[go: up one dir, main page]

US20030113701A1 - Self-scoring method and apparatus for early self-screening of neurological disease - Google Patents

Self-scoring method and apparatus for early self-screening of neurological disease Download PDF

Info

Publication number
US20030113701A1
US20030113701A1 US10/015,442 US1544201A US2003113701A1 US 20030113701 A1 US20030113701 A1 US 20030113701A1 US 1544201 A US1544201 A US 1544201A US 2003113701 A1 US2003113701 A1 US 2003113701A1
Authority
US
United States
Prior art keywords
odor
olfactory test
self
instruction
containing source
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Abandoned
Application number
US10/015,442
Other languages
English (en)
Inventor
William Gartner
Steven Feyrer-Melk
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
FMG INNOVATIONS Inc
Original Assignee
FMG INNOVATIONS Inc
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by FMG INNOVATIONS Inc filed Critical FMG INNOVATIONS Inc
Priority to US10/015,442 priority Critical patent/US20030113701A1/en
Assigned to FMG INNOVATIONS, INC. reassignment FMG INNOVATIONS, INC. ASSIGNMENT OF ASSIGNORS INTEREST (SEE DOCUMENT FOR DETAILS). Assignors: FEYRER-MELK, STEVEN, GARTNER, WILLIAM
Assigned to Quarles & Brady Streich Lang LLP reassignment Quarles & Brady Streich Lang LLP SECURITY INTEREST (SEE DOCUMENT FOR DETAILS). Assignors: FMG INNOVATIONS, INC.
Priority to PCT/US2002/039800 priority patent/WO2003051177A2/fr
Priority to AU2002353133A priority patent/AU2002353133A1/en
Publication of US20030113701A1 publication Critical patent/US20030113701A1/en
Priority to US10/694,664 priority patent/US6957038B1/en
Abandoned legal-status Critical Current

Links

Images

Classifications

    • G—PHYSICS
    • G09—EDUCATION; CRYPTOGRAPHY; DISPLAY; ADVERTISING; SEALS
    • G09B—EDUCATIONAL OR DEMONSTRATION APPLIANCES; APPLIANCES FOR TEACHING, OR COMMUNICATING WITH, THE BLIND, DEAF OR MUTE; MODELS; PLANETARIA; GLOBES; MAPS; DIAGRAMS
    • G09B3/00—Manually or mechanically operated teaching appliances working with questions and answers

