Outcomes assessment 1997-otolaryngology---head-and-neck-surgery

1. Outcomes assessment
DONALDLEOPOLD,MD, BERRYLINJ. FERGUSON,MD, and JAY F.PICCIRILLO,MD, Baltimore, Maryland, Pittsburgh,
Pennsylvania, and St. Louis, Missouri
This section of the report of the Task Force on
Rhinosinusitis focuses on instruments available for use
in outcomes research. An instrument for classifying
patient-based general health status is recommended.
Although a single disease-specific health-status instru-
ment is not recommended, the available instruments are
discussed.
REQUIREMENTS FOR PROSPECTIVE OUTCOMES
RESEARCH
Based on review of the literature 1-6 and experience
in evaluating patients with nasal and sinus symptoms, it
is suggested that prospective outcomes research include
a description of the patient at baseline and at subse-
quent period(s) after baseline:
1. The baseline description of the patient usually
includes demographic information, a history of
the present illness (including appropriate symp-
toms as judged by the examiner or the patient), a
medical history, a list of the medications the
patient is taking, previous medications taken and
the patient's responses to them, the findings of the
physical examination, and the results of recently
performed diagnostic tests.
2. Information required from subsequent periods
includes the patient's general and disease-specific
health status, the findings from diagnostic proce-
dures, the types of medical and surgical treat-
ments, the response to treatment, and the patient's
satisfaction with care.
From the JohnsHopkinsMedicalInstitutions,Baltimore,Md. (Dr.
Leopold); the Department of Otolaryngology,University of
Pittsburgh,Pa. (Dr.Ferguson);andtheClinicalOutcomesResearch
Center,WashingtonUniversityMedicalCenter,St.Louis,Mo. (Dr.
Piccirillo).
Reprint requests: Donald Leopold, MD, Johns Hopkins Medical
Institutions,4940EasternAve.,Baltimore,MD21224.
OtolaryngolHeadNeckSurg 1997;117:$58-$68.
Copyright© 1997 by the AmericanAcademyof Otolaryngology-
HeadandNeckSurgeryFoundation,Inc.
0194-5998/97/$5.00 + 0 23/0/83508
General and disease-specific health-status instru-
ments can be helpful in gathering some of the suggest-
ed baseline and follow-up information in a reliable,
repeatable, comprehensive, and valid manner.
GENERAL HEALTH-STATUS INSTRUMENTS
A measure of a patient's general health-status and
functional well-being is important in outcomes research
because the response to treatment and the need for sub-
sequent medical care are in large measure based on the
patient's baseline level of function and well-being.
The Medical Outcomes Study Short Form-36 (SF-
36; Fig. 1)7 is a valid and widely used general health-
status measure that contains 36 items measuring func-
tion in eight domains: physical functioning, role physi-
cal, bodily pain, general health, vitality, social func-
tioning, role emotional, and mental health. Scores for
each domain can range from 0 to 100, with 100 repre-
senting perfect health. Normative values are available
for the general population 8 and for rhinosinusitis
patients 9,10
A shortened version of the SF-36 has been devel-
oped. However, normative values are not yet available
for this 12-item health-status measure, and it is not
clear that the instrument can discriminate subtle health-
status changes as well as the 36-item version can.
Recommendation
Because the SF-36 has already been validated, is so
widely accepted, and has normative values for the rhi-
nosinusitis population, the Task Force on
Rhinosinusitis recommends its use as the general
health-status instrument.
DISEASE-SPECIFIC HEALTH-STATUS INSTRUMENTS
Rhinosinusitis is a condition that has few reliable
and easily defined physical signs. Imaging of the nose
and sinuses with computed tomography (CT) is expen-
sive and often is not immediately available; further-
more, CT findings do not correlate well with symptoms
(Leopold DA, Hong SC, Oliverio PJ, et al., unpublished
data, 1977). Thus, until a physiologic or imaging mark-
er for rhinosinusitis is determined, the disease is best
described by its associated symptoms. This is especial-
S58

2. I SF-36HEALTH
STATUS
SURVEY 1
LEOPOLD, FERGUSON, and PICCIRILLO $59
3. The following items are about activities you might do during a typical day.
Does xour health now limit you in these activities? If so, how much?
(circle one number on each line)
INSTRUCTIONS:
This survey asks for your views about your health. Tqis information will
help keep track of how you feel and how weU you are able to do you- usual activities.
Answer every question by marking the answer as indicated, if you are Jn~u~'eabout how
to answer a question, please give the best answer you can, ~i~i':i'~.i,.
1. : ; (circle one)
...... 2
...... 3
...... 4
...... 5
2. Compared to one ye'~'6',%i~'~'ou~, you rate your health in g~.meral now?
.......
~
..... ' ~i:~i~ i!~" (circle one)
:~i~'i~i~'~i~i~ M'u'ch better now than one year aqo ..... 1
"i i-i:~iii:i!i;;{,!!i!ii~i~" Somewhat better now than one year ago .. 2
' ~i:~! i! About the same as one year ago ....... 3
Somewhat worse now than one year ago • • 4
Much worse now than one year ago ..... 5
Otolaryngology-
Head and Neck Surgery
Volume 117 Number 3 Part 2
5, During the past 4 weeks, have you had any of the following problems with your work
or other regular daily activities as a resutt of any emotional problems (such as feeling
depressed er anxious)?
(circle one nulTber on each line)
YeS NO
a. Cut down the amount of time you spent on work or other :1 2
activities !iii%
b. Accomplished less than you woucl ike i:~i~,i~i!~i 2
c: Didn't do work or other activiti~!~sii~refully as usual i~i~':~ i~ i~!! 2
6. During the &6.st 4 weeks, to ;~1~ e~'f~as your pb#s~ca[ l~e~ith Or em:otiona
problems inte~ered with~our normal S6c al act Vt es w~t6~ ~ ft ~, ne ghbors
or groups? , ,il i:~;!~!::~t,~:ii~:~, :i~;' ii!:i,
,i~!:i~,:'..... ~i~, " i':,i~,i.~;' :.... """':" (circle one)
:% Not at aii~i~!
'. ....... ~%.!~!~:~'~'~.~:~
............
~'~
i:!isiighii~:i: , .... :il:ii'~:... i".!":i~
~~i!~ i' . ........ 2
~i'~iii~i"ii~'~i~i~ii' Moderately ..,;i:~ii... i-i!ii~.~ ~................. 3
....~ii~;!i~,. Quite a bit . .:~-i~-~,i
...... 'iiiii~ ............... 4
7. HOW much ~ pa!~e:~/~had during the past 4 weeks? (circle one)
.... ~!i~ .i~e ........................ t
,~,.iiiii:.~i'~ii;~i ':'~%~i~"verymild . . . . . . . . . . . . . . . . . . . . .
i~ ~.~.~
~!~i?~%i~" M,~ . . . . . . . . . . . . . . . . . . . . . . . . .
....iii~i!ii~i~!i~,, Moderate ..................... 4
Severe ....................... 5
Very severe ................... 6
8. During the past 4 weeks, how much did 8.EeZQinterfere with your normal work
(including both work outside the home and housework)?
