Proceeding
`Party
`
`Trademark Trial and Appeal Board Electronic Filing System. http://estta.uspto.gov
`ESTTA89751
`ESTTA Tracking number:
`07/13/2006
`
`Filing date:
`IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`BEFORE THE TRADEMARK TRIAL AND APPEAL BOARD
`91158512
`Plaintiff
`American Medical Rehabilitation Provider Association
`American Medical Rehabilitation Providers Association
`1710 N Street, N.W.
`Washington, DC 20036
`
`Correspondence
`Address
`
`DEBORAH M. LODGE
`Patton Boggs LLP
`2550 M Street N.W.
`Washington, DC 20037
`
`Submission
`Filer's Name
`Filer's e-mail
`Signature
`Date
`Attachments
`
`dlodge@pattonboggs.com
`Plaintiff's Notice of Reliance
`Mary Frances Love
`mlove@pattonboggs.com
`/Mary F. Love/
`07/13/2006
`Notice of Reliance (includes Ex K Part 2 of 3).PDF ( 181 pages )(8090659 bytes
`)
`
`

`
`IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE TRADEMARK TRIAL AND APPEAL BOARD
`
`AMERICAN MEDICAL
`REHABILITATION PROVIDERS
`
`ASSOCIATION,
`
`Opposer,
`
`v.
`
`U B FOUNDATION ACTIVITIES, INC.,
`
`Applicant.
`
`Opposition No. 91148512
`(Consolidating Cancellation No. 92043381)
`Serial No. 75/497,362
`Registration No. 2,647,644
`
`NOTICE OF RELIANCE
`
`Pursuant to Rule 2.122 of the Trademark Rules of Practice, 37 C.F.R. § 2.122 and TBMP
`
`§ 704.02,, Opposer/Petitioner, American Medical Rehabilitation Providers Association, hereby
`
`gives notice that it may rely on any or all of the materials attached hereto in the trial of this
`
`matter as described below:
`
`A. A photocopy of App1icant’s Response to Opposer’s First Set of Interrogatories (Nos.
`
`1- 16).
`
`B. A photocopy of App1icant’s Response to Opposer’s First Request for Production of
`
`Documents and Things to Applicant (Nos. 1-25).
`
`C. A photocopy of Applicant’s Response to Opposer’s Second Set of lnterrogatories to
`
`Applicant (Nos. 1-2).
`
`D. A photocopy of App1icant’s Response to Opposer’s First Request for Admissions to
`
`Applicant (Nos. 1-16).
`
`481442lv1
`
`

`
`Applicant’s Response to Opposer’s Request to Applicant for the Admission to the
`
`Genuineness of Documents.
`
`Applicant’s Response to Opposer’s Second Set of Requests For Production of
`
`Documents and Things to Applicant.
`
`. Applicant’s Supplemental Response to Opposer’s Second Set of lnterrogatories To
`
`Applicant.
`
`. Applicant’s Supplemental Response to 0pposer’s Request To Applicant For
`
`Admission to the Genuineness of Documents
`
`Applicant’s Produced documents as listed by bates number below and incorporated
`
`by reference in-items B and F above:
`
`UBF001 1-0014; UBF0030-0037; UBF0095—0102; UBFOI 13; UBF0123-0125; UBF0892-
`
`0894; UBF0774; UBF093l; UBF0969: FIM coding sheets from 1985 through 1998.
`
`J. Photocopies of Applicant’s Produced documents as listed by bates number below and
`
`incorporated by reference in items B and F above:
`
`UBF0046-0048; UBF066-0070; UBF0076-UBFOO80: Documents produced in response
`
`to Request No. 4.
`
`K. Photocopies of Applicant’s Produced documents as listed by bates number below and
`
`incorporated by reference in items B and F above:
`
`UBF0086-0129; UBFOI49-0150; UBF0l 51 -0153; UBFOl54-0161; UBFO 1 74-0245;
`
`UBF0254-0258; UBF0263-0271; UBF0272; UBF0275; UBF0276; UBG0277; UBF0376;
`
`UBF0377-0397; UBF0433-043 8; UBF0439-0444; UBF0445-0446; UBF0048-0450;
`
`UBF0458; UBF0459; UBF0463-0469; UBF0472-0479; UBFO491-0495; UBF0502-0505;
`
`UBF0506-0508; UBF0509-0510; UBF05l 1-0520; UBF052l-0531; UBF0532-0536;
`
`4814421vl
`
`

