NORTH AMERICAN
`
`HOME PARENTERAL AND ENTERAL NUTRITION
`
`PATIENT REGISTRY
`
`ANNUAL REPORT
`
`WITH OUTCOME PROFILES
`
`1985-1992
`
`SPECIAL FEATURE
`
`AN ANALYSIS OF HEN CLINICAL OUTCOME
`
`IN PATIENTS WITH NEUROMUSCULAR
`
`DISORDERS OF SWALLOWING
`
`1994
`
`H
`
`TheOleyFoundation
`
`Albany,NewYork
`
`NPS EX. 2089
`CFAD v. NPS
`
`IPR2015—00990 Page 1
`
`Page 1
`
`

`
`NORTH AMERICAN
`HOME PARENTERAL AND ENTERAL NUTRITION
`PATIENT REGISTRY
`
`CONTENTS
`
`Introduction
`
`Participating Programs
`
`Data Collection and Analysis
`
`Representativeness of the Registry Sample
`
`An Estimate of the Number of USA HPEN Patients
`
`Clinical Outcome Profiles
`
`Special Analysis: The Influence of Age on HEN Outcome
`
`Therapy and Disease Specific Profiles
`
`HPN
`
`Crohn's Disease
`lschemic Bowel Disease
`
`Motility Disorders
`Congenital Bowel Defects
`Hyperemesis Gravidarum
`Chronic Pancreatitis
`Radiation Enteritis
`Chronic Adhesive Obstruction
`
`Cystic Fibrosis
`Neoplasm
`AIDS
`
`HEN
`
`Neuromuscular Disorders of Swallowing
`Neoplasm
`
`Conclusions
`
`Acknowledgments
`
`Appendix:
`
`Sample registry data form
`
`1
`
`1
`
`5
`
`6
`
`6
`
`6
`
`8
`
`10
`11
`
`12
`13
`14
`15
`16
`17
`
`18
`19
`20
`
`21
`22
`
`23
`
`23
`
`241
`
`Page 2
`
`Page 2
`
`

`
`Introduction
`
`This is the eighth annual report of the North American Home Parenteral and Enteral Nutrition Patient
`Registry and the third annual report to use a longitudinal analysis format.
`It presents the clinical experience of
`Registry patients from 1985 to 1992. A special feature of this report is a more extensive analysis of HEN patients
`with neuromuscular disorders of swallowing.
`In addition, three HPN diagnostic groups have now accumulated
`sufficient patient numbers to break them out of the “Other” category and include separate clinical outcome profiles.
`The three HPN groups are patients with cystic fibrosis, chronic pancreatitis and hyperemesis gravidarum.
`
`Participating Programs
`
`The registry is in effect a large joint research enterprise which attempts to characterize clinical outcome for a
`wide range of North American patients at home on nutrition support therapy. Once collated and described, these data
`are available to all clinicians advising patients and their families about the benefits and risks of HPEN treatment.
`The analyzed, tabulated or raw data are also available to individuals doing primary research on HPEN, once their
`project is approved by the Oley Foundations's Registry Advisory Committee.
`
`Collecting annual data is in many respects a tedious and time consuming task, particularly for the
`individuals responsible for the annual extraction of chart-based information. The 223 programs that have
`participated in this task are listed in Table I below. Over the years, many progams have been regular contributors of
`information even through several have undergone organizational and name changes. Some programs have dropped
`out and new ones have entered. Table I indicates the years each program has participated. Programs that reported
`1992 data had the option of including the names of the responsible physicians. This table of HPEN programs and
`physicians provides useful information for those who wish to locate experienced physicians and programs in specific
`geographic locations.
`
`North American Home Parenteral and Enteral Nutrition Patient Registry
`Participating Programs / Institutions / Physicians
`
`Table I.
`
`UNITED STATES PROGRAMS
`
`State
`AL
`
`City
`Birmingham
`
`AK
`
`AR
`
`AZ
`
`CA
`
`Prattville
`
`Anchorage
`
`Little Rock
`
`Phoenix
`
`Tucson
`
`Chico
`Los Angeles
`
`Years
`86-89
`89-90
`85-92
`
`Programs / Institutions*
`Baptist Medical Center-Princeton
`The Children's Hospital of Alabama
`University of Alabama
`
`87-90
`
`Unicare /I.V.Services
`
`90-92
`86-92
`87-88
`86
`86-92
`90-92
`87-88
`85, 89-92
`
`85, 89
`85-89
`89
`85-91
`84-92
`
`Pediatric Consultants of Alaska
`Providence Hospital
`Alliance Homecare Infusion
`Baptist Medical Center
`University Hospital of Arkansas
`Critical Care America
`Integrated Medical Specialties
`Tucson Medical Center
`
`University Medical Center
`OPTION Care
`Cedars-Sinai Medical Center
`Children's Hospital of Los Angeles
`UC-Los Angeles Medical Center
`
`Physicians**
`
`Ronald L. Weinsier, Donna ChrisAnderson-
`Hill, Donald D. Hensrud, Sarah L. Morgan,
`Louis J. Wilson
`
`Clinton B. Lillibridge
`
`V. Suzanne Klimberg
`
`Richard Carmona, Joel Childers, Mary Jo
`W00
`Ghotly, Charles Krone, Thomas Daniel, Steven
`
`Marvin Ament, Jorge Vargas
`
`* During participation in the registry, a number ofprograms, institutions and service companies have changed their names and
`locations.
`this listing contains errors or is not current, we apologize and ask you to please notify us.
`- Editors.
`*" The physicians listed are only those who indicated their interest in being identified in the report of 1992 data. Where
`identified to us, the director /co—directors of nutrition support programs are given first. Otherwise, alphabetic order is used.
`
`l‘'1‘!r1-w.-w-
`
`.4.ii
`
`
`
`Page 3
`
`Page 3
`
`

