Patent Application
20120203465
Fields of the invention include systems, methods and program products for collecting, and organizing health data. Another field is wellness data determination.
Health of individuals is important for obvious reasons. Individuals often seek medical advice for diagnosis of disease and as an aid in the evaluation of an individual's overall health and wellness (e.g. as part of a periodic check-up). Unfortunately, consultation with medical professionals often has an economic cost associated with it that limits access for many.
The understanding of the science of health continues to increase. It is now possible to perform certain biochemical measurements on an individual's body fluid(s) and use the results as an indicator of risk for becoming afflicted with a variety of different ailments (e.g. cholesterol and lipoprotein analyses on blood samples). Due to the costs of seeking professional medical advice, the cost of the analyses themselves, in addition to other problems in the art, however, corresponding advances in the science of health and disease risk assessment have not been fully utilized.
One example embodiment of the invention is a system for collecting, measuring and outputting health data. The system comprises a plurality of test readers that each determine a plurality of different bodily fluid measurements in a bodily fluid sample and that generate a test data set for each bodily fluid sample that comprises the plurality of different biomarker measurements and communicate the test data sets over a network. A central computer is linked to each of the plurality of test readers over the network and receives the test data set and stores the test data sets in a memory, the central computer associating at least a first security key with the test data set. The central computer responds to a first request for a test output report received over a network that includes the first security key by communicating a test output report that includes a plurality of bodily fluid test measurements and transmits it over the network.
Another example embodiment comprises a computer program product comprising executable instructions stored in a non-volatile non-transitory memory (with examples including but not limited to magnetic, chemical and optical memory media), the instructions when executed causing one or more computers to execute steps comprising: receive a plurality of individual test data sets over a network from test readers that are connected to the network, each of the plurality of test data sets generated from a bodily fluid sample taken from an individual and including bodily fluid measurement data for at least three different biomarkers that are useful to estimate oxidative damage, antioxidant capacity, and inflammatory status; store the plurality of data sets in a memory; associate a plurality of the test data sets with a first security key that corresponds to a related group in the memory; receive over a network a first request for a group output report, the request including the first security key; use the first security key to identify from the memory the plurality of test data sets that correspond to the group; calculate averages for each of the bodily fluid measurements from all of the test data sets that correspond to the group; and prepare a group output report that includes the bodily fluid measurement averages for the group and communicate the group output report over the network.
Before describing example embodiments of the invention, it will be appreciated that the invention may be embodied in one or more of a system, method, software, or program product. Accordingly, it will be appreciated that in describing one example embodiment of the invention, description of other embodiments may likewise be had. As an example, when describing a system of the invention, description of a method, software or program product may also be had. Additionally, a method of the invention may be carried out by a system of the invention, and a program product of the invention may be stored on one or more non-volatile memories linked to a system of the invention that when executed cause the system to carry out a method of the invention.
Example systems, methods and program products of the invention are directed to collecting, storing, processing, and outputting health data. As an example, a system can be provided for collecting, storing, processing and outputting data obtained from measurements performed on bodily fluid samples from individuals, with or without additional information on the individual (such as height, weight, age, gender, lifestyle and health history data that may be input manually or electronically populated and is incorporated into the complete record for a specific test) in a highly efficient manner to provide a useful indication of the individual's overall health, wellness and/or relative risk for contracting one or more illnesses. The bodily fluid sample is contained in a test sample holder, which may contain discrete components for the measurement of multiple substances in bodily fluids for convenience and to reduce time and expense. Resulting test data is measured by a device which may be comprised of a single physical unit or multiple separate components for the measurement of biomarker(s) and for the control of certain aspects of the function of the measurement component and for computation of the results, processing of an on-site report, and transmission of data to a central computer, stored, processed by a central computer. Resultant test reports can be provided to individuals and others in a variety of useful and customizable formats. In some embodiments test results are stored over time so that individuals and others can measure changes in the levels of biomarkers and other metrics of health and wellness over time. In some embodiments, the tests and results are particularly well suited for estimating an individual's overall wellness, which may be thought of as health and/or resistance to one or more chronic diseases.
In further embodiments, pluralities or even multiplicities of individuals that are related to one another to form a group can have their test data organized, analyzed, and otherwise treated as a group. This provides some powerful and useful advantages and benefits over the prior art. One example group is a selected general demographic category(s) (any combination of age, geographic location, gender, lifestyle profiles), another may be employees of a particular employer or students from a particular school, and others are combinations of these (e.g., all women between ages of 35-40 that are employees of a particular company). Such groups can obtain an overall health profile for their members, map it over time, compare individuals or group averages to other selected groups or universes, and in some embodiments make predictive projections of health care costs, incidences of particular diseases and other predictions.
Description of particular example embodiments may now be had, with reference drawn to
Although other bodily fluids may be utilized in invention embodiments, it has been discovered that many embodiments find significant utility through use of urine. Urine offers advantages in many embodiments since its collection is relatively easy and noninvasive, collection and handling poses minimal infectious disease risk to participants and operators of the testing system and since urine provides sufficient volume for multiple assays. Urine specimens are well suited for large studies because they can be collected and stored by participants, costs of collection are relatively low, and compliance is high.
A test subject such as a person (not illustrated) may provide a urine sample that is communicated to the bodily fluid test device 10 through immersion, dropwise addition, capillary flow, or other manner. In some embodiments the bodily fluid test device 10 includes a plurality of reagents that react with a plurality of different biochemical components of urine. The term biomarker as used herein broadly refers to a substance or group of substances in a biological sample that is (are) associated with a specific disease or condition, with an example being glucose in urine being associated with a hyperglycemic condition of a diabetic individual. The product of the reaction of a given biomarker with reagents, chemicals or antibodies in a specific pad or channel of the test panel device test panel device 10 may result in a color or other detectable change, which detectable change that can be detected and preferably quantified by the reader device 16A. In some embodiments, a bodily fluid test panel device 10 may be comprised of test pads or channels that discretely measure the levels of two biomarkers, in others three biomarkers, others four biomarkers, others five biomarkers, others six biomarkers, others seven biomarkers, and others additional numbers of biomarkers. Including a plurality of different biomarkers on a single bodily fluid test device 10 provides advantages related to efficiency of time, cost, effort and others.