`
`UBF0537-0540; UBF0541-0567; UBF0568-0572; UBF0573-0575; UBF0587-0590;
`
`UBF0592-0595; UBFO596; UBF0597-0599; UBF0600-0604; UBF0607-0608; UBF0618;
`
`UBF0626; UBF063 3-0644; UBF0655-0658; UBF0659-0660; UBF0661-0664; UBF067 8-
`
`0680; UBF0693; UBF0730—0731; UBF0732-0733; UBF0738-0739; UBF0752-0753;
`
`0
`
`UBF0754; UBF0778-07 81; UBF07 82-0788; UBF0794-0803; UBF0806-0813; UBF0814-
`
`0821; UBF0826-0830; UBF0831-0843; UBF0844-0849; UBF0850-0851; UBF0863-
`
`0865; UBF0866-0868; UBF0876-0877; UBF0878-0881; UBF0882-0883; UBF0888-
`
`0894; UBF0897-0899; UBF0921-0922; UBF0925-0928; UBF0933-0937; UBF093 8-
`
`0941; UBF0943—0944; UBF0946; UBFO948; UBFO950; UBFO95l-0967; UBF0975-
`
`0980; UBF0993-0996; UBF1018-1024; UBF 1068-1075; UBF1105-1110; UBF1111-
`
`1112; UBF1118-1124; UBF1145-1147;UBFl148-1152;UBF1186-1189;UBF1218-
`
`1219; UBF1220-1221; UBF1222-1231; UBF1232-1234; UBF1243; UBF1244-1251;
`
`UBF1262; UBF 1263-1273: Documents produced in response to Request No. 5.
`
`L. Photocopies of Applicant’s Produced documents as listed by bates number below and
`
`incorporated by reference in items B and F above: UBF1762-1796; UBF1797—1 871;
`
`UBF001873; UBF001872; UBF001919-1923; UBF001936-I943; UBF001944-1946;
`
`UBF001947-1956; UBF001958-1961; UBF001992-1996; 002049-2052; UBF002071-
`
`2081; UBF002082-0289; UBF002102-2108; UBF002109-2118; UBF002130-2135;
`
`UBF002141-2147; UBFOO2259-2402: Documents produced in response to Request No.
`
`20.
`
`M. A photocopy of Opposer’s Supplemental Response to App1icant’s First Set of
`
`Requests for Production of Documents and Things.
`
`4814421v1
`
`

`
`N. Photocopies of Opposer’s produced documents as listed by bates number below and
`
`incorporated by reference in item M above: AMPO2581-02705 and AMPO2705-02768:
`
`Documents produced in response to Request Nos. 2, 10 and 15.
`
`Dated: July 12, 2006
`
`AMERICAN DICAL RE - 1 ILITATION
`
`
`
`PATTON BOGGS LLP
`
`2550 M Street, N.W.
`Washington, DC. 20037
`Telephone: 202-457-6000
`
`CERTIFICATE OF SERVICE
`
`I hereby certify that a true and correct copy of the foregoing “Notice of Reliance” with
`attachments was served by sending a copy of the same by first class mail, postage prepaid to:
`
`Paul I. Perlman, Esq.
`Hodgson Russ LLP
`One M&T Plaza, Suite 2000
`Buffalo, NY 14203-2391
`
`on this 12 day of July, 2006.
`
`4814-421v1
`
`
`
`

`
`" ii sMR»/FIM
`
`UNIFORM DATA SYSTEM FOR MEDICAL REHABILITATION / FUNCTIONAL INDEPENDENCE MEASURE
`
`March 28, 1997
`
`Cedric W. Tealer
`
`Marketing Coordinator
`Community Hospital of Los Gatos
`815 Pollard Road
`
`Los Gatos, CA 95030
`
`FAX TRANSNIITTAL 408-866-4077
`
`Dear Mr. Tealerz
`
`Thank you for your request for permission to reproduce a generic copy ofthe patient
`FIMS“ Profile to include in your new marketing folder designed to educate physicians
`about the FII\/I5" instrument.
`'
`
`Permission is hereby granted to reproduce the PM profile based on the conditions that
`the profile is generic and does not name a specific individual and that the copyright
`statement is intact.
`A
`“
`'
`
`For further inforniation, we are attaching an information sheet regarding our trademarks,
`service marks and other uses for titles of UDSMR products.
`
`Sincerely,
`
`W @722“),
`
`April Peters
`Copyright Librarian
`
`KMD/JEB
`
`_
`Uniform Data System for Medical Rehabilitation
`232 Parker Hall, University at Buffalo. 3435 Main Street. Buffalo, N.Y. 14214-3007
`Telephone: (716) 829-2076 - FAX: (716) 829-2080 - E-mail: fimnet@ubvms.cc.buffalo.edu
`
`
`
`
`
`Centerfor Functional Assessment Research - Department ofRehabilitation Medicine .
`
`
`
`School of Medicine and Biomedical Sciences - State University of New York at Buffalo
`
`UBFO826
`
`

