further application, the present invention can assist general medical practitioners in differentiating between psoriasis and other skin conditions. For example, in some cases, patients with psoriasis may have been incorrectly diagnosed and are actually suffering from another similar skin condition, such as atopic dermatitis, seborrhic ketatosis and other skin conditions which could look similar to psoriasis in a general medicine practice.
A further object of the present invention is to aggregate and store patient data, in order to give some broader indications of how PsA is prevalent through the population.
A further object of the present invention is the identification of PsA
patients for clinical trials where investigators are looking for patients with the PsA to be recruited for a research project.
A further object of the present invention is to identify newly diagnosed patients from general practice, dermatology clinics or even on a website if ethical approval for this is obtained.
A yet further object of the present invention is to identify the prevalence of PsA in a certain population (e.g. genetic studies in a community) for use in epidemiological studies.
Other features and advantages of the invention will be apparent from the description and the drawings, and from the claims.
DESCRIPTION OF DRAWINGS
Figure 1 shows the standardized set of questions and their respective scoring of the prior art PASQ.
Figure 2 shows the representative diagram of the prior art PASQ.
Figure 3 shows the scoring scheme for the diagram of the prior art PASQ.
Figure 4 is a screenshot of the user interface in accordance with an embodiment of the present invention.
Figure 5 is a screenshot of the user interface in accordance with an embodiment of the present invention.
Figure 6 shows a schematic computer system in accordance with an embodiment of the present invention.
Figure 7 shows a block diagram of a computer system in accordance with an embodiment of the invention.
DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS
Introduction Diagnosing a patient with psoriasis as having psoriatic arthritis (PsA) can be challenging due to the similarity in symptoms between PsA and other diseases such as rheumatoid arthritis, reactive inflammatory bowel disease and anykylosing spondylitis and due to the fact that psoriasis (PSO) can exist with other conditions such as osteoarthritis, soft tissue rheumatism, septic arthritis and true rheumatoid arthritis. As a result, the rapid and accurate diagnosis of PsA is difficult and hampers early and effective treatment of the disease.
The present invention is based, in part, upon the accuracy of identifying the presence or severity of PsA-related symptoms based upon the individual's response to a series of questions.
Definitions As used herein, the following terms have the meanings ascribed to them unless specified otherwise.
As used herein, the term psoriatic arthritis or PsA includes an inflammatory condition associated with psoriasis characterized by, but not limited to, inflammatory arthropathy affecting the distal interphalangeal joints of the hands, feet and spine.
As used herein, the term "profile" includes any set of data that represents the distinctive features or characteristics associated with a disease or disorder such as psoriasis or PsA.
The term encompasses a "symptom profile" that identifies one or more PsA-related clinical factors (i.e. symptoms) an individual is experiencing or has experienced, and combinations thereof.
The term "individual", "subject" or "patient" refers to humans presenting with PSO-related or PsA-related symptoms.
As used in this application, the terms "step", "module", "component", "model", "system", and the like are intended to refer to a computer-related entity, either hardware, a combination of hardware and software, software, or software in execution. For example, a module may be, but is not limited to being, a process running on a processor, a processor, an object, an executable, a thread of execution, a program, and/or a computer.
By way of illustration, both an application running on a server and the server can be a module. One or more modules may reside within a process and/or thread of execution and a module may be localized on one computer and/or distributed between two or more computers.
Also, these modules can execute from various computer readable media having various data structures stored thereon. The modules may communicate via local and/or remote processes such as in accordance with a signal having one or more data packets (e.g., data from one module interacting with another module in a local system, distributed system, and/or across a network such as the Internet with other systems via the signal).
Description of the Embodiments The present invention provides a computer-implemented system and method for accurately identifying whether an individual has or is likely to develop PsA.
The present invention is also useful for ruling out one or more diseases or disorders that present with PSO-like or PsA-like symptoms and ruling in PSO or PsA using empirical data.
Accordingly, the present invention provides an accurate diagnostic prediction of PsA and prognostic information useful for guiding treatment decisions.
In one embodiment, the present invention is directed to a computer-implemented method of automatically diagnosing a medical condition. The method has the steps of gathering basic symptom information of the patient to determine a symptom profile for the patient, assigning point values to the basic symptom information, and evaluating the basic symptom information point values to determine a possible diagnosis.
The first step of the method is the display of a computer-readable questionnaire and diagram depicting parts of the body to a user. The user is then prompted to input answers to the questions posed as well as to mark, on the diagram, the location at which they experience or experience joint pain. User input is achieved electronically by use of, for example, a keyboard or a mouse. Once user input has been completed, the answers to the questions and markings on the diagrams are assigned score, the method of which is described in further detail herein and the respective scores of the questionnaire and the diagram are automatically tabulated to generate a cumulative score. Once the cumulative score reaches a predetermined threshold, the diagnosis will be considered probable. In the final step of the method of the present invention, the diagnosis is presented to the user.
In the preferred embodiment, the present invention is directed to a computer-implemented method of automatically diagnosing PsA in psoriatic individuals. However, is it recognized that the method described herein may apply to the diagnosis of various other medical conditions presenting with similar symptoms to PsA, such as rheumatoid arthritis.
In a preferred embodiment, the method of ruling in PsA comprises a computer-implemented system and method for determining a symptom profile using a computer-readable questionnaire. The questionnaire comprises a standardized set of questions for the purpose of gathering information from respondents regarding their current and/or recent PsA-related symptoms. The questionnaire includes questions which query the user about a presence or severity of the user's PsA-related symptoms and other related risk factors. Examples of the questions asked are provided in FIG. 1. In addition to the questionnaire, the present invention also comprises in addition to a diagram comprising a set of circles depicting parts of the body upon which the patient marks the location at which they experience or experience joint pain. An example of the diagram is shown in FIG. 2.
In the preferred embodiment, the answers to the questions in the questionnaire and the number of areas marked on the diagram are automatically assigned a score using the algorithmic-based methods described herein.