(circle one)
Not at all ..................... 1
A little bit ..................... 2
Moderately ............... ;~ .... 3
9. Thesequestionsareabouth~w~o~i~ia~'~':~awthings:havedee~wii~!~
the oest 4 weeks. For each quest[o~ ~iease give the on~;~hswer tF'latComes c osest
HoW ~uoh of the '~ime:d~dr)~t~.E~.$t 4 weeks -
(circle one ~mber,on each line)
:.i. !~'~,me:°"baT'm° l~ii~'~"" :~"° I ~ma O,T,.a,
bO
newous perso~iiiii~ :~!i~%5i
c. Have you felt so down .,:i :'~q~iii~i~iiii~i~i~!ii
......
in the dumps that ,,ii~ii` ii 1 '~;!ii! :;~'" 3 4 5 6
nothing could cheer:~
d. Have you felt calm and'{ili ~l~i~:ii~ iiii~:'2 3 4 5 S
peaceful? .,ii~i~!!~i~!i:.
~i, %i#i~!~
e. Did you ~Ei~ii!~-~ t .... ~ ~ ~ ~
energy? %i~,;!;;!-!i ; ~i~!j
i~i~i%!iiii!{ii~'
f. Have you felt~'%~:~ iii..... 1 2 3 4 5 6
downhearted an~i'~'~:
g. Did you feel worn ou~ 1 2 3 I 4 5 8
h. Have you been a happy 1 2 3 I 4 5 8
person?
i. Did you feel tired? 1 2 3 4 5 6
Fig. 1. Medical Outcomes Stuay Short Form (SF-36; continued on page S60). Copyright ©
New England Medical Center Hospitals, Inc. All rights reserved.

3. S60 LEOPOLD,FERGUSON,and PICCIRILLO
Otolaryngology-
Head and Neck Surgery
September 1997
10. During the past 4 weeks, how much ofthe time has your.ghysicalhealth or emotiona=
oroblems interfered withyour socialactivities (likevisitingwithfriends, relatives, etc.)?
(circle one]
All of the time 1
Most of the time 2
Some of the time . !i~i!i~!~i,.. 3
....i~ii?>i:.ii~littleof the time ..... i~........ ~:o~i~ii, 4
....ii~@ i" ~@cle Oii~iiN~r on each line)
";'i~i%~i~, Definitely ~'~ly '~i~n't Mostly Definitely
"[~Qii~,~:, "~i~ Know False False
a. I seem to get sick a ..":{z~iii~ii[i~
little easier than other, i~ 1 ..... "~i~i: 3 4 5
people .:i~
b. I am as healthy as "%~~i~ ~i'!''A~i'~,. 2 3 4 5
anybody I know ..
e. I expect my.~i, :~"~': 2 3 4 5
5
'~iii%:
Copydg~O N~ ~g~nd Me~l~q Center Hosp~ In¢,
~,~ 5
Fig. 1. Continued from page S59.
ly important for evaluations performed at the time the
patient is seen.
At present, the specific symptoms of rhinosinusitis
are unclear. Furthermore, many of the symptoms that
occur in this disease are also present in other condi-
tions, such as migraine, temporomandibular joint dys-
function syndrome, and cerebrospinal fluid rhinorrhea.
Most of the more common major and minor symptoms
that have been associated with rhinosinusitis are as fol-
lows:
1. Major symptoms: facial pain/pressure, facial con-
gestion/fullness, inability to move air through
each nostril (congestion/obstruction), rhinorrhea
(nasal discharge/postnasal drip [quality, quantity];
nostril and/or nasopharynx), decreased sense of
smell (right and left), fever (acute rhinosinusitis
only), and cough not due to asthma (children).
2. Minor symptoms: headache, fever (all nonacute
disease), halitosis, fatigue, dental pain, cough
(adults), and ear pressure or pain.
In a general assessment of patients with possible
nasal and sinus disease, it is important to evaluate the
commonly associated symptoms as well as other less
obvious symptoms that may be responsible for equal or
greater problems, such as sleep disturbance, general
malaise, or a decreased ability to concentrate. This will
ensure that correlations performed as part of a particu-
lar study do not miss important variables.
Measures of the severity and duration of rhinosi-
nusitis are also important. Key features that describe
the severity of this disease are the quantity and degree
of sinus-related symptoms. The duration can be
assessed by the length of time the symptoms have been
a problem. Because rhinosinusitis can be a recurring ill-
ness, questionnaires take into consideration that
patients may have periods of reduced or absent symp-
toms between exacerbations.
Use of the response to treatment as a defining fea-
ture of rhinosinusitis is questionable for several rea-
sons. One problem is that this assessment can only be
performed after two patient visits. In addition, medica-
tion dosages vary, as does patient compliance with drug
therapy. Patient responses to the same medication can
also vary. Finally, this approach does not consider other
factors that may be responsible for a change during the
dosing time. Consequently, the Task Force on
Rhinosinusitis does not recommend measurement of
disease based on response to treatment.
Five disease-specific health-status instruments are
currently available.
Rhinoconjunctivitis Quality of Life Questionnaire
The 28-item Rhinoconjunctivitis Quality of Life
Questionnaire (RQLQ; Fig. 2) describes symptoms in
seven domains: sleep, non-hay fever symptoms, practi-
cal problems, nasal symptoms, eye symptoms, activi-
ties, and emotional function. 11With the assistance of an
interviewer, the patient identifies three specific activi-
ties that are restricted by rhinoconjunctivitis. The rest of
the questionnaire is self-administered. On average, this
instrument requires 5 to 10 minutes to complete. The
RQLQ is intended to be used repeatedly over time for
longitudinal assessment.
Rhinosinusitis Outcome Measure
The Rhinosinusitis Outcome Measure (RSOM-31;
Fig. 3) is a health-status and quality-of-life measure
that contains 31 items classified into seven domains:
nasal, eye, sleep, ear, general, practical, and emotion-
al. 1° For each category, there are two rating scales. This
allows the patient to rate each item based on how severe
the problem is (magnitude scale) and how important it
is to him or her (importance scale). The product of the
magnitude and importance scores creates the symptom-
impact score, a unique patient-specific score for each
item. The individual-item magnitude and symptom-

4. Otolaryngology-
Head and Neck Surgery
Volume 117 Number 3 Part 2 LEOPOLD,FERGUSON,and PICCIRILLO S6|
NAME: DATE:--
(Visit l--identify 3 aetivat,es thathave be~ Iirmted by nose/eye
symptoms alumna the grevlous week.)
Please score every item:
SLEEP {Yellow Card)
HOWtroubled have you be~ by each of these s~eeppmble~ during
tun last week as a resuk ofyo~ nose/eye Synlpte~?
(a)Diffthultygettlngtosleep o I 2 3 4 5 6
(b)Wakeupdudngthenight o 1 2 3 4 5 6
(e) Imckofagoodnhght'ssleep 0 I 2 3 4 5 6
NON-HAYFEVERSYMPTOMS (Yellow Card)
How troubled have you been by these symptoms dunng the last week
as a result of your nose/eye sylnptom~?
(a) Fatigue o 2 3 4 5 6
0) Thirst 0 I 2 3 4 5 6
(e) RedueedproduetMty o I 2 3 4 5 6
(d) Tiredness 0 I 2 3 '~ 5 6
(e) Pooreone~tratlon 0 1 2 3 ,$ 5 6
~) l.Ieadaehe o 1 2 3 4 5 6
Worn out 0 ] 2 3 4 5 6
PRACTICALPROBLEMS (Yellow Card)
How troubled have you beell by each of these problel~ during file
last week zs a result of your nose/eye syrrrpto~?