The bodily fluid test panel device 10 may be provided in any number of different mechanical, chemical and/or immunochemical configurations in different invention embodiments. As indicated above, in some embodiments it may include a polymer cartridge containing a urine dipstick. Many aspects of the science of bodily fluid testing, with urine testing being one example, are generally well understood by those knowledgeable in the art and these aspects need not be detailed herein and will not be for sake of brevity. A brief summary of relevant aspects, however, is provided for completeness.
Many (but not all) embodiments of the test panel device 10 use dry chemistry technology. A dry chemical media is provided and attached, held by, supported by or otherwise contained in or on a plastic frame or holder. The dry chemical media may include a dry carrier such as paper, powder (which may be compressed into a solid), pad, gel, glass or plastic fiber or other media that is loaded, embedded, impregnated or otherwise carries one or more reagents which, when exposed to a bodily fluid such as urine, will react to produce a detectable (and in many embodiments a quantitatively measurable) change in physical property. In some embodiments, the reaction product results in a color change. Other examples of physical changes include fluorescence and a change in redox potential.
Again, when practicing an invention embodiment that is directed to testing of urine, urine dipstick technology may be utilized with the dry dipstick media carried in a polymer case for convenience, hygiene, security and other reasons. As further indicated above, in many invention embodiments the bodily fluid test device 10 provides for convenient testing of a plurality of different biomarkers in a single test. Accordingly, some test panel device 10 include different reagents arranged in a particular spatial order with discrete sections to allow for measurement of different biomarkers from a single bodily fluid sample.
In some invention embodiments that utilize urine, adjustments are made to account for the concentration of the urine specimen. The concentration of biomarkers in urine specimens can depend on an individual's hydration status, time since last urination, and other factors. In some embodiments, test subjects may be directed to follow certain instructions prior to fluid sample collection, such as not urinating for at least 30 minutes prior to the sampling, restricting the intake of fluids on the day (or other period of time) in which the sample is to be obtained, avoiding caffeinated beverages, following other dietary guidelines for a particular time period, and the like. In addition to these steps, some embodiments further include quantitative measurement of a parameter associated with urine concentration. Some invention embodiments may measure the creatinine level in a urine sample and/or the specific gravity of the sample as an indicator of the relative concentration of the sample. Urine specific gravity is the ratio of the density of a urine specimen to the density of water, and increases with solute concentration. It can be measured, for example, by refractometry. Alternatively, dry chemistry technology can be used in which a change in color is directly proportional to the specific gravity of the sample at a given pH value. Creatinine is a byproduct of muscle activity, and is cleared from the bloodstream by the kidneys and excreted in urine. Urinary creatinine concentrations can be determined by colorimetric assay, and analyte concentrations are usually reported as a ratio of the analyte concentration to creatinine concentration. Creatinine is typically present in urine in a generally known range. Likewise, urine typically has relatively known specific gravity ranges, and the average specific gravity of random urine specimens for individuals within a population have been reported (e.g. 1.020 for North American adults).
Embodiments of the invention can measure one or more of these and use the measurement to estimate urine concentration. In some embodiments, the measurement is used as a pass/fail determination—if in an allowed range the sample is deemed acceptable and vice versa, but no changes to the bodily fluid measurements are made. In other embodiments bodily fluid measurements are adjusted or normalized based on the estimated urine concentration.
In one embodiment, the concentration of creatinine in the specimen is measured using a discrete dry chemistry test pad, the general compositions of which are known and need not be discussed in detail herein for sake of brevity. If the creatinine concentration falls within a specified range, then the measured values for all of the biomarkers measured by the test panel device 10 are divided by the concentration value obtained for creatinine and may be expressed in common units such as micrograms/milligram of creatinine. In this embodiment, if the concentration of creatinine is below a specified value (e.g. below 10 mg/dL in some but not all embodiments) then in some invention embodiments the sample may be considered too dilute to permit accurate analysis of the biomarkers therein, and a report may be generated indicating that the sample is too dilute and that the subject should provide another sample at a later time to permit more accurate analysis. In some embodiments employing creatinine for normalization, an upper limit may also be specified to improve accuracy since the relationship of the color produced in typical creatinine dry chemistry technologies is logarithmically related to the concentration of the specimen such that the change in color approaches a plateau value at high levels of creatinine. In this case, (a) a report may be generated indicating that the sample is too concentrated to permit accurate measurement of biomarkers, (b) the operator may dilute and reanalyze the sample, or (c) a fixed high creatinine value may be used for normalization of concentrated specimens.
In another embodiment the specific gravity, measured by refractometry or by a discrete channel or dry chemistry test pad or other method, the general steps of which are well established and need not be discussed herein for sake of brevity, is used for normalization. Further, given the known dependence of the typical colorimetric methods for measurement of specific gravity on the pH of a sample, an additional test pad or channel may be included in the test panel device 10 to measure the pH of the specimen, and this value may be applied to mathematically correct the apparent specific gravity measurement for improved accuracy of the normalization process in some but not all embodiments. As for normalization employing creatinine, if the specific gravity falls within a specified range (e.g. 1.003-1.040 in some embodiments), then the measured values for all of the biomarkers measured by the test panel device 10 are normalized based on the specific gravity measurement in some but not all embodiments. One algorithm that may be employed is to adjust the value obtained for each biomarker to that which would be observed in a sample with the specific gravity of the population norm. Thus, for North American adults, the sample concentration value is multiplied by (1.020−1.0)/(the specific gravity of the sample−1.0), so that for a specimen with a specific gravity of 1.010, the normalized value of a biomarker would be twice that of the measured value.
As for normalization to creatinine, if the specific gravity is below a specified value (e.g. below 1.003) then the sample is considered too dilute to permit accurate analysis of the biomarkers therein, and in some embodiments a report or indicator may be generated indicating that the sample is too dilute and/or that the subject should provide another sample at a later time to permit more accurate analysis. In this embodiment employing specific gravity, which is linearly related to the concentration of the specimen, there is less error introduced for concentrated specimens so that normalization is expected to be accurate over the entire specific gravity range for that population, provided that the raw or unnormalized concentrations of each biomarker lie within the measurable range for each of the discrete test pads or channels of the test panel device 10. Thus normalizing concentration of each biomarker reported for an individual based on the concentration of the sample significantly improves the utility of urine biomarkers for evaluation of health and wellness compared to others within the population and for longitudinal tracking of an individual's health and wellness. It will be noted once again, however, that normalization is not necessary to all invention embodiments and some embodiments may find utility in avoiding any normalization steps. The example bodily fluid test device 10 also includes a unique identifier (“ID”).