`
`
`
`North American Home Parenteral and Enteral Nutrition Patient Registry
`Participating Programs / Institutions / Physicians (continued)
`
`UNITED STATES
`State
`CA
`(continued)
`
`City
`Orange
`Sacramento
`
`San Diego
`
`San Francisco
`
`San Jose
`Santa Fe Springs
`Stanford
`Denver
`
`Greeley
`Pueblo
`New Haven
`
`Washington
`
`Dunedin
`Fort Lauderdale
`Gainesville
`Jacksonville
`
`Orlando
`Tampa
`
`Atlanta
`Augusta
`Honolulu
`Tripler AMC
`
`Chicago
`
`Chillicothe
`Elk Grove Village
`Hines
`Joliet
`Morton Grove
`Mount Prospect
`North Chicago
`Peoria
`Rockford
`
`Springfield
`Sterling
`Sycamore
`Urbana
`
`Beech Grove
`Fort Wayne
`South Bend
`
`Iowa City
`Ottumwa
`
`Kansas City
`
`CO
`
`CT
`
`DC
`
`GA
`
`HI
`
`IL
`
`IN
`
`IA
`
`KS
`
`PROGRAMS
`Years
`87-92
`87
`85-86, 91
`88-90
`84-89
`89
`85-88
`85-91
`87
`86
`
`85-92
`
`85-86
`92
`85-92
`
`89
`89-91
`86
`85-89
`87-90
`87-88
`87-88
`85-87
`86-89, 91-92
`90-91
`86-91
`86-89, 91-92
`86, 88
`87
`89
`86-91
`
`87-91
`85-92
`
`90-92
`
`90
`90
`
`88
`89-90
`
`(continued)
`
`Instituti0ns*
`/
`Programs
`UC—Irvine Medical Center
`NMC Homecare
`UC-Davis Medical Center
`U.S. Naval Hospital
`UC-San Diego Medical Center
`Pacific Presbyterian Medical Center
`UC-San Francisco
`Santa Clara Valley Medical Center
`Abbott Homecare
`Stanford University Medical Center
`
`P/SL Health Care Systems
`(St. Luke's Hospitals)
`
`The Children's Hospital
`North Colorado Medical Center
`Saint Mary-Corwin Hospital
`Yale University/ New Haven Hospital
`
`Children's National Medical Center
`Howard University Hospital
`Veterans Administration Med. Center
`Washington Medical Center
`
`Mease Hospital
`Transmed Medical, Inc.
`Shands Hospital
`Mayo Clinic-Jacksonville
`Nemours Childrens Clinic
`Orlando Regional Medical Center
`H. Lee Moffitt Cancer Center
`Tampa General Hospital
`
`St. Josephs Hospital of Atlanta
`Medical College of Georgia
`Caremark
`Tripler Army Medical Center
`
`Home Hyperalimentation Service
`Northwestern Memorial Hospital
`University of Chicago Medical Center
`
`Wyler Children's Hospital
`Home IV of Central Illinois
`Alexian Brothers Home Health
`Veterans Administration Hospital
`Saint Joseph Medical Center
`NMC Homecare
`Abbott Home Care
`North Chicago VA Medical Center
`Saint Francis Medical Center
`Rockford Gastroenterology Associates
`Rockford Memorial Hospital
`Saint Anthony Medical Center
`Saint John‘s Home Infusion Therapy
`Community General Hospital
`OPTION Care
`Carle Foundation Hospital
`
`Indianapolis Gastroenterology
`Indiana Regional Medical Consultants
`
`Saint Joseph Medical Center
`
`University of Iowa Hospital
`McWilliams OPTION Care
`
`Care Plus
`Caremark
`
`Physicians**
`
`Thomas
`J. McGonagle.
`Howard P. Sherr
`
`Thomas Overett,
`
`C. Richard Fleming
`Donald E. George
`
`Jay J. Mamel,
`
`Diane K. Smith
`
`Robert Kushner, Michael D. Sitrin, Charles
`Baum
`
`R. Michael Galley
`
`Charles Welford
`
`Michael T. Isenberg, Edward V. Schultz, Vance
`V. VanDrake
`
`Page 4
`
`Page 4
`
`

