Download Final Paper - Research - Vanderbilt University

Hair Loss Evaluation
Efficiency Study
Vanderbilt University
Department of Biomedical Engineering
April 22, 2003
Peter Claise
Barb Visher
Advisors:
Dr. Paul King
Dr. Lloyd King
Dr. Sara Whitehead
Dr. Jennifer Dempsey
ABSTRACT
Alopecia, baldness occuring in both males and females of all ages and races is still
largely a mystery to physicians and researchers. Genetic correlations have been attributed
to androgenetic alopecia while autoimmune diseases have some linkage to alopecia areata.
Unfortunately, positive treatment outcomes are still sporadic with little few breaking
developments in the fields.
Although hair loss is a significant problem, research efforts in the US have been
sporadic and incoherent due to lack of clinical communication and a centralized
information system for collected data. Therefore, efforts for learning more about and
stopping hair loss are slow and tedious. The goal of this project is to assist in the overview,
containment and efficiency of a useful hair loss study by creating a database with a wide
variety of fields that are easily sortable for a large number of records in order to allow
researchers the ability of developing genotypic correlations regarding hair loss.
After attempting several database formats, the final database project is a complex
interlinking with defined relationships consisting of tables, forms and queries. The data is
acquired through a series of forms that are connected through linking relationships. The
majority of the fields in the database are stored as either “yes/no” or “text” fields, thus
minimizing user error and maintaining consistency.
Efficiency in patient meetings was noted with significant implications on the
possible increase of patients seen overall. Not only was patient waiting time decreased,
but time spent between doctor and patient was optimized by focusing discussion on current
problems, changes and treatments rather than medical history. Future possibilities of a
larger scale trial would yield large amounts of data necessary to determine correlations in
the etiology and pathology of alopecia.
INTRODUCTION
Hair loss affects millions of Americans annually. Loss of hair may be related to a
hormonal imbalance, poor receptor biomechanics, follicular detriment, malnutrition, severe
stress, disease, genetics, allergies and/or medication. Types of hair loss range as vastly as
the causes to include alopecia areata, androgenetic alopecia, alopecia totalis and alopecia
universalis.
Alopecia areata, an autoimmune disorder of unknown cause, affects 4 million
people in the United States alone, and 1.7% of people globally (www.alopeciaareata.com).
With a prevalence equivalent in males and females, alopecia areata is characterized by
patchy, circular, bald spots through out the scalp. Progression of the disease may lead to
alopecia totalis, complete scalp hair loss, or eventually alopecia universalis, total body hair
loss. However, diagnosis of alopecia areata does not have to precede the latter two.
Together alopecia totalis and alopecia universalis affect 800,000 people in the US. While
no gender, race or age group is immune, occurrence is most often diagnosed in children.
Heredity influences the likelihood of alopecia areata as 20% of those afflicted have a
relative who also suffers from the disease (www.alopeciaareata.com).
Hair loss is often temporary with alopecia areata. However the course of the
disease fluctuates and recurrent episodes may be detected in up to one-third of alopecia
areata patients (Goldstein et. Al.). Atopy, a prepubertal state, widespread development
(alopecia totalis or alopecia universalis), pathology duration greater than five years, or
peripheral scalp involvement may all decrease the potential for regrowth (Goldstein 5).
Regardless of the extent of hair loss, follicles lay dormant until appropriate signals are
received to stimulate normal hair production (www.alopeciaareata.com).
Approximately 95% of hair loss is caused by androgenetic alopecia, commonly
known as male or female pattern baldness (www.hairlossfyi.com). Known for its genetic
linkage, androgenetic alopecia is characterized by a receding hairline and centered bald
spot (which eventually may meet) in men and a general thinning at the top of the head in
women. Common patterns of hair loss for men and women with male and female pattern
baldness respective is shown if figures 1 and 2.
However, some argue that female pattern baldness may not necessarily be the
equivalent counterpart of male pattern baldness. “The majority of women with pattern hair
loss do not have the degree or the synchronization of miniaturization in a given region of
the central scalp as men do and, thus, do not have the same recognizable patterns of hair
loss as in effected men” (Olsen 2003). Research is currently studying ovarian and adrenal
hormones to better understand the etiology of female androgenetic alopecia in fear that
development of new effective therapies are being hindered due to an over generalization of
defining characteristics in male/female pattern baldness (Olsen, September 2001).
Diagnosis of alopecia is variable; literature on the topic fluctuates in the diagnostic
symptoms used to categorize patients. Universally, smooth and discrete areas of hair loss
in round patches are noted for diagnosis of alopecia areata. Examination of hair roots and
follicles also yield pertinent information for diagnosis and pathology. Biopsies are not
standard protocol for general diagnosis but do assist in more specific categorization.
Available treatments currently offered to reduce the visibility of alopecia
include topical and injectable medications including minoxidil, propecia, and rogaine.
Laser assisted hair transplantation and hair prostheses are also common tools in dealing
with alopecia symptoms. Current research strongly supports gene profiling and hair cycle
control to diminish alopecia’s results. Unfortunately, findings are still non specific and
small scale with limited expectation of near future solutions. While some reported studies
show that certain patients do benefit from treatment, often times statistical analysis is not
done to truly represent the likelihood of causation between treatment and regrowth and
reported data is therefore skewed.