`
`fie COMMUNITYHOSPITAL
`
`o1= LOS GATOS
`Tenet Hoalthsystam
`
`CONFIDENTIAL INFORMATION
`
`FAX 'I'RANSM1'l‘TAL SHEET
`
`Contidentially Note: The documents accompanying this tramtnision contain information
`which is confidential andlor legally privileged. This information is intended only for the use
`of the individual or entity named in this transmission sheet. If you are not the intended recipient.
`you are hereby notified that any disclosme. copying. distribution oi: the taking of any action in
`reliance on the contents of this telecopy information is strictly pmohihted and that the documents
`should be returned to COMMUNITY HOSPITAL» 01-‘ L05 GATOS immediately.
`In this
`regard, if you have received this telecopy in error. please notify us by telephone immediately and
`we will arrange the return of the document was.
`’
`-
`
`'
`
`Thank You.
`
`
`
`
`
`Date ‘I‘ransmitted: >’
`No. of Pages Following Cover Sheet:_2=_._..
`Please call (408) 5664020 if there are any problems receiving this tax.
`
`
`
`B15 Pollard Rood. Les Baton, CA 95030 _
`(409) 379-3131
`
`MFR 27 ’97 11141
`
`UBFO827
`
`45.93554977
`
`PRGEB1
`
`

`
`March 26, 1997
`
`Dear Ms. Peters:
`
`Community Hospital ofLos Gatos Rehabilitation Center {identification # K16 (rehab)
`andD61(TCU)}, hasbeenasubscribertoUDSsin
`1994. Recentlywehave developed
`
`'
`- '
`-.-‘I’ eo
`
` educate hysicians about HM measurements, and inform
`that we can provide. When we took the profiles to the copy center to be reproduced, we
`were told that HM Profile is copyrighted and could not be reproduced without a written
`
`approval from UDS.
`'
`
`
`We equatetheuseofthis Pmfileto bethesame asweusein our dailybusiness. The
`
`:
`
`Profilesaremailedtoourexistingphysicianstoinformthemoftheirpatients’progress.
`
`The PM Profiles use in marketing is virtually the same, to inform prospective physicians
`that this is service that we can provide.
`
`We are requesting an interpretation ofthe UDS copyright agreement with their
`subscribers. Ifwe are able to duplicate the FM Profile, could you provide us with a
`signed release, in the event that we run into the same problem in the fixture.
`
`Ifyou have any further questions, please contact me at 408/866-3857. It would be "
`appreciated ifyou could fax your response to 408/866-4077 to expedite this process.
`
`Thank you for your time.
`
`Sincerely,
`
`&}“""
`
`Cedric W. Tealer
`
`Marketing Coordinator
`
`"1Auad:meut FIMProfile
`
`MRR 2'? '9'? 11341
`
`4888664877
`
`PPoGE.B2
`
`UBF0828
`
`

`
`Fill PROFILE FOR
`
`
`Facility: LOSGA1'OSREH\BIUl'A1'!ONCENTER
`Repalfbde: 011101193
`
`
`Patient
`Plfimtcode:
`
`linhbahc
`cunenuqu:
`
`I
`Gcnlht:
`case Summary
`Adlllnionfllu-:
`
`llpllmuitfirup:
`
`ouzinsas
`62y-Iv. sun!-an
`
`Fonda
`
`hildflellfiilim
`
`12
`
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`hvolvmul (Lmkila)
`
`Onufflll:
`
`Eflobgicbiauiolls:
`Asflsalc
`
`11I1«ll‘1%
`
`434
`
`“days
`Achn‘II.engflIufS‘I:y:
`fifimlauhdshy:
`zadwyu (+-13¢!-10.81’-4)
`
`
`Adam nu scans by Assessment
`1
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`
`Mm:-"'
`11:31:13
`
`Dunno"
`tznams
`
`4
`5
`1
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`5
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`
`5
`s
`
`4
`4
`1
`
`4
`1
`
`As
`17
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`4
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`
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`33
`
`7
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`5
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`PATIENTIMAE:
`. PATIENTCODE
`
`-—
`
`—
`
`93
`5.2
`
`—
`
`MOP 9'? N31‘? 11:41
`
`UBF0829
`
`4
`
`POGF fl?
`
`

`
`flmvr March28, 1997
`
`Cedric W. Tealer
`
`Marketing Coordinator
`Community Hospital of Los Gatos
`815 Pollard Road
`
`Los Gatos, CA 95030
`
`FAX TRANSMITTAL 408-866-4077
`
`Dear Mr. Tealerz
`
`Thank you for your request for permission to reproduce a generic copy of the patient
`FIM“ Profile to include in your new marketing folder designed to educate physicians
`about the FIMS“ instrument.
`
`Permission is hereby granted to reproduce the FIM profile based on the conditions that
`the profile is generic and does not name a specific individual and that the copyright
`statement is intact.
`
`For further information, we are attaching an information sheet regarding our trademarks, .
`service marks and other uses for titles of UDSMR products.
`
`Sincerely,
`
`April Peters
`Copyright Librarian
`
`KMD/JEB
`
`UBF0830
`
`