`
`
`
`North American Home Parenteral and Enteral Nutrition Patient Registry
`Participating Programs / Institutions / Physicians (continued)
`
`UNITED STATES
`
`PROGRAMS
`
`(continued)
`
`State
`LA
`
`MD
`
`City
`Houma
`Lafayette
`Lake Charles
`New Orleans
`
`Falmouth
`
`Annapolis
`Baltimore
`
`Silver Spring
`
`MA
`
`Boston
`
`MI
`
`MN
`
`MO
`
`NE
`
`NJ
`
`NY
`
`Melrose
`Pittsfleld
`Waltham
`
`Ann Arbor
`Detroit
`
`Grand Rapids
`
`Lansing
`Mount Clemens
`
`Southield
`Traverse City
`
`Minneapolis
`Rochester
`
`Saint Louis
`
`Lincoln
`Omaha
`
`Edison
`Newark
`Totowa
`
`Albany
`
`Binghamton
`B uffalo
`
`Cohoes
`Manhasset
`Mineola
`Mount Kisko
`New York
`
`Years
`90-91
`84-87
`89-90
`85-88
`92
`
`87-88
`
`85-87
`86
`87
`91-92
`
`85-87
`89-92
`
`85, 87-92
`88
`84-92
`86-92
`89-91
`88
`89-92
`
`85-92
`85-86
`85-92
`85-91,
`86-92
`
`86-89
`86-88, 90-91
`
`85-92
`92
`
`85-89
`84-92
`
`86-90
`
`89-92
`85, 87-91
`86-91
`85-89
`86-87
`8587-89
`91
`87-88
`87-88
`
`84-92
`
`89-90
`89-92
`
`\O9\ON
`
`O0OO\Oxi‘O0:-—
`
`ooxoxooooooooo
`
`/
`
`Institutions*
`
`Programs
`OPTION Care
`Caremark
`Lake Charles Infusion Care
`Medical Center of East New Orleans
`Octsna Foundation Hospital
`Hospital Home Health Care, Inc.
`Anne Arundel Medical Center
`Bashar Pharoan, M.D.
`University of Maryland Medical System
`Pharmacy Corporation of America
`
`Beth Israel Hospital
`Briglnm & Women's Hospital
`
`Children's Hospital
`Dana Farber Cancer Institute
`New England Deaconess Hospital
`University Hospital / Boston University
`Abbott Home Care Program
`Berkshire Health-at-Home
`Chartwell Home Therapies
`
`University of Michigan Hospital
`Henry Ford Hospital
`Sinai Hospital
`Harper Hospital
`Butterworth Hospital
`
`Physicians‘*
`
`James Smith. Teresa Zimmerman
`
`Louis Dennis, Richard DiGioia, Laurence
`McDonald
`
`Douglas W. Wilrnore, Danny 0. Jacobs.
`Thomas Momlssey, Thomas Nattakom
`Clifiord Lo
`
`George Blackbum, Edward Mascioli
`Garry F. Fitzpatrick. Robert H. Lerman
`
`Jason H. Bodzin
`
`James D. Paauw, David E. Scheeres, Donald
`J. Scholten
`
`MHC Health Quest Infusion Therapies
`Mount Clemens General Hospital
`
`Kari Hortos
`
`Providence Hospital
`Munson Medical Center
`
`University of Minnesota Hospital
`Mayo Clinic
`
`Lawrence P. Zablocki, Steven Miles
`
`Darlene G. Kelly, Daniel L. Hurley,
`W. Fredrick Schwenk
`
`(Jewish
`American Home Therapies
`Hospital at Washington University)
`Deaconess Hospital
`Saint Louis University Hospital
`
`Robert Wright
`
`Bryan Memorial Hospital
`Critical Care America
`Methodist Hospital
`University of Nebraska Med. Cntr.
`Critical Care America
`University Hospital / UMDNJ
`Critical Care America
`
`Albany Medical College
`
`Lyn Howard, Shahab Aftahi, Sharon Alger,
`James Betzhold
`
`Equicare
`Veterans Administration Medical Center
`
`Twin Tier Home Health, Inc.
`Buffalo General Hospital
`Children's Hospital of Buffalo
`Vital Care (Millard Filmore Hospital)
`Syncor Homecare Services
`North Shore University Hospital
`Winthrop University Hospital
`-
`North Westchester Hospital Center
`Memorial—Sloan Kettering Institute
`Memorial—Sloan Kettering Institute
`Saint Luke's / Roosevelt Hospital
`
`Frank Booth, Robert Moseowitz
`
`(parenteral)
`(enteral)
`
`Page 5
`
`Page 5
`
`