(a) Ineo~venle~ee of ha~ing to emry
tissues or handke~hief o 1 2 3 4 5 6
(b)Need tombnose/eyes 0 I 2 3 4 5 6
(c)Needtoblowyour~ose~peatedly o i 2 3 4 5 6
~SaL SYMPTOMS (Vet~ow C~rd)
HOW~oubled have you been by each of thes~symptoms dating the
last week?
(a) StuftyAlloeked nose 0 ~ 2 3 4 5 6
(b)R~ynose 0 l 2 3 4 5 6
(e) sneeza~ 0 i 2 3 4 5 6
(d)ltchynose o I 2 3 4 5 6
EYE SYMPTOMS (velIaw Card]
HOWtrouble~Ihaveyou been by each of these synTptoms during the
last week?
(a)Rehyeyes 0 1 2 3 4 5 6
(b)Wateryeyes o 1 2 3 4 5 6
(e) Soreeyes o 1 2 3 4 5 6
(d) Swollen eyes o ] 2 3 4 5 6
ACTj'VITIES ('¢'e]low e~d)
HOWtroubled have you been by egehof these aenvilles during tile
I~t week ~ a r~ult of your nose/eye symptom?
(a)Activity 1 0 I 2 3 4 5 6
(b)Aefiwty2 0 1 2 3 4 5 6
(e)AetJvlty 3 0 1 2 3 4 5 6
EMOIIO.A1. (Crle~ Card)
How ofl~ during the I~t week ha~e you been troubled by these
emogons as a ~suh ofyo~ nose/eye sympto~?
(a) Frustrated 0 I 2 3 4 5 6
(b)lmpzli~tormsfless o I 2 3 4 5 6
(e)Imtable 0 I 2 3 4 5 6
(d) Embossed by your
symolo~ 0 I 2 ~ 4 ~ 6
YELLO~ CAeJ5
pl~se indieat~ how muob you have be~ ~ubled by ~ach i~
during the last week, as z ~sult of} our nose'eye gyrrroto~/
Please use the followiug s~le;
(6) Extremely troubled
(5) Very troubled
(4) Quite a bit tI~ubthd
(3) Moderatefy troubled
(2) So.what troubled
(1) I~r dly ~o~tbled at all
(0) Not troubled
al~Eg ~RD
Please indicate how ofm~ duRng tla~]~t ~ek you have been
t'oubled by each of these itelm ~ a result of your nose/eye
symptom. Please use tile folIo'Mng scale:
(0)All of the ti~
(1) Most of the time
(2) A ~ood part of the arae
(3) Some of the time
(4) A s~lI part of the ti~
(5) Hardly any time at all
(6) No~e of the time
Fig. 2. Rhinoconjunctivitis Quality of Life Questionnaire
(RQLQ). The order of the questions has been changed
since the original 1990 version. © 1996 by QOL
Technologies, inc. The RQLQ is copyrighted and cannot
be altered, translated, or adapted for another medium
without the permission of the author, Professor Elizabeth
Juniper, 1200 West Main St., West, Hamilton, Ontario,
Canada L8N 3Z5.
impact scores are then summed within each subscale
and for the overall instrument. The RSOM-31 requires
approximately 20 minutes to complete.
Since the original article demonstrating the validity
of the RSOM-31 was published] ° the instrument has
undergone three modifications to make it easier to use
and simpler to score. First, the number of items has
been reduced from 31 to 20. Second, the magnitude
scale has been changed from a five-category to a three-
category scale. Third, the importance scale has been
removed; instead, tile patient is asked to indicate the
five problems most important to him or her. Two scores
are then computed: the total instrument magnitude
score (calculated as the sum of the magnitudes of the
individual items) and the sum of the magnitude of the
important items. Response to treatment is evaluated by
the change in total instrument magnitude score and the
change in the magnitude score of the important items.
Psychometric and clinimetric work now being per-
formed suggests that the modified instrument, referred
to as the Sinonasal Outcome Test-20 (SNOT-20; Fig.
4), is valid and easy to use.
Chronic Sinusitis Survey
The Chronic Sinusitis Survey (Fig. 5) is a six-item
duration-based monitor of sinusitis-specific outcomes
that has a symptom-based section and a medication-
based section.`3 In the symptom-based section, the
patient is asked to answer questions concerning the
duration of the following three symptoms in a two-
month period: sinus headaches/facial pain or pressure,
nasal discharge, and nasal congestion or obstruction.
The medications assessed include oral antibiotics, pre-
scription nasal sprays, and over-the-counter sinus med-
ications. Two subscores (i.e., the symptom-based score
and the medication-based score) and a total score are
calculated and normalized by a scale of 0 to 100, with
0 being the worst possible score and 100 the best possi-
ble score.
Symptom Score
In the Symptom Score (Fig. 6) instrument, a visual
analog scale is used to assess the severity of five symp-
toms: facial pain or pressure, headache, nasal blockage
or congestion, nasal discharge, and olfactory distur-
bance. 12 Overall discomfort is also assessed. The
patient indicates symptom severity On an unmarked
line, with the origin of the line labeled 0 and the termi-
nus labeled 10. The relative distance from the origin is
measured, and the value is rounded to the nearest inte-
ger. A score of 0 is given when a symptom is not pre-
sent. Numbers up to 10 are given when a symptom is
present, with 10 indicating the greatest severity. The
patient is also asked to rank, in order of severity, his or
her three worst symptoms. Rank order of symptoms can
distinguish the relative importance of symptoms that
have the same visual analog severity score, thereby
making the patient's priorities clearer.
Rhinosinusitis Disability Index
The Rhinosinusitis Disability Index (RSDI; Fig. 7)
was developed from well-established and validated
methods of creating instruments that evaluate the self-
perceived impact of disease-specific head and neck dis-
orders such as dizziness, hearing loss, finnitus,
headache, and voice problems. 13 In a first-pers0n
descriptive format, the patient is asked to relate nasal
and sinus symptoms to specific limitations on daily
functioning. Answers are given on a five-point scale
designated by the words "never" (0), "almost never" (1),
"sometimes" (2), "almost always" (3), and "always" (4).
Critical Evaluation of the Five Disease-Specific
Instruments
The RQLQ was designed to measure treatment
effectiveness for rhinoconjunctivitis. Therefore, it fails

5. $62 LEOPOLD,FERGUSON,and PICCIRILLO
Otolaryngology-
Head and Neck Surgery
September 1997
I]):
RHINOSINUSITIS OUTCOME MEASURE PRE-TREATMENT
Below you will find a list of symptoms, functional limitations, and emotional consequences of your rhinosinusitis. We would like to know
more about these problems and wouldappreeiate your answering the following questions to the best of your ability. There are no "fight" or "wrong"
answers, and only ~ can provide us vath this information. Please rate your problems as they have been over the past two weeks. Thank you for
your participation. Do not hesitate to ask our research assistant or other office staff members for assistance if necessary.
Listed after the symptoms, functional limitations, and emotional consequences are two columns labeled Magnitude and Importance. Please
refer to the following instructions and scales provided below to answer these questions.
Nasal Symptoms
1. Stuffy/blocked nose .......................
. Runny nose ....................................
• Sneezing ........................................