Because most applications for invention embodiments will be related to health and medical testing, it can be important to maintain a reliable and secure chain of identity—to ensure that the bodily data obtained using the test panel device 10 is correctly associated with an individual subject that provided the bodily fluid and to ensure that the privacy of test results can be maintained. It is also useful to provide for the recognition by the test reader 16 of specific lot numbers of test panel devices 10, which may be valuable to avoid an operator using an expired lot, to reduce the possibility of inferior counterfeit test panel device 10 devices, to allow for lot-specific adjustments to standard curves or other parameters. It can also be used in combination with the reader device 16 to permit the analysis of multiple test panel device 10 configurations, such that the identifier encodes the nature and order of the dry chemistry or other analytical components and signals that the reader should analyze the reflectance or other physical change at specified wavelengths after specified time intervals.
One example way to benefit these needs is to provide each test panel device 10 with a unique ID which can be recorded at the time of bodily fluid submission (or another time) and related to an individual test subject's name and/or other personal or identifying information. Many varieties of unique ID's can be provided with different invention embodiments. These include, but are not limited to, alphanumeric strings, one two or other dimensional barcodes, other optical means, radio frequency identifiers, and others. The schematic of
The bodily fluid test device 10 is submitted to a test reader 16 for measurement of the concentrations of a set of biomarkers in a bodily fluid. The test reader 16 may be configured in many different manners in different invention embodiments. In some embodiments a test reader may be a dedicated electronic device that is connected to a processor based device such as a computer that controls it, records the resultant data as well as other biometric information that may be manually or electronically added to the file, performs the normalization, generates a report for that sample. The connection may be through a traditional BUS or other analog/digital connection. In other embodiments a different test reader may be integral with a computer, or may otherwise include a processor, memory, display and other computer related components. Many other potential test readers are contemplated in other embodiments. As an example, in still other embodiments a test reader may be a highly compact, portable and wireless handheld device that optically scans a test panel device 10.
In the attached FIGS., the test reader is illustrated as a stand-alone electronic device 16A connected to a separate computer 16B. “A” and “B” designations have been used with the two components in
In many embodiments, the test reader 16 finds utility in portability. Portability allows for convenient use in applications such as mobile testing, for example. In an example application, employees at an office, factory or other location may be tested. Portability of test reader 16 allows for convenient use in such applications, with a test operator traveling to the location and administering tests on site. This is particularly useful in applications that include testing of bodily fluid samples that have a relatively short time window of accuracy, with an example being many urine biomarker applications. In some urine testing embodiments, depending on the urine dipstick and other technology used, the sample may be refrigerated or treated with a preservative to impede bacterial growth. However, for greater accuracy in the analysis of a number of urinary biomarkers, preservatives or cold storage may influence the measured biomarker, so that the sample should be analyzed within a few hours—test results in some embodiments lose accuracy after this time period. In some embodiments, testing is performed within 1 hour, within 2 hours, within 3 hours, within 4 hours, or within other time limits. Portability helps address related issues since urine samples can be obtained on-site for groups and the like.
The test reader 16 may operate in any number of different functional manners suitable for performing different bodily fluid measurements. As used herein, the term “bodily fluid measurements” is intended to broadly refer to measuring some aspect of a bodily fluid, including but not limited to measuring a biomarker contained within the bodily fluid, whether measured directly or indirectly. In many (but not all) embodiments a bodily fluid measurement includes a quantitative or semi-quantitative measurement of the presence or concentration of a biomarker. As used herein, a quantitative measurement is intended to broadly refer to one in which a relatively accurate numerical value (e.g., for a concentration) is determined, and a semi-quantitative measurement is one in which an approximate numerical value (e.g., for a concentration) can be estimated. Other embodiments include making qualitative measurements in which no numerical value is determined, but instead a determination is made regarding a quality indicator (e.g., color, pass/fail, presence/absence, other).
It will be appreciated that there are a multitude of potential manners of operation of different test readers of the invention to perform a bodily fluid measurement. Many aspects of the technical operation of a reader suitable for use in invention embodiments are known in the art and need not be detailed herein. The configuration of a particular test reader will depend necessarily on the configuration of the bodily fluid test panel device 10. In most embodiments, a cooperating relationship exists between the test panel device 10 and test reader 16—the test reader 16 necessarily is configured to measure concentration indicators that the test panel device 10 is configured to indicate, and in particular to cooperate with the biomarker to be measured. One example bodily fluid test reader 16 and cooperating test panel device 10 exploits chemical reagents embedded in the test panel device pads 12 (
Chemical compositions that produce colored products upon interaction with a number of biomarkers are generally known, but will be briefly described herein below. A wide range of chemical compounds are known to absorb light, with the result that exposing a compound to a known spectrum and measuring light that absorbed and/or reflected at or near certain wavelengths can be used to identify the presence of particular compounds, and/or their concentration. In embodiments of the invention that exploit this technology, the test reader 16A is configured to employ photodiodes or other elements that emit light of particular wavelengths and/or intensity and photodetectors to measuring reflectance/absorbance to determine color and/or degree of color change. By comparison to results obtained for known standard biomarkers, the resulting reflectance/absorbance measurements can be converted to determine a particular biomarkers concentration within a bodily fluid using a known calibration that may be stored on the reader 16A, a computer 16B or elsewhere. In addition to performing bodily fluid measurements, the test reader 16A reads the unique sample and test panel ID 14 (
The test reader 16A may include various digital and analog components useful to perform the bodily fluid measurements, to read the unique ID 14, and to create a resulting test data set. For example, in an example test reader 16A a plurality of light emitting and reflectance/absorbing measuring components may be spatially arranged to cooperate with the test panel device 10 and its arrangement of pads 12 and unique ID 14 (
Further, test reader 16 and test panel device 10 may be configured in a cooperating manner so that the test panel device 10 is received in a particular and predictable orientation so that pads 12 and unique ID 14 are located in a known location upon insertion of the test panel device 10 in the test reader 16. This can be accomplished in any number of manners, with examples including a mechanical arrangement featuring a cooperating slot or keyed arrangement, a motor driven loading tray that loads the test panel device 10 along a consistent path to a known location. A test reader 16A may also be provided with a digital checking mechanism that includes one or more location markers on the test panel device 10 that are confirmed to be in their required locations before test reading was undertaken. In many embodiments, the test reader 16 makes the plurality of bodily fluid biomarker measurements simultaneously for purposes of efficiency, speed of sample throughput and others. In some other embodiments, the measurements of different pads are not simultaneous, but done in series by a one or more scanners and other components that travel along the length of the test panel device 10.