In the preferred embodiment, the computer-readable questionnaire is programmed to comprise ten questions for which a positive and negative response is assigned a score of 1 and 0, respectively, with a maximum score of 15. The patient enters a "yes"
or "no"
answer by clicking the appropriate response. Examples of the user interface are shown in FIG. 4 and FIG. 5.
In the preferred embodiment, the computer-readable diagram comprises a set of circles depicting 68 joints plus the spine. Patients are requested to indicate, by clicking on the appropriate circle, where they experience or experienced joint swelling or pain (FIG. 5).
Unlike the in the paper-based PASQ, the electronic diagram has 68 green coloured circles for joints in the hands, feet and one large circle for the spine. The individual is able to drag and click on a joint but not on any other part of the diagram. This is unlike the prior art paper-based PASQ diagram where patients typically mark the joints or any part of the diagram, which is a limitation of the prior art. Although green is a preferred colour for the circles in the diagram, it is readily understood that any colour, or no colour at all, may be used.
In the preferred embodiment, the computer-readable diagram is scored 0, 1, 3 or 5 depending on the distribution of the markings (FIG. 2). The rules governing scoring of the diagram are as follows:
= Five points are awarded in three scenarios: 1) Only the spine button and one other major joint button (shoulders, hips, knees) have been selected; 2) The total number of joints selected is greater than zero but less than six, except for case 1 for three points;
or 3) The total number of DIP joints (joints on fingers furthest from the wrist) exceeds five, and they are the only joints selected = Three points are awarded in two scenarios: 1) Only one major joint is selected (the spine, shoulders, hips, knees). In this case, even though the number of joints is less than five (and thus according to five points case 2 it should give five points) it will only give three points; and 2) The joints are asymmetrical. In this case, variables have been assigned to the right and left joints; if one side has more affected joints than the other by a 2 or more, then three points are awarded. In addition, each joint has been matched with its "mirror" (save for the spine); if one is selected and it's mirror not, then a variable called "notscore" will increase by one. If the notscore is greater than 2 then three points will also be awarded. Finally, the number of joints in the hands and feet cannot be equal for three points to be awarded.
= One point is awarded in only one scenario: 1) The joints are symmetrical (unless they number less than six, at which point see five points, case one). The diagram determines symmetry through the use of the left side/right side totals mentioned in three points, case 2. In this case, as long as the number of joints on either side are within +/- 1 of each other, then the diagram considers the affected individual to have symmetrical joint problems and awards one point.
= Zero points will be awarded if the patient does not select any joints at all.
In the preferred embodiment, the scores of the questionnaire and diagram are automatically tabulated to generate a cumulative score useful for predicting or identifying PsA in patients with PSO.
The automatic tabulation of the computer-readable questionnaire and diagram scores in the present invention presents a distinct advantage over the prior art paper-based PASQ.
More specifically, the present invention eliminates the need for manual tabulation and scoring and therefore eliminates possible inaccuracies in scoring as a result of human error.
In the preferred embodiment, the computer-readable questionnaire and diagram comprises instructions in computer-readable form on each electronic page explaining to the patient the method for completing the electronic questionnaire and diagram as shown in Figs. 1, 2 and 3.
In a preferred embodiment, the computer-readable questionnaire and diagram is self-administered by the patient and, accordingly, may be completed without requiring the patient to attend at a health clinic or doctor's office to obtain a diagnosis.
An evaluation of the present invention and validation against the prior art paper-based PASQ has demonstrated that the present invention can identify PsA or the risk of PsA with high sensitivity and specificity in PSO patients (Experiments - Example 1).
In the preferred embodiment, the ROC (as described above) is used to determine the optimal cut-off score (optimal sensitivity and specificity) of the computer-readable questionnaire and diagram. In the preferred embodiment a cut off score of 7 yields 97.62% sensitivity and 75.00% specificity. A cut-off point of 8 yielded a sensitivity of 88.10% while still maintaining a specificity of 75.00%. It will be recognized to those skilled in the art that different cut-off scores may be chosen depending on the desired outcomes.
For example, if the desired outcome is to identify the most cases of PsA
(greater sensitivity), a lower cut off score may be chosen, although a greater number of false positives (i.e. persons incorrectly identified as having PsA) will result (lower specificity).
In another embodiment, the present invention is directed to a computer-implemented system for diagnosing a medical condition. The system comprises: (1) a display module for displaying to a user a computer-readable questionnaire and diagram as well a diagnosis or other message based on an evaluation of user input; (2) a receiver module for receiving input from the user in response to the questionnaire and diagram;
(3) a scoring module for calculating a score based on the user input; and (4) a diagnosis module for making a diagnosis based on the score.
In a preferred embodiment, the present invention is directed to a computer-implemented system for diagnosing PsA. However, is it recognized that the system described herein may apply to the diagnosis of various other medical conditions such as rheumatoid arthritis.
FIG. 6 shows a general computer system on which the invention might be practiced. The general computer system comprises of a display device (1.1) with a display screen (1.2).
Examples of display device are Cathode Ray Tube (CRT) devices, Liquid Crystal Display (LCD) Devices etc. The general computer system can also have other additional output devices like a printer. The cabinet (1.3) houses the additional basic components of the general computer system such as the microprocessor, memory and disk drives. In a general computer system the microprocessor is any commercially available processor of which x86 processors from Intel and 680X0 series from Motorola are examples.
Many other microprocessors are available. The general computer system could be a single processor system or may use two or more processors on a single system or over a network. The microprocessor for its functioning uses a volatile memory that is a random access memory such as dynamic random access memory (DRAM) or static memory (SRAM). The disk drives are the permanent storage medium used by the general computer system. This permanent storage could be a magnetic disk, a flash memory and a tape. This storage could be removable like a floppy disk or permanent such as a hard disk.