4. Decreased sense of smell or taste..
5. Post-nasal discharge .......................
6. Thick nasal discharge/debris ..........
Eye Symptoms
. Itchy, watery eyes ..........................
• Swollen, sore eyes .........................
Sleep
9. Difficulty ~etting to sleej~.............
10. Wake up auring the nigiat.............
1 I. Lack of a good night's sleep .........
12. Wake up tired ...............................
~ ~.db 719~
Magnitude Scale
Considering how severe the problem
is when you get it and how frequently
it happens, please rate each item
below on how "bad" it is using the
following scale:
0 = Not present/no problem
= Very mild problem
= Mild or slight problem
4 = Moderate problem
= Severe problem
5 = Problem is as "bad as it can he"
Importance Scale
For each item that you rate the
magnitude as 1, 2, 3, 4, or 5,
please rate how important it is to
you.
Use the following scale:
I ~ Not important
2 = Somewhat important
3 = Moderately important
4 ~ Extremely important
MAGNITUDE IMPORTANCE
.......0 1 2 3 4 5
.......0 1 2 3 4 5
.......0 1 2 3 4 5
.......0 1 2 3 4 5
.......0 1 2 3 4 5
.......0 1 2 3 4 5
.......0 1 2 3 4 5
.......0 1 2 3 4 5
.......0 1 2 3 4 5
.......0 1 2 3 4 5
....... 0 1 2 3 4 5
.......0 1 2 3 4 5
1
....... 1 2 3 4
....... 1 2 3 4
....... 1 2 3 4
....... 1 2 3 4
....... 1 2 3 4
....... 1 2 3 4
....... 1 2 3 4
....... 1 2 3 4
....... 1 2 3 4
....... 1 2 3 4
....... 1 2 3 4
....... 1 2 3 4
MAGNITUDE
Ear Symptoms
13. Fullness .........................................
14. Ringing .........................................
15. Dizziness .......................................
16. Pain ...............................................
17. Decreased hearing .........................
....... 0 1 2 3 4 5
....... 0 1 2 3 4 5
....... 0 1 2 3 4 5
....... 0 1 2 3 4 5
....... 0 1 2 3 4 5
General Symptoms
18. Fatigue/worn out ...........................
19. Reduced productivity ....................
20. Poor concentration ........................
21. Headache ................... ~...................
22. Facial pain/pressure . . . . . . . . . . . . . . . . . . . . . . .
23. Cough ............................................
24. Short of breath ..............................
....... 0 1 2 3 4 5
....... 0 1 2 3 4 5
....... 0 1 2 3 4 5
....... 0 1 2 3 4 5
....... 0 1 2 3 4 5
....... 0 1 2 3 4 5
....... 0 1 2 3 4 5
Practical Problems
25. Inconvenience of having to
carry tissues/handkerchief. ............
26. Need to rub nose/eyes ...................
27. Need to blow your nose
repeatedly ......................................
28. Bad breath .....................................
....... 0 1 2 3 4 5
....... 0 1 2 3 4 5
....... 0 1 2 3 4 5
....... 0 1 2 3 4 5
Emotional Consequences
29. Frustrated, impatient, restless
or irritable .....................................
30. Feeling depressed or sad ...............
31. Embarrassed by your symptoms...
....... 0 1 2 3 4 5
....... 0 1 2 3 4 5
....... 0 1 2 3 4 5
Please feel free to add any additional comments below. Thank you for your participation.
ADDITIONAL COMMENTS:
rsorr~pre.db 7~9J.
IMPORTANCE
....... 1 2 3 4
....... 1 2 3 4
....... 1 2 3 4
....... 1 2 3 4
....... 1 2 3 4
....... 1 2 3 4
....... I 2 3 4
....... 1 2 3 4
....... 1 2 3 4
....... 1 2 3 4
....... 1 2 3 4
....... 1 2 3 4
....... 1 2 3 4
....... 1 2 3 4
....... 1 2 3 4
. . . . . . . 1 2 3 4
....... 1 2 3 4
....... 1 2 3 4
....... 1 2 3 4
Fig. 3. Rhinosinusitis Outcome Measure (RSOM-31).© 1994 by Jay E Picciriilo, MD. All rights
reserved.

6. Otolaryngology-
Head and Neck Surgery
Volume 117 Number 3 Part 2 LEOPOLD,FERGUSON,and PICCIRILLO $63
SINO-NASALOUTCOMETEST
Be[~ yourag frednl/stofsympt~msa~dsoeiaUemo6o~I~as:quemeesofyourrhi~os/n~it~ WewouldILke
toknow
more about6ae~eproblemsandwouldappreciateyour~ering thefollowingquestionstothebestofyot~rability.There
are no 6ght or wrong answers,ando~y ~ ¢~aprovideuswithffdsinfom~aon. Pi~e mt¢yourpmblcans~ theyha~a
beenovertilepa~p~o¢a~. Thankyouforyourparticipatie~.Donothesitateto~k our r~eareh~islant or other
offi~st~ffmeraherforazs~ee ifnecessa~.
L Co~idering
howseve~thaprobIemiswh~you~penenceit
andhowfrequ~flyi~happens,pi~e roteeachitem beJowon
how"bad"it ~sbyeiregngtheaumberthateorr~pondswith
howyou feelusingthiss~le:
2. Shoeing
4. Coegh
6. Thick
nasaldlseharge
8 D~ne~s
1D. FarJalp~'Jpressa~
IL WaReup at nigh¢
14. W~keap fired
1.6. Reducedproductivity
L Fnl.ct~ated/resth~slirrit~ble
20. Embarrassed
o ~ o
0 [ O
o i o
0 I
0 I O
0 I O
0 ~ O
0 I O
0 I O
0 ~ O
0 ] --O
?
2. Ple~ markthemostimportantitemsaffectingyourhealth(max~umof5 ~ra~)__
Fig, 4. Sinonasal Outcome lest (SNOT-20).© 1996 by Jay F.
Piccirillo, MD. ,Allrights reserved.
to include several rhinosinusitis-specific items, such as
thick nasal discharge, cough, and ear fullness.
Furthermore, a trained research assistant is required to
assist the patient in identifying the patient-specific
activity items.
The RSOM-31 and the SNOT-20 contain items that
consider nonrhinologic areas, such as sleep distur-
bance, which are important to many patients. The
SNOT-20 was developed from the RSOM-3 l by elimi-
nating the 11 items that did not have the greatest clini-
cal relevance or psychometric validity. However, in
shortening the RSOM-31 instrument, the questions on
nasal congestion and olfaction were eliminated. The
question of whether this decision was valid cannot be
answered at this time, although clinical experience and
other studies (Leopold DA, Hang SC, Oliverio PJ, et
al., unpublished data, 1977) suggest that nasal conges-
tion and olfactory disturbance may be important in
defining rhinosinusitis. Although the RSOM-31 has
been shown to be responsive to change, such as after a
therapeutic intervention, this facet of the SNOT-20
remains to be determined.
Although the Chronic Sinusitis Survey has good
psychometric properties and face validity, it has two
important shortcomings. One is that the instrument
includes only three nasal- and sinus-specific symptoms:
facial pain or pressure, nasal drainage, and. difficulty
[ - - CHRONIC SINUSITIS SURVEY
Name Date
This survey asks for your view about your sinus symptoms and lxeatment. This information will
remain in your medical record to help you doctor keep track of how you feel.