`
`1e— SMR»/FIM
`
`UNIFORM DATA SYSTEM FOR MEDICAL REHABILITATION I FUNCTIONAL INDEPENDENCE MEASURE
`
`February 26, 1997 '
`
`R Michael Poole, M.D.
`Director, CNS Clinical Research
`Parke-Davis Pharmaceutical Research
`
`2800 Plymouth Road
`Ann Arbor, MI 48105
`
`Dear Dr. Poole,
`
`
`
`Thank you for your letter of January 23 requesting permission to modify the Functional '
`Independence Measure (FIMSM instrument) for your research project. The Uniform Data
`System for Medical Rehabilitation is the sole developer and owner of the copyrighted
`instrument known as the FIMSM instrument.
`In order to protect our intellectual property
`rights, it has been necessary to establish certain guidelines under which the instrument may
`be used.
`
`Permission is denied to modify the Functional Independence Measure (FIM instrument).
`Furthermore, only data that has been submitted to Uniform Data System for Medical
`Rehabilitation (UDSMRSM) and processed through UDSMR’s standard set of proprietary
`error-checking and processing protocols can be referred to FIM data. Data not submitted
`to UDSMR for processing should be referred to as data collected by using the FIM
`instrument.
`.
`
`Since you have determined that the F1M instrument is not appropriate for collecting data
`for your study, we trust you will be able to find or develop an alternate instrument or
`method for assessing the cognitive limitations ofyour patients with TBMIM
`
`Sincerely,
`
`AgPeters,M.L.S.,AHIP
`
`Librarian
`
`Uniform Data System for Medical Rehabilitation
`232 Parker Hall, University at Buffalo, 3435 Main Street, Buffalo, N.Y. 14214-3007
`Telephone: (716) 829-2076 - FAX: (716) 829-2080 - E-mail: fimnet@ubvms.cc.buffalo.cdu
`
`
`
`
`
`Centerfor Functianal Assessment Research * Department ofRehabilitation Medicine
`
`
`
`School ofMedicine and Biomedical Sciences 0 State University ofNew York at Buffalo
`
`

`
`.....--.:u nu: V5.
`
`IVVJ.
`
`
`
`3:
`
`Pharmaceutical
`Research
`
`2800 Plymouth Road Phone: 313-956-1000
`AnnArbor,Ml
`
`‘
`
`;
`
`,
`
`*
`
`~’
`V
`. ® PARKE-DAVIS
`Peop|eWhoCare
`
`_
`
`43105
`
`. “ c.
`
`..
`4’
`P. /
`.»''/zC’.-¢..‘ ___r
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`
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`
`.
`Ianuary23, 1997
`Uniform Data System for Medical Rehabilitatioi
`SUNY at Buffalo
`232 Parker Hall
`343 SouthMain St
`Bufl'a1o,NY 14214
`
`_
`
`ATTENTION: COPYRIGHT LIBRARIAN
`
`To Whom it may concern,
`
`I
`
`3. 3
`
`TheParke-Davis Company is organizing arandomized, dot
`
`(Eli?)
`
`_
`1
`trial of a drug to treat patients with traumatic brain injury.
`comparisons of functional ability in this patient population to patients in larger studies,
`we would like to use a modified version ofthe Functional Independence Measure that
`was employed in the Multiple Trauma Outcome Study (abbreviated in one publication as
`the “FIM—MTOS”, see reference below). The domains chosen for MTOS were feeding,
`locomotion and expression with four levels of fimction in each domain (4 = complete
`independence; 3 = independent with assistive device; 2 = modified dependence; '1 =
`complete dependence). Please let me know if you require more infonnation.
`
`Thank you very much for your consideration.
`
`Sincerely,
`
`'
`
`:0 2 8
`Reference: Gennarelli TA, et al. J Trauma 1994. 37(6):9b2 "
`\
`‘
`
`R Michael Poole, M.D.
`
`Director, CNS Clinical Research
`Office: 313-998-3443
`Fax:
`313-998-3322
`
`,1 Oil/‘Qevew
`
`Division of Warner-Lambert Company
`
`UBF0832
`
`ZONE]
`
`SND SIAV(I-EDIHVJ
`
`8271. 966 819 XV.:l 179380 18:1
`
`1.6/W.‘/T0
`
`

`
`———_\.- mu.
`
`r~.vI1\/L
`
`
`
` L
`
`:
`
`-
`
`TO:
`
`A
`
`COPYRIGHT LIBRARIAN
`
`TELEPHONE NUMBER:
`
`716-829-2076
`
`TELECOPIER NUMBER:
`
`716-829-2080
`
`FROM:
`
`. Robert Michael Poole,
`
`TELEPHONE NUMBER:
`
`(313) 998-3443
`
`TELECOPIERNUMBER:
`
`(313) 998-3322
`
`DATE:
`
`January 24, 1997
`
`PAGES TO FOLLOW:
`
`1
`
`h
`
`Dr Heerden: Let me know if you need more information.
`
`flu‘: facsimile it intended onlyfor the use q/the individual or entity to which 1! is addressed and may cmuain blforrnation that is
`NOTICE:
`privilaged confidential and eumptfi-om di.rclo.x-ure. J the render of this facsimile I‘: not the intended recipient. or an employee or agent
`resparuible for delivering the facsimile to the intended recipient, you are hereby notified that any review. disclosure. dmeminatim.
`dixtrlbuliall or copying afthe communication is strictiyprohibited. [fyau have received thi: oanununicatlon in errar, please notfir the under
`immediately at the telephone numberflsj listed and return the originalfacsimile to u.1_at the abave addrexr by US mail, the cast of which will
`be reimbursed Thankyau.
`
`100
`
`I
`
`SNO SIAV(I'EDRlV:{
`
`9Zi'L 966 EN.‘ XVJ 89390 Hid L6/V2/I0
`
`UBF0833
`
`