`
`ll‘
`
`
`
`North American Home Parenteral and Enteral Nutrition Patient Registry
`Participating Programs / Institutions / Physicians (continued)
`
`State
`NY
`(continued)
`
`City
`Rochester
`
`NC
`
`ND
`
`OH
`
`Saratoga Springs
`
`Schenectady
`Staten Island
`Syracuse
`
`Chapel Hill
`Durham
`Greenville
`Winston-Salem
`
`Fargo
`
`Akron
`
`Cincinnati
`
`Cleveland
`
`Columbus
`
`OH
`
`Columbus (continued)
`
`PA
`
`RI
`
`SC
`SD
`
`TN
`
`TX
`
`Dayton
`
`Kettering
`Mansfield
`Miamisburg
`Toledo
`
`Allentown
`Danville
`Hershey
`Philadelphia
`
`Pittsburgh
`Providence
`
`Spartanburg
`Sioux Falls
`
`Kingsport
`Knoxville
`Memphis
`Nashville
`
`Carswell AFB
`Dallas
`
`Galveston
`Houston
`
`Lubbock
`
`Years
`84, 92
`92
`85, 89
`92
`90, 92
`92
`90-91
`86-87
`87
`85-92
`
`89-92
`85-90
`85-92
`88,90
`84-92
`
`Institutions*
`/
`Programs
`Strong Memorial Hospital
`Rochester General Hospital
`The Genesee Hospital
`University of Rochester
`OPTION Care
`Home Care of New York
`Advanced Infusion Management
`Staten Island Hospital
`Saint Joseph's Hosp. Health Cntr.
`SUNY University Hospital
`
`University of North Carolina (Ped.)
`University of North Carolina
`Duke University Medical Center
`CNS Nutrition Support
`North Carolina Baptist Hospital
`
`87-88
`85-86, 89-91
`
`OPTION Care
`Saint Luke's Hospitals
`
`85-92
`88
`85-87
`86
`85-90
`86-87
`84-92
`84-90
`90-92
`85-86
`85-90
`
`89-91
`85-89
`88-91
`87, 89
`87
`89-90
`88
`91
`89
`85-86
`
`85-92
`87-89
`92
`85
`84-89
`85-91
`84-88,91
`
`87,90
`87-89
`
`88-91
`88, 91
`86-89
`85, 87-92
`85-91
`85-89,91
`
`90
`85-88,90
`88,90
`85-91
`85-91
`89-92
`88
`86-90
`85
`85-88
`91.92
`
`Akron General Medical Center
`Saint Thomas Medical Center
`Children's Hospital Medical Center
`Good Samaritan Hospital
`Univ. Cincinnati Medical Center
`Cleveland Clinic Foundation (Pedl)
`Cleveland Clinic Foundation (Adult)
`Saint Vincent Charity Hospital
`Veterans Affairs Medical Center
`Children's Hospital of Columbus
`Clinical Pharmacists Consultants
`(Ohio State University Hospital)
`
`Mount Carmel East Hospital
`Mount Carmel Medical Center
`OPTION Care
`Saint Anthony Medical Center
`Children's Medical Center
`Dayton VA Medical Center
`Kettering Medical Center
`Hursh I.V. Associates
`Kettering Homecare Products
`The Toledo Hospital
`
`Lehigh Valley Hospital
`Geisinger Medical Center
`Hershey Medical Center
`Albert Einstein Medical Center
`Hospital, University of Pennsylvania
`Children's Hospital of Pittsburgh
`R.I.Home Nutritional Support Svc.
`
`Spartanburg Regional Med. Cntr.
`Sioux Valley Hospital
`
`Holston Valley Hospital/Medical Center
`Nutritional Support Services, Inc.
`LeBonheur Children's Medical Cntr.
`PharaThera, Inc.
`Saint Thomas Hospital
`Vanderbilt University Hospital
`
`R.L.Thompson Strategic Hospital
`Baylor University Medical Center
`Children's Medical Center of Dallas
`Presbyterian Hospital of Dallas
`University of Texas/Southwestern
`University of Texas Medical Branch
`Critical Care America
`Texas Children's Hospital
`University of Texas Health Science Cntr.
`Infusion Care
`OPTION Care of Lubbock
`
`Physicians**
`Marilyn R. Brown, Harry C. Sax
`
`Peter Weinberg
`
`Michael M. Meguid
`
`Martin Ulshen, Steven Lichtman, Marc Rhoads
`John P. Grant
`
`John Maxwell, Andrew Fenron, Mark Jaroch
`
`Ezra Steiger, Douglas Seidner
`
`Fredrick Webel, Allen Bloom
`
`Larry B. Feldman
`
`Samuel Klein
`
`Jane
`Sinn Annuras, Maurice Asmudden,
`Galdthorn, Mark Persa, Dale Rhoades, Eduardo
`Riff, Randy Rozean, David Wagononer, W. C.
`Williams
`
`Temple
`
`85-90
`
`Scott & White Hospital
`
`4 P
`
`age 6
`
`Page 6
`
`

`
`
`
`North American Hour Parenteral and Enteral Nutrition Patient Registry
`Participating Programs I Institutions / Physicians (continued)
`
`State
`UT
`
`VT
`VA
`
`City
`SfiI.J:C.'ly
`
`Bum
`fiklzwi
`
`WA
`
`WI
`
`F-ms Cbci
`Norfolk
`Ridnmnd
`Kenlefick
`Redmmd
`Scaxk
`Tacoma
`
`E11 03':
`Green Bay
`Lacrosse
`
`Militia:
`
`Neenah
`
`Years
`BI!
`
`PI-tutu J
`LIB Emmi
`
`Institutions*
`
`Physicians**
`Terry P. Clemmer, James F.0rme Jr.
`
`3-”
`
`6
`B-D
`
`13. Can: :f Vermont
`C};
`‘::.L Center of University
`I V.“
`Chm} if ’~';:-gmia Health Sciences
`(7:
`E Fab
`547
`WEI: :’:-r R‘ Therapy
`I
`E-E i C.1'!£-gt rf Vuginia Hosp.
`D
`(X11153 Cm:
`9|
`Cm £L1:ne;2:e
`I5-8|
`lbw afW:mm.g::t: Med. Ctr.
`$91
`5'1 fit
`Home Infus.
`
`Donald F. Kirby, Mark Delegge,
`
`3
`D
`‘Q2
`
`Stud Em:
`ii !'%.-a:_» i l~ie:«;th.:are Ctr.
`("mu Clan:-;
`l.a:rosse Lutheran James Kauphusman
`fig‘
`
`V
`
`_
`
`ll.”-92 Sui (‘:1 3: ‘Vascular Surgery
`5 m luhsiiuni Grcup. Ltd.
`85-”
`{iii Gm: Tzezfa Clark _\Ied.Ctr)
`
`James H. Woods
`
`CANADIAN PROGRAMS
`
`Province
`
`Alberta
`
`City
`
`Calgary
`
`Edmomon
`
`British Columbia
`
`Vancouver
`
`Yars
`
`Pinyin I Institution *
`
`Physicians
`
`**
`
`K5-9'2
`
`92
`
`89-90
`89-90
`89
`89-90
`
`Ii livqmai
`
`Lhuxy cf Alum
`
`hi Ciu. Gmliuts Hospital
`H? 51:} at‘ Hail:
`I.‘-nun} lhsgtai iL'BC~ \'a.ncouver
`\’na:1rc-u’ Cam’. Hfital
`
`Noel Hershfield, Howard Parronr, Roy
`Preshaw, Lorne Price
`
`Manitoba
`
`Ontario
`
`Winnipeg
`
`92
`
`it Hem: §\'11:rmcn PIi)_fi11'I]
`
`Toronto
`
`S6-91
`8'.’-89.91
`84-92
`
`Iii fit Sack Chfien
`Sin Josqis Bab Cemre
`Tutu Gzzul D'."-‘S136 of
`"I1: Tmma Hzszuaf.
`
`Johane Allard, Kursheed N. Jeejeebhoy
`
`
`
`Data Collection and Analysis
`
`In the first two months of each calendar year all of the
`Data are collected retrospectively and annually.
`participating programs receive a package of single page patient data questionnaires (Appendix A). The questionnaire
`is designed to be as simple and brief as possible to
`the burden of data extraction. Patient confidentiality is
`preserved by the use of initials, sex and date of birth only as identifiers. These identifiers plus the underlying
`diagnosis and date of starting HPEN have proved sufficient for tracking patients who move between programs, who
`discontinue HPEN but later resume treatment or who are doubly reported by a physician directed program and a
`service company. To ensure capture of longitudinal data. the clinician extracting the data is prompted by followup
`forms preprinted with the initials, date of birth, diagnosis and start of therapy date for all patients reported as still on
`therapy at the end of the previous year.
`
`Completed forms are returned to the Registry over the next 9 months. Once received, the information is
`entered into a database program (VA FileManager, version 17). A unique record is created for each new patient and
`follow—up information is added to the record of an established patient. During the next several months the calendar
`based information is reviewed, edited and reconciled with previous data, and finally it is reformatted into a separate,
`longitudinally continuous database so that clinical events can be analyzed over a span of time to create the outcome
`5
`
`Page 7
`
`Page 7
`
`