Besides this, the cabinet (1.3) can also house other additional components like a Compact Disc Read Only Memory (CD-ROM) drive, sound card, video card etc. The general computer system also had various input devices like a keyboard (1.4) and a mouse (1.5).
The keyboard and the mouse are connected to the general computer system through wired or wireless links. The mouse (1.5) could be a two-button mouse, three-button mouse or a scroll mouse. Besides the said input devices there could be other input devices like a light pen, a track ball, etc. The microprocessor executes a program called the operating system for the basic functioning of the general computer system. The examples of operating systems are UNIXTM, WINDOWSTM and OS XTM. These operating systems allocate the computer system resources to various programs and help the users to interact with the system. It should be understood that the invention is not limited to any particular hardware comprising the computer system or the software running on it.
FIG. 7 shows the internal structure of the general computer system of FIG. 6.
The general computer system (2.1) consists of various subsystems interconnected with the help of a system bus (2.2). The microprocessor (2.3) communicates and controls the functioning of other subsystems. Memory (2.4) helps the microprocessor in its functioning by storing instructions and data during its execution. Fixed Drive (2.5) is used to hold the data and instructions permanent in nature like the operating system and other programs.
Display adapter (2.6) is used as an interface between the system bus and the display device (2.7), which is generally a monitor. The network interface (2.8) is used to connect the computer with other computers on a network through wired or wireless means. The system is connected to various input devices like keyboard (2.10) and mouse (2.11) and output devices like printer (2.12). Various configurations of these subsystems are possible. It should also be noted that a system implementing the present invention might use less or more number of the subsystems than described above. The computer screen which displays the diagnosis results can also be a separate computer system than that which contains components such as database 360 and the other modules described above.
In a preferred embodiment, the scoring module of the system calculates separate score for the questionnaire and the diagram, as well as a composite score for the questionnaire and the diagram, based on user input according to the scoring rules described above.
In a preferred embodiment, the diagnosis module of the system assigns a probable diagnosis based on the calculated score in relation to a predetermined threshold score which must be reached in order for an affirmative diagnosis to apply.
In a further embodiment, the present invention is directed towards a computer-readable medium having computer-executable instructions operable to cause a computer to: (1) receive patient profile data that identifies patient and disease characteristics; (2) automatically evaluate the patient profile data in light of one ore more diagnosis rules and (3) automatically assign a medical diagnosis to the patient based on the evaluation.
In one aspect of this embodiment, the patient profile data comprises data defining the individual patient's symptoms and genetic characteristics. The patient profile data is evaluated in light of one or more diagnosis rules which define a relationship among or between data that comprises the patient profile data. More specifically, the diagnosis rules comprise a scoring rule which defines a threshold score in order for an affirmative diagnosis to apply.
In a preferred embodiment, the computer-readable medium contains instructions operable to cause a computer to automatically assign a diagnosis of PsA to a patient based on the evaluation. In this regard, assigning a diagnosis of PsA to the patient comprises the steps of: (1) receiving input from the patient defining the presence or severity of PsA-related symptoms; (2) selecting a threshold score beyond which a diagnosis of PsA will apply; (3) automatically assigning a calculating a score based on answers input by the patient in response to the questions; and (4) assigning a diagnosis to the patient based on the patient's score relative to the threshold score.
In a preferred embodiment, the computer-readable medium will additionally comprise instructions for automatically asking questions of the patient, as well as for displaying to the patient instructions on how to complete the questionnaire and diagram.
In a preferred embodiment, the threshold score will be chosen using the receiver operating curve, as described in detail above, to determine the score which will give optimal specificity and sensitivity.
In a preferred embodiment, the computer readable medium will contain instructions for determining whether the patient requires follow-up care with a physician or specialist.
In another embodiment, the computer-readable medium comprises a database to store and aggregate patient data for determining the prevalence of PsA in the population of patient affected with psoriasis.
In a further embodiment of the present invention, the user is assigned a unique identifier.
The user's input and score is stored in a storage device. Unique identifiers, inputs and scores from a plurality of users may be aggregated to carry out epidemiological studies.
Such stored information may also be transmitted over communications networks.
EXPERIMENTS
Example 1: Valuation and Validation of the Electronic PASQ Against PASQ
The electronic PASQ Data was collected from a prospective cohort of 42 patients with early PsA (meeting the CASPAR criteria), and from 12 PSO patients without PsA.
The electronic version of the PASQ (EPASQ) was developed using Adobe Creative Suite 4 software, and was based on the previous paper version of the PASQ. The EPASQ
was programmed to provide a maximum of 15 points. The PASQ contained 10 differently weighted questions as well as a diagram where patients marked where they had or have had pain and or swelling. The same questions were included in the EPASQ in addition to a diagram with 68 joints plus the spine. Validation was conducted using the stored questionnaires from 42 patients with confirmed PsA (mean disease duration 12 months).
Questionnaires from 12 psoriasis patients without PsA were used as a control.
Comparison of scores obtained from the manual and the electronic versions were conducted. A receiver operating curve (ROC) was determined for both the paper version as well as the electronic version using MedCalc software to pick the optimal cut off point (optimal sensitivity and specificity) for each component of the PASQ and EPASQ
(questionnaire and diagram). Descriptive statistics for both were obtained using SPSS.
The EPASQ Data was collected from a prospective cohort of 42 patients with early PsA
(meeting the CASPAR criteria), and from 12 psoriasis patients without PsA. All but one of the PsA patients scored 8 or more in the paper PASQ. Concordance of the paper and electronic scores was very high with only one patient who scored 7 f in the paper PASQ
and 11 in the present invention. The ROC Curve of the entire group yielded an optimal 97.62% sensitivity and 75.00% specificity for a cut-off score of 7. A cut-off point of 8 yielded a sensitivity of 88.10% while still maintaining a specificity of 75.00%.