Although hair loss is not terminal, results are profound due to the unpredictable
nature and recurrence of alopecia. Society places a high value on personal appearance and
hair is a large source of beauty and self-confidence for many. The sudden theft of this
visible trait can be a difficult and painful process for anyone to endure, especially a young
child. Emotional consequences are often times larger than medical consequences resulting
in years of therapy, and low self esteem, in addition to countless treatments for the
disorder. Additionally much of society is unaware of the disorder and its symptoms.
However, the problem is not just cosmetic, much speculation and study has linked alopecia
to a range of autoimmune diseases including rheumatoid arthritis, diabetes, lupus, and
multiple sclerosis.
Currently no universally effective treatments exist. However if the etiology of
alopecia is better understood, great strides can be made in understanding, localizing and
preventing pathological recurrence (Brzezińska-Wcisło et. Al.). Despite the significance
of the hair loss problem, research efforts in the US have been sporadic and incoherent due
to lack of clinical communication and a centralized information system for collected data.
Therefore, efforts for learning more about and stopping hair loss are slow and tedious.
Etiology, pathology and personal patient history must be presented on a clinical scale to
facilitate a wide pool of patient information for further study. Therefore, the goal of this
project is to assist in the overview, containment and efficiency of a useful hair loss study
by creating a database with a wide variety of fields that are easily sortable for a large
number of records in order to allow researchers the ability of developing genotypic
correlations regarding hair loss. Because of the large volume of data and the possibility of
future widespread use efficiency in data collection, requested information and storage is
essential for an effective study.
METHODS & RESULTS
Several possibilities were proposed for creation and set up of a hair loss
database. However, in choosing parameters and an overall organizational structure of the
intake information many trials were attempted. Originally, examples of phone screenings
and arbitrary trial questionnaires were studied to gain a sense of understanding regarding
the organizational structure and general information necessary. Personal patient
information is now separated from all other relative medical screening to insure patient
privacy protection in accordance with the Health Insurance Portability and Accountability
Act of 1996 (HIPPA).
The first database trial consisted of mostly open ended questions, which to date had
been recorded by hand. Although the general fields and overview were a valid first
attempt, this first trial allowed for far too much variability in the data within a given field.
Additionally, because the attempt was made to encompass all relative topics in regard to
hair loss from total family history to a description of all discernable phenotypic
characteristics organization was muddled.
Further attempts led to drop down boxes, lists, yes/no choices and check boxes,
leaving little to no room for severe variability in answer types. While answers may vary
significantly (with over 50 past medication possibilities, and any combination of the
choices), human error is drastically decreased because the clinicians are no longer
responsible for typing in the answer. Therefore spelling errors and compatibility errors (1
vs. one) are negated.
In order to increase efficiency and
organization a branching structure was proposed
as seen in figure 3. The purpose of this format
was to direct data acquisition to only those topics
associated with the patient’s condition and
minimize extraneous lines of questioning as well
as time spent per visit. However, in assembling
Fig. 3. Proposed structure for data
acquisition and organization.
such a structure the overall purpose of obtaining all information that would later be useful
in determining genetic correlations was lost. This method reverted back to storing only
that information which appeared to have a direct relationship with the prevalent disorder
rather than storing all possible data factors to be later sorted and evaluated.
The patient evaluation is now reformatted to encompass all characteristics
associated with hair loss in an organized and convenient manner. The final database
project is a complex interlinking with defined relationships consisting of tables, forms and
queries. The data is acquired through a series of forms that are connected through linking
relationships. There is a series of 12 tables consisting of “General Information”,
“Characterization of Main Complaint”, “Past Medical History”, “Family Medical History”,
a series of general and specific symptoms, “Physical Exam”, “Labs” and “Common
Drugs.” These sections could not be separated perfectly into one table each because of the
large quantity of information and the limit to the number of fields in a given table by
Microsoft Access. Each table can only store a finite number of fields so it is essential to
have multiple tables to store the immense amount of information.
Each table is maintained and organized for later use with specific “Primary Keys.”
The “primary key” is a single field in the table, which is used to automatically sort all
fields within the table. “Primary keys” must be unique so these were artificially created in
most cases due to the reproducibility of the information stored in the database.
Additionally, “primary keys” are essential in linking different tables to one another. The
linking of tables is referred to as “relationships” and is necessary to combine multiple
forms and tables in searches and analyze the data inputted.
Each field in the table is associated with a specific data type such as “yes/no”,
“number”, “text”, “memo”, “date/time”, “currency” and “hyperlink.” The majority of the
fields in the database are stored as either “yes/no” or “text” fields, thus minimizing user
error. Additionally, human error is further minimized by using “combo” and “list boxes”,
also known as drop boxes that store preset text answers for text inputs in a given field,
such as race (see figure 4).
Fig. 4. A list box is set up with all pertinent choices of classification for the ‘Race’ field.
A series of forms were also created to assist in user input. Multiple forms allowed
for an artificial tracking number to be created using “primary keys” for each patient to
comply with HIPPA regulations. The multiple forms also make it more efficient for the
user to enter information into the database because they do not have to scroll down (see
figure 5). Multiple forms allow for quick movement onto the next page while still looking
at the work they are doing. In addition, on the forms themselves, precautions were taken to
ensure the correct and useful data is entered into the database. Access 2000 is a very
helpful program in that if the field is set to “numbers” and the user inputs characters then
an error message immediately comes on the screen and will not let the user move on until
the error is solved. All values entered into the database that are not “toggle buttons” or
Fig. 5. Example of the Physical Exam form. Drop boxes, check boxes and default values can be seen.
combo boxes have some degree of freedom which can create bad data and produce an
inefficient database.