In some applications there can also be commercial advantages to including security information on the test panel device 10. In some commercial applications, revenue will be received through sales of test panel devices 10. In these applications, there may be risk that a competitor will reverse engineer the test panel device 10 and sell competing products at a lower price that can be used with the test reader 16. To mitigate the risk of this, including the potential for inferior test panel device 10 counterfeits the results from which may not be derived from standard curve data for authentic test panel device 10, some embodiments of test panel device 10 include digital or other security information that acts as a “key” for use of the test reader 16. In these embodiments test reader 16 initially examines the test panel device 10 searching for the presence of the security information before conducting a test. If the information is not present, no test is performed. The security information may be overt or covert, with some examples including a digital bar or other code (similar or identical to ID strip 14), a second digital or other code that in addition to ID strip 14, an RFID chip (which may be on or embedded within the test panel device 10), and others.
The above discussion has focused on a test reader 16 and test panel device 10 that utilize color change and cooperating optical measurement technology to measure biomarker concentration and/or presence. As indicated, many other technologies will be useful in other embodiments. These may include, but are not limited to, illumination at a specified wavelength of light and, e.g. by employing band pass filters, measurement of only the light emitted at a different wavelength by fluorescence, measurement of the refraction of light as it passes through a chamber within the FTD 10 device, (e.g. wherein the refraction of light may be used to determine the specific gravity to evaluate the relative concentration of a urine sample), the measurement of light emitted at a wavelength at which a specific chemical reaction used to quantify a biomarker does not exhibit any significant change in intensity with the biomarker concentration (known as the isobestic point) for purposes of internally calibrating the change in intensity at a second wavelength that is responsive to the concentration of the biomarker, control reaction pads that are sensitive to temperature and which can be used to detect exposure of the test panel device 10 to conditions that would damage its function, control chemical components in the test panel device 10 that may be used to quantify the relative amount of fluid that is taken up by the device and thus the amount of the sample being analyzed, control pads or channels that may be used to correct for endogenous absorption, reflection and/or fluorescence of light by the specimen (e.g. yellow or amber colors of urine or plasma specimens) and/or determination of the redox potential of a biofluid.
The test reader 16 after performing bodily fluid measurements, with or without the separate input (manually or from remote data source) of additional biometric data on the individual being tested, creates a test data set. The test data set may include, for example, quantitative concentrations of biomarkers present in the bodily fluid measured by the test panel device 10, normalized values after adjustment (e.g. based on creatinine or specific gravity values determined by the test panel device 10) in addition to a value corresponding to the unique ID 14. The test data set may be in the form of a digital file that includes numerical values representing biomarker concentrations, identifying and biometric information on the individual tested and an alphanumeric string that corresponds to the unique ID 14, for example, with one value corresponding to the concentration of each biomarker (and corresponding bodily fluid biochemical component) present in the bodily fluid sample 10.
The particular bodily fluid measurements made in invention embodiments will vary with application. Again, in many embodiments, a plurality of measurements are made simultaneously from a single test panel device 10. In some embodiments, bodily fluid measurements that measure concentration of biomarkers that correspond to oxidative stress, anti-oxidative activity, and inflammation are useful. A number of different such bodily fluid measurements will be useful in different invention embodiments, with examples including the following:
TBARS (Thiobarbituric Acid Reactive Substances)
Organic Hydroperoxides
Protein Carbonyls
Measure of oxidative damage to specific molecules
Lipids
Proteins
Nucleic Acids
Small Molecules and Ions
Direct Methods—Measure Reaction with Redox Probe
Indirect Methods (Measure Resistance to Oxidation of a Probe by an Added Oxidizer)
Measurement of Molecules that Contribute to the Total Antioxidant Capacity
Cytokines (TNF-α, IL-6, IL-8)
Other Proteins
Eicosanoids
Other Molecules
In one example embodiment, an oxidative bodily fluid measurement can incorporate either a relatively specific method to quantify malondialdehyde (MDA) or 4-hydroxyonenal (4HNE) as biomarkers for lipid peroxidation and/or the less specific thiobarbituric acid reactive substances (TBARS) method to measure a broader range of substances oxidized to aldehydes and ketones due to the actions of free radicals. These tests are known in the art and can be performed by an appropriate analyzing mechanism. Several other biomarkers can be used to test for oxidative damage to specific biomolecules or classes of biomolecules with some examples listed above. High levels of these biomarkers indicate the level of oxidative stress that is occurring in an individual, while low levels of these biomarkers indicate a relatively healthy individual.
Oxidative stress occurs when an abnormal level of reactive oxygen species (ROS), such as superoxide and/or hydroxyl ions, and/or hydrogen peroxide, lead to damage of molecules in the body. ROS can be produced from fungal or viral infection, aging, UV radiation, pollution, excessive alcohol/tobacco consumption, drug metabolism, the uncoupling of electron transport systems in mitochondria, among other conditions. ROS can further cause many pathological conditions including age-related macular degeneration and cataracts, and is known to play a role in the development of multiple chronic illnesses including type 2 diabetes, cancers and cardiovascular diseases.
Antioxidants help to control the level of ROS in the body and thus minimize oxidative damage to biomolecules and pathologies that may result. Tests have been developed to quantify many of the antioxidants that are produced by the human body. However, none of these have thus far been reduced to practice for the routine assessment of overall health and wellness. A number of complex tests have been developed to estimate the total level of all antioxidants in a specimen. Many of these tests, e.g. the ORAC test that is widely used to assess that antioxidant activity of foods and beverages, are intended for relatively sophisticated laboratories and involve the addition to a biological specimen of a dye that changes color upon oxidation, along with a source of ROS. In such tests, the higher the antioxidant activity of the specimen, the longer it takes for the dye to change color. Some embodiments of the invention utilize colorimetric tests for monitoring the antioxidant power of a biological sample due to multiple component antioxidants. These antioxidant power tests, sometimes called an antioxidant capacity tests, that employ copper-cuprione complexes (typically neocuprione or bathocuprione) or other complex that has a redox potential of approximately −0.6. In particular the CUPRAC (cupric reducing antioxidant capacity) method, which employs a copper-neocuprione complex, for measuring the sum of the antioxidant activity due to multiple endogenous as well as exogenous (e.g. antioxidants derived from food and vitamin supplements) is particularly useful for providing as integrated value for an individual's ability to maintain a healthy response to ROS.