Definitions

  • the present invention relates in general to a screening apparatus and method for evaluating a person's olfactory function and, more particularly, to a self-administered and self-scored apparatus and method for self-screening of human diseases and disorders.
  • AD Alzheimer's Disease
  • the disease manifests in the degeneration of nerve cells responsible for memory and thought processes.
  • AD has two physiological hallmarks: (1) plagues of largely insoluble plaques of beta-amyloid that develop in areas of the brain responsible for memory and cognitive functions and (2) neurofibrillary tangles, or abnormal collections of twisted threads inside nerve cells.
  • the ultimate cause of the disease remains unknown. Therefore, the diagnosis of AD can only be completely confirmed by examination of brain tissue following death to determine whether the levels of plaques and tangles in certain brain regions are characteristic of AD. Because there is no cure for AD, early diagnosis of AD is critical for patients in giving them the benefit of drug therapies that may alleviate more moderate, early symptoms of AD and enhance their quality of life. Early diagnosis allows for the most effective treatment, medical and social management, and personal and family planning.
  • AD Alzheimer's disease
  • physicians employ a battery of diagnostic tests, including a complete medical history, physical exam, blood and urine analysis, and memory and psychiatric assessment, such as the Wechsler Memory Test and the Mini Mental State Examination.
  • Assessment of olfactory function is employed in diagnosing AD.
  • Patients with various neurological disorders, including AD, Parkinson's Disease, Huntington's Disease, Down's Syndrome and schizophrenia often suffer an impaired sense of smell.
  • the patients exhibit signs of olfactory dysfunction even before the patients manifest other symptoms of AD.
  • Differential olfactory performance recognized between healthy and affected patients, along with lack of awareness of olfactory deficit provide a mechanism for early screening and diagnosis of AD.
  • Studies suggest that assessment of olfactory function is more reliable than standard cognitive capacity tests, and that diminished sense of smell, along with other factors, such as memory loss and genetic factors, provides the best indicator of AD.
  • Both principal methods are designed for general evaluation of olfactory function.
  • the vial test is reused until the scent diminishes.
  • the vial test requires a health care professional, such as a physician or nurse practitioner, to administer and score the test and then read and interpret the results.
  • the test card method may be self-administered, but a healthcare professional must still score the test and then read and interpret the results.
  • Both the vial test and test card methods are designed for and dependent on the active involvement of a healthcare professional to screen and interpret the resulting score for indications of neurological disease.
  • FIG. 1 is the front view of the contents of the self-screening olfactory test kit
  • FIG. 2 is the front view of a self-contained, self-administered, and self-scoring olfactory test booklet
  • FIG. 3A is the front view of the inside front cover of the olfactory test booklet and FIG. 3B is the front view of the outside back cover of the olfactory test booklet;
  • FIG. 4 is the front view of one odor page of a plurality of substantially uniform odor pages contained in the olfactory test booklet;
  • FIG. 5 is a three-dimensional view of one odor page of a plurality of uniform odor pages contained in the test booklet;
  • FIGS. 6A, 6B, 6 C, and 6 D are the front views of the self-scoring and self-screening instructions and mechanism contained in the olfactory test kit.
  • FIGS. 7A, 7B, 7 C, and 7 D are flowcharts depicting the self-administered, self-scoring and self-screening olfactory test method.
  • a self-screening olfactory test kit includes a test booklet 12 , a sharpened pencil 18 , an information booklet 14 , and a physician's information card 16 .
  • the components are packaged in a sealed paper box 10 with an expiration date placed on the box.
  • FIG. 2 shows a self-contained, self-administered, disposable test booklet 12 for detecting decreased olfactory function as an early sign of neurological disease, in particular, Alzheimer's disease.
  • Test booklet 12 comprises a plurality of individual strips of paper each measuring 32.0 cm in length by 8.0 cm in width. The strips are folded in half length-wise and are stapled twice in middle of the length, creating pages in booklet form that are 16.0 cm in length by 8.0 cm in width.
  • Test booklet 12 uses seven strips of paper, creating fourteen pages, each with a front side and a back side, when assembled, including twelve inside pages, a front cover and a back cover. The outside of the front cover of test booklet 12 is illustrated in FIG.
  • FIG. 3A Inside front cover 22 is illustrated in FIG. 3A. Outside back cover 24 is illustrated in FIG. 3B. Inside back cover 38 is answer key 40 illustrated in FIG. 6A. Odor pages 28 are substantially uniform, each oriented to a different odor-containing source, odor strip 36 , and laid out as shown in FIG. 4. The first eleven odor pages 28 are blank on the back side. Back side of last odor page 44 is illustrated in FIG. 6B.
  • FIG. 3A shows inside front cover 22 of test booklet 12 .
  • Bulleted points labeled “important” are written on inside front cover 22 .
  • the bulleted points include: (1) smell loss is the among the first signs of Alzheimer's disease; this screening test measures your ability to smell; (2) do not attempt this screening test if you currently have nasal congestion or long-lasting smell loss due to other known causes; (3) do not scratch the odor strip until you are ready to sniff the odor; (4) poor performance on this screening test does not necessarily mean you have Alzheimer's disease; (5) this screening test works only if the directions are followed precisely as noted; (6) this screening test can only be used one time and prior to the expiration date; discard after use; (7) decreased olfactory function (sense of smell) is not the only indicator of Alzheimer's disease; (8) decreased olfactory function (sense of smell) can be found in older individuals without Alzheimer's disease; (9) do not turn to the answer key or look at the answer key until you have completed the test.
  • FIG. 3B shows outside back cover 24 of test booklet 12 .
  • Bulleted points labeled “test booklet storage and handling” are written on outside back cover 24 .
  • the bulleted points include: (1) store this screening test kit in a dry place below 86° F. (30° C.); do not refrigerate; (2) do not scratch microencapsulated odor strips until ready to use; (3) sniff microencapsulated odor strips immediately after scratching; (4) do not contact microencapsulated odor strips with any liquid; (5) do not re-use microencapsulated odor strips; discard test after use; (6) this screening test can only be used one time and prior to the expiration date.
  • Phrase 26 “single use only —discard after use” is written below the bullet points.
  • FIG. 4 shows one odor page 28 of a plurality of substantially uniform pages.
  • Test booklet 12 is comprised of twelve substantially uniform pages.
  • the back of odor page 28 is blank, except back side of last odor page 44 which is shown in FIG. 6B.
  • Each odor page 28 contains the same instructions 30 on the left side of the front of odor page 28 labeled “easy step-by-step instructions.” Instructions 30 comprise illustrated step-by-step directions for self-administration of the test.
  • the first instruction is numbered as one and says “use pencil provided, scratch odor strip in a ZIG-ZAG.”