However, these errors are minimized with a series of specific rules set in Access
such as “validation rules”, “default values” and “input masks.” The “Input Mask” property
is used to display literal display characters in the field with blanks to fill in. For example, if
all phone numbers you enter in a field have the same format, you can create an input mask
such as a spacing (___) ___-____. This minimizes the likelihood for the user to
misinterpret the information wanted. “Validation rules” block the user from entering data
that does not correspond to the field. These can be set by altering the properties of
individual fields to fit the specifications. For instance, someone’s age is stored as a
number in the field “age.” A number can be anything from negative infinity to positive
infinity but by setting reasonable “validation rules” the user is limited to entering a number
from 0 to 110 assuming that no one over 110 is going to be participating in the study.
“Default values” also assist in this process so the user knows what type of entry is
expected, for example number of nails affected is set at 0 until an amount is added thereby
assuming the patient has no nail problems until otherwise specified. (See Appendix A for
a complete patient visitation evaluation form used to create the prototype database).
With good, helpful data stored under fields in tables within the database it is now
possible to use the abundance of information. Access 2000 has the ability to enter a
number of queries to sort and filter the data in a useful manner. The user sets queries by
selecting tables and fields within the tables and isolates data stored in the field that matches
the criteria the user sets. Some sample queries that were created examine all individuals
that have had symptoms since they were younger than 10, have a family history of asthma,
have a family history of psoriasis, experience leg swelling and have been on the
medication Amantadine. The results received were high due to the artificial data inputted
for testing purposes.
Additional queries were programmed, but there will be a delay until enough
information has been added to the database to produce some useful outputs. With minor
training anyone can become a professional at writing queries.
The market for this product is substantial. To date there have been no
comprehensive studies of hair loss. There are a hundred’s of doctors researching the
subject narrowly and inefficiently who could be greatly assisted by a comprehensive
database. The price of this product is fairly inexpensive at $ 349.99 based on student work
(including consultation and research) for 200 hours at $ 15.00 per hour.
The maintenance on the product is negligible besides a complementary two-hour
training course with phone support 5 days a week. There are very low marketing costs
associated because target audiences would be found at hair loss conventions where the
product would be displayed. Thus isolation of a large population with a very high
probability of buying the product would incur. Shipping is also minimal which is
attractive to potential buyers.
The lifecycle of the product can be determined by the success of the product. With
a high success rate it is possible to improve on the program and produce new editions that
can be deemed superior to the older editions and sold at the same price with a small
discount to repeat buyers.
Benefits of such a program are both personal and public. Obviously today’s hair
loss market is enormous with hair club for men, propecia, rogaine, and others. If a precise
factor leading to hair loss, such as a hereditary gene or increase in specific hormones, was
determined the economic upshot would be incredible. Additionally, the emotional torment
surround this disorder would be alleviated for millions.
In designing a classification system based on the pathology of alopecia, clinical
evaluation is now more succinct. To increase efficiency, a patient handout was loaded
onto our website. This handout (Appendix B) is primarily used to increase productivity
during subject/doctor interaction. Patients are asked to download and fill out the Read
only file by hand so that they will come in with current information pertinent to their visit.
Most doctor visits require lengthy screening questionnaires which can be long and
frustrating if you do not have access to all necessary answers. Often times, having a
patient fill out such a personal health questionnaire ahead of time gets them thinking about
their medical history, relevant questions to ask and changes in a condition they should
share with a doctor. A disclaimer was also placed on the website stating that this handout
Fig. 7. Expected flow chart of a patient’s clinical visit.
was not for diagnostic
purposes, but simply a
tool to assist the patient
in relaying all necessary
information to a
physician.
By incorporating this
questionnaire and the
database as part of the
routine clinical visit, we expect to cut patient wait time by at least 30 minutes (figure 7).
Currently three patients on average are seen weekly. Within several months we
hope to double patient intake to six weekly. If a large enough patient pool exists in the
geographic area, this would be possible due to time saved with implementation of the
patient handout and working knowledge of the database by the clinician. A projected time
efficiency evaluation allows for more time for the clinician to input data and manage the
patient record (figure8). Less time is needed in reviewing patient history because of the
Fig. 8. Time efficiency comparison.
Total time spent previously: 90 minutes
Total time spent currently (projected): 70 minutes
questionnaire which the patient will bring already filled out. Lastly, time is allotted for the
physician to review past visits, compare current and past treatments and even run a quick
sampling of all visits by the focal patient.
CONCLUSION
Through review of material, group meetings, experimentation and extensive
question/answer sessions we were able to distinctly define what would be necessary for a
comprehensive clinical approach to studying and recording the etiology, pathology and
terminology of alopecia. Standardization of techniques is critical to the overall goal of
obtaining reproducible, storable and easily manipulated data. Efficiency in patient
meetings was noted with significant implications on the possible increase of patients seen
overall. Not only was patient waiting time decreased, but time spent between doctor and
patient was optimized by focusing discussion on current problems, changes and treatments
rather than medical history.
With the limitations of the Access program, it is likely that a more wide scaled
program would be needed to mass produce an efficient software package especially
because of the large number of fields to be incorporated. However, relative to our
advisors’ goals, we have produced a smaller scale system capable of intaking, sorting,
correlating and storing large amounts of data pertinent to patient information. This system
will allow the physicians to run trials of a study that is constantly changing and will give
them the option of adding in more fields as necessary. Additionally, this trial will assist
them in determining exactly how to assess patients while attempting to conduct a wide
spanning study.