In some invention embodiments, further information may be included in the test data set. It may be useful in many embodiments that measure individual wellness data to collect various additional physical, personal and demographic data. As used herein the term demographic data is intended to broadly refer to data that may be useful to establish a related group. This might include, for example, demographic categories such as residence information, employer information, gender information, and other. In some embodiments, for example, additional information is provided by a test subject. This data may be manually provided through oral or written communications, or in another manner (with examples including scanning of an identity card such as a license/credit card, finger print scanning, retina scanning, and other). An operator can enter the information at the computer 16B using a keyboard, mouse or other. In some embodiments, a credit card, license or other media with personal information can be scanned by the computer 16B. Personal, physical and demographic data that may be collected in invention embodiments includes but is not limited to demographic categories including:
This and other data may be included with the test data set. Some of this information does not change, with an example being the name, gender, social security number and date of birth. This information that remains constant over time is referred to herein as “permanent personal information.” As will be detailed further below, in some invention embodiments individuals or groups may submit for multiple different tests over time. In such embodiments, this permanent personal information need not be represented every time a test subject submits a test, but instead can be recalled from prior tests for convenience. In some embodiments the test reader 16 may also record a timestamp that corresponds to the time of measuring the bodily fluid test panel device 10, and includes this timestamp with the test data set. The timestamp may be, for example, a day, month and year. It may be calculated using a clock internal to the test reader 16, may be retrieved from the network 20, may be manually input by an operator, or may otherwise be provided.
Also, for security or sensitivity purposes, some data (including demographic data) may be modified or otherwise adjusted. As an example, in some embodiments a user social security number could include only the final four digits or some other portion, the date of birth may be limited to only a month and year (no day), residence information may be limited to city and state only (no street), user names may be partial or assigned pseudo-names, and the like. In these embodiments, some advantage may be had in terms of security by not collecting and storing highly sensitive information such as a social security number.
Once a test data set is created by the test reader 16, the dataset with or without a copy of a comprehensive text profile generated based on algorithms that are dependent on the biomarkers and other data, is communicated over a data link 18 to a network 20, then to a central computer 30. The data link 18 may be a wired or wireless link, with examples including a cellular phone communications link, a radio frequency connection, a PSTN communications link, a digital communications link, and the like. Similarly, the network 20 may be any of a number of different communications networks, with examples including a wired or wireless phone network, PSTN, a digital network, a local area network, a wide area network, the internet, an internet successor such as the fast internet or next generation internet, a cellular communications network, combinations of one or more of these, and the like.
The central computer 30 may be any number of processor based devices, with examples including a laptop, desktop, or server computer, a mainframe computer, and others. The computer 30 may include one or more memories (volatile and/or non-volatile), one or more displays, one or more data input devices (with examples including keyboards, mouse, microphone, others). The central computer 30 may be executing a program product of the invention, or a server incidence of a program product of the invention, and may have the same stored on a volatile or non-volatile memory. Although the central computer 30 has been illustrated as a single computer in
In many embodiments, the central computer 30 serves important data processing, organizing, storing, and reporting functions. In many (but not all) embodiments the central computer 30 stores in a memory, for example, average ranges for bodily fluid measurements that can be compared to the bodily fluid measurements from an individual test data set for calculation of a relative bodily fluid measurement. In some other embodiments, the reader 16 (and/or computer 16B) may store these average values in a memory so that these calculations of relative measurements can be made without access to the central computer 30. As used herein, the term “relative” when used in this context refers to a measurement that is compared to a population range of the same measurements. As an example, a relative measurement may include a percentile or scaled or similar ranked measurement, with the result that an individual's bodily fluid measurements may be reported in comparison to a larger universe for context (e.g., “oxidative stress level is in the 35th percentile,” or “oxidative stress is a 7.2 on a scale of 1 to 10,” etc.).
The central computer uses this stored data and the test data set communicated from the test reader 16 to create a test output report. The test output report may be configured in any number of different forms as may be desirable. Indeed, as will be detailed below, one of the advantages of systems and methods of the invention is the ability to create highly customized test output reports to serve different needs. In many embodiments, however, the test output report will include a plurality of relative bodily fluid measurements in addition to some personal and demographic information.
As illustrated in
It has been discovered that test output reports that present biomarker measurement results in this relative form are more easily understood and are more likely to have an impact on individuals. For example, it has been discovered that in the context of invention embodiments individuals appreciate health test results favorably through use of color coding which can include, for example, green for healthy readings, yellow for less healthy measurements, and red for most unhealthy measurements, with gradual color shading used to transition from one to the other.
It has also been discovered that obtaining and providing a plurality of different relative bodily fluid measurements in a single test output report has similar benefits and advantages. The impact of multiple test results that may be related to one another appears to be much more impactful than a single test result might be. Also, some invention embodiments are directed to measuring an individual's so-called wellness (generally recognized as including metrics such as physical activity, body mass and lifestyle that are healthy and/or low levels of biomarkers that are indicative of risk for chronic illnesses), as opposed to diagnosis of a particular disease or ailment. These embodiments make measurements of biomarkers in body fluids useful to generally assess an individual's capacity to resist general classes of disease and ailments. For these embodiments, a test output report that includes a plurality of relative biomarker measurements in body fluids including the following has been discovered to be particularly useful: oxidative stress or damage (e.g. bodily fluid measurements of the biomarkers TBARS and MDS), inflammation (e.g. bodily fluid measurements of urinary protein and for NOx), and total antioxidant capacity (e.g. relative bodily fluid measurements of TAC). In addition to bodily fluid measurements, a test output report may include other results with one example including a body mass index (BMI) that is calculated based on input of an individual's height and weight. Other data such as age, ankle and/or wrist diameter, waist and chest diameter, may also be useful to assess wellness relative to one's peers. Some or all of the personal and demographic data may also be provided. The central computer also stores the bodily fluid test data set and the corresponding test output report in one or more memories.