`
`
`
`profiles. These updated profiles are then summarized and published in this annual report. Since the entire process
`of data collection, review and analysis takes approximately 22 months, HPEN experience from 1992 is published in
`late 1994.
`
`Between 1985 and 1992 the 223 participating programs have registered a total of 12,239 HPEN patients, of
`whom 9,565 (5481 HPN, 4084 HEN) entered the Registry during their first year on therapy. Clinical outcome
`profiles are developed solely from this latter group, since for these patients their entire clinical course is known
`through to their last follow up report. Over this eight year period, in 78% of the programs the patient outcome was
`reported by their managing physician or a clinical designee; in 22% of the programs the data were reported by a
`service company clinician. Thirty six percent of the physician-reporting programs registered 1-5 patients, 39%
`registered 6-20 patients and 25% registered 21 or more patients. The service company data were chiefly from less
`urbanized geographic areas where there were no large physician-directed programs and where the physicians involved
`managed 1-5 patients. This experience was included to counterbalance the preponderance of large programs in the
`physician-reported sample. As shown in the 1992 annual report, HPEN patients entered by physicians and service
`company clinicians had similar diagnoses, age range and insurance coverage.
`
`Representativeness of The Registry Sample
`
`There is currently no mandatory requirement to report patients receiving HPEN to any central data collection
`system in either the United States or Canada and therefore the size and characteristics of the general North American
`HPEN patient pool is not known. However, using two large data bases, the Medicare utilization and the Registry
`patient demographics, an estimate of patient numbers and patient outcome can be made. Although both Medicare
`and Registry samples are large, they are not randomly selected and hence the conclusions drawn should be treated
`with caution.
`
`An Estimate of the Number of USA HPEN Patients
`
`In 1992 Medicare was
`Table II shows the number of Medicare patients on HPEN between 1989 and 1992.
`25% of the Registry HPN sample and 48% of the Registry HEN sample and therefore a rough estimate of the total
`United States HPEN population in 1992 was 40,000 HPN patients and 152,000 HEN patients. Between 1989 and
`1992 the Registry sampled 5% of the HPN and 1% of the HEN national experience.
`
`Table II.
`
`An Estimate of the Number of Home Pareteral and Enteral Nutrition
`Medicare Beneficiaries
`1989-1992 1
`
`Parenteral therapy
`Number of beneficiaries
`
`Enteral therapy
`Number of beneficiaries
`
`1989
`
`4,503
`
`1990
`
`7,784
`
`1991
`
`9,837
`
`1992
`
`10,035 2
`
`34,280
`
`51,017
`
`66,129
`
`73,323
`
`1 Estimates derived from Medicare Pan B PEN workload statistics compiled by Blue Cross/Blue Shield of South
`Carolina, one of two PEN specialty Medicare carriers 1985-1993. This carrier processed approximately 75% of the
`Medicare PEN claims. Their workload statistics have been increased to provide an estimate of the total national activity.
`2 This total does not include the 3271 beneficiaries receiving intradialytic parenteral nutrition in 1992.
`Data from Blue Cross/Blue Shield of South Carolina, personal communication.
`
`Clinical Outcome Profiles
`
`The clinical outcome of these patients is described on pages 10 to 23. Clinical outcome is assessed by
`four longitudinal parameters: 1) Survival rates while receiving HPEN are calculated by the life-table method.
`the patient dies or discontinues therapy to resume full oral nutrition, this clinical change is noted at year end.
`Thereafter the surviving patient is not tracked unless he or she resumes HPEN.
`2) Therapy status assesses the
`patient’s clinical situation one year after starting therapy. It describes the percentage of patients who resume full oral
`
`If
`
`6
`
`Page 3
`
`Page 8
`
`