Using this program will allow the clinicians to bypass the beauracracy and
legalities of obtaining permission to run a study trial through the VA. No data or patient
information has been taken from any larger institutions, thereby allowing the Hair Loss
Evaluation Study to remain its own entity. If trial runs are productive, possible future
funding may be sought to create a solid, network accessible national database. However,
obtaining grant money and HIPPA approval would be tedious and time consuming.
“Great strides have been made during the last 20 years in the methodology of
clinical trials of pattern hair loss. The standardization of various techniques, and
recognition of what each is actually measuring have been key to producing reliable results”
(Olsen 2003). With continued effort alopecia will one day loose its mystery.
RECOMMENDATIONS
Currently, pictures are not incorporated into our final database protocol per request
of our advisors. However, we believe the completed clinical study database should have
uplink and storage capabilities of all photographs to ensure a complete patient file. In the
future, pictures should record all four scalp quadrants
during each patient visit and upon repeat evaluations
in addition to the more specific pictures taken of
target problem areas (Figure 7). This will allow for
tracking of the disease spread and tangible records for
later comparison, as fluctuations in hair growth and
thickness are expected for alopecia patients.
Additionally, treatment progress can be
Fig. 7. Proposed quadrants for
photographic records (Olsen 2001).
monitored with the possibility of quantitative assessments in the future. A feature that is
imperative to label treatment as successful. Quantification of future treatment testing must
be specific to determine differences in ‘hair increase’ because an increase in hair may be
due to escalating thickness of existing hairs, growth and sustainability of new hair, or a
combination of both. However, qualitative analysis of treatment is equally significant to
maintain structural integrity of the hair and follicle through out the growth cycle. For truly
precise and comparable results a stereotactic positioning device would be ideal to keep the
patient’s head stationary. The camera would also be fixed to ensure exact view and
magnification amongst successive visits (Olsen 2003). Other factors that would impede
successful follow up comparisons include varying hairstyles, different hair colors or in
some cases, extreme tanning of the scalp.
In implementing such a possibility, space would be the largest limiting factor. Film
would not be a consideration as everything would be stored digitally.
The largest ethical and legal concern surrounding this project was ensuring
confidentiality of current and future subjects. Because this Access database is on a smaller
scale than originally planned, only the clinical investigators will have access to the
software that is password protected. Personal information of each patient will be requested
only once and stored with a patient ID. In all following forms only the patient ID number
will be visible to discern patients. Therefore, no personal information will be divulged or
accessible to anyone other than the regulating clinicians in accordance with HIPPA.
Ethically, the only factor regarding this project is proper explanation so as not to
provide false hope to the general public. It must be made clear that this Hair Loss
Evaluation is only in the research stages and data collection is the primary focus so as not
to confuse subjects seeking to participate in a Phase III study of a new medication.
However, with continued support this study can become a pioneering tool to unlocking the
mystery of alopecia.
REFERENCES & ACKNOWLEDGEMENTS
Brzezińska-Wcisło L; Szeremeta-Bazylewicz G; Talik V. “Scalp diseases inducing
cicatricial alopecia.” Wiadomosci Lekarskie 53 (January 2000): 522-9.
Kaufeld, John. Access 2000 for Windows for Dummies. New York: Hungry Minds, Inc.,
1999.
Microsoft Access 2000 Copyright  1992-1999 Microsoft Corporation.
Olsen EA. “Female pattern hair loss: Clinical features and potential hormonal factors.”
Journal of the American Academy of Dermatology 45 (September 2001): S69.
Olsen EA, Weiner MS, DeLong E, Pinnell SR. “Topical minoxidil in early male pattern
baldness.” Journal of the American Academy of Dermatology 13 (August 1985): 185-92.
Olsen EA. “Current and novel methods for assessing efficacy of hair growth promoters in
pattern hair loss.” Journal of the American Academy of Dermatology 48 (February 2003):
253-62.
Olsen EA, Bergfeld WF, Cotsarelis G, Price V, Shapiro J, Sinclair R, Solomon A, Sperling
L, Stenn K, Whiting D. “Summary of North American Hair Research Society (NAHRS)sponsored Workshop on Cicatricial Alopecia, Duke University Medical Center, February
10 and 11, 2001.” Journal of the American Academy of Dermatology 48 (February 2001):
103-10.
Russ Waitman. Personal Interview. January 2003.
Wempen, Faithe. Microsoft Access 2002: fast & easy. Prima Publishing, CA. 2001.
www.hairlossfyi.com
www.alopeciaareata.com
www.aad.org
www.uptodate.com : Goldstein BG, Goldstein AO. “Hair loss.” 2002.