In some invention embodiments, the demographic data may also be used in formulating a test output report and/or test output data. Demographic data may be used in combination with numerical results to further estimate some aspects of a subject's wellness and disease risk and to provide information on the test output report. For example, demographic data indicating that a subject is a heavy smoker or heavy user of alcohol and that has an elevated level of a biomarker(s) for oxidative stress might be useful to provide a recommendation for lessening the oxidative stress level. At least some literature supports the proposition that smoking cessation reduces oxidative stress using one biomarker. Hence, individuals with high levels of oxidative damage and whose demographic data indicate they are a smoker may obtain a test output report identifying the smoking as a major source of oxidative stress and recommending cessation. Other literature show that exercise increases an individual's antioxidant capacity, so subjects that provide demographic data suggesting they are sedentary and who have with low values for an antioxidant biomarker(s) may receive a test output report that suggests increased exercise to improve antioxidant levels.
Additionally, it is known that strenuous exercise increases oxidative stress biomarkers in the short term, but that the levels return to the basal level within 12-24 hrs. However, systematic exercise programs elevate the endogenous antioxidant levels, which otherwise deteriorate with age or reduced physical activity. So for test subjects that provide demographic data that indicate high levels of physical activity and whose test results indicate high levels of antioxidant biomarker(s) and oxidative damage biomarker(s), the report may indicate that they be retested after abstaining from strenuous exercise for some period of time (e.g., 24 hrs).
Test output reports may be communicated as desired. Individuals that submitted a bodily fluid sample will be one destination for test output reports. These individuals may be mailed (by physical or electronic mail) a test output report. The test output report may be communicated over the communications network 20 to a computer 16B for printing on an attached printer (not illustrated), viewing on a display, or for storing in a memory for future use. Also, an advantage of many invention embodiments is that the test output reports are stored in a memory by the central computer 30 for presentation as desired. An individual may be provided access to the central computer 30 over the data network 20 (or otherwise) so that they can retrieve their test output report as desired whenever and wherever they may be. The individual may submit a request from a home computer, from a work computer, from a portable computer, from a portable communications device or from any number of other devices capable of communicating with the communications network 20. Again, for purposes of ensuring security of what may be sensitive information, test output report communication and storage may be encrypted. Storage and communication may utilize other high security measures to avoid data breach.
By way of example,
In order to associate an individual with their corresponding bodily fluid test data set and/or a corresponding test output report, the central computer necessarily must be able to identify the stored data with the individual referenced in the request it has received. There are a number of particular steps that can be undertaken to achieve this, but most have in common that some information included in the request can be used to identify the stored data. This may be, for example, personal data such as an individual's name, social security number, address or the like. Also, in many invention embodiments, the test reader 16 and central computer 30 are configured to provide and recognize a unique security key that is associated with an individual. As used herein, the term “security key” is intended to broadly refer to a unique identifier that may be communicated digitally. It can be, for example, an alphanumeric string such as a password.
In some corresponding invention embodiments, the test reader 16 is configured to provide the security key to the individual before the test data set is communicated to the central computer 30, while in other embodiments a request is communicated to the central computer to create a security key which is then communicated to the test reader 16 before the test data set is communicated to the central computer 30. In still other embodiments, the initial test data set may be communicated to the central computer 30 which then creates a corresponding security key and communicates it to the test reader 16. Individuals may also be permitted to create a desired security key for convenience.
In some embodiments more than one security key is provided. As an example, an individual may be asked to create a username and password (each of which may be a security keys in the context of the invention). In these embodiments, the central computer may confirm that the user name and password are available for use through a dialogue, and then assign these to the individual as well as corresponding test data sets and test output reports. Indeed, data used in various invention embodiments may include sensitive personal information, including identification and health related data. Some invention embodiments may include numerous features to ensure a high level of data communication, storage and reporting security. This may include, for example, multiple security keys, data encryption, highly reliable storage procedures, and the like. Data communicated to and from central computer 30, including but not limited to test data sets and test output reports, may be encrypted. In some embodiments encryption may include installation of a client codec on client devices, sharing of a digital encryption key between client and server, and the like.
It may also be useful for one or more others to have access to test data sets and test output reports in addition to the individual that submitted the bodily fluid test sample. Health care professionals that care for the individual, relatives, employers, insurers and others are some examples of others that may find utility in accessing stored test data sets and/or stored test output reports. In these embodiments, the individual can provide his security key to others as he desires so that they can access stored data. Or, in some other embodiments the test reader 16 and/or the central computer 30 are configured to provide one or more additional security keys. In some embodiments different security keys may carry different levels of access, with a first security key allowing access to all stored data, a second security key providing access to only a limited subset of the stored data, a third security key providing access to a still further limited data set, etc.
It may also be useful to organize test data sets, test output reports and other data by groups and to treat that data as a group. Groups may be any number of individuals that are related to one another in some manner. As an example, an employer may contract to administer testing to all of its employees. In addition to providing test output reports to individual employees, in such embodiments the employer may wish to have access to the test output reports for all of its employees. Accordingly, the central computer may provide a security key to the employer that is common to all employees. The different security keys may have different levels of access so that a first security key can access more stored data than a second key. This can be useful, for example, so that an employer can access some but not all stored data for its employees, while employees can access all information.
As discussed above, the central computer 30 of invention embodiments provides unique benefits and advantages through novel data processing, organizing, segmenting, storing, and output features. Some of these features correspond to organizing test data sets into groups. Organizing data into groups may be useful for a variety of different purposes. Groups can be created using data stored by the central computer, or can be defined when submitting data. As an example, in some embodiments a group could be created using demographic data for all women between the ages of 30-35, for all individuals that reside in a particular geographic location (e.g., city, state, county, zip code(s), etc.), all individuals of a certain vocation, and any number of other selections using existing, stored data. In still other embodiments, a group can be created upon submission of initial test data sets. As an example, a test reader 16 operator may input data confirming that a data set to be created by the reader is part of a group. A plurality of corresponding test data sets may include a common group identifier, which may be an assigned alphanumeric string.