`
`
`
`nutrition, stay on HPEN, die or have some ‘other’ status. This ‘other’ percentage includes patients who at-one year
`have switched therapies, are back in hospital or who have been lost to followup by their reporting program.
`3) Rehabilitation status on HPEN is an assessment made by the patient‘s supervising professional and is a
`description of how the patient functioned overall that year, rather than at a specific time point.
`It is described as
`complete, partial or minimal in relation to the patient‘s ability to sustain normal age-related activities.
`"Complete"
`describes a patient who is fully functioning, "partial" implies some limitation of activity such as part time in school
`or part time at work, and "minimal" describes a patient who is barely ambulatory.
`4) Complication rates per
`year include only those complications that result in rehospitalization. They are divided into complications that are
`HPEN related, and those that are non-HPEN related, but due to the underlying _diagnosis or some other medical
`problem. HPN complications are subdivided into "infectious", "metabolic", "mechanical" and “other”. HEN
`associated complications were probably not adequately solicited in the original questionnaire format. More specific
`HEN complications were solicited starting in 1994. To properly weigh complications in patients who remain on
`therapy for less than one year, the complication rates are calculated per month on HPEN treatment and converted to
`an annual rate.
`
`Each clinical profile includes the number of patients analyzed, and their sex and age distributions. For the
`most part these outcome profiles are self explanatory, but brief interpretive comments are added. Figure 1 provides
`an overview of the diagnostic distribution of the 9,565 HPEN patients who entered the Registry during their first
`year on therapy between 1985 and 1992.
`
`Figure 1
`
`Distribution of Registry Diagnoses
`
`Parenteral (n = 5481)
`
`Enteral (n = 4084)
`
`Crohn's
`Disease
`Ischemic
`Bowel
`
`Motility
`Disorders
`
`Congenital
`Bowel
`
`Hyperemesis
`Gravidarum
`Chronic
`Pancreatitis
`Radiation
`Enteritis
`Chronic
`Obstruction
`
`Cystic
`Fibrosis
`
`Neoplasm
`
`AIDS
`
`Neuromus.
`Dis. Swallow
`
`Other
`
`Crohn's
`Disease
`Ischemic
`Bowel
`
`Motility
`Disorders
`
`Congenital
`Bowel
`
`Hyperemesis
`Gravidarum
`Chronic
`Pancreatitis
`Radiation
`Enteritis
`Chronic
`Obstruction
`
`Cystic
`Fibrosis
`
`Neoplasm
`
`AIDS
`
`Neuromus.
`Dis. Swallow
`
`Other
`
`Percent
`
`Percent
`
`0
`
`10
`
`20
`
`30
`
`40
`
`50
`
`Page 9
`
`Page 9
`
`

`
`ll
`
`Special Analysis
`
`Home Enteral Nutrition for Patients
`with Neuromuscular Swallowing Disorders
`
`In a third of all patients starting HEN the diagnosis is a neuromuscular disease impairing swallowing.
`Only in patients with head and neck cancer is HEN usage more frequent. As shown on page 21, two thirds of the
`neuromuscular dysphagic HEN patients were 65 years or older and although the Registry does not solicit detailed
`information about the primary neuromuscular disease, in most older patients the primary defect was a cerebrovascular
`accident (CVA). One fifth of patients were 24 years or younger, where the diagnosis was more frequently cerebral
`palsy or another developmental abnormality of swallowing.
`
`Figure 2.
`
`Survival on HEN
`Neuromuscular Disorders of Swallowing
`
`<>
`©°©@®®@eeeeéee
`3
`32..
`AA
`
`0 All ages
`Under 25
`A 65 and over
`
`Survival (12 mo)
`
`Months on HEN
`
`0 <25 expected
`
`A > 64 expected
`
`6
`
`8 1012141618
`
`An overall anaylsis of this group (Figure 2 and Table II) creates a rather discouraging outcome picture:
`with a median patient survival of 1.5 years; only 19% resuming full oral nutrition; 75% experiencing minimal
`rehabilitation. This poor outcome reflects the high proportion of older patients with CVAs and extensive
`neurological impairment, limiting overall recovery. To evaluate the outcome of younger patients with disorders
`other than CVAS, the patients were separated into different age strata. As shown in Figure 2, the patients with a
`neuromuscular swallowing disorder, 65 years or older, had an observed survival rate at one year of 54 i 3% (mean 1
`SEM) compared to an expected survival rate for age and sex matched individuals in the general population of 93%.
`This gave a standard mortality ratio (SMR‘ ) of 5.4 for these patients.
`In patients under 25 years, the observed
`survival rate at one year was 89 1 4%, compared to an expected survival rate of greater than 99%. The SMR for
`this group of patients was 29. These differences confirm that survival was related to age, but that age per se could
`not explain more than a small percentage of the difference and therefore the underlying disease process is the chief
`determinant of survival.
`
`1 Standard Mortality Ratio: observed deaths / expected deaths
`
`8
`
`Page 10
`
`