Answer every question by circling the appropriate number. If you axetms~e about how to
answer a question, please give the best answer you can,
1. During the past ~ how many ~ have you had: (circle one answer in each row)
a. Sinushaadaches, facia] pain or 0weeks l-2weeks 3-4weeks 5-6weeks 7-aweeks
pressure
b. Nasal drainage or post-nasa] drip 0 weeks 1-2weeks 3-4 weeks 5-6 weeks %8 weeks
e. Nasa] congestion or difficulty- 0 weeks 1-2 weeks 3-4 weeks 5-6 weeks 7-8 weeks
breathing through your nose
2. During the past~, how many~ have you taken: (circle one answer it. each row)
a. Antibiotics 0 weeks 1-2 weeks 3-4 weeks 5-6 weeks 7-8 weeks
b. Nasal sprays prescribed by 0 weeks !-2 weeks 3-4 weeks 5-6 weeks 7-8 weeks
your doctor
c, SinusmedieationsLnpillthrm 0weeks I-2weeks 3-4weeks 5.fiweeks 7-8~eeks
(such as antihistamines, deeongesza~ts)
3: Who completed this form? (circle one number)
I filled it out myself 1
Somcoue ~k~d me the questicm 2
By Telephone 3
4. Have you had any revision surgery in the pastyeer o~ your sinuses?
(for one yearpost surgerypatients only)
~o~lc s~srm ~w;
Yes No
2
Fig. 5. Chronic Sinusitis Survey. © 1993 by Richard E.
Glicklich, All rights reserved.
moving air through nose. Thus, the instrument does not
cover the wide range of problems that rhinosinusitis
patients experience. For example, the failure to include
other physical and functional problems is important
because both Piccirillo et al.~° and Juniper and Guyatt11
found that sleep and practical problems were affected
most by sinusitis. Although only a few signs or symp-
toms may ultimately be determined to represent rhino-
sinusitis or a subset of rhinosinusitis, data to support a
"short list" are not currently available. Therefore, it is
important to include a larger number of items in a rhi-
nosinusitis survey.
The second shortcoming of the Chronic Sinusitis
Survey is that it does not allow the patient to indicate
which items are most important to him or her. The
inclusion of patient-specific indicators of importance is
recommended by Gill and Feinstein14in their article on
the quality of quality-of-life research. Other investiga-
tors~5A6have given the same recommendation.
Like the Chronic Sinusitis Survey, the Symptom
Score has a limited number of items, and it fails to con-
sider nonrhinologic areas. Furthermore, the use of a
visual analog scale is time-consuming because a
research assistant must measure the length of each line.
However, this problem could be overcome with com-
puter-assisted response forms. At this time, there
appears to be no published literature describing the psy-
chometric properties and validity of the Symptom
Score.

7. $64 LEOPOLD,FERGUSON,and PICCIRILLO
Otolaryngology-
Head and Neck Surgery
September 1997
DEMOGRAPHIC INFORMATION
Last name: Operation:
Firstname: Operation date:
Sex: Surgeon:
Date of birth: Nasal diagnosis (0-4):
Age: Systemic diagnosis:
Hospital no.: General or local anaesthetic:
Duration (rains) of surgery:
Postoperative Medication:
Complications:
RADIOLOGICAL GRADING
Sinus systems (0-2) R
Maxillary:
Anterior ethmoids:
Posterior ethmoids:
Sphenoid:
Frontal:
OMC (0 or 2):
TOTAL:
L
Anatomic variants (0-1)
Absentfrontal sinus:
Concha bullosa:
Paradoxical middle turbinate:
Everted uncinateprocess:
Haller cells:
Agger nasi cells:
SURGICAL SCORE (0-1)
Uncinectomy:
Middle meatal antrostomy:
Anteriorethmoidectomy:
Posterior ethmoidectomy:
Sphenoidotomy:
Frontal recess surgery:
Reduction of middle turbinate:
TOTAL:
Septal surgery Yes/No
Previous surgery Yes/No
SYMPTOM SCORE (0-10)
Pre-op 3/12 6/12 12/12 24/12
Nasal blockage/
congestion/pressure:
Headache:
Facial Pain:
Problems of smell:
Nasal discharge:
Overall:
ENDOSCOPIC APPEARANCES (0-2)
Pre-op 3/12 6/12
KL RL RL
Polyp:
Discharge:
Oedema:
Scars or adhesions:
Crusting:
12/12 24/12
R L RL
EMOTIONAL SUBSCALES
1. Because of my problem I feel stressed in
relationships with friends and family.
2. Because of my problem I feel confused.
3. Because of my problem I have difficultypaying
attention.
4. Because of my problem I avoid being around
people.
5. Because of my problem I am frequently angry.
6. Because of my problem I do not like to socialize.
7. Because of my problem I frequently feel tense.
8. Because of my problem I frequently feel irritable.
9. Because of my problem I am depressed.
10. My problem places stress on my relationships
with members of my family or friends.
FUNCTIONAL SUBSCALES
1. Because of my problem I feel handicapped.
2. Because of my problem I feel restricted in
performance of my routine daily activities.
3. Because of my problem I restrict my recreational
activities.
4. Because of my problem I feel frustrated.
5. Because of my problem I feel fatigued.
6. Because of my problem I avoid traveling.
7. Because of my problem I miss work or social
activities.
8. My outlook on the world is affected by my
problem.
9. Because of my problem I fred it difficult to
focus my attention away from my problem and
on other things.
10. My sexual activity is affected by my problem.
PHYSICAL SUBSCALES
1. The pain or pressure in my face makes it difficult
for me to concentrate.
2. The pain in my eyes makes it difficult for me to
read.
3. I have difficulty stooping over to lift objects due
to face pressure.
4. Because of my problem I have difficulty with
strenuous yard work and housework.
5. Straining increases or worsens my problem.
6. I am inconveniencedby my chronic runny nose.
7. Food does not taste good because of my change
in smell.
8. My frequent sniffmg is irritating to my friends
and family.
9. Because of my problem I don't sleep well.
10. I have difficulty with exertion due to my nasal
obstruction.
11. My sexual activity is affected by my problem.
Fig. 7. RhinosinusitisDisability Index (RSDI).© by Michael
Fig. 6. Symptom Score, S.Benninger, MD, All rights reserved.

8. Otolaryngology-
Head and Neck Surgery
Volume 117 Number 3 Part 2 LEOPOLD, FERGUSON, and PICCIRILLO S6S
USER'S MANUAL
Chronic Sinusitis TyPE Specification
TyPE Specification
CHRONIC SINUSITIS 10108193
eHealth O~tsomes Institute, 1993
Health Outcomes Institute
Chronic Sinusitis TyPE Specification
TERMS OF USE
The Health Outcomes institute hereby gr~nts permission to copy and use the Chionin
Sinusitis TyPE Specification in accordance with the following conditions which shall be
assumed by sil to have been agreed to as a consequence of accepting and us4mgthis
document.
1. Changes to the Cinonic Sinusitis TyPE Specification may be made without the written
permission of the Health Outcomes Institute. However, all such changes shall be
clearly identified as having been made by the recipient.
2. The user of the Chronic Sinusitis TyPE Specification accepts fnil respoasihility, and
agrees to indemnify and hold the HealthOutcomes Insfimts harrnles~ for the accuracy
of any transiatiuns of the CI~or~c Sinusitis TyPE Specification into another lmguage or
format, and forany errors, omissions, m.lsinterp~tations, or consequences thereof.