  • Immediately under the instruction is an illustration of odor strip 36 with a zig-zag line crossing horizontally from the left to the right, back to the left and then again to the right.
  • the next instruction is numbered as two and says “place odor strip directly under both nostrils and sniff.”
  • To the right of instruction number two is an illustration of odor page 28 of test booklet 12 with an arrow pointing from odor strip 36 to the right to an illustration of a front view of a human head, the arrow terminating below the nostrils.
  • the next instruction is numbered three and says “circle the best answer. You must circle one answer.” Immediately under the instruction is the phrase “your choice” with a circle around it.
  • the next eleven odor pages 28 contain identical instructions 30 , in the same orientation.
  • the right side of the front of odor page 28 has an odor number 32 , labeled as “ODOR #,” written in the upper right corner.
  • the first odor page is labeled “Odor # 1 ,” and each of the next eleven odor pages 28 are labeled with an increasing sequential odor number 32 , e.g., “Odor # 2 ,” “Odor # 3 ,” etc.
  • Below odor number 32 the phrase “this odor smells most like:” is written. Immediately underneath that phrase, in parentheses, is written “circle one.”
  • odor labels 34 are listed above the odor-containing source, odor strip 36 .
  • Odor labels 34 are displayed in a right-justified, vertical list with one odor label per horizontal line.
  • Four possible odor labels 34 are listed as possible identities for each odor strip 36 where one odor label is the correct identity for each odor strip 36 .
  • Using four possible odor labels 34 for each odor strip 36 decreases the expected score on the basis of random responding to three, or twenty-five percent. Therefore, this increases the probability that a low score, between four and eight, is due to olfactory dysfunction and not a false-positive result due to malingering.
  • the sets of odor labels 34 as possible identities for each odor strip 36 are: (1) fruit, cinnamon, woody and coconut, where cinnamon is the correct identity; (2) turpentine, soap, dog and black pepper, where turpentine is the correct identity; (3) motor oil, garlic, rose and lemon, where lemon is the correct identity; (4) apple, grass, smoke and grape, where smoke is the correct identity; (5) lemon, strawberry, chocolate and black pepper, where chocolate is the correct identity; (6) mint, rose, lime and fruit where rose is the correct identity; (7) watermelon, peanut, rose and paint thinner, where paint thinner is the correct identity; (8) banana, garlic, cherry and motor oil, where banana is the correct identity; (9) smoke, whiskey, pineapple and onion, where pineapple is the correct identity; (10) rose, lemon, apple and gasoline, where gasoline is the correct identity; (11) soap, black pepper, chocolate and peanut, where soap is the correct identity; (12) chocolate, banana, onion and fruit, where onion is the correct identity.
  • Odor labels 34 listed above are used because studies indicate that particular scents corresponding to odor labels 34 are universally familiar and recognizable by persons from a variety of cultures.
  • the terms used as odor labels 34 are also selected to maximize recognition across a diverse population. For example, the term “woody” is used instead of “pine” because “woody” is a culture-free response as opposed to “pine.”
  • Using cross-culturally recognized odor labels 34 reduces examinee confusion resulting from unfamiliarity with the scent corresponding to each odor label. Therefore, false-positive test results detecting examinee confusion due to cultural unfamiliarity with odor labels 34 , rather than actual olfactory dysfunction, are reduced.
  • odor labels 34 are grouped in a particular manner described above because the scents corresponding to odor labels 34 on each odor page 28 are different and distinct from one another. Providing groupings of odor labels 34 with readily distinguishable scents decreases examinee confusion not due to actual olfactory dysfunction. Gross, rather than small, differences in scent between odor labels 34 , decreases the likelihood of false-positive test results due to a confusion between scents. Therefore, the particular selection and grouping of odor labels 34 decreases the occurrence of false-positive test results and increases the reliability of the olfactory test as an indicator of olfactory dysfunction.
  • the printed rectangle allows for consistent uniform attachment of odor strip 36 to odor page 28 during assembly of test booklet 12 .
  • Each odor page 28 has a different odor strip 36 attached in the printed rectangle to odor page 28 via adhesive.
  • FIG. 5 is a three-dimensional view of odor page 28 .
  • Odor strip 36 is an odor-containing source. Odor strip 36 contains a plurality of rupturable microcapsules. A distinct scent is located within the microcapsules which is emitted when the microcapsules rupture or burst, as a result of scratching the surface of odor strip 36 with pencil 18 . Other objects can be used to scratch the surface of odor strip 36 so as to accomplish rupture. As the microcapsules are ruptured, a burst of fragrance of the distinct scent contained within the microcapsules is given off. Pencil 18 is provided in the test kit for the examinee to use to scratch the surface of odor strip 36 and rupture the microcapsules.
  • Odor strip 36 is a rectangular strip of paper with rounded corners measuring 4.0 cm in length by 1.25 cm in width. Each odor page 28 contains one odor strip 36 each containing one of the following odors: cinnamon, turpentine, lemon, smoke, chocolate, rose, paint thinner, banana, pineapple, gasoline, soap, and onion. A particular odor strip 36 is chosen from the grouping of odor labels 34 to provide a diverse, cross-cultural olfactory test. Odor strips 36 comprise six food-related odor strips and six nonfood-related odor strips. Odor strips 36 are also chosen based on commercial availability.
  • Each odor strip 36 has a unique distinguishing visual feature.
  • Each odor strip 36 is a different color. The following color corresponds to each odor strip 36 : (1) for cinnamon, brown; (2) for turpentine, light yellow; (3) for lemon, light green; (4) for smoke, peach; (5) for chocolate, light pink; (6) for rose, white; (7) for paint thinner, gray; (8) for banana, dark pink; (9) for pineapple, orange; (10) for gasoline, green; (11) for soap, dark yellow; and (12) for onion, blue.
  • Different colored odor strips are used for post-assembly verification and quality assurance.
  • each odor page 28 can be checked to ensure that the correct odor strip 36 was attached to its respective corresponding odor number 32 .
  • Other colors can be used to distinguish odor strips 36 .
  • other coding schemes using distinguishing visual features can be employed.
  • FIG. 6A is inside back cover 38 of test booklet 12 containing answer key 40 .
  • Answer key cover 43 is paper, 16.0 cm in length by 7.0 cm in width attached 1.0 cm below the top of inside back cover 38 via adhesive. The paper is dense to prevent the text of answer key 40 from being visible through answer key cover 43 .
  • the bottom of inside back cover 38 and bottom of answer key cover 43 are attached with a breakable seal. Answer key cover 43 hides answer key 40 from view until the seal is broken and answer key cover 43 is lifted to view answer key 40 .
  • Odor # 1 cinnamon
  • Odor # 2 turpentine
  • Odor # 3 lemon
  • Odor # 4 smoke
  • Odor # 5 chocolate
  • Odor # 6 rose
  • Odor # 7 paint thinner
  • Odor # 8 banana
  • Odor # 9 pineapple
  • Odor # 10 gasoline
  • Odor # 11 soap
  • FIG. 6B illustrates top half 46 of back side of last odor page 44 .
  • Top half 46 of FIG. 6B is labeled “scoring the test” and gives instructions for self-scoring the olfactory test from answer key 40 .