`
`
`
`Table II summarizes the other clinical data for patients in the group as a whole, for those 65 years or older,
`and for those under 25 years. After one year 17 1 2% of older patients had resumed full oral nutrition as compared
`to 23 1 5% of younger patients. Only 14 i 3% of older patients experienced complete or partial rehabilitation
`compared to 55 1 6% of younger patients. The HEN and nonHEN related complication rates resulting in
`rehospitalization were infrequent and similar in both groups. The listing for HEN therapy status omits those
`patients who were reported as "other," i.e., those who changed therapy modes, were in a hospital or nursing home, or
`were lost to followup.
`
`Table II. Neuromuscular Disorders of Swallowing
`
`H E N Clinical Outcome Measures by Age Group
`
`All Ages
`
`Under 25
`
`65 and Over
`
`Number of Patients
`Female : Male
`
`1134
`587 : 547
`
`Average Age in Years
`(Standard Deviation)
`
`64.8
`(26.2)
`
`Survival on HEN (%)
`(% at 12 months 1 SEM)
`
`Expected Survival (%)
`
`54.3
`(i 2.4)
`
`96.2
`
`Rehabilitation Status
`
`(% at 12 mos)
`Complete
`Partial
`Minimal
`
`H E N Therapy Status
`(% at 12 mos)
`Resume Oral
`Continue H E N
`Died
`
`Complication Rates
`(Rehospitalizations / Pt yr)
`H E N
`Non-H E N
`
`4
`20
`76
`
`19
`27
`46
`
`146
`60 2 86
`
`6.1
`(6.4)
`
`88.6
`(i 4.1)
`
`99.7
`
`15
`39
`46
`
`23
`59
`14
`
`787
`436 : 351
`
`79.1
`(7.6)
`
`45.9
`(i 2.8)
`
`92.8
`
`2
`12
`86
`
`17
`21
`53
`
`0.29
`0.91
`
`0.27
`0.95
`
`0.34
`0.94
`
`These findings indicate remarkably poor outcome for the older patients with neuromuscular swallowing
`defects. Since tube enteral feeding is commonly recommended in this clinical situation, more in-depth quality of
`life studies are needed to determine when 1-IEN is the most appropriate advice for these patients and their families.
`Younger patients with long term tube feeding dependence appear to have a much better chance of meaningful
`rehabilitation.
`
`Page 11
`
`Page 11
`
`

`
`
`
`Crohn’s Disease
`
`Survival on HPN
`
`HPN Therapy Status
`
`100%
`
`9099
`
`agsaaafiaa
`
`®9eee
`
`90%
`
`807
`
`0
`
`EJResume
`
`oral
`
`Continue
`on HPN
`
`Other
`
`I Died
`
`340
`36 .0
`
`222
`3 7 .0
`
`
`SURVIVALRATEONHPN(%)
`HPN DURATION
`
`® Survival
`
`0 Expected
`(12 mos)
`
`60%
`50%
`
`300/
`0
`207
`0
`10%
`0%
`
`9121518 2124 27
`
`30
`
`33
`
`36
`
`MONTHS ON HPN THERAPY
`
`HPN DURATION
`
`Rehabilitation on HPN
`
`Complications
`Rehospitalization rates / patient—year
`
`100%
`90%
`80%
`70%
`60%
`50%
`
`40%
`30%
`20%
`10%
`0%
`
`HPN related
`Infection
`
`Sepsis
`Tunnel
`Metabolic
`Mechanical
`SVC thrombosis
`Other
`
`Total
`
`Non-HPN related
`
`Primary diagnosis
`Other problems
`Total
`
`Comments
`
`1. Mortality rate: five percent per year.
`2. Seventy percent have resumed full oral nutrition at 1 year.
`3. Seventy percent experienced complete rehabilitation at 1 year.
`4. Rehospitalization for sepsis once every 2 years.
`
`10
`
`Page 12
`
`Page 12
`
`

`
`
`
`Ischemic Bowel Disease
`
`Survival on HPN
`
`HPN Therapy Status
`
`9
`
`O
`
`100%
`
`90%
`
`e@@
`
`9e
`
`$33
`
`%®®$ee
`
`Q Survival
`
`0 Expected
`(12 mos)
`
`9121518 2124 27
`MONTHS ON HPN THERAPY
`
`30
`
`33
`
`36
`
`El Resume
`oral
`
`Continue
`on HPN
`
`Other
`
`I Died
`
`Rehospitalization rates / patient—year
`
`HPN related
`Infection
`
`
`SURVIVALRATEONHPN(%)
`H Minimal Complications
`Total
`
`Rehabilitation on HPN
`
`100%
`90%
`80%
`70%
`
`50%
`
`El Complete
`Partial
`
`HPN DURATION
`
`
`
`Sepsis
`Tunnel
`Metabolic
`Mechanical
`SVC thrombosis
`Other
`
`Total
`
`Non—HPN related
`
`Primary diagnosis
`Other problems
`
`Comments
`1. Mortality rate: twelve percent per year.
`2. Twenty seven percent resumed full oral nutrition at 1 year.
`3. Fifty percent experienced complete rehabilitation at 1 year.
`4. Rehospitalization for sepsis once every 6 months.
`
` 11
`
`Page 13
`
`
`Page 13
`
`

`
`
`Motility Disorders
`
`Survival on HPN
`
`HPN Therapy Status
`
`
`
`SURVIVALRATEONHPN(%)
`
`6
`
`O
`
`®@® ®
`
`3@@®®@®
`
`@®®®@
`
`® Survival
`
`Q Expected
`(12 mos)
`
`9121518 2124 27
`MONTHS ON HPN THERAPY
`
`30
`
`33
`
`36
`
`El Resume
`oral
`
`Continue
`on HPN
`
`Other
`
`I Died
`
`100%
`
`90%
`
`80%
`
`70%
`
`60%
`
`50%
`
`40%
`
`30%
`
`20%
`
`10%
`
`0%
`
`s.~.1~‘sa~‘
`
`axe-:»:~i
`
`6mo
`
`lyr
`
`HPN DURATION
`
`Rehabilitation on HPN
`
`Complications
`Rehospitalization rates / patient-year
`
`100%
`90%
`80%
`70%
`60%
`
`50%
`40%
`30%
`20%
`1 0%
`0%
`
`HPN DURATION
`
`HPN related
`Infection
`
`Sepsis
`Tunnel
`Metabolic
`Mechanical
`SVC thrombosis
`Other
`
`Total
`
`Non-HPN related
`
`Primary diagnosis
`Other problems
`Total
`
`Comments
`
`1. Mortality rate: twelve percent per year.
`2. Thirty percent resumed full oral nutrition at 1 year.
`3. Fifty percent experienced complete rehabilitation by 1 year.
`4. Rehospitalization for sepsis once every 18 months.
`
`12
`
`Page 14
`
`Page 14
`
`