3. The user of the Chionic Si~usiLlsTyPE Specification accepts thLlresponsibility, and
agrees to indemnify and hold the Health Outcomes Institute hzemiess for arty
consequences resuiting from the use of the Chronic Sinusitis TyPE Specification.
Please note that the TyPE spesificalions are frequsnriy tmdergoing review and revision. We
suggest you contactHealthOutcomes Institute
priortoimplementing may ofthe inslaxmlents
to insure that all materials are current.
(01~6)
USER'S MANUAL
Chronic Sinusitis TyPE Specification
Introdu~i~.
The TyPE (Technology of Patient Experience) specification for chronic sinusiLls is a set of data
collection instruments designed for integration into the Outcomes Managemeat System (OMS),
which analyzes a longitudinal~es of patients'exposiencas. Tllevariablesconsidered most
important in terms of patientoutcome are incinded as well as characteristicsnec~sary for
making an appropriatediagnosisand evaluatingtherapeuticoutcomes. Other variablesincluded
are covariates associated with patient outcome that axe important for case-rrix adjustment.
The spoeifin elements of this TyPE sponifinatico were derived from a thorough review of the
pertinent literature madwith input from a group of foremost experts in sinus disease. Portability
was a major consideration in creating this tool. FacLlLladng widespread implementation of the
OMS required that tbe individual TyPE speeifiuations be eormise. We recog~tLzethat many other.
additional data dements may also be important or desired by users. Nevertheless, we feeI those
items included in the TyPE specification for etaonic sinusitis represent the _m~mEm necessar$
for adequate evaluation and interpretation cf outcomes. We encourage users to supplement these
items with others that they foal are especially wmthy of collection. Additionally, we consider
this a dynamic precess. With more research and experience, we anticipate modifinaLlons,
refinements, and improvements in the instmmem.
The ChzonlcSinusitisTyPESp~ificafioa~ developedfor theHemld~Outcom~lnstltu~by SanfordR. ]{offman,
M.D..Clininni
Amistant
prorex,
sotofOb31aryngology,
State
University
ofNew York,Buffalo.C.o-developers
included
Euge~ B.Kern,M.D.,~d GeorgeW. Eaeer,
M.D.,Mayo Medie~/Seh~1;DovaldA.Leopold,M.D.,SUNY Health
ScieReeCenter;D~vidW. Kennedy,M.D., U~iverd~yofPennsy~a; DnieH. P/~, M.D., UniversityofS~t~
Cnilfornie;andStevenD. S~fer, M.D.,UniversityofTe~.
eHee&ttOuteoraes
la~tut~,I010S/93
-i-
USER'S ~gd4UAL/C~rovioSinusLtisTyEI~Sp~ifica~i~
~ t Sde,ctlo_n
These forms are to he administered to patients in ambulatory care set~gs and are intc~'ldedfor
patients with chronic sinusitis. Patients should have signs and sympterus of sinusitis for at least
three, months.
Data ¢olleetion Procedures
This TyPE specification consists of four forms. These shoeld be completed in addition to Uhe
Health Status Questinnnalse 0-1SQ) as indicated in the table below,
FORMS #/)MINISTRATION SCIIEDI/LE
*If~e pat~e~c~ntlnu~~ e:~erler:~ symptomloney~ a~er~e~ent, ~t~ a~pmpds~
re4~¢~1
r-orra 123 at ~wetwmontba,lindat six~e~athinterval~w~le ~rmptom~per6~
I~P-Jg sm,cificatio~Ja~
Several important prognostic variables will be routinely collected for all patients in the OM$ and
thus are not included in the TyPE ~cation for ckronic sinusitis.These variablesinclude
basicdemographic informationsuch as age; sex, madtai status,socioeo3norMc stat~as,
insurance
coverage, and seLf-reportedfencrionzlstems and well-bning,comorbidities,and healthrisks.
The following sections describe the rationale for the inclusion of the specific items in this 'I3jPE
specification.
©H~ Outcmmea~ta~, 10108/93
-2-
Fig. 8. Chronic Sinusitis TyPE Specific Questionnaire. Continued on page S66. © by Health
Outcomes Institute. All rights reserved.
The RSDI is similar to the RSOM-31 in the types of
questions it contains. The RSDI can be completed eas-
ily and quickly (in approximately 5 minutes).
Furthermore, the instrument is worded in the first per-
son, enabling the patient to individualize the impact of
rhinosinusitis on his or her life. Whether this first-per-
son format is ultimately more useful in gathering data
on rhinosinusitis is still unclear, but it does make the
RSDI different from the other instruments.
Unlike the RSOM-31 and the SNOT-20, the RSDI
does not allow the patient to indicate his or her most
important problems. It does, however, consider the
patient's physical, emotional, and social functioning, so
that a more general instrument, such as the SF-36, does

9. 566 LEOPOLD,FERGUSON,and PICCIRILLO
Otolaryngology-
Head and Neck Surgery
September 1997
USER'S~=~qLrAIJChrogic Sln~itis TyPE Sp~ifi~Eoe
Form 12~--InitiaI Patient Symptoms and Previous Therapeutic Modalities
This recta sets out the symptom complexes experienced by the patient coupled with r~lated nasal
symptoms and previous therapies given to the patient for sinus disease.
The data under the heading of "Recurrent Sinus Infection or Disease" and "Previous Sinus
Surgery" assess previous therapy for sinus disease (no time fimit). The "Previous Sinus
Surgery" section is self-explanatory. Obviously, it would be preferable to explore, in depth, all
previous sinus surgeries, but this would be impractical in many instances.
Form 12.2--Clininal Conclusion for ClassLCyingChronic Sinus Patiants--Medieal Versus
Surgery
This form is used to evaluate the patient's disease proe~s, interpret the findings in a meaningful
way, and quantify the treatment given to the patient. In the first section, the care provider is
asked to assess the patient's weLl-being, symptoms and clinical condition. The next two sections
ask speei~ c[uestions about medical versus surgical treatment, and the last section (Surgical
Complications) is important in evaluating any problems associated with previous surgical
intervention.
Form l~,3
This form, which is to be completed by the patient, again helps to quantify the post.operative
symptoms and early results of therapy instituted by the care provider. Form 12.3 is similar to
the original symptom index, which facilitates oomparing symptoms at the two points in time.
©Irw.altkOutcomea Imtitut¢, 10/08/93
-3-
Mod. of Colleadon
Self-Administered ...... 1 []
PerSonal Intewiew ..... 2 []
Telephone Interview .... 3 []
Mail ................ 4 []
Other ............... 5 []
I OFFICE USE ONLY
I DATE: I J II I II II
Me DAY YR
PATIENT QUESTIDNNAIRS
CHRONIC SINUSITIS FORM 12.1
Sanford R. Hoffman, M.D.
George W. Facer, M.D.
David W. Kennedy, M.D.
Eugene B. Kern, M.D,
Donald A. Leopold, M.D.
Dale H. Rice, M.D.
Steven D. Schaefer, M.D.