  • Self-scoring reveals the number of odor-containing sources examinee incorrectly identified. The total number of incorrect identifications is used in self-screening a positive or negative result of the olfactory test.
  • the step-by-step instructions for self-scoring are: (1) after sniffing all 12 odor strips 36 and circling one answer per page, remove answer key cover 43 and look at answer key 40 , FIG. 6A, to the right of this page; (2) starting with Odor # 1 , compare the correct answer found on answer key 40 with the one you circled; if the two do not match, place a line through Odor # 1 on answer key 40 ; (3) a scoring example if answer key and the odor label choice do not match is given in information booklet 14 ; (4) if you chose correctly and the two match, go to Odor # 2 ; continue until you have viewed and scored each odor for correctness (Odor # 1 through Odor # 12 ); (5) after comparing each of your circled answers to answer key 40 , total the number of odors you have placed a line through (incorrect answers); and (6) write that number in blank box 42 provided on answer key 40 .
  • FIG. 6B also illustrates bottom half 48 of back side of last odor page 44 .
  • Bottom half 48 provides instructions for self-screening to determine a positive or negative result of the olfactory test based on the total number of incorrect answers self-scored from answer key 40 .
  • Bottom half 48 is labeled “reading the results.” Below the label are the self-screening instructions: “after carefully totaling the number of incorrect answers and writing that number in the ‘total number incorrect’ box, you can read your results. If you have 4 or more incorrect items you should consult your physician. If you do not have 4 or more incorrect items and are experiencing symptoms of Alzheimer's disease (see signs and symptoms of section found in the information booklet), contact your physician.
  • Early Alert is not a diagnostic test nor a conclusive test for Alzheimer's disease. Early Alert has been designed to assist in early detection of possible Alzheimer's disease by testing your sense of smell. Further testing is recommended. Poor performance on this screening test does not necessarily mean you have Alzheimer's disease. See information booklet.”
  • FIG. 6C is information booklet 14 .
  • Information booklet 14 comprises one blue sheet of paper 28.0 cm in length by 16.75 cm in width. The paper is folded in half lengthwise to create a four page booklet that is 14.0 cm in length by 16.75 cm in width. On the first page, information booklet 14 is titled “Information Booklet” and subtitled “Early Alert Home Screening Test for Alzheimer's Disease.”
  • the first page contains an initial instruction under the subtitle to “please read all of the instructions completely before performing the screening test. The directions will help you correctly perform the test and read the results.” A telephone help line number and a website address are also listed. Following the initial instruction is text labeled “information about the test.” The text states that “smell loss is among the first signs of Alzheimer's disease (AD).
  • the Early Alert Alzheimer's Home Screening Test is a smell test that allows an individual to determine if a loss of olfactory function (the ability to smell) is present. Although not all older persons with smell loss have AD, such loss, alone or in combination with memory problems and/or certain genetic markers, is among the best predictors or indicators of AD.
  • the text lists the contents of the test kit as described in FIG. 1.
  • bulleted statements labeled “test booklet storage and handling” follow.
  • the bulleted statements are the same as the bulleted points described on outside back cover 22 .
  • Additional bulleted statements labeled “test limitations” subsequently follow.
  • the statements are: (1) the Early Alert screening test works only if the directions are followed precisely as noted; (2) the Early Alert screening test kit can only be used one time and prior to the expiration date; (3) decreased olfactory function (sense of smell) is not the only indicator of potential AD; and (4) decreased olfactory function (sense of smell) can be found in older individuals without AD.
  • test validity and reliability is the most widely employed means of quantitatively assessing the sense of smell. Numerous published scientific and medical studies have employed this exact format and a number have found smell loss to be among the first, if no the first signs of AD. In some cases these studies demonstrated that such loss more or less predicts who, among at-risk individuals, will likely develop AD eventually.”
  • the second page located on the reverse of the first page, is titled “directions” and subtitled “how to take the test.”
  • the second page is divided into two sections.
  • the first section is labeled “cautions,” and comprises bulleted statements.
  • the statements are: (1) do not attempt the screening test if you currently have nasal congestion or long-lasting smell loss due to other known causes; (2) do not scratch the odor strip until you are ready to sniff the odor; (3) poor performance on the screening test does not necessarily mean you have Alzheimer's disease; (4) read all of the contents of this information booklet before you begin the screening test; (5) do not turn to the answer key or look at the answer key before completing the test.
  • the second section is labeled “directions” and contains sequentially numbered instructions and illustrations. Instruction number one is “open the screening test booklet to the first page, which is titled Odor # 1 .” The next two instructions are the same as the first two instructions 30 on odor page 28 , with the same illustrations.
  • Instruction number four is “look at the choices provided on the page located above the odor strip. If you are not sure or no smell is present, pick the one that seems closest. Circle the best answer. You must circle one answer.” Centered under instruction number four is the phrase “example of answer choice.” Centered below the phrase is a vertical list, one choice per horizontal line, of four odor labels: fruit, cinnamon, coconut, and woody. Fruit is circled. Instruction number five is “turn the page of the test booklet to the second page which contains Odor # 2 . Repeat Step 2 through Step 4 above.” Instruction number six is “continue this process until all 12 odor strips have been sniffed and an answer has been circled for each odor.”
  • the third page labeled “directions” comprises three sections.
  • the first section is labeled “how to score the test.”
  • the text in the first section is the same as top half 46 of back side of last odor page 44 .
  • the text is an illustration of how to self-score each answer.
  • the example shows “Odor # 1 Woody” with a line through, i.e. “Odor # 1 Woody.”
  • an illustration of blank box 42 1.75 cm in length by 0.4 cm in width, is given to the right of the phrase “total number incorrect.”
  • the second section is labeled “reading the results.”
  • the text in the second section is the same text found in bottom half 48 of back side of last odor page 44 .
  • the third section is labeled “frequently asked questions.” Seven questions, each question labeled on the left with a “Q,” are paired with an answer, labeled on the left with an “A.” The seven questions and paired answers are: (1) Why do I want to take a home screening test for Alzheimer's? Early diagnosis is very important. Increasing you awareness of possible Alzheimer's disease can help you receive further testing which may lead to potential diagnosis.
  • the fourth page is untitled and contains three sections.
  • the first section is labeled “Alzheimer's Disease—more information.”
  • the first section provides general information on Alzheimer's Disease and lists websites with more information on Alzheimer's Disease.
  • the second section is labeled “signs and symptoms.”