`
`®@®®@
`
`Survival on
`
`HPN Therapy Status
`
`O
`
`100%
`
`90%
`
`6 a 3 @ ®
`
`®
`
`® ® % ® %
`
`g
`
`%
`
`@ Survival
`0 Expected
`(12 mos)
`
`.
`
`0
`0..
`
`_.
`
`_
`
`DResume
`oral
`on
`
`Other
`
`I Died
`
`80%
`70%
`
`50%
`
`40%
`
`30%
`20%
`10%
`0%
`
`
`SURVIVALRATEONHPN(%)
`HPN DURATION
`
`MONTHS ON HPN THERAPY
`
`9 1215 18
`
`21
`
`24
`
`27
`
`30
`
`33
`
`36
`
`lyr
`
`HPN DURATION
`
`Rehabilitation on HPN
`
`Complications
`Rehospitalization rates / patient—year
`
`>-Ov->—*Ol\>l\J>—*~l>
`
`U.)
`
`3 3 1 2 0 0 1 0
`
`\ll\)
`
`HPN related
`Infection
`
`Sepsis
`Tunnel
`Metabolic
`Mechanical
`SVC thrombosis
`
`Other
`
`Total
`
`Non—HPN related
`
`Primary diagnosis
`Other problems
`Total
`
`1.44
`0.14
`0.25
`0.30
`0.00
`
`_Q._m
`2.23
`
`0.71
`1
`1.05
`
`100%
`90%
`80%
`70%
`60%
`50%
`
`40%
`30%
`20%
`10%
`0%
`
`Comments
`
`1. Mortality rate: seven percent per year.
`2. Thirty percent resumed oral nutrition at 1 year.
`3. Seventy three percent experienced complete rehabilitation at 1 year.
`4. Rehospitalization for sepsis once or twice per year.
`
`111
`
`ll
`
`1
`
`Page 15
`
`

`
`
`
`HPN Therapy Status
`
`Hyperemesis Gravidarum
`
`100%
`90%
`80%
`El Resume
`
`70%
`"31
`60%
`Continue
`
`50%
`on HPN
`40%
`Other
`I Died
`30%
`
`
`
`
`
`Survival on HPN
`
`®<® $|®l®1.
`
`Q Survival
`
`Q Expected
`(12 mos)
`
`9121518 21
`
`24
`
`27
`
`30
`
`33
`
`36
`
`MONTHS ON HPN THERAPY
`
`
`SURVIVALRATEONHPN(%)
`Total
`
`
`
`
`
`20%
`
`10%
`
`0%
`
`6mo
`
`HPN DURATION
`
`Rehabilitation on HPN
`
`Complications
`
`Rehospitalization rates / patient—year
`
`100%
`90%
`80%
`70%
`60%
`
`50%
`40%
`
`6mo
`
`HPN DURATION
`
`HPN related
`Infection
`
`Sepsis
`Tunnel
`Metabolic
`Mechanical
`SVC thrombosis
`Other
`
`Total
`
`Non—HPN related
`
`Primary diagnosis
`Other problems
`
`Comments
`
`1. Survival rate: 100%.
`2. For ninety five percent of patients, the duration of HPN is less than 6 months.
`3. Eighty percent of those on for 6 months experienced complete rehabilitation.
`4. One in four patients experienced a rehospitalization for sepsis during 6 months on HPN.
`
`
`
`14
`
`Eagejg
`
`
`
`Page 16
`
`

`
`Survival on HPN
`
`HPN Therapy Status
`
`
`
`SURVIVALRATEONHPN(%)
`
`@
`
`O
`® ® ® 3 3
`
`@
`
`® @
`
`® Survival
`O Expected
`(12 mos)
`
`9121518 2124 27
`
`30
`
`33
`
`36
`
`MONTHS ON HPN THERAPY
`
`100%
`
`90%
`80%
`70%
`60%
`50%
`
`40%
`
`30%
`20%
`10%
`0%
`
`.~'..~..~..~.’x4‘~
`
`6mo
`
`lyr
`
`HPN DURATION
`
`Rehabilitation on HPN
`
`Complications
`Rehospitalization rates / patient-year
`
`100%
`90%
`
`80%
`70%
`
`50%
`50%
`40%
`30%
`20%
`10%
`0%
`
`-
`
`'
`.
`
`.
`
`'
`
`HPN related
`Infection
`
`Sepsis
`Tunnel
`
`Metabolic
`Mechanical
`SVC thrombosis
`Other
`
`Total
`
`Non—HPN related
`
`Primary diagnosis
`Other problems
`
`ElResume
`°““
`Continue
`on HPN
`
`Other
`
`I Died
`
`CI) (‘DN
`
`oc>4>:5§{‘o’\1uaw4>.oZ
`
`
`
`ot\>4>§§’{5’_;‘ui.i>i\>o'712°
`
`76
`
`80
`
`Comments
`
`1
`1
`I
`
`1. Mortality rate: ten percent at one year.
`2. Eighty five percent resumed full oral nutrition at 1 year.
`3. Fifty five percent of patients on therapy for 6 months experienced complete rehabilitation.
`4. Fifty