Dr. Paul King
Dr. Lloyd King
Dr. Jennifer Dempsey
Patient Education Handout: “Baldness”
Dr. Sara Whitehead
Chapter 1: Understanding Alopecia Areata provided by Dr. Whitehead
APPENDIX A
NON-SCARRING ALOPECIA
Name:
Date of visit:
Sex: male
DOB:
Age:
female
Race: White
Black
Hispanic
Other___________________
American Indian/Alaskan Native
Asian/Pacific
MAIN COMPLAINT:
[]
Hair: loss excessive growth
affecting: scalp,face, body
[]
Skin: ulcers papules pustules plaques nodules abscesses
[]
Nails: brittle thickened dystrophic discolored grooves ridges splitting
[]
Teeth:
HISTORY OF MAIN COMPLAINT:
Duration of symptoms: ____# of years ____# of months _____# of weeks
Characterization of main complaint:
 Age at onset (#)______________
 Number of episodes:_____________
 Pattern of hair loss: patchy[] general/diffuse[] Other[]
N/A[]
 Onset: sudden[]
gradual []
 Course: continuous[]
intermittent[]
 Is hair loss area is able to be camouflaged: yes
no
n/a
 Daily hair loss count: 1-50 51-100 101-150 >150
 Approximate % of hair loss (most severe episode): 0 25 50 75
 Scalp changes: yes no
 Hair changes: yes no
 Skin changes: yes no
 Affected areas:
scalp
eyebrows
eyelashes
beard
mustache
chest/breasts
back
abdomen
arms
legs
underarms
genital area
other__________________
100
Characterization of regrowth if applicable:
 Current regrowth: yes
no
unknown
 History of regrowth: yes
no
unknown
 Time for regrowth: [] < 1 year
[] > 1 year
 Any residual scarring or deformity: yes
no
or, hair changes: yes no
Symptoms:
 []Pruritis
[]Pain/tenderness
[]Parasethia []other__________________
 Relationship to hair loss: []before []ongoing []with regrowth
[]other____________________________________
 Relationship to main complaint:________________________________

Stressors/environmental triggers:__________________________________
PHYSICAL EXAM
General:
Wt:
Ht:
BP:
Pulse:
HAIR:
 Strand appearance: normal
exclamation point
broken
 Part width:
Midline- normal abnormal
Right- normal abnormal
Left- normal abnormal
 Hair pull: (#/10 x 5 times) /10
/10
/10
/10
/10
Total #: anagen________
telogen_________
Total %: anagen________
telogen_________
SCALP: (0-3 scale)
Erythema
[]
Scale/crusting []
Pustules
[]
Extent [] See Diagram/photos
Pull test
[]
Follicular markings []
Perifollicular hyperkeratosis []
Tufting[]
Telangiectasia
[]
Atrophy []
Pigmentary changes
[]
KP
[]
NAILS:
 Number affected: []none
[]hands (1-10)______ []feet (1-10)______
 Appearance: [] Thin []Thick []Dystrophic []Pitting []Striations
[]Grooves []splitting []onycholysis []Koilonychia []Leukonychia
[]Red spotted lunula
BODY:
 Other areas affected by hairloss: yes
no
If yes, list:__________________
 Other skin abnormalities:_____________________________________________
_________________________________________________________________
_________________________________________________________________
LABS:
Test
C. pneumoniae
PBMC
CBC/plt
Ferritin
ANA
TSH
LH
Prolactin
Total
testosterone
Y/N
Date
Results
Test
Lipid panel
Urinalysis
ESR/CRP
RPR/VDRL
HIV
KOH
Bacterial culture
Fungal culture
AST/ALT/alkaline
phosphatase
Y/N
date
Results
Bilirubin
Eye exam
DHEA-S
Creatinine
Microscopy:
 Root:_________________________________________________________
 Shaft:_________________________________________________________
 Tip:___________________________________________________________
BIOPSY
Site: scalp
other___________
 Size punch: _____mm
 Active center
leading edge
other__________________
 []Lymphocytic
[]Neutrophilic
[]Mixed
[]Non-specific
Histologic Staging: Acute []
Persistent
[]
Telogen to anagen
conversion []
Recovery []
Clinical Diagnosis:
PATIENT VISIT CHECKLIST
Questionnaire completed
Photography:
 Scalp: front back left right top
 Nails
 Other:_______________________________________
Biopsy collection:
Sample sent to: UDP VA Baylor Stratton
Mitchell(Auburn)
Blood collection:
 today
previous visit
future visit
Patient given copy of NAAF brochure
Patient given referral to HPI
Patient interested in participation in alopecia registry
Patient interested in future correspondence
Patient mailing address:
____________________________
____________________________
____________________________
Patient phone number: (
)
Yes
Yes
No
No
N/A
N/A
Yes
No
N/A
Yes
No
N/A
Yes
Yes
Yes
Yes
No
No
No
No
N/A
N/A
N/A
N/A
APPENDIX B
Hair Loss Clinic
Please answer the following questions prior to your visit.
Name:
Date of Birth:
Age:
Address:
Phone number:
Sex: male
female
Race: White
Black
Hispanic
American Indian/Alaskan Native
Asian/Pacific
Other___________________
MAIN COMPLAINT: Please check all that apply to you.
I am most concerned about my…
[]
Hair: (please circle one)
I am losing it.
It is growing excessively.
[]
Skin: (describe)
[]
Nails: (describe)
[]
Teeth: (describe)
HISTORY OF MAIN COMPLAINT:
Please answer these questions regarding the problem that is most concerning to you.
How long have you been experiencing symptoms?