  • the section begins with “the following information is taken from a widely distributed list of warning signs for Alzheimer's disease.”
  • the statement is then followed eight items arranged in a two column vertical unnumbered list, with four items in each column.
  • the items in the first, left column are: (1) misplacing things; (2) word finding problems; (3) poor or decreased judgment; and (4) recent memory loss.
  • the items in the second, right column are: (1) difficulty performing familiar tasks; (2) disorientation to time and place; (3) loss of interest; and (4) changes in mood or behavior.
  • the third section is labeled “medical and scientific references.” The third section lists journal articles on Alzheimer's Disease and olfactory dysfunction.
  • FIG. 6D is physician's information card 16 labeled “physician's information.”
  • Physician's information card 16 comprises one sheet of paper, 17.0 cm in length by 8.5 cm in width.
  • Physician's information card 16 has text printed on both the front side of the card and the back side of the card.
  • Immediately below the title on the front side of the physician's information card are the statements: “we strongly recommend that you bring this card with you when conferring with your physician. We also suggest that you bring the screening test and information booklet.”
  • Physician information card 16 is then formatted as a letter to the physician, beginning, “dear physician.” The text of the letter explains the olfactory test methodology and indications of a positive result.
  • FIG. 7A is a flowchart of the preparation for self-administration the olfactory test.
  • An examinee opens in step 60 the sealed paper box 10 and removes in step 60 the contents: test booklet 12 , information booklet 14 , physician information card 16 , and pencil 18 .
  • step 62 examinee reads information booklet 14 .
  • step 64 if examinee has long lasting smell loss due to other known causes, examinee is instructed in step 76 not to take the olfactory test. If not, but in step 66 examinee currently has nasal congestion, examinee is instructed in step 78 not to take the olfactory test and, in step 86 , to store the test until nasal congestion clears. In steps 80 through 84 , examinee stores the test in a dry place at a temperature below 30° C. (86° F.), but does not refrigerate the test. If examinee fails to comply with the storage instructions, then step 76 instructs examinee not to take the olfactory test and to discard the test.
  • step 76 instructs examinee not to take the olfactory test and to discard the test. If not, then in step 74 , examinee may begin the olfactory test.
  • FIG. 7B is a flowchart of the self-administration method of the olfactory test.
  • examinee breaks the seal of test booklet 12 and in step 90 opens test booklet 12 to inside front cover 22 .
  • step 92 examinee reads the points labeled “important” on inside front cover 22 . If examinee has looked at answer key 40 in step 94 , then in step 96 , examinee is instructed not to take the olfactory test.
  • step 94 if examinee has not looked at answer key 40 , then in step 98 , examinee looks at first odor page 28 .
  • step 100 examinee uses the sharp end of pencil 18 to scratch odor strip 36 several times in a zig-zag fashion, releasing the odor from the odor-containing area.
  • step 102 examinee places odor strip 36 directly under both nostrils and in step 104 , sniffs odor strip 36 .
  • step 106 examinee looks at odor labels 34 and in step 108 , uses pencil 18 to circle the odor label that odor strip 36 smells most like.
  • step 110 if odor page 28 is not odor # 12 , then in step 112 , examinee turns to the next odor page 28 and repeats steps 100 through 110 . When in step 110 the odor number is twelve, then examinee begins to score the test in step 114 .
  • FIG. 7C is a flowchart of the olfactory test's self-scoring method to determine a number of incorrect answers that indicate a positive result.
  • step 114 after examinee circles an odor label for Odor # 12 , examinee turns in step 116 to back side of last page 44 , and in step 118 reads the “scoring the test” section on top half 46 .
  • step 120 examinee looks at answer key 40 on inside back cover 38 .
  • step 122 examinee looks at the answer for odor # 1 .
  • step 124 examinee then looks at the circled odor label for odor # 1 .
  • step 126 if the circled label for odor # 1 matches the answer for odor # 1 in answer key 40 , examinee looks at the next odor number and repeats steps 124 through 132 . If in step 126 , the answer for odor # 1 does not match the circled odor label for odor # 1 , then examinee, in step 128 , uses pencil 18 to draw a line through the answer in answer key 40 , and then repeats steps 124 through 132 .
  • step 132 When in step 132 , the odor number is twelve, examinee counts in step 134 the answers in answer key 40 with a line through (the incorrect answers). In step 136 , examinee records the total number of incorrect answers in blank box 42 provided next to the phrase “total incorrect number.” In step 138 , examinee then self-screens the score.
  • FIG. 7D is a flowchart of the olfactory test's self-screening method to determine a positive or negative result from the total number of incorrect answers self-scored from answer key 40 .
  • examinee reads bottom half 48 of back side of last odor page 44 , “reading the results.” If examinee's total incorrect number is four or more, examinee is instructed to consult a physician in step 150 . If the examinee needs to consult a physician in step 150 , then examinee is further instructed in step 152 to take physician's information card 16 to the physician.
  • step 142 if examinee's total incorrect number is less than four, then examinee is instructed in step 144 to read the section in information booklet 14 labeled “signs and symptoms.”
  • step 146 if examinee is experiencing any of the listed signs or symptoms of Alzheimer's Disease, examinee is instructed in step 150 to consult a physician. If the examinee needs to consult a physician in step 150 , then examinee is further instructed in step 152 to take physician's information card 16 to the physician. If examinee's total number incorrect is less than four in step 142 and examinee is not experiencing any listed signs or symptoms of Alzheimer's Disease in step 146 , examinee in step 148 needs to take no further action.
  • the self-screening olfactory test kit eliminates the need for healthcare professional involvement for initial screening of neurological disease.
  • the olfactory test kit requires only a small time commitment since an individual can self-administer and self-score the olfactory test in about five minutes. Additionally, the cost of the olfactory test kit for individual desiring initial screening of neurological disease is minimal compared with an office visit to a healthcare professional.
  • the olfactory test kit provides individuals with a simple self-screening method to determine a positive result of the olfactory test upon incorrectly identifying one-third or more of the total number of odor-containing areas.
  • a positive result of the olfactory test is an indication of olfactory dysfunction which is not a diagnosis of neurological disease rather an indication that an individual should take further action regarding possible neurological disease, such as consulting a physician.
  • Individuals not only self-administer the olfactory test in a private, in-home setting, but also self-score the olfactory test to determine themselves if the results indicate that further action is required.
  • the olfactory test kit is a quick, inexpensive, private, self-screening, diagnostic tool that does not incur anxiety associated with healthcare professional involvement. As a result, the olfactory test kit will avail more individuals of the benefits of early screening of possible neurological disease.