What has been described above includes examples of the present invention. It is, of course, not possible to describe every conceivable combination of components or methodologies for purposes of describing the present invention, but one of ordinary skill in the art may recognize that may further combinations and permutations of the present invention are possible. Accordingly, the present invention is intended to embrace all such alterations, modifications and variations that fall within the spirit and scope of the appended claims. Furthermore, to the extent that the term "includes" is used in either the detailed description or the claims, such term is intended to be inclusive in a manner similar to the term "comprising" as "comprising" is interpreted when employed as a transitional word in a claim.
REFERENCES
1. Peters JP, van der Horst-Bruinsma IE, Dijkmans BA, Nurmohamed MT.
Cardiovascular risk profile of patients with spondyloarthropathies, particularly ankylosing spondylitis and psoriatic arthritis. Seminars in Arthritis and Rheumatism, 2004;34: 585-592.
2. Stern RS. The epidemiology of joint complaints in patients with PSO. J
Rheumatol 1985;12:315-2.
3. Morgan C, Lunt M, Bunn D, Scott DG, Symmons DP. Five-year outcome of a primary-care-based inception cohort of patients with inflammatory polyarthritis plus PSO. Rheumatology 2007;46:1819-23.
4. Gladman DD, Mease PJ, Healy P, Helliwell PS, Fitzgerald 0, Cauli A, Lubrano E.et al . Outcome measures in psoriatic arthritis. J Rheumatol 2007;34:1159-66.
5. Helliwell PS, Taylor WJ. Classification and diagnostic criteria for psoriatic arthritis.
Ann Rheum Dis 2005;64 Suppl 2:ii3-8.
6. Taylor WJ, Helliwell PS. Psoriatic arthritis is a joint-damaging disease -a call for action! Rheumatology 2007;46:1747-1748.
7. Gladman DD, Antoni C, Mease P et al. Psoriatic arthritis: epidemiology, clinical features, course,and outcome Ann Rheum Dis 2005;64(Suppl ll):ii14-ii17.
In the preferred embodiment, the answers to the questions in the questionnaire and the number of areas marked on the diagram are automatically assigned a score. The scores of the questionnaire and diagram are automatically tabulated to generate a cumulative score useful for predicting or identifying PsA in patients with PSO.
The methods of the invention allow the accurate diagnosis of PsA in patients with skin PSO who are likely to develop PsA, at or before disease onset, thus reducing or minimizing the debilitating and often morbid effects of PsA. The method can be applied in persons with PSO who are free from clinical symptoms of PsA, in those who already have clinical PsA, those who have a family history of PsA or in those who have an elevated level or levels of risk factors of PsA.
The major application of the current invention involves the identification PsA
or the risk of developing PsA in those patients who have been diagnosed with PSO.
A key aspect of the present invention is that it may be self-administered by a patient without requiring the patient to attend at a health clinic or doctor's office.
After taking the test, the patient receives an indication as to whether PsA or a risk of PsA
was identified and whether further treatment by a physician or specialist is required.
In another application, the present invention may be used as a part of a comprehensive evaluation and diagnosis of PsA by a rheumatologist by serving as an indicator of patients at risk that should receive further follow-up by a specialist and as a means to assist that specialist in choosing appropriate treatment choices. Better means of identifying those individuals having or an risk of developing PsA should lead to better preventative and treatment regimens. For example, dermatologists tend to treat mild and moderate PSO
without arthritis with creams and/or UV therapy. If these patients have a diagnosis of PsA, then the treatment in these patients may change and include medications that work on both the skin and the joints such as methotrexate and biologics such as etanercept (Enbrel(D) or infliximab (Remicade ). These more effective therapies can induce significant clinical improvement in both the arthritis and the skin components of the diseases).
In a further application, the present invention can assist general medical practitioners in differentiating between psoriasis and other skin conditions. For example, in some cases, patients with psoriasis may have been incorrectly diagnosed and are actually suffering from another similar skin condition, such as atopic dermatitis, seborrhic ketatosis and other skin conditions which could look similar to psoriasis in a general medicine practice.
A further object of the present invention is to aggregate and store patient data, in order to give some broader indications of how PsA is prevalent through the population.
A further object of the present invention is the identification of PsA
patients for clinical trials where investigators are looking for patients with the PsA to be recruited for a research project.
A further object of the present invention is to identify newly diagnosed patients from general practice, dermatology clinics or even on a website if ethical approval for this is obtained.
A yet further object of the present invention is to identify the prevalence of PsA in a certain population (e.g. genetic studies in a community) for use in epidemiological studies.
Other features and advantages of the invention will be apparent from the description and the drawings, and from the claims.
DESCRIPTION OF DRAWINGS
Figure 1 shows the standardized set of questions and their respective scoring of the prior art PASQ.
Figure 2 shows the representative diagram of the prior art PASQ.
Figure 3 shows the scoring scheme for the diagram of the prior art PASQ.
Figure 4 is a screenshot of the user interface in accordance with an embodiment of the present invention.
Figure 5 is a screenshot of the user interface in accordance with an embodiment of the present invention.
Figure 6 shows a schematic computer system in accordance with an embodiment of the present invention.
Figure 7 shows a block diagram of a computer system in accordance with an embodiment of the invention.
DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS
Introduction Diagnosing a patient with psoriasis as having psoriatic arthritis (PsA) can be challenging due to the similarity in symptoms between PsA and other diseases such as rheumatoid arthritis, reactive inflammatory bowel disease and anykylosing spondylitis and due to the fact that psoriasis (PSO) can exist with other conditions such as osteoarthritis, soft tissue rheumatism, septic arthritis and true rheumatoid arthritis. As a result, the rapid and accurate diagnosis of PsA is difficult and hampers early and effective treatment of the disease.
The present invention is based, in part, upon the accuracy of identifying the presence or severity of PsA-related symptoms based upon the individual's response to a series of questions.
Definitions As used herein, the following terms have the meanings ascribed to them unless specified otherwise.