Characterization of main complaint:
 At what age did you first begin to notice these symptoms:______________
 How many episodes have you experienced since that time:___________
 How frequently do these episodes occur:____________
 How long do these episodes last:_____________
 Do your symptoms begin suddenly or gradually?___________
 Are your symptoms continuous (present all the time) or intermittent (come and
go)?______________
 Are you able to camouflage your condition: yes
[]
no
[]
 How severely does this problem impact your activities of daily living: (please
circle one) not at all
minimally
moderately
severely
debilitating
 What areas are affected by this problem: (circle all that apply)
scalp
eyebrows
eyelashes
beard
mustache
chest/breasts
back
abdomen
arms
legs
underarms
genital area
other__________________
 Please list any factors that aggravate or alleviate this
problem:_________________________________
 Are there any other symptoms associated with this problem:_________________
 Does anyone in your family have a similar condition:_______________________
Social:
 Please describe your diet:_______________________________________
 How often do you exercise:______________________________________
 Do you smoke?_____ If yes, how many cigarettes/day.
 Do you drink alcohol?______If yes, how many drinks/week.
 Who lives at home with you?_________________________________
 Please list the stressors in your life:_______________________________
Current Medications: Please list all medications that you are currently taking. Include
all over-the-counter medications as well as vitamins and herbal medications.
_______________
_______________
_______________
_______________
_______________
_______________
_______________
_______________
_______________
_______________
_______________
_______________
_______________
_______________
_______________
Please list your allergies:
Previous evaluation:
 Have you been evaluated for this problems in the past?_________________
 Were you given a diagnosis?______________________________________
 Did your evaluation include any laboratory tests or skin biopsies?____________
If yes, when were those tests done?_____________________________________
Previous treatments:
 Have you been treated for this problem in the past?____________
 Please list any treatments that you have tried for this problem:
______________
Response:_______________________________________
______________
Response:_______________________________________
______________
Response:_______________________________________
______________
Response:_______________________________________
______________
Response:_______________________________________
WHAT DO YOU THINK CAUSED THIS PROBLEM?
WHAT IS YOUR MAIN CONCERN REGARDING THIS PROBLEM?
PAST MEDICAL HISTORY:Please check all that apply to your medical history.
Allergies/asthma
Arthritis/joint problem
Dermatitis/eczema
Blood disease
Immune disorder
Skin condition
(anemia/bleeding)
Ear problem
Autoimmune disorder
Psoriasis
Eye problem
Rheumatoid arthritis
Acne
Respiratory/chest disease
Lupus
Blistering skin disease
Heart condition
Muscle problem
Vitiligo
Bowel/digestive problem
Nerve problem
Psychiatric disorder
Liver problem/gall bladder
Vein/vascular problem
Reproductive system
problem/hepatitis
problems
Diabetes
Kidney or urinary problem
Infertility problems
Thyroid disease
Cyst/polyp/tumor
Parathyroid disease
Cancer
Other medical problems: …………………………………………………………………..
FAMILY HISTORY:Please check all that apply to your family’s medical history.
Allergies/asthma
Arthritis/joint problem
Dermatitis/eczema
Blood disease
Immune disorder
Skin condition
(anemia/bleeding)
Ear problem
Autoimmune disorder
Psoriasis
Eye problem
Rheumatoid arthritis
Acne
Respiratory/chest disease
Lupus
Blistering skin disease
Heart condition
Muscle problem
Vitiligo
Bowel/digestive problem
Nerve problem
Psychiatric disorder
Liver problem/gall bladder
Vein/vascular problem
Reproductive system
problem/hepatitis
problems
Diabetes
Kidney or urinary problem
Infertility problems
Thyroid disease
Cyst/polyp/tumor
Parathyroid disease
Cancer
Other medical problems: …………………………………………………………………..
Review of systems: Please circle all symptoms that you have had in the last week.
 General: weight change, fatigue, fever, chills, night sweats
 Head/ears/eyes/nose/throat: headache, visual changes, blurriness, tearing, itching
eyes, runny nose, congestion, nose bleed, hearing loss, ringing in ears, dizziness,
earache, bleeding gums, hoarseness, sore throat, swollen neck, swollen lymph
nodes (“glands”)
 Lungs: shortness of breath, wheezing, coughing, coughing up blood, coughing up
mucus, pneumonia, asthma, bronchitis, emphysema, TB
 Heart: high blood pressure, heart murmur, chest pain, heart “skipping-abeat”/racing
 Stomach/bowels: change in appetite, nausea, vomiting, diarrhea, constipation,
bleeding, abdominal pain, jaundice, hepatitis
 Kidneys/bladder: change in urinary frequency, burning/pain with urination,,
difficulty with urinating, blood in urine, accidents/losing urine
 Vascular/veins: leg swelling, pain in legs, varicose veins, history of clots
 Musculoskeletal: muscle weakness, pain, joint stiffness, joint instability, redness,
swelling, arthritis, gout
 Psychiatric: mood change, anxiety, depression, tension, memory change
 Neurologic: decreased sensation, numbness, tingling, tremors, weakness,
paralysis, fainting, blackouts, seizures
 Hematologic: anemia, easy bruising, easy bleeding, transfusions
 Endocrine: heat/cold intolerance, excessive sweating, thyroid problems, diabetes
APPENDIX C
INNOVATION WORKBENCH
Ideation Process
Innovation Situation Questionnaire
1. Brief description of the problem
Hair loss is a problem for over 40% of the population, however very little is known regarding
genetic implications and correlations between hair loss and other medical diagnosis.
2. Information about the system
2.1 System name
Hair Loss Database using Microsoft Access or Magic.