Landscapes

  • Engineering & Computer Science (AREA)
  • Business, Economics & Management (AREA)
  • Physics & Mathematics (AREA)
  • Educational Administration (AREA)
  • Educational Technology (AREA)
  • General Physics & Mathematics (AREA)
  • Theoretical Computer Science (AREA)
  • Investigating Or Analysing Biological Materials (AREA)
  • Medicines Containing Plant Substances (AREA)
US10/015,442 2001-12-13 2001-12-13 Self-scoring method and apparatus for early self-screening of neurological disease Abandoned US20030113701A1 (en)

Priority Applications (4)

Application Number Priority Date Filing Date Title
US10/015,442 US20030113701A1 (en) 2001-12-13 2001-12-13 Self-scoring method and apparatus for early self-screening of neurological disease
PCT/US2002/039800 WO2003051177A2 (fr) 2001-12-13 2002-12-12 Methode et dispositif auto-evalues pour l'auto-depistage precoce de maladies neurologiques
AU2002353133A AU2002353133A1 (en) 2001-12-13 2002-12-12 Self-scoring method and apparatus for early self-screening of neurological disease
US10/694,664 US6957038B1 (en) 2001-12-13 2003-10-29 Self-scoring method and apparatus for early self-screening of neurological disease

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
US10/015,442 US20030113701A1 (en) 2001-12-13 2001-12-13 Self-scoring method and apparatus for early self-screening of neurological disease

Related Child Applications (1)

Application Number Title Priority Date Filing Date
US10/694,664 Continuation US6957038B1 (en) 2001-12-13 2003-10-29 Self-scoring method and apparatus for early self-screening of neurological disease

Publications (1)

Publication Number Publication Date
US20030113701A1 true US20030113701A1 (en) 2003-06-19

Family

ID=21771428

Family Applications (2)

Application Number Title Priority Date Filing Date
US10/015,442 Abandoned US20030113701A1 (en) 2001-12-13 2001-12-13 Self-scoring method and apparatus for early self-screening of neurological disease
US10/694,664 Expired - Fee Related US6957038B1 (en) 2001-12-13 2003-10-29 Self-scoring method and apparatus for early self-screening of neurological disease

Family Applications After (1)

Application Number Title Priority Date Filing Date
US10/694,664 Expired - Fee Related US6957038B1 (en) 2001-12-13 2003-10-29 Self-scoring method and apparatus for early self-screening of neurological disease

Country Status (3)

Country Link
US (2) US20030113701A1 (fr)
AU (1) AU2002353133A1 (fr)
WO (1) WO2003051177A2 (fr)