As used herein, the term psoriatic arthritis or PsA includes an inflammatory condition associated with psoriasis characterized by, but not limited to, inflammatory arthropathy affecting the distal interphalangeal joints of the hands, feet and spine.
As used herein, the term "profile" includes any set of data that represents the distinctive features or characteristics associated with a disease or disorder such as psoriasis or PsA.
The term encompasses a "symptom profile" that identifies one or more PsA-related clinical factors (i.e. symptoms) an individual is experiencing or has experienced, and combinations thereof.
The term "individual", "subject" or "patient" refers to humans presenting with PSO-related or PsA-related symptoms.
As used in this application, the terms "step", "module", "component", "model", "system", and the like are intended to refer to a computer-related entity, either hardware, a combination of hardware and software, software, or software in execution. For example, a module may be, but is not limited to being, a process running on a processor, a processor, an object, an executable, a thread of execution, a program, and/or a computer.
By way of illustration, both an application running on a server and the server can be a module. One or more modules may reside within a process and/or thread of execution and a module may be localized on one computer and/or distributed between two or more computers.
Also, these modules can execute from various computer readable media having various data structures stored thereon. The modules may communicate via local and/or remote processes such as in accordance with a signal having one or more data packets (e.g., data from one module interacting with another module in a local system, distributed system, and/or across a network such as the Internet with other systems via the signal).
Description of the Embodiments The present invention provides a computer-implemented system and method for accurately identifying whether an individual has or is likely to develop PsA.
The present invention is also useful for ruling out one or more diseases or disorders that present with PSO-like or PsA-like symptoms and ruling in PSO or PsA using empirical data.
Accordingly, the present invention provides an accurate diagnostic prediction of PsA and prognostic information useful for guiding treatment decisions.
In one embodiment, the present invention is directed to a computer-implemented method of automatically diagnosing a medical condition. The method has the steps of gathering basic symptom information of the patient to determine a symptom profile for the patient, assigning point values to the basic symptom information, and evaluating the basic symptom information point values to determine a possible diagnosis.
The first step of the method is the display of a computer-readable questionnaire and diagram depicting parts of the body to a user. The user is then prompted to input answers to the questions posed as well as to mark, on the diagram, the location at which they experience or experience joint pain. User input is achieved electronically by use of, for example, a keyboard or a mouse. Once user input has been completed, the answers to the questions and markings on the diagrams are assigned score, the method of which is described in further detail herein and the respective scores of the questionnaire and the diagram are automatically tabulated to generate a cumulative score. Once the cumulative score reaches a predetermined threshold, the diagnosis will be considered probable. In the final step of the method of the present invention, the diagnosis is presented to the user.
In the preferred embodiment, the present invention is directed to a computer-implemented method of automatically diagnosing PsA in psoriatic individuals. However, is it recognized that the method described herein may apply to the diagnosis of various other medical conditions presenting with similar symptoms to PsA, such as rheumatoid arthritis.
In a preferred embodiment, the method of ruling in PsA comprises a computer-implemented system and method for determining a symptom profile using a computer-readable questionnaire. The questionnaire comprises a standardized set of questions for the purpose of gathering information from respondents regarding their current and/or recent PsA-related symptoms. The questionnaire includes questions which query the user about a presence or severity of the user's PsA-related symptoms and other related risk factors. Examples of the questions asked are provided in FIG. 1. In addition to the questionnaire, the present invention also comprises in addition to a diagram comprising a set of circles depicting parts of the body upon which the patient marks the location at which they experience or experience joint pain. An example of the diagram is shown in FIG. 2.
In the preferred embodiment, the answers to the questions in the questionnaire and the number of areas marked on the diagram are automatically assigned a score using the algorithmic-based methods described herein.
In the preferred embodiment, the computer-readable questionnaire is programmed to comprise ten questions for which a positive and negative response is assigned a score of 1 and 0, respectively, with a maximum score of 15. The patient enters a "yes"
or "no"
answer by clicking the appropriate response. Examples of the user interface are shown in FIG. 4 and FIG. 5.
In the preferred embodiment, the computer-readable diagram comprises a set of circles depicting 68 joints plus the spine. Patients are requested to indicate, by clicking on the appropriate circle, where they experience or experienced joint swelling or pain (FIG. 5).
Unlike the in the paper-based PASQ, the electronic diagram has 68 green coloured circles for joints in the hands, feet and one large circle for the spine. The individual is able to drag and click on a joint but not on any other part of the diagram. This is unlike the prior art paper-based PASQ diagram where patients typically mark the joints or any part of the diagram, which is a limitation of the prior art. Although green is a preferred colour for the circles in the diagram, it is readily understood that any colour, or no colour at all, may be used.
In the preferred embodiment, the computer-readable diagram is scored 0, 1, 3 or 5 depending on the distribution of the markings (FIG. 2). The rules governing scoring of the diagram are as follows:
= Five points are awarded in three scenarios: 1) Only the spine button and one other major joint button (shoulders, hips, knees) have been selected; 2) The total number of joints selected is greater than zero but less than six, except for case 1 for three points;
or 3) The total number of DIP joints (joints on fingers furthest from the wrist) exceeds five, and they are the only joints selected = Three points are awarded in two scenarios: 1) Only one major joint is selected (the spine, shoulders, hips, knees). In this case, even though the number of joints is less than five (and thus according to five points case 2 it should give five points) it will only give three points; and 2) The joints are asymmetrical. In this case, variables have been assigned to the right and left joints; if one side has more affected joints than the other by a 2 or more, then three points are awarded. In addition, each joint has been matched with its "mirror" (save for the spine); if one is selected and it's mirror not, then a variable called "notscore" will increase by one. If the notscore is greater than 2 then three points will also be awarded. Finally, the number of joints in the hands and feet cannot be equal for three points to be awarded.
= One point is awarded in only one scenario: 1) The joints are symmetrical (unless they number less than six, at which point see five points, case one). The diagram determines symmetry through the use of the left side/right side totals mentioned in three points, case 2. In this case, as long as the number of joints on either side are within +/- 1 of each other, then the diagram considers the affected individual to have symmetrical joint problems and awards one point.