2.2 System structure
The database must be easily sortable by a number of different parameters. Also the data must be
able to be sorted using correlations between two or more data parameters. In addition information
must be easily submitted into the database without allowing the user to continue unless all the
information has been entered. The database should be user friendly with pop down windows with a
variety of features displayed. Error messages should be user friendly explaining why the user is
unable to continue. Ideally it should be very self explanitory so patients can acess and submit
without doctor or technical supervision.
2.3 Functioning of the system
The function of this database is to organize, store and compile enormous amounts of patient
history's in order to assess possible genotypic correlations of hair loss to existing medical diagnosis
or family history. Additionally, it may be used in future applications for correlation with the mapping
of the human genome.
2.4 System environment
This database must be network accessible with an easy to integrate format, so that existing
information can be successfully imported and manipulated. Because the database will be accessed
by many, password precautions will need to be made, as well as safeguards to the deletion of
information.
3. Information about the problem situation
3.1 Problem that should be resolved
No such wide-spanning database currently exists with regard to alopecia. In order to better
understand the cause and nature of the disorder all characteristics and parameters must be
accounted for and studied.
3.2 Mechanism causing the problem
Because so many research facilities exist, many studies are being done regarding hair loss.
However there is no centralized database for the variety of studies being done, nor the findings and
correlations regarding alopecia.
3.3 Undesired consequences of unresolved problem
Therefore many studies are redundant or exhaustive. Because researchers are not constantly
aware of the work of their colleagues, much of the possible collaboration between facilities and
studies is lost. It becomes difficult to work off the findings of others because of the delay in
publishing findings, especially those regarding parameters associated with hair loss.
3.4 History of the problem
There are plenty of existing databases, however none of which contain the wide range of
parameters nor ways to sort using one or more of such parameters.
3.5 Other systems in which a similar problem exists
Any database which does not contain all necessary parameters or encompasses an area of
research that is constantly being updated and therefore needs to be revised continuously, such as
a database regarding the human genome.
3.6 Other problems to be solved
Variety of smaller databases that can only correlate one problem at a time. However an overseeing
system capable of manipulating one database to another.
4. Ideal vision of solution
A correlation between hair loss and all other diagnosis is known and no database is necessary.
The data is already sorted, relating specific correlations to hair loss.
5. Available resources
Large processing unit
Large storage capabilities
Quick display of information
Quick error feedback
6. Allowable changes to the system
Changes:
3. Small changes are allowed such as addition of new field parameters, improvements in sorting
algorithms as technology and software vary and alterations in database interface for data
acquisition.
Limitations:
1. Data fields and subjects can not be removed from main database, while stored information within
field parameters may be updated.
2. Because correlations are unknown it is better to keep all information available so that later,
unlikely correlations can be justified.
3. Never
4. Not applicable
7. Criteria for selecting solution concepts
Data can be sorted using multiple parameters, query's can be easily compiled to support possible
correlations.
The data base will cost nothing to vanderbilt however will cost $ 400 to additional organizations
who wish to use the database.
concept development 12/02 - 1/03
evaluation of potential solutions 1/03 - 2/03
Implementation of solutions 2/03 - 3/03
High degree of novelty because the system can and will be constantly updated
8. Company business environment
Financial resources not applicable
9. Project data
Hair loss database
Create a system to easily enter, store, and sort high volumes of data with multiple parameters.
concept development 12/02 - 1/03
evaluation of potential solutions 1/03 - 2/03
Implementation of solutions 2/03 - 3/03
Barbara Visher, Peter Claise, Dr. Lloyd King, Dr. Jennifer Dempsey, Dr. Sara Whitehead, Dr. Paul
King
contact: http://vubme.vuse.vanderbilt.edu/srdesign/2002/group20/
Problem Formulation
1. Build the Diagram
2. Directions for Innovation
12/11/02 4:14:12 PM Diagram1
1. Find an alternative way to obtain [the] (Input Data) that offers the following: provides or
enhances [the] (Large Volume of Data) and (Possible Correlations), does not require [the] (Input
Screen Interface), (Supplies Information) and (Hair Loss Problem), is not influenced by [the] (Lack
of Family History Knowledge).
2. Find a way to eliminate, reduce, or prevent [the] (Hair Loss Problem) then think how to provide
[the] (Input Data) and (Subjects).
3. Try to resolve the following contradiction: The harmful factor [the] (Hair Loss Problem) should not
exist in order to avoid harmful results and should be in place in order to provide or enhance [the]
(Input Data) and (Subjects).
4. Find an alternative way to obtain [the] (Subjects) that offers the following: provides or enhances
[the] (Supplies Information), does not cause [the] (Lack of Family History Knowledge), does not
require [the] (Hair Loss Problem).
5. Try to resolve the following contradiction: The useful factor [the] (Subjects) should be in place in
order to provide or enhance [the] (Supplies Information), and should not exist in order to avoid [the]
(Lack of Family History Knowledge).
6. Find an alternative way to obtain [the] (Large Volume of Data) that offers the following: provides
or enhances [the] (Possible Correlations), does not require [the] (Input Data), is not influenced by
[the] (Lack of Family History Knowledge).
7. Find an alternative way to obtain [the] (Input Screen Interface) that provides or enhances [the]
(Input Data).
8. Find an alternative way to obtain [the] (Possible Correlations) that offers the following: provides
or enhances [the] (Sorting Algorithm), does not require [the] (Input Data) and (Large Volume of
Data), is not influenced by [the] (Lack of Family History Knowledge).
9. Find an alternative way to obtain [the] (Sorting Algorithm) that offers the following: provides or
enhances [the] (Correlation Screen Interface), does not require [the] (Possible Correlations).