These and other aspects of data storage and organization of systems, methods and program products of the invention can be further illustrated through consideration of a portion of an example database of an invention embodiment as shown in
As indicated, each example test data set includes an individual name, a username (representing a first security key), two additional security keys, a birthdate (DOB), a test date (date the test was given), residence, race (coded), group, gender, tobacco use profile (expressed in a code corresponding to severity of use), education (expressed in number of years), vocation (coded), body mass index (BMI—expressed in a code), and normalized (and/or un-normalized or raw) bodily fluid measurement values for five different biomarkers (BM1-BM5). This information can be organized as desired, and may be grouped as has been illustrated in
By way of further illustration of this aspect of the invention, in some invention embodiments the test output report can be generated (including making of all required calculations as described above) can be performed by the local computer 16B. The local computer can store, for example, in a memory all of the data required to generate normalized or relative measurement data. This can be advantageous, for example, in applications in which a network 18 is not available and for other reasons. Again, encryption of the data report may be used in some embodiments for security purposes when it is stored and/or communicated over the network 20.
To further illustrate various features of invention embodiments, assume that a company named “Acme” desires to estimate the overall wellness of its employees. Further assume that Acme has a facility in Chicago and one in Milwaukee. This information may be input by one or more operators using a computer 16B, central computer 30 or other device over network 20. Central computer 30 responds by creating a first group for Acme (indicated by “acme” in
A plurality of employees at each of the Acme Chicago and Milwaukee facilities are then tested. Each employee provides a bodily fluid sample which may be urine. A different test panel device 10 is exposed to each urine sample. Permanent personal data (
Individual test panel device 10 for each Acme employee are then read by a first test reader 16 that is temporarily located at the Acme Chicago facility and by a second test reader 16 that is temporarily at the Acme Milwaukee facility. Individual test data sets are created for each individual employee including the data as indicated in
This may be accomplished, for example, by computer 16B requesting creation of a new individual account from central computer 30 which responds by providing a unique username and password to computer 16B. An individual account may be thought of as a user identity that will be associated with one or more test data records. Computer 16B may have also included in its request to central computer 30 that the new account would be associated with the Acme group as well as the appropriate subgroup. Or, in an alternate embodiment, when creating the Acme group and Chicago/Milwaukee subgroups, central computer 30 may have been informed of the total number of employees to be tested at each facility (and in some embodiments their names) and created a corresponding number of new accounts.
Each individual test panel device 10 is then read by reader 16A to make individual biomarker measurements BM1-BM5. The body mass index may be calculated by computer 16B (or may be calculated by central computer 30). An individual report may be created by the computer 16B and, along with the test data record communicated from computer 16B over the links 18 and network 20 to central computer 30. Central computer 30 stores the data records in a memory using the general organization as shown in
The final row of
The request received from Mr. Smith (or someone acting on his behalf) might specify particular desired report characteristics. These might be, for example, a request for a test output report including only relative data for BM1 and BM2.
Additionally, the data of
As indicated above, some of the advantages and benefits of invention embodiments are related to the operation of the central computer in generating highly customizable and useful test output reports. This can be accomplished using the data organized in the table of
The central computer 30 first receives a request for a test output report from the network 20 (block 52). The request may be communicated from an individual such as Mr. Smith, an employer such as Acme, a health care provider representing an individual, or from another source. It can be communicated using any device in communication with the network 20, including computer 16B, smart phone 34, or other device.
The central computer then queries the request to identify what individual(s) a test output report is desired for (block 54). This step also includes the central computer confirming that that request has presented sufficient security key(s) to access the requested data (block 54). If the proper security keys are not provided, an error message results (block 58) and no data is provided. If a request includes proper security keys, the process of collecting and organizing data continues (block 60).
By way of further illustration with regard to resolving security keys, a request may have been received for an output report that specifies the name “Hank Right” or otherwise specifies Mr. Right as shown in row 8 of
A different request received by the central computer that specifies Mr. Smith may include the third security key shown in col. G of
Referring once again to
In almost all output reports data from a test data set will be required. In the manner generally discussed above, the central computer 30 retrieves required data from the corresponding test data record(s) (block 62). Again, the required data will vary depending on details of the desired output report. Many requests will require retrieval of only a single test data set, while others may require retrieval of a plurality. As also discussed above, many embodiments feature output reports that provide relative data. This has been discovered to offer unique benefits and advantages as discussed above. To provide relative data, an individual test data set is compared to a larger universe of data to provide further context. A wide variety of universes may be selected and will be determined by the central computer through specifications in the request (block 64).
The central computer 30 may store the universe data in a memory (local or accessible over network 20). Taking the BMI data from
Also, in some invention embodiments, advantages and benefits are achieved by configuring the central computer 30 to develop universe data as desired using stored test data sets, as reflected in block 64. Development of universe data is further customizable in invention embodiments as may be desired. It has been discovered, for example, that great utility can be achieved by allowing users to define their own universe. As an example, the Acme employer or an individual Acme employee may wish to view the results of his biomarker measurements relative to the universe of all Acme employees. In this case, test output reports for an individual could be prepared which compared that individual's BM1 measurement to the overall universe of BM1 measurements of all members of the Acme group.
The central computer 30 accomplishes this by retrieving all records specifying the Acme group identifier in column H of the table of
Referring again to
In some embodiments availability of various output reports will also vary with level of security key access. As an example, a representative of the Acme employer may wish to view overall results for the universe of Acme employees, or a selected sub-group such as the Acme Milwaukee facility, male employees between the ages of 30 and 35, or other. The Acme representative may have been provided only the security key “AcmeJ23” shown in column G of
Test output reports may also present biomarker measurement data taken over time. Again, it has been discovered that this allows for benefits and advantages related to individuals and groups being able to measure changes over time as behavior, diet, and other factors change. A request processed by the central computer may specify, for example, that a particular user desires to have all their bodily fluid measurements charted over time, either in raw (i.e., not relative) form or in relative form. This could be accomplished, for example, by a user specifying some or all of their permanent personal data, security key information, or other data that is associated with each of their test data sets, and the central computer 30 then using this to search a memory or database and identity every test data set that corresponds to that user. Referring to
The unique data gathering, storing and reporting capabilities of invention embodiments can be exploited in a number of other ways to offer other valuable benefits and advantages not previously available. As an example, the data stored by invention embodiments can serve as the basis for predictions of future events. As an example, correlations can be utilized to predict future rates of incidents of various diseases, health care costs, and the like for groups or individuals. A correlation could be referenced, for example, that associates the average BM1, BM2, BM3 and BM4 for the Acme employer to predicted health care costs for the coming years. Acme might provide access to its security key 3 to an actuary or other entity that could review data and make such predictions.