Cited By (18)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20060183099A1 (en) * 2005-02-14 2006-08-17 Feely Richard A Education and test preparation system, method and computer program product
WO2006135368A1 (fr) * 2005-06-10 2006-12-21 The Trustrees Of Columbia University In The City Of New York Tests d’identification olfactive pour maladies et troubles cognitifs
WO2009045481A1 (fr) * 2007-10-04 2009-04-09 Nestec S. A. Compositions et procédés permettant d'améliorer la fonction cognitive
FR2923064A1 (fr) * 2007-10-31 2009-05-01 Hill Rom Sas Soc Par Actions S Dispositif pour stimuler la memoire d'un patient.
EP2174585A1 (fr) * 2008-09-29 2010-04-14 Carlo Maremmani Kit de test d'identification olfactive pour déterminer des troubles neurologiques
US20130059283A1 (en) * 2011-09-07 2013-03-07 Sharp Kabushiki Kaisha Dementia care support system
WO2014113645A1 (fr) * 2013-01-18 2014-07-24 University Of Florida Research Foundation, Inc. Procédés et tests pour troubles dégénératifs du système nerveux central
US20140349260A1 (en) * 2013-05-24 2014-11-27 Deborah L. HILL Promises tracking device and method thereof for enhancement of behavior control
US20150177202A1 (en) * 2013-12-20 2015-06-25 University Of Tennessee Research Foundation Odor threshold test
US20150216414A1 (en) * 2012-09-12 2015-08-06 The Schepens Eye Research Institute, Inc. Measuring Information Acquisition Using Free Recall
US20160220165A1 (en) * 2015-06-30 2016-08-04 Safa Taherkhani Detecting olfactory malingering
US20170345334A1 (en) * 2016-05-25 2017-11-30 Michael DIGIORGIO Online Training with Live Instruction
JP2018143281A (ja) * 2017-03-01 2018-09-20 小林製薬株式会社 嗅覚検査キット
TWI701015B (zh) * 2019-06-27 2020-08-11 牛耳國際生技有限公司 嗅覺測試裝置及嗅覺測試方法
WO2021217118A1 (fr) * 2020-04-24 2021-10-28 The General Hospital Corporation Systèmes et procédés d'administration de test olfactif par rapport à des coronavirus à sras et à la covid-19
US11337640B2 (en) * 2020-10-16 2022-05-24 Monell Chemical Senses Center Multifunctional smell test
USD972421S1 (en) 2020-07-17 2022-12-13 Derek Kalev Toomre Multi-odorant testing device
WO2025221811A1 (fr) * 2024-04-15 2025-10-23 The General Hospital Corporation Méthodes d'évaluation de la maladie d'alzheimer au stade préclinique

Families Citing this family (10)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US7835922B2 (en) * 2004-07-08 2010-11-16 Astrazeneca Ab Diagnostic system and method
US7422435B2 (en) * 2004-12-02 2008-09-09 Holt Christopher L Task-oriented book with functional features for facilitating experiential learning
US20070248542A1 (en) * 2006-04-24 2007-10-25 Bodybio, Inc. Devices and methods for individualized detection of nutrient imbalance via olfactory system
US20090287064A1 (en) * 2008-05-15 2009-11-19 Medical Interactive Education, Llc Computer implemented cognitive self test
US8043214B2 (en) * 2009-03-05 2011-10-25 Puthalath Koroth Raghuprasad Neuro-aid
US20130081961A1 (en) * 2011-10-03 2013-04-04 Ferdinand Konan Kouadio Fragrance testing strips combined with a nose clearing devise
US9801581B2 (en) 2013-10-22 2017-10-31 Inspired Technologies, Inc. Devices, systems and methods for detecting a bilateral differential in olfactory threshold for pure odorants
US9717454B2 (en) 2014-07-11 2017-08-01 Inspired Technologies, Inc. Method of ruling out Alzheimer's disease
EP3245944A1 (fr) * 2016-05-20 2017-11-22 Institut Pasteur Moyens olfactifs pour diagnostiquer des complications neurologiques d'une infection du système nerveux
USD1010664S1 (en) 2020-09-12 2024-01-09 u-Smell-it LLC Display screen with a graphical user interface

Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3570139A (en) * 1969-08-18 1971-03-16 Janice S Ladd Teaching apparatus
US4687203A (en) * 1986-05-15 1987-08-18 Donald Spector Scratch and smell game

Family Cites Families (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US2977689A (en) * 1958-10-30 1961-04-04 Gerhard T Rugland Multiple choice response device
US3359656A (en) * 1966-01-13 1967-12-26 Courier Citizen Company Answer sheet indicating correctness and recording errors
WO1989000398A1 (fr) * 1987-07-17 1989-01-26 The Regents Of The University Of California Test utilise pour le diagnostic de la maladie d'alzheimer
US5230629A (en) * 1991-03-01 1993-07-27 Albert Einstein College Of Medicine Of Yeshiva University Device and method for assessing cognitive speed
US5380765A (en) 1992-09-30 1995-01-10 Hirsch; Alan R. Chemosensory olfactory assay for psychiatric disorders
US5447439A (en) * 1993-07-09 1995-09-05 Nathanson; Ted Interactive story book using stickers and a method of teaching
US6325475B1 (en) 1996-09-06 2001-12-04 Microfab Technologies Inc. Devices for presenting airborne materials to the nose
US6152887A (en) * 1998-02-27 2000-11-28 Blume; Richard Stephen Method and test kit for oral sampling and diagnosis
US6557394B2 (en) * 2001-04-02 2003-05-06 Richard L. Doty Smell test device

Patent Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3570139A (en) * 1969-08-18 1971-03-16 Janice S Ladd Teaching apparatus
US4687203A (en) * 1986-05-15 1987-08-18 Donald Spector Scratch and smell game