`
`+:_,
`
`- '
`I
`- ® PARKE-DAVIS
`=
`People Who Care
`
`'
`
`”
`
`r
`
`Phannaeoulieal
`Research
`
`2800 Plymouth Road Phone: 313-996-7000
`Ann Arbor, MI
`
`48105
`
`January 23, 1997
`
`Uniform Data System for Medical Rehabilitation
`SUNY at Buffalo
`
`232 Parker Hall
`343 South Main St
`
`Buffalo, NY 14214
`
`ATTENTION: COPYRIGHT LIBRARIAN
`
`To Whom it may concern,
`
`The Parke-Davis Company is organizing a randomized, double-blind, placebo controlled
`trial of a drug to treat patients with traumatic brain injury. In order to make meaningful
`comparisons of functional ability in this patient population to patients in larger studies,
`we would like to use a modified version of the Functional Independence Measure that
`was employed in the Multiple Tratnna Outcome Study (abbreviated in one publication as
`the “FIM-MTOS”, see reference below). The domains chosen for MTOS were feeding,
`locomotion and expression with four levels of function in each domain (4 = complete
`independence; 3- = independent with assistive device; 2 = modified dependence; 1 =
`complete dependence). Please let me know if you require more information.
`
`Thank you very much for your consideration.
`
`Sincerely,
`
`Mn ljooiai
`
`R. Michael Poole, M.D.
`Director, CNS Clinical Research
`Office: 313-998-3443
`
`Fax:
`
`313-998-3322
`
`Reference: Gennarelli TA, et al. J Trauma 1994. 37(6):962
`
`Division of Warner-Lambert Company
`
`UBF0834
`
`

`
`
`
`voI.s1.N.;
`measu-
`
`COMPARISON OF MORTALITY, MORBIDITY, AND SEVERITY is
`59,713 HEAD INJURED PATIENTS WITH 114,447 PATIENTS
`
`WITH EXTRACRANIAL INJURIES
`
`Thomas A. Gennarelll, MD,‘ Howard H. Champion, FRCS (Edin)," Wayne 6. copes, PhD,” and
`William J. Sacco, PhD”
`
`An analysis of the completed Major Trauma Outcome Study (MTOS) data set was
`undertaken to compare the incidence. mortality, morbidity. and injury severity of
`patients with head injuries (HI) with those of patients with extracranial injuries
`(ECI). The MTOS was completed recently after data from 174,160 patients
`submitted from 165 trauma centers from 1982 through 1989 were collated and
`validated. Data were analyzed with regard to the effect of injury causation for
`vehicular-related, nonvehlcular-related, and penetrating injuries for patients with (
`Hi, ECI, or both. Detailed analyses of relationships between AIS-85 and Glasgow
`Coma Scale score from the entire data base, and between discharge status,
`functional independence measures (FIM scores), and severity of Hi and ECI in a
`subset of 70,000 surviving patients were performed. Vehicular-related injuries
`(49.7%) were divided into those to vehicle occupants (36.4%), pedestrians (7.2%),
`and motorcyclists (6.0%). Nonvehicular-related blunt injuries included falls (18.4%)
`and assaults (13.2%) and penetrating injuries consisted of gunshots (8.7%).
`stabbings (8.0%), and other penetra ons (1.8%). There were 59,713 patients with
`Hi (34%) and 114,447 with no head injuries (NHI) (66%). Vehicular causes produced
`more l-ll (66.6%) than all other causes, despite the preponderance of nonvehlcular-