TyPE Spe=ificetion
CHRONICSINUSITIS 10/08193
¢Health Outcomes Institute, 1993
CHROr~tCSINUSITI~FORM1Z.I
INSTRUCTIONS:
This survey asks for your views about your sinus symptoms and treatment. This information will be
summarized in your medical record and will help your doctnts keep track of how you feel
Answer every question by circling the appropriate number, 1,2,3, ... or writing a number where
~equested to do so. If you are unsure about how to answer a question, #ease give the best answer
you can and make a comment in the left maroin.
Symptom Index
1. During the 9 weeks prior to seekino medical h~g. how often did you have: (circ/e one number
in each row)
Number of times
Never I 2 3 4 5 6 7 +
a. Sinus headaches, facial pain, or
pressure . . . . . . . . . . . . . . . . . . . 0 1 2 3 4 5 6 7
b. Significant postnasal drainage .... O 1 2 3 4 5 6 7
c. Marked nasal congestion ....... O 1 2 3 4 5 6 7
d. The need to take sinus medlca-
tions such as over-the-counter
decongestants or antibiotics ..... O 1 2 3 4 5 6 7
e. Sinus infections .............. 0 1 2 3 4 5 S 7
f. Breathing difficulties ........... 0 1 2 3 4 5 6 7
g. Tooth pain .................. D 1 2 3 4 S 6 7
Recurrent Sinus Infection or Disease
2. How many years have you had sinus problems? [circle one number)
Less than one year ......................... f
One to two years .......................... 2
Three to four years ........................ 3
Five to s~x years .......................... 4
Seven or more years ....................... 5
3. How many times have you previously been treated for sinus infections? Icirc/e one number)
Never .................................. 1
One to two times .......................... 2
Three to four times ........................ 3
Five to six times .......................... 4
Seven or more times ....................... 5
4. Has this treatment included antibiotics? {circle one number}
Yes ................................... 1
No ................................... 2
°Haal~ Omcom~ [netltute,10/08/93
-2-
CHRONICSINUSITISFORM12~.1
5. Has this treatment included antihistamines or decongestants? /circle one numbed
Yes ................................... 1
No 2
6. Has this treatment included nasa[ or oral steroids? [circle one number)
Yes ................................... 1
No ................................... 2
7. Do you have nasal alfergMs? (circle one number)
Yes ...................................
No 2
8. Do you receive treatment for your nasal allergies? (eircfe one number)
Yes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . I
NO ................................... 2
9. Does the allergy treatment include desensitization? [circle one number)
Yes ................................... 1
No 2
10. Does the allergy treatment include local nasal steroids? (circle one number)
Yes ................................... 1
No 2
11. Does the allergy treatment include oral steroids? [circle one number)
Yes ................................... 1
No ................................... 2
Previous Sinus Surgery
12. HOW many s~nus operations have you had? (circle one number)
None .................................. 0
One ................................... 1
Two ................................... 2
Three .................................. 3
Four or more ............................. 4
©HealthOutcomesInJ~lute. 10108/g3
"3-
Fig.8. Continued from page $65. Continued on page S67.
not need to be administered. Since the RSDI was pub-
lished, it has successfully undergone test/retest reliabil-
ity validation.
Recommendation
Because all of the currently available disease-specif-
ic instruments have some benefits and because the
symptoms of rhinosinusitis have yet to be fully charac-
terized, the Task Force on Rhinosinusitis cannot recom-
mend a particular instrument at this time.
COMPREHENSIVE OUTCOMES INSTRUMENT
The Health Outcomes Institute has created survey
instruments to conduct outcomes research on a number

10. Otolaryngology-
Head and Neck Surgery
Volume 117 Number 3 Part 2 LEOPOLD, FERGUSON, and PICCIR1LLO $67
CHRONICSINUSITISFORM12.1
13. In what month and year was your last surgery? ........
Social History
14. Do you currently smoke cigarettes? (clrcle one number)
Current t~moker ..........................
Former smoker ...........................
Never smoker ...........................
a. if qurr~t, or former srnoke£: How many cigarettes
do (did) you smoke in an average day? ..........
(1 pack = 20 cigarettes)
b. What c~lendar year did you start smoking? .......
c. If former smoker: What calendar year did
you stop smoking? ........................
15. Do you drink ~lcoholic beverages? fdrcle one numbed
Yes ..................................
No ..................................
a. If yes, number of serving each week:
Less than one ...........................
One to two
Three to five ............................
Seven to ten ............................
Eleven or more . . . . . . . . . . . . . . . . . . . . . . . . . .
16. Who completed this form? (circle one numbed
I filled it ~ut with no help ...................
I filled it out with help from family or friends ......
I filled it out with help from a health care provlder . .
Family or friends .........................
Health care provider .......................
eHeelthO~come~ In~tlt~te, 10/08/a3
-4-
L_L_I L_[_i {I
month year
L L L L J cigarettes
19111
~slll
CHRONIC SINUSITIS FORM 12,2
..... LJ_J I t I ~
1,
2.
3a,
3h.
6.
7.
Be.
PATIE~ I
D
E
N
T
I
F
I
C
A
T
I
O
N
MO DAY YR
CIInicsi Conclusion for Classifying Chronic Si~us Pedants
Medical Versus Surgica~
[circle one number for each question}
Do you think the patient's quality of life is or was Yes NO
being significantly altered by his/her sinus problems?
...................................... 1 2
DO the patient's sinus problems effect hls/her sense
of smell7 (objectively) ...................... 1
Does the patient have intranasal polyps bilatera)ly? ..
Does the patient have intranasal polype unilaterafly? .
4. Are the polyps clearly arising from the middle
meatus? .............................. I
5. Are the po[yps diffuse with no specific origin? . •. 1
Does the petie~t have an obstructed nasal see[urn
deviation? ............................... 1
Was an endoscopic exam performed during the
evaluafion of the pal/ant? .................... 1
Was a sinus CT scan performed during the eva!uation
of the patient? ............................ 1
8b. Did the sinus CT show anatomic deformity
with occult s)nus disease, llmlted to the
ethrnold sinus? ...................... 1
gc, Did the sinus CT show bilateral ethmoid
disease with involvement of one dependent
8d.
8e.
2
1 2
1 2
2
2
2
2
2 tltno, ~ip ¢oqu~=~on~o;
2
sinus? ............................ 1 2
Did the sinus CT show bilateral ethmoid
disease with two or mere dependent sinuses
on each side? ....................... 1 2
Did ',he sinus CT show diffuse sinus and nasal
po]yposis? ......................... t 2
TyPE Specification
CHF,
ONtC
SlNUSm~lO~OEm3
~salth Oumo~e~[~t~, 199~
(circle one number for each question}
Yes No
9a. Does the patient have a concha buflosa on CT scan
bilaterally? ............................. 1 2 {~fye~ ,~/p ~ ~¢s~n tOj
9b. Does the patient have a concha bullosa on CT scan
unilaterally? ............................ 1 2
10. Was a sinus MRI scan performed during the
evaluation of the patient? .................. 1 2
11a. Has the patient had multip{e sinus infections as an
indication for surgery? .................... 1 2 {if ye=, =k/p t= ques#=n 12/
11 b. Has the patient had a single intractable infection as
an indlcation for surgery? .................. 1 2
12. Do you think the patient is likely to have recurrent
sinusitis if the surgery is not performed? ....... 1 2
13. Is the patient a candidate for long-term medical
treatment for his/her sinus disease? ........... 1 2
Non-Surgicsi Treatment
14. If the patient was only treated medically (no surgery}, please circle all tr(~atment
modal/lies that apply,
a. AUergy desensitization ................. 1
b. Antibiotic therapy ..................... 2
c. AntlhlstamJne/decongestant therapy ........ 3
d. Localsterold therapy .................. 4
e, Systemic steroid therapy ............... 5
f. Other (please specify) . . . . . . . 6
15. If surgery was performed to control the sinus problems, what surgery w~s performed?
Circle LII that apply and indicate the side{s) where surgery was performed.