= Zero points will be awarded if the patient does not select any joints at all.
In the preferred embodiment, the scores of the questionnaire and diagram are automatically tabulated to generate a cumulative score useful for predicting or identifying PsA in patients with PSO.
The automatic tabulation of the computer-readable questionnaire and diagram scores in the present invention presents a distinct advantage over the prior art paper-based PASQ.
More specifically, the present invention eliminates the need for manual tabulation and scoring and therefore eliminates possible inaccuracies in scoring as a result of human error.
In the preferred embodiment, the computer-readable questionnaire and diagram comprises instructions in computer-readable form on each electronic page explaining to the patient the method for completing the electronic questionnaire and diagram as shown in Figs. 1, 2 and 3.
In a preferred embodiment, the computer-readable questionnaire and diagram is self-administered by the patient and, accordingly, may be completed without requiring the patient to attend at a health clinic or doctor's office to obtain a diagnosis.
An evaluation of the present invention and validation against the prior art paper-based PASQ has demonstrated that the present invention can identify PsA or the risk of PsA with high sensitivity and specificity in PSO patients (Experiments - Example 1).
In the preferred embodiment, the ROC (as described above) is used to determine the optimal cut-off score (optimal sensitivity and specificity) of the computer-readable questionnaire and diagram. In the preferred embodiment a cut off score of 7 yields 97.62% sensitivity and 75.00% specificity. A cut-off point of 8 yielded a sensitivity of 88.10% while still maintaining a specificity of 75.00%. It will be recognized to those skilled in the art that different cut-off scores may be chosen depending on the desired outcomes.
For example, if the desired outcome is to identify the most cases of PsA
(greater sensitivity), a lower cut off score may be chosen, although a greater number of false positives (i.e. persons incorrectly identified as having PsA) will result (lower specificity).
In another embodiment, the present invention is directed to a computer-implemented system for diagnosing a medical condition. The system comprises: (1) a display module for displaying to a user a computer-readable questionnaire and diagram as well a diagnosis or other message based on an evaluation of user input; (2) a receiver module for receiving input from the user in response to the questionnaire and diagram;
(3) a scoring module for calculating a score based on the user input; and (4) a diagnosis module for making a diagnosis based on the score.
In a preferred embodiment, the present invention is directed to a computer-implemented system for diagnosing PsA. However, is it recognized that the system described herein may apply to the diagnosis of various other medical conditions such as rheumatoid arthritis.
FIG. 6 shows a general computer system on which the invention might be practiced. The general computer system comprises of a display device (1.1) with a display screen (1.2).
Examples of display device are Cathode Ray Tube (CRT) devices, Liquid Crystal Display (LCD) Devices etc. The general computer system can also have other additional output devices like a printer. The cabinet (1.3) houses the additional basic components of the general computer system such as the microprocessor, memory and disk drives. In a general computer system the microprocessor is any commercially available processor of which x86 processors from Intel and 680X0 series from Motorola are examples.
Many other microprocessors are available. The general computer system could be a single processor system or may use two or more processors on a single system or over a network. The microprocessor for its functioning uses a volatile memory that is a random access memory such as dynamic random access memory (DRAM) or static memory (SRAM). The disk drives are the permanent storage medium used by the general computer system. This permanent storage could be a magnetic disk, a flash memory and a tape. This storage could be removable like a floppy disk or permanent such as a hard disk.
Besides this, the cabinet (1.3) can also house other additional components like a Compact Disc Read Only Memory (CD-ROM) drive, sound card, video card etc. The general computer system also had various input devices like a keyboard (1.4) and a mouse (1.5).
The keyboard and the mouse are connected to the general computer system through wired or wireless links. The mouse (1.5) could be a two-button mouse, three-button mouse or a scroll mouse. Besides the said input devices there could be other input devices like a light pen, a track ball, etc. The microprocessor executes a program called the operating system for the basic functioning of the general computer system. The examples of operating systems are UNIXTM, WINDOWSTM and OS XTM. These operating systems allocate the computer system resources to various programs and help the users to interact with the system. It should be understood that the invention is not limited to any particular hardware comprising the computer system or the software running on it.
FIG. 7 shows the internal structure of the general computer system of FIG. 6.
The general computer system (2.1) consists of various subsystems interconnected with the help of a system bus (2.2). The microprocessor (2.3) communicates and controls the functioning of other subsystems. Memory (2.4) helps the microprocessor in its functioning by storing instructions and data during its execution. Fixed Drive (2.5) is used to hold the data and instructions permanent in nature like the operating system and other programs.
Display adapter (2.6) is used as an interface between the system bus and the display device (2.7), which is generally a monitor. The network interface (2.8) is used to connect the computer with other computers on a network through wired or wireless means. The system is connected to various input devices like keyboard (2.10) and mouse (2.11) and output devices like printer (2.12). Various configurations of these subsystems are possible. It should also be noted that a system implementing the present invention might use less or more number of the subsystems than described above. The computer screen which displays the diagnosis results can also be a separate computer system than that which contains components such as database 360 and the other modules described above.
In a preferred embodiment, the scoring module of the system calculates separate score for the questionnaire and the diagram, as well as a composite score for the questionnaire and the diagram, based on user input according to the scoring rules described above.
In a preferred embodiment, the diagnosis module of the system assigns a probable diagnosis based on the calculated score in relation to a predetermined threshold score which must be reached in order for an affirmative diagnosis to apply.
In a further embodiment, the present invention is directed towards a computer-readable medium having computer-executable instructions operable to cause a computer to: (1) receive patient profile data that identifies patient and disease characteristics; (2) automatically evaluate the patient profile data in light of one ore more diagnosis rules and (3) automatically assign a medical diagnosis to the patient based on the evaluation.