`related HI in the overall series (50.3%). The overall MTOS mortality rate was 8.3%,
`but was three times higher in the HI group (14.5%) than in the NHI patients (5.1%).
`injury severity measured by Als-85 had, as expected, a profound influence on
`mortality of both HI and NHI groups. A similar high correlation was found between
`Glasgow Coma Scale score and mortality for head injured patients. Discharge
`disposition to home and FIM scores showed that surviving HI patients were more
`impaired than any Ecl group at discharge. Head injuries remain the most
`important single injury contributing to traumatic mortality and morbidity.
`
`
`
`fh
`
`‘ ooze-5232/54/mos-o9e2sos.ooIo
`THIJDURNAI-OYTIAUIIA
`Copyn'd1tO1994byWilliAma&Wilkina
`
`THE HEAD has been appreciated as an important site.
`of injury leading to death and disability after trauma.
`However, there are few recent large scale studies on
`the importance of head injury compared with extracta-
`nial injury with respect‘to death, and fewer still that
`compare the outcomes after nonfatal injury. To address
`this question, an analysis of the recently completed
`Major Trauma Outcome Study (MTOS) data base is
`presented. We tested the hypothesis that mortality and
`morbidity of patients with head injury are worse than
`if no head injury occurred. To our knowledge this series
`reports the largest number of traumatic head injuries
`
`'
`
`to date and is the first documentation in the li
`regarding specific differences in fimctional outcome a;
`tween patients with and without head injuries. D ‘ ‘
`advances in delivery and care, head injuries re
`_
`the most important cause of death and disability "-‘
`
`METHODS
`
`
`
`2-*:_I-'2'5-1:"‘'2
`
`
`
`Over the 8-year period from 1982 through 1989,
`prescribed forms from 165.hospitals were submitted __
`,
`tarily to the Major Trauma Outcome Study (MTOS). Of ,
`hospitals, 85% were designated as trauma centers - Q,
`gional authorities and 15% were self designated. For the
`18 months, participating centers submitted data 0 if
`trauma deaths that occurred in the hospital (inclu
`1"
`From the ' Head injury Center, Division of Neurosurgery, University
`emergency department) plus either all trauma pati
`of Pennsylvania. Philadelphia, and the °Trauma Service, Washington
`mitted to hospital or all trauma patients admitted to
`Hospital Center. Washington. DC.
`sive care units. Subsequently, all centers contribu
`Presented at the Seventh Scientific Assembly of the Eastern Asso-
`trauma deaths and all hospitalized trauma patients. As) _
`elation tor the Surgery oi Trauma, January 12-15, 1994, Freeport,
`Bahamas.
`,
`'
`study proceeded, more trauma center hospitals sub '
`'_
`data. For the first 4 years the data base consisted‘?
`Address for reprints: Thomas A. Gennarelll. MD. Division of Neuro-
`hospitals, and was expanded to 165 by the end of the
`sur'goe4ry. University of Pennsylvania, 3400 Spruce St.. Philadelphia, PA
`19
`.
`tion period. The information was collated and analyzed .
`962
`
`-
`
`_
`
`=':---:w====
`
`.
`
`--».._...
`
`..-.
`
`-..
`
`.
`
`-1
`
`
`
`UBFO835
`
`