Embodiments of the invention also include developing such correlations. Acme and other employers could provide their health care costs by year, for example, which can then be compared to average bodily fluid measurement data to create a health care cost correlation. Such predictive data will find utility in a multitude of applications. One example includes actuarial applications for insurance companies. An insurance company providing insurance cost estimates or determining annual premiums for the Acme company, for instance, could find great use in having all Acme employee test data records and applying a correlation factor to their average measurements to predict future health care costs.
In further invention embodiments, comparisons of different groups' statistical data values can be made for predictive purposes or other purposes. As an example, assume that a central computer 30 of the invention stores test data sets for 17 different Acme facilities, each located remotely from the other. If Acme is considering closing one facility, expanding one facility, it could find utility in comparing statistical data for each different facility to identify those that may have particularly high or particularly low relative bodily fluid measurement data (e.g., particularly healthy or unhealthy facilities). Doing so may be useful to predict expected relative health care costs which can aid decision making. Similarly, Acme may wish to identify which of its 17 facilities has the healthiest workforce so that other facilities can model operations on that facility.
Still other embodiments include further features of analyzing data sets. As the system acquires new data sets, multiple data analysis and cultivation opportunities are presented. Indeed, an important advantage of some invention embodiments lies in their scalability. As the volume of data collected grows, the value of statistical and other information to be gained from the data grows. Analysis of accumulated data is not limited to averages for populations or groups. As an example, as data sets are added, some embodiments further interrogate and identify subgroups at a highly granular level. Such identification can be useful to achieve further predictive usefulness.
In addition to a relatively straightforward subgroup such as Acme employees from one factory, an illustrative example includes identifying a subgroup based on a behavioral change. Data sets for users that stop smoking, begin exercising, or have other behavior change(s) may be useful to offer guidance for others considering the same change as to how data will change in the future and otherwise what to anticipate in the future. Changes other than behavior can be used as well, with examples including loss of a specified amount of weight, geographic moves, employment changes, and others. Further, analysis may be performed from a results perspective going backward to identify subgroups. As an example, some embodiments may employ statistical analysis to identify common traits among users that have reported some measureable change in one or more biomarkers or other data (e.g., a weight loss of 10% or more). Some subgroup may be identified through such analysis that share some common trait(s).
In still another embodiment, a further security key(s) may be provided to access multiple different groups for comparison sake by a third party. Assume that in addition to Acme, the data of
Invention embodiments offer still further opportunities to achieve valuable benefits and advantages. As an example, in addition to test data, the central computer may receive, associate with a user and store in a database such as that illustrated in
In a still further example embodiment, advertising revenue is collected based on targeted advertising to users as they access data or otherwise interact with central computer 30. Some system, method, and program product embodiments of the invention provide targeted advertising over the network 20. As used herein, the term “targeted advertisement” is intended to broadly refer to selecting particular advertisements for specific users based on some data for that user, as opposed to using the same advertisement for all users. In invention embodiments the advertising is targeted based on some defined criteria using data stored by the central computer 30 related to particular users. In invention embodiments, the targeted ads may be determined based on test data sets, demographic data, or other data.
As an example, in some invention embodiments users that indicate they are high frequency exercisers may be targeted for exercise equipment advertising, users that are identified as having lost a significant amount of weight may be targeted for clothing advertisements (since they may need new clothing), users that indicate they are heavy alcohol users may be targeted for alcohol ads (or substance abuse treatment ads), suggestions for birthday dinners may be provided to a user in advance of a user birthday, and the like. Almost infinite opportunities will exist for targeted advertising as the scale of stored data grows. Advertisements may appear as pop-up or other visual content on a screen connected to the network 20, may be in the form of telephone calls, e-mail instant or other electronic communications, paper mail, or other.
Still other features of some invention embodiments include automated communication of test readers 16 over the network 20. This can be useful to update software running on test readers 16, to diagnose test readers 16 that require maintenance, to automatically track status of test readers 16, and for other purposes. In most embodiments, test readers 16 require execution of some stored program code. Such code will be updated from time to time, with different versions being identified using different version numbers. Likewise, test readers 16 may require periodic maintenance to check and/or repair operation of various components. In some invention embodiments, test readers 16 are configured to communicate over the network 20 with central computer 30 or other computer to address these tasks in an automated manner.
As an example, in some invention embodiments test readers 16 are configured to communicate over the network 20 with the central computer 30 or other computer on some regular interval to perform routine diagnostics. The diagnostics may check operation of various test reader 16 components and operation, and may identify test readers 16 or its components for repair. The interval may be selected as desired, with examples including every time the test reader 16 connects to the network 20, once a week, once a month, once quarterly, and once annually.
Likewise, in some embodiments test readers are configured to communicate over the network 20 with the central computer 30 or other computer on some regular interval to check for operating software updates. The test reader 16 may compare the version number of its operating software with that of the most currently available version available over the network 20, and if a more recent version is available it may automatically download the update. Again, the interval may be selected as desired, with examples including every time the test reader 16 connects to the network 20, once a week, once a month, once quarterly, and once annually.
Further, as described above in some embodiments test readers 16 are configured to store data necessary to provide test output reports without accessing the central computer 30. In these embodiments, test readers will store universe data on a local memory so that relative output data can be calculated. This universe data may be updated from time to time. In some embodiments, such updates are done automatically on a desired interval over the network 20. The test reader may communicate with the central computer 30 or other computer over the network 20 to determine if updated universe data is available. If it is, the test reader 16 may download it.
Various illustrations and discussion of example features of some invention embodiments has been made herein. It will be appreciated that this has been done by way of illustration only, and not limitation. Various features and elements of different embodiments can be altered, substituted for one another, omitted, changed in sequence or inter-relation, and otherwise altered within the scope of the invention as claimed.
| Number | Date | Country | |
|---|---|---|---|
| 61367486 | Jul 2010 | US |
| Number | Date | Country | |
|---|---|---|---|
| Parent | PCT/US2011/044786 | Jul 2011 | US |
| Child | 13397360 | US |