In one aspect of this embodiment, the patient profile data comprises data defining the individual patient's symptoms and genetic characteristics. The patient profile data is evaluated in light of one or more diagnosis rules which define a relationship among or between data that comprises the patient profile data. More specifically, the diagnosis rules comprise a scoring rule which defines a threshold score in order for an affirmative diagnosis to apply.
In a preferred embodiment, the computer-readable medium contains instructions operable to cause a computer to automatically assign a diagnosis of PsA to a patient based on the evaluation. In this regard, assigning a diagnosis of PsA to the patient comprises the steps of: (1) receiving input from the patient defining the presence or severity of PsA-related symptoms; (2) selecting a threshold score beyond which a diagnosis of PsA will apply; (3) automatically assigning a calculating a score based on answers input by the patient in response to the questions; and (4) assigning a diagnosis to the patient based on the patient's score relative to the threshold score.
In a preferred embodiment, the computer-readable medium will additionally comprise instructions for automatically asking questions of the patient, as well as for displaying to the patient instructions on how to complete the questionnaire and diagram.
In a preferred embodiment, the threshold score will be chosen using the receiver operating curve, as described in detail above, to determine the score which will give optimal specificity and sensitivity.
In a preferred embodiment, the computer readable medium will contain instructions for determining whether the patient requires follow-up care with a physician or specialist.
In another embodiment, the computer-readable medium comprises a database to store and aggregate patient data for determining the prevalence of PsA in the population of patient affected with psoriasis.
In a further embodiment of the present invention, the user is assigned a unique identifier.
The user's input and score is stored in a storage device. Unique identifiers, inputs and scores from a plurality of users may be aggregated to carry out epidemiological studies.
Such stored information may also be transmitted over communications networks.
EXPERIMENTS
Example 1: Valuation and Validation of the Electronic PASQ Against PASQ
The electronic PASQ Data was collected from a prospective cohort of 42 patients with early PsA (meeting the CASPAR criteria), and from 12 PSO patients without PsA.
The electronic version of the PASQ (EPASQ) was developed using Adobe Creative Suite 4 software, and was based on the previous paper version of the PASQ. The EPASQ
was programmed to provide a maximum of 15 points. The PASQ contained 10 differently weighted questions as well as a diagram where patients marked where they had or have had pain and or swelling. The same questions were included in the EPASQ in addition to a diagram with 68 joints plus the spine. Validation was conducted using the stored questionnaires from 42 patients with confirmed PsA (mean disease duration 12 months).
Questionnaires from 12 psoriasis patients without PsA were used as a control.
Comparison of scores obtained from the manual and the electronic versions were conducted. A receiver operating curve (ROC) was determined for both the paper version as well as the electronic version using MedCalc software to pick the optimal cut off point (optimal sensitivity and specificity) for each component of the PASQ and EPASQ
(questionnaire and diagram). Descriptive statistics for both were obtained using SPSS.
The EPASQ Data was collected from a prospective cohort of 42 patients with early PsA
(meeting the CASPAR criteria), and from 12 psoriasis patients without PsA. All but one of the PsA patients scored 8 or more in the paper PASQ. Concordance of the paper and electronic scores was very high with only one patient who scored 7 f in the paper PASQ
and 11 in the present invention. The ROC Curve of the entire group yielded an optimal 97.62% sensitivity and 75.00% specificity for a cut-off score of 7. A cut-off point of 8 yielded a sensitivity of 88.10% while still maintaining a specificity of 75.00%.
What has been described above includes examples of the present invention. It is, of course, not possible to describe every conceivable combination of components or methodologies for purposes of describing the present invention, but one of ordinary skill in the art may recognize that may further combinations and permutations of the present invention are possible. Accordingly, the present invention is intended to embrace all such alterations, modifications and variations that fall within the spirit and scope of the appended claims. Furthermore, to the extent that the term "includes" is used in either the detailed description or the claims, such term is intended to be inclusive in a manner similar to the term "comprising" as "comprising" is interpreted when employed as a transitional word in a claim.
REFERENCES
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Claims (33)
1. A computer-implemented method of automatically diagnosing a medical condition, comprising the steps of:
displaying to a user a questionnaire and diagram;
receiving input from the user in response to the questionnaire and diagram;
calculating a score based on the user input;
establishing the diagnosis when the score exceeds a predetermined threshold;
presenting the diagnosis or other message to the user.
displaying to a user a questionnaire and diagram;
receiving input from the user in response to the questionnaire and diagram;
calculating a score based on the user input;
establishing the diagnosis when the score exceeds a predetermined threshold;
presenting the diagnosis or other message to the user.
2. The method of Claim 1, where the medical condition is psoriatic arthritis (PsA).
3. The method of Claim 1, wherein the questionnaire comprises a standardized set of questions for the purpose of gathering information from users regarding their current and/or recent symptoms;
4. The method of Claim 3 wherein the standardized set of questions include questions asking said users about a presence or severity of medical condition symptoms and asking users about other related risk factors.
5. The method of Claim 4, wherein the questionnaire prompts a user to input a "yes" or "no" answer in response to the questions by clicking the appropriate response.
6. The method of Claim 5, wherein the "yes" or "no" answer is assigned a score of 1 and 0, respectively.
7. The method of Claim 6, wherein a total score is automatically calculated based on the answers input by the user.
8. The method of Claim 1, wherein the diagram comprises a set of circles depicting parts of the body.
9. The method of Claim 8, wherein the parts of the body comprise 68 joints plus the spine.
10. The method of Claim 9, wherein a user marks the locations at which they experience or experience joint swelling or pain by clicking on the circles representing the respective joints and/or spine, where marks are only allowed on the circles representing the respective joints and/or spine.
11. The method of Claim 10, wherein the diagram is automatically scored 0, 1, 3 or 5 depending on the distribution of the markings.