`
`’ -3-9 37, No. 6
`
`Head Injury in the Multiple Trauma Outcome Study
`
`963
`
`'
`
`nshington Hospital Center. For the present study, only a
`number of the many elements of the MTOS data base
`4 ’ analyzed at the University of Pennsylvania.
`
`'
`
`- pulation Descriptors
`
`‘
`
`‘
`
`Patients were divided into two major categories, those with
`v d injury (HI) and those with no head injury (NHI). Pa-
`tents were considered to have a head injury if at least one
`ijury to the brain or skull was present. Therefore, at least
`-V we skull or brain injury with an Abbreviated Injury Scale
`_. NS) severity code greater than zero existed. All other inju-
`I”
`ties, including those to the face, were not considered head
`‘_
`injuries and were designated as extracranial injuries (ECI).
`llma all patients with NHI had head or skull AIS scores of
`5
`.. era. The I-II patients were further classifiedaccording to the
`, presence or absence of EC] in addition to their head
`1'
`lhus, some patients in the HI category may have had ECI as
`Z, rel] as head injury, but no patient in the NHI category had
`.5 rhead injury. In both the HI and NH! groups, a patient may
`"_ Irmay not have had more than one
`If this were the
`f use, only the injury with the highest severity was used for
`malysis.
`The patients were also categorized by mechanisms of in-
`f
`jury causation. Motor vehicle occupants, motorcycle riders,
`’
`. and pedestrians were combined as vehicular injuries. Pene-
`._
`(rating injuries included gunshot wounds, stab wounds, and
`*' other penetrations. Falls and assaults were considered as
`: amvehicular—related injuries. The latter category also con-
`~
`trained a small number of other injury mechanisms such as
`’
`sports injuries.
`
`1 Severity Descriptors
`
`care facility, rehabilitation facility, or other site. This dispo-
`sition at the termination of acute care was used as a surro-
`gate descriptor of impairment or disability from injury. It
`was recognized that being discharged home does not in any
`way equate with the absence of impairment or disability.
`‘However, it was viewed that not being discharged home was,
`overall, indicative of a higher probability that disability was
`present and a greater likelihood that the disability was more
`severe than if the patient were" discharged home.
`Functional Independence Measures. The MTOS coded
`a variant of the functional independence measure (FIM)
`score in the latter years of data collection."5 This tool is an
`ordinal scale that measures disability defined by actions that
`subjects actually perform and is obtained from physical ex-
`amination of each patient. The original FIM consists of seven
`levels in each of 18 domains. Scores from the 18 domains are
`summed to derive a total FIM score that ranges from 18
`(worst, completely dependent in all domains) to 126 (best,
`completely independent in all domains). When the MTOS
`added a measure of morbidity to its data collection, -it was
`decided that the FIM.would be useful, but that the entirety of
`the FIM score would be difficult for many participating cen-
`ters to collect without additional personnel. In conjunction
`with originators of the FIM, we therefore decided to collect
`only a subset of the FIM domains and to collapse the levels of
`independence within those domains. The chosen domains
`were those shown to be most relevant to overall indepen-
`dence. Subsequent analysis by one of us (W. S. C.) has deter-
`mined that there is a linear relationship between the original
`FIM and that used by MTOS (unpublished observations).
`The FIMM-ms, used in this paper, scored three domains, each
`of which used a four-point scale so that the summed total
`ranged from 3 (worst) to 12 (best). Preliminary analysis of the
`total FIMM1-Os showed high correlation to the total (original)
`FIM score. The domains chosen for MTOS were feeding,
`locomotion, and expression. The four levels of function were 4
`= complete independence, 3 = independent with assistive
`device, 2 = modified dependence, 1 = complete dependence.
`
`The Study Population
`
`RESULTS
`
`The MTOS data base contained injury information
`for 174,160 patients. Of these, 114,447 (66%) had no
`head injury (NHI) and 59,713 (34%) incurred a head
`injury (HI). Only 8137 of the head injured patients had
`no extracranial injury (ECI); thus the incidence of pure
`head injury was 5% and the true incidence of all ECI
`was 95%. However, 28,508 patients with head injury
`had only very minor ECI of AIS scores 1 or 2 (usually
`abrasions, contusions, or skin lacerations, so that there
`were 36,645 patients with almost pure head injury
`(21%).
`The causes of the injuries are shown in Table 1.
`Overall, vehicular causes were the most common and
`
`
`
`Table 1
`Incidence of Injury mechanisms (n = 174.160)
`
`Totals (56)
`NH! (96)
`' HI (96)
`Injury Mechanism
`81.3
`48.6
`32.7
`Blunt
`49.7
`26.9
`22.8
`Vehicular-related
`31 .6
`21 .7
`9.9
`Nonvehlcular-related
`
`Penetrating 18.5 1.5 17.0
`
`
`
`UBF0836
`
`
`
`
`
`.
`
`AIS. All injuries in all areas of the body were coded accord-
`ingto the 1986 version of the Abbreviated Injury Scale (AIS)‘
`by the Washington Hospital Center staff. The AIS ranks
`_ injuries on an ordinal scale of increasing severity from 1
`'
`(minor) to 6 (maximal injury, virtually unsurvivable). Be-
`j_ cause of the type of data available from the trauma centers,
`, ieveral coding conventions were adopted that differed
`“
`slightly from those recommended in the AIS manual. The
`« convention that most affected the head injury coding was
`*
`that only the anatomic section of the AIS dictionary was
`i used. Consistent information regarding the length of uncon-
`; sciousness and the level of unconsciousness precluded injury
`coding using these two sections of the AIS.
`Glasgow Coma Scale Score. The Glasgow Coma Scale
`score (GCS) at admission was used as a severity measure
`‘ independent of the AIS.” The Glasgow Coma Scale is an
`. ordinal scale consisting of the sum of scores in three catego-
`ries (eye opening, best motor response, verbalization) that
`ranges from 3 (worst) to 15 (best). It has been widely used to
`- define important physiologic responses to brain injury and
`has been correlated to mortality and to quality of survival in
`‘many studies.”-3
`
`.
`
`jouicome Descriptors
`
`—
`
`Mortality. Death, either in the emergency department or
`during hospital admission, was considered a mortality. Pa-
`lients dead on arrival to emergency department were not
`‘ entered into the study.
`_ Discharge Status. The MTOS discharge status categories
`,
`' were collapsed into two mutually exclusive groups for survi-
`" vote in this analysis: (1) discharged to patient’s home, (2)
`' discharged to facility other than the patient’s home. The
`latter included relative’s homes, another hospital, nursing
`
`»
`
`