No Right Left Bilateral
a. Sop[a1 surgery ........................ 1 2 3 4
b. Ethmoid surgery--limited ................ 1 2 3 4
c. Ethmoid surgery--total .................. 1 2 3 4
d. Caldwell Luc ......................... 1 2 3 4
e. Fronts/surgery ....................... 1 2 3 4
f. Sphen~id surgery ...................... 1 2 3 4
g. Middle turblnate surgery ................. 1 2 3 4
h. Inferior turbinate surgery ................. 1 2 3 4
i. Middle meatal antrostomy ................ 1 2 3 4
j. Inferior meatal antrostomy ............... 1 2 3 4
©Heslt~OuttemeaInstltute,10/08/93
"2"
16a,
16b.
16c.
CHRONICS~USlT~S FORM 12.2
(circ/e one number for each question)
Yes NO
Was endoscopic surgery the primary method used
dudng the operation? ..................... I 2
Was it necessarY to stage surgery? . . . . . . . . . . . 1 2
Was a laser used during surgery? ............. 1 2
fiurgical Compllcadons
(circle one number for each question)
Yes No
Intraoperatlv6
a. Excessive b[eedlng--requidng transfusion ..... 1 2
b. Intraorbltal hematoma .................. 1 2
c, CSF leak ............................ 1 2
d. Brain injury .......................... 1 2
e. Injury to structures in lateral wall of
sphenoid sinus ........................ 1 2
f. Other {Please specify). 1 2
Postoperative within 4 weeks
a. Visual deficit ......................... 1 2
b. Slindness 1 2
c. 0culomotor muscle injury (diplopia) ......... f 2
d. Epiphota ............................ 1 2
e. CSF leak ............................ 1 B
f. Brain abscess ........................ I 2
g, Bleeding needing packing ................ 1 2
h. Repeat surgery ....................... t 2
i. Other (Please specify}_ 1
©HealthOutcom~ In~tilute,10108193
-3-
Fig. 8. Continued from pages S65 and S66. Continued on
page $68.

11. S68 LEOPOLD, FERGUSON, and PICCIRILLO
Otolaryngology-
Head and Neck Surgery
September 1997
Mode of ColleCtion
Self-Administered ....... 1 []
Personal Interview ....... 2 []
Telephone Interview ...... 3 []
Mall ................. 4 []
Other ................ S []
OFFICE USE ONLY
I DATE: l llllllll
Me DAY YR
PATIENT QUESTIONNAIRE
CHRONIC SINUSITIS FORM 12.3
Sanford R. Hoffman,M.D.
GeorgeW. Faeer,M.D.
DavidW. Kennedy,M.D.
EugeneB. Kern, M.D.
DonaldA. Leopold,M.D.
Dale H. Rice,M.D.
StevenD. Schaefer,M.D.
TyPE specification
CHRONIC SINUSITIS 10/08/93-M~4
(Z~HeaifhOutcomes Institute, 1093
CHRONICSINUSmS FORM12.3
Post-Treatment Survey
1. During the past eight weeks, how often have you had: (circle one number in each row)
Number of times
Never 1 2 3 4 5 6
a. Sinus headaches, facial pain, or
pressure .................... o 1 2 3 4 5 6
b. Significant postnasal drainage ..... o 1 2 3 4 5 6
c. Marked nasaI congestion ........ O 1 2 3 4 5 6
d. The need to take sinusmedica-
tions such as over-the-counter
decongestants or antibiotics ...... O 1 2 3 4 9 6
e. Sinus infections ............... o 1 2 3 4 5 6
f. Breathing difficulties ............ 0 1 2 3 4 5 6
g. Tooth gain ................... O 1 2 3 4 5 6
Who completed this form? (circle one number)
I tilled it out with no help ....................... 1
I filled it out with help fr(~mfamily or friends ......... 2
I filled it out with help from a health care provider .... 3
Family or friends ............................ 4
Heaifh care provider .......................... 5
@HeaithOutcomesInstitute.10/08193-M~
-2-
7~
7
7
7
7
7
7
7
Fig. 8. Continued from pages S65-S67.
of different chronic conditions, including chronic rhi-
nosinusitis. The Chronic Sinusitis TyPE Specific
Questionnaire (Fig. 8) has three forms. Form 1 collects
data on nasal and sinus symptoms and prior treatment,
form 2 collects data on the clinical classification of
sinus disease, and form 3 collects data on nasal and
sinus symptoms after sinus surgery. Hoffman et al.6
used these three forms, the Health Status Questionnaire
(a minor modification of the SF-36), and a short survey
of health conditions and health-risk inventory in a data-
management information system for their project on
patient outcomes after surgical management of chronic
sinusitis.
The Health Outcomes Institute has placed its three
forms in the public domain for general and unrestricted
use. Although the Chronic Sinusitis TyPE Specific
Questionnaire may very well provide a scientifically
sound framework of outcomes instruments, it has not
been fully and completely evaluated. The Task Force on
Rhinosinusitis recommends that this comprehensive
system be more thoroughly evaluated. The latest ver-
sion of the forms is presented in Fig. 8.
REFERENCES
1. Maklan CW, Greene R, Cummings MA. Methodological chal-
lenges and innovations in patient outcomes research. Med Care
1994;32(suppl):JS13-JS21. (grade C)
2. Rosenfeld RM. Pilot study of outcomes in pediatric rhinosinusitis.
Arch Otolaryngol Head Neck Surg 1995;121:729-36, (grade B)
3. Gliklich RE, Metson R. Techniques for outcomes research in
chronic sinusitis. Laryngoscope 1995;105:387-90. (grade A)
4. Isenberg SF, Rosenfeld RM. Problems and pitfalls in communi-
ty-based outcomes research. Otolaryngol Head Neck Surg (In
press). (grade C)
5. Piccirillo JE Outcomes research and otolaryngology.
Otolaryngol Head Neck Surg 1994;111:764-9, (grade C)
6. Hoffman SR, Mahoney MG, Chmiel JF, et al. Symptom relief
after endoscopic sinus surgery: an outcomes-based study. Ear
Nose Throat J 1993;72:413-4, 419-20. (grade B)
7. Ware JE Jr, Sherbourne CD. The MOS 36 Item Short-Form
Health Survey (SF-36): I. Conceptual framework and item selec-
tion. Med Care 1992;30:473-83. (grade A)
8. Ware JE Jr, Snow KK, Kosinski M, et al. SF-36 Health Survey:
Manual and interpretation guide. Boston:The Health Institute;
1993. (grade A)
9. Gliklich RE, Metson R. The health impact of chronic sinusitis in
patients seeking otolaryngologic care. Otolaryngol Head Neck
Surg 1995;113:104-9. (grade A)
10. Piccirillo JF, Edwards D, Haiduk A, et al. Psychometric and
clinimetrie validity of the 31-item rhinosinusitis outcome mea-
sure