Cited By (21)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20060183099A1 (en) * 2005-02-14 2006-08-17 Feely Richard A Education and test preparation system, method and computer program product
WO2006135368A1 (fr) * 2005-06-10 2006-12-21 The Trustrees Of Columbia University In The City Of New York Tests d’identification olfactive pour maladies et troubles cognitifs
WO2009045481A1 (fr) * 2007-10-04 2009-04-09 Nestec S. A. Compositions et procédés permettant d'améliorer la fonction cognitive
RU2507742C2 (ru) * 2007-10-04 2014-02-27 Нестек С.А. Композиции и способы усиления когнитивной функции
FR2923064A1 (fr) * 2007-10-31 2009-05-01 Hill Rom Sas Soc Par Actions S Dispositif pour stimuler la memoire d'un patient.
WO2009056766A1 (fr) * 2007-10-31 2009-05-07 Hill-Rom S.A.S. Dispositif pour stimuler la memoire d'un patient
EP2174585A1 (fr) * 2008-09-29 2010-04-14 Carlo Maremmani Kit de test d'identification olfactive pour déterminer des troubles neurologiques
US20130059283A1 (en) * 2011-09-07 2013-03-07 Sharp Kabushiki Kaisha Dementia care support system
US20150216414A1 (en) * 2012-09-12 2015-08-06 The Schepens Eye Research Institute, Inc. Measuring Information Acquisition Using Free Recall
WO2014113645A1 (fr) * 2013-01-18 2014-07-24 University Of Florida Research Foundation, Inc. Procédés et tests pour troubles dégénératifs du système nerveux central
US20140349260A1 (en) * 2013-05-24 2014-11-27 Deborah L. HILL Promises tracking device and method thereof for enhancement of behavior control
US20150177202A1 (en) * 2013-12-20 2015-06-25 University Of Tennessee Research Foundation Odor threshold test
US20160220165A1 (en) * 2015-06-30 2016-08-04 Safa Taherkhani Detecting olfactory malingering
US20170345334A1 (en) * 2016-05-25 2017-11-30 Michael DIGIORGIO Online Training with Live Instruction
JP2018143281A (ja) * 2017-03-01 2018-09-20 小林製薬株式会社 嗅覚検査キット
TWI701015B (zh) * 2019-06-27 2020-08-11 牛耳國際生技有限公司 嗅覺測試裝置及嗅覺測試方法
WO2021217118A1 (fr) * 2020-04-24 2021-10-28 The General Hospital Corporation Systèmes et procédés d'administration de test olfactif par rapport à des coronavirus à sras et à la covid-19
USD972421S1 (en) 2020-07-17 2022-12-13 Derek Kalev Toomre Multi-odorant testing device
USD1027687S1 (en) 2020-07-17 2024-05-21 Derek Kalev Toomre Multi-odorant testing device
US11337640B2 (en) * 2020-10-16 2022-05-24 Monell Chemical Senses Center Multifunctional smell test
WO2025221811A1 (fr) * 2024-04-15 2025-10-23 The General Hospital Corporation Méthodes d'évaluation de la maladie d'alzheimer au stade préclinique

Also Published As

Publication number Publication date
WO2003051177B1 (fr) 2003-10-30
AU2002353133A1 (en) 2003-06-30
US6957038B1 (en) 2005-10-18
WO2003051177A2 (fr) 2003-06-26
AU2002353133A8 (en) 2003-06-30
WO2003051177A3 (fr) 2003-09-25

Similar Documents

Publication Publication Date Title
US6957038B1 (en) Self-scoring method and apparatus for early self-screening of neurological disease
Franzen et al. The detection of malingering in neuropsychological assessment
Duclos et al. Impairment of social cognition in neurological diseases
Nies et al. Neuropsychological assessment and malingering: A critical review of past and present strategies
McCarthy Situated clinical reasoning: Distinguishing acute confusion from dementia in hospitalized older adults
Pentzek et al. Odor identification in Alzheimer’s disease and depression
Pryor et al. Laxative abuse among women with eating disorders: an indication of psychopathology?
Tidwell et al. Youth at risk: In search of a definition
US20070077204A1 (en) Olfactory identification tests for cognitive diseases and disorders
Mancini et al. Graduate nursing students and stress
Sala et al. Slowly progressive impairment of spatial exploration and visual perception
Kay et al. Preliminary evaluation of a scale to assess cognitive function in adults with Down's syndrome: the Prudhoe Cognitive Function Test
WO2006135368A1 (fr) Tests d’identification olfactive pour maladies et troubles cognitifs
Kean et al. A study of confidential unit exclusion
Glascoe Developmental and behavioral screening
Gamino et al. Who needs grief counseling? A report from the Scott & White Grief Study
Gass Use of the MMPI-2 in Neuropsychological Evaluations.
JP2005013713A (ja) 注意機能の測定と学習方法及び装置
Clarizio et al. A survey of school psychologists' perspectives and practices with childhood depression
Creswell et al. Underlying self-esteem in chronic fatigue syndrome
Hodges et al. The multidisciplinary memory clinic approach
Rapin Physicians' testing of children with developmental disabilities
Horton Jr The Halstead-Reitan neuropsychological test battery: past, present, and future
Davis PEDIATRIC
Hutchinson The Luria-Nebraska Neuropsychological Battery controversy: A reply to Spiers.

Legal Events

Date Code Title Description
AS Assignment

Owner name: FMG INNOVATIONS, INC., ARIZONA

Free format text: ASSIGNMENT OF ASSIGNORS INTEREST;ASSIGNORS:GARTNER, WILLIAM;FEYRER-MELK, STEVEN;REEL/FRAME:012597/0768;SIGNING DATES FROM 20011127 TO 20011218

AS Assignment

Owner name: QUARLES & BRADY STREICH LANG LLP, ARIZONA

Free format text: SECURITY INTEREST;ASSIGNOR:FMG INNOVATIONS, INC.;REEL/FRAME:013096/0578

Effective date: 20020708

STCB Information on status: application discontinuation

Free format text: ABANDONED -- FAILURE TO RESPOND TO AN OFFICE ACTION