10. Find an alternative way to obtain [the] (Supplies Information) that offers the following: provides
or enhances [the] (Input Data), does not require [the] (Subjects).
11. Find a way to eliminate, reduce, or prevent [the] (Lack of Family History Knowledge) under the
conditions of [the] (Subjects).
12. Find an alternative way to obtain [the] (Correlation Screen Interface) that does not require [the]
(Sorting Algorithm).
13. Consider transitioning to the next generation of the system that will provide [the] (Correlation
Screen Interface) in a more effective way and/or will be free of existing problems.
Prioritize Directions
1. Directions selected for further consideration
First priority
11. Find a way to eliminate, reduce, or prevent [the] (Lack of Family History Knowledge) under the
conditions of [the] (Subjects).
4. Find an alternative way to obtain [the] (Subjects) that offers the following: provides or enhances
[the] (Supplies Information), does not cause [the] (Lack of Family History Knowledge), does not
require [the] (Hair Loss Problem).
7. Find an alternative way to obtain [the] (Input Screen Interface) that provides or enhances [the]
(Input Data).
1. Find an alternative way to obtain [the] (Input Data) that offers the following: provides or
enhances [the] (Large Volume of Data) and (Possible Correlations), does not require [the] (Input
Screen Interface), (Supplies Information) and (Hair Loss Problem), is not influenced by [the] (Lack
of Family History Knowledge).
6. Find an alternative way to obtain [the] (Large Volume of Data) that offers the following: provides
or enhances [the] (Possible Correlations), does not require [the] (Input Data), is not influenced by
[the] (Lack of Family History Knowledge).
Long-term
2. Find a way to eliminate, reduce, or prevent [the] (Hair Loss Problem) then think how to provide
[the] (Input Data) and (Subjects).
13. Consider transitioning to the next generation of the system that will provide [the] (Correlation
Screen Interface) in a more effective way and/or will be free of existing problems.
Out-of-scope
3. Try to resolve the following contradiction: The harmful factor [the] (Hair Loss Problem) should not
exist in order to avoid harmful results and should be in place in order to provide or enhance [the]
(Input Data) and (Subjects).
8. Find an alternative way to obtain [the] (Possible Correlations) that offers the following: provides
or enhances [the] (Sorting Algorithm), does not require [the] (Input Data) and (Large Volume of
Data), is not influenced by [the] (Lack of Family History Knowledge).
9. Find an alternative way to obtain [the] (Sorting Algorithm) that offers the following: provides or
enhances [the] (Correlation Screen Interface), does not require [the] (Possible Correlations).
12. Find an alternative way to obtain [the] (Correlation Screen Interface) that does not require [the]
(Sorting Algorithm).
Other
5. Try to resolve the following contradiction: The useful factor [the] (Subjects) should be in place in
order to provide or enhance [the] (Supplies Information), and should not exist in order to avoid [the]
(Lack of Family History Knowledge).
10. Find an alternative way to obtain [the] (Supplies Information) that offers the following: provides
or enhances [the] (Input Data), does not require [the] (Subjects).
2. List and categorize all preliminary ideas
Ways to minimize incomplete information?
Drop down boxes and no room for user input all done with preset conditions.
All done in binary.
Ways to make the application more user friendly?
Work with close correlation with Doctors who will be using the device.
Create variations in colors, sound and buttons to help the user along with a tutorial.
Methods to secure program?
Limit the users so there is no interaction with outside users.
Add secure system with password encoding.
Create random user Id's so there is correlation with HIPAA
Ways to create completeness of form?
Acquire finalized form form doctor with total list of possible correlations.
Allow future administrator to add additional fields.
Develop Concepts
1. Combine ideas into Concepts
There are two ways to secure the program. One is to create a secure site that cannot be hacked
into or altered. The other idea is to limit the users who are able to access the program. We can
create enhanced security by limit the users and creating a secure site that cannot be altered.
2. Apply Lines of Evolution to further improve Concepts
Once the initial creation of the database is completed and a debugging phase has finished then
there will be no need for evolution in the system that it was designed for. If the user decides to
expand the system then there is room for evolution. For instance if the system required to work
over the internet, then the site must be very secure and created with no space for user to input bad
data. Additionally, the number of users will have increased from 2-4 to hundreds and this could
cause problems with unknown terms and a help page would need to be created. Additionally the
system could be expanded to work with the VA network. In that case a larger database than
Microsoft Access would be needed such as oracle and a new platform would need to be created.
Also to reduce the size of the server the system would need to access information in the VA server
while writing information acquired to the VA server.
Evaluate Results
1. Meet criteria for evaluating Concepts
There are no secondary problems with the initial design of the database, that cannot be resolved.
2. Reveal and prevent potential failures
Failures:
1. Misinformation given could be a large potential problem.
2. Data entry error.
3. Patient lacking knowledge of concepts for doctor to assess.
4. A lack of variables implemented into the database.
5. Failure in server and all data is lost.
Prevention:
1. There is no solution unless the doctor has access to prior visits
2. A warning will be produced if there is a contradiction in the inputted data
3. If the Patient could access an online dictionary this would be solved
4. The database is created to be flexible so new fields can be added
5. A back up database with Zip files will be made after each day or week of trials
3. Plan the implementation
What platform would be the most secure for an online questionaire?
Read only file that must be downloaded to the users computer
What are some other fields that could be useful in the study?