`
`December 1994_ 1;-
`OVERALL MORTALITY
`1
`
`mos 1993
`“
`
`MEAN
`
`PERCENT MORTALITY
`
`
`
`'." 4
`A
`AIS
`Figure 1. Mortality of head lnlured (HI) and non-head Injured (N1-n:,.;
`patients by AlS-85 severity.
`;'
`
`.
`
`
`
`had 59.5% of the deaths. Deaths with head injury‘?
`therefore are disproportionately high. The high num-_:§
`ber of head injury deaths results in a very high mor-
`tality rate for head injured patients. The overall mor- "‘
`tality rate with HI of 14.5% was three times higher .
`than if no head injury occurred (5.1%).
`-
`AIS Correlations to Mortality. Table 2 and Figure "
`demonstrate the relationship of mortality to AIS as
`,
`measure of injury severity. As AIS severity increased
`from 1 to 6, mortality of the entire population increased E ‘_
`'
`by a power function best fitted to a cubic polynomial.
`1
`the entire series, mortality remained" low through A183 -
`level 3 injury and then roughly doubled for each le
`above AIS 4. A substantial proportion of injured «
`tients at AIS level 6 survived. The mortality rate of
`level 6 injuries was 87.3% not 100% as is often
`sumed, supporting the proposition that equating
`AIS score of 6 with death is incorrect. This relatio: 5.
`was also true for both the HI and NI-II groups (Fi
`and for the three causes of injury (Tables 2 8: 3).
`Table 2 shows that, in general, the mortality re '
`was higher for penetrating injuries (12.5%) than
`vehicular-related injuries (8.9%), whereas nonvelu
`lar-related blunt injuries had a slightly lower mortall,
`rate (5.0%). This ranking held principally because "If
`increased mortality for penetrating injury at -_
`
`.
`
`NS
`5°”
`1
`2
`3
`4
`5
`6
`
`All
`
`Vehicular
`
`NHI
`0.6
`1.2
`2.7
`15.7
`31.2
`80.8 .
`5.2
`
`HI
`
`2.9
`19.2
`29.0
`46.8
`97.8
`13.3
`
`V Non-vehicular
`NHI
`1.1
`0.6
`2.3
`11.0
`17.8
`77.8
`2.5
`
`Hl
`
`1.3
`8.9
`21.7
`50.7
`94.3
`10.4
`
`Penetrating
`
`NH:
`0.3
`0.9
`2.0
`10.9
`48.0
`86.5
`8.4
`
`Hl
`
`3.9
`34.2
`41.8
`73.7
`97.4
`59.0
`
`NHl
`0.7
`0.9
`2.4
`12.9
`37.3
`82.8
`5.1
`
`All Patients
`
`'2"!-'-inc-—-p~.......-.
`
`
`__
`V’ F
`:11
`5
`
`UBF0837
`
`The Journal of Trauma
`964
`
`Table 2
`Overall mortality
`
`.23.
`
`»=~~»-«=~a we
`vows es»
`
`1
`0.6
`1.1
`'
`0.3
`0.7
`2
`2.3
`0.9
`1.0
`1.7
`3
`7.8
`3.4
`2.8
`5.4
`4
`23.6
`19.1
`14.3
`20.2
`5
`38.3
`31.9
`56.5
`45.3
`6
`86.5
`82.8
`89.5
`87.3
`8.9
`5.0
`12.5
`8.3
`
`All
`
`this patient group made up almost half of this series
`(49.7% of all patients). Nonvehicular-related injuries
`ranked next in frequency and contributed nearly one
`third of the patients (31.6%). Penetrating injuries were
`the cause in one sixth of the population (18.5%).
`Of all the head injuries, twp thirds (66.6%) were
`vehicular in origin. Almost halfwere sustained by ve-
`hicle occupants (48.7%), by far the leading cause of H1
`in this trauma center population. Vehicle occupants
`incurred more than three times the number of HI of the
`
`next most frequent cause of H1 (falls, 14.6%) and al-
`most equalled the number of 1-H produced by all other
`causes combined. Pedestrian (10.2%) and assault
`(14.3%) mechanisms produced head injuryalmost as
`commonly as falls, and motorcycle riders constituted
`7.7% of the head injuries. Penetrating injuries were
`uncommon causes of H1 (4.4%).
`Pedestrians sustained head injury most commonly.
`Of all injured pedestrians, 48.6% had a head injury,
`whereas, of injured occupants and cyclists, 45.9% and
`43.3%, respectively, sufiered head injuries.
`
`Fatal Outcomes: Mortality and Correlations to
`Severity Measures
`7
`
`The overall mortality rate in this series was 8.3%
`(14,506 of 174,160). The numbers of dead with I-Ils
`(8.636) were 1.5 times greater than of those with NHIs
`(5,870) (59.5% vs. 40.5%). This is a striking difference,
`especially when considering the much smaller num-
`bers of H1 patients in the whole series (59,713 and
`114,447,
`respectively). Thus, although HI patients
`were only one third of the whole series (33.6%), they
`
`Table 3
`Percentage of mortality by mechanism and presence of head Injury
`
`
`
`
`
`_V>.-...:-3:-_-:-_?f:;_\5:_:¢~nmVh\-dimers-gu§_?~».a?nv-....._...r'm$Ij§n. -.-
`
`

`
`'0 5.,,.
`
`19 " .Vol. 37, No. 6
`
`Head Injury in the Multiple Trauma Outcome. Study
`
`965
`
`;
`
`1"
`1-.~
`
`2
`
`GCS AND MORTALITY
`HEAD INJURED ONLY. n = 45,977
`NUMBER or PATIENTS nmounmm
`pzncmr MORTAUTY
`
`*1
`
`HOME ON DISCHARGE
`MTOS 1993
`
`PERCENT HOME
`
`
`
`M521
`
`M832
`
`AIS-4
`AIS-3
`AIS OF INJURY
`
`NS-B
`
`AIS-I
`
`Figure 3. Percentage of head injured (HI) and non-head injure