12. The method of Claim 11, wherein a score of five points is awarded when: a) Only the spine button and one other major joint button (shoulders, hips, knees) have been selected by the user; b) The total number of joints selected by the user is greater than zero but less than six, except for case 1 for three points; or c) The total number of DIP joints (joints on fingers furthest from the wrist) exceeds five, and they are the only joints selected by the user.
13. The method of Claim 11, wherein a score of three points is awarded when:
a) only one major joint is selected (the spine, shoulders, hips, knees) by the user;
and b) the joints are asymmetrical.
a) only one major joint is selected (the spine, shoulders, hips, knees) by the user;
and b) the joints are asymmetrical.
14. The method of Claim 11, wherein a score of one point is awarded when the joints selected by the user are symmetrical.
15. The method of Claim 11, wherein a score of zero is awarded when no joints are selected any joints.
16. The method of Claim 1, wherein a composite score is automatically calculated for the questionnaire score and the diagram score.
17. The method of Claim 1, wherein the method of self-administered by a user.
18. A computer-implemented system for diagnosing a medical condition comprising the steps of:
a display module for displaying to a user a questionnaire and a diagram, and presenting a diagnosis or other message to the user;
a receiver module for receiving from the user input in response to the questionnaire and the diagram;
a scoring module for calculating a score based on the user input;
a diagnosis module for making a diagnosis based on the score;
a display module for displaying to a user a questionnaire and a diagram, and presenting a diagnosis or other message to the user;
a receiver module for receiving from the user input in response to the questionnaire and the diagram;
a scoring module for calculating a score based on the user input;
a diagnosis module for making a diagnosis based on the score;
19. The system of Claim 18, wherein the medical condition is psoriatic arthritis (PsA).
20. The system of Claim 18, wherein the scoring module calculates separate scores for the questionnaire and the diagram, as well as a composite score based on user input.
21. The system of Claim 18, wherein the diagnosis module assigns a probably diagnosis based on the calculated score in relation to a predetermined threshold score which must be reached in order for a diagnosis of PsA to apply.
22. A computer-readable medium having computer-executable instructions operable to cause a computer to Receive patient profile data that identifies patient and disease characteristics;
Automatically evaluate the patient profile data in light of one ore more diagnosis rules, the diagnosis rules defining a relationship among or between data that comprises the patient profile data; and Automatically assign a diagnosis of medical diagnosis to the patient based on the evaluation.
Automatically evaluate the patient profile data in light of one ore more diagnosis rules, the diagnosis rules defining a relationship among or between data that comprises the patient profile data; and Automatically assign a diagnosis of medical diagnosis to the patient based on the evaluation.
23. The computer-readable medium of Claim 22, wherein the computer-readable medium has computer-executable instructions operable to cause a computer to automatically assign a diagnosis of PsA based on the evaluation.
24. The computer-readable medium of Claim 22, wherein the patient profile data includes data defining the individual patient's symptoms and genetic characteristics.
25. The computer-readable medium of Claim 22, wherein the diagnosis rule comprises a score rule, which defines a threshold score in order for a diagnosis of PsA
to apply.
to apply.
26. The computer-readable medium of Claim 22, wherein assigning a diagnosis of PsA
to the patient comprises:
Receiving input from the patient defining the presence or severity of PsA-related symptoms;
Selecting a threshold score beyond which a diagnosis of PsA will apply;
Automatically assigning and calculating a score based on answers input by the patient in response to the questions;
Assigning a diagnosis to the patient based on the patient's score relative to the threshold score.
to the patient comprises:
Receiving input from the patient defining the presence or severity of PsA-related symptoms;
Selecting a threshold score beyond which a diagnosis of PsA will apply;
Automatically assigning and calculating a score based on answers input by the patient in response to the questions;
Assigning a diagnosis to the patient based on the patient's score relative to the threshold score.
27. The computer-readable medium of Claim 26, additionally comprising instructions for automatically asking questions of the patient.
28. The computer-readable medium of claim 26, additionally comprising instructions for patients describing how to complete the questionnaire.
29. The computer-readable medium of Claim 26, wherein the threshold score is chosen using the receiver operating curve to determine the score which gives optimal specificity and sensitivity.
30. The computer-readable medium of Claim 26, further comprising, based on the diagnosis, determining whether the patient requires follow-up care with a physician or specialist.
31. The computer-readable medium of Claim 26, further comprising a database to store and aggregate patient data for determining the prevalence of PsA in the population of patients affected with psoriasis.
32. The computer-readable medium of Claim 26, wherein a the user is assigned a unique identifier.
33. The computer-readable medium of Claim 26, wherein the user's input and score is stored in a storage device and aggregated.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CA2683169A CA2683169A1 (en) | 2009-10-16 | 2009-10-16 | A method for diagnosing psoriatic arthritis in patients with skin psoriasis |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CA2683169A CA2683169A1 (en) | 2009-10-16 | 2009-10-16 | A method for diagnosing psoriatic arthritis in patients with skin psoriasis |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CA2683169A1 true CA2683169A1 (en) | 2011-04-16 |
Family
ID=43875606
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CA2683169A Abandoned CA2683169A1 (en) | 2009-10-16 | 2009-10-16 | A method for diagnosing psoriatic arthritis in patients with skin psoriasis |
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| Country | Link |
|---|---|
| CA (1) | CA2683169A1 (en) |
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN111653359A (en) * | 2020-05-30 | 2020-09-11 | 吾征智能技术(北京)有限公司 | Intelligent prediction model construction method and prediction system for hemorrhagic diseases |
-
2009
- 2009-10-16 CA CA2683169A patent/CA2683169A1/en not_active Abandoned
Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN111653359A (en) * | 2020-05-30 | 2020-09-11 | 吾征智能技术(北京)有限公司 | Intelligent prediction model construction method and prediction system for hemorrhagic diseases |
| CN111653359B (en) * | 2020-05-30 | 2023-09-08 | 吾征智能技术(北京)有限公司 | Intelligent prediction model construction method and prediction system for hemorrhagic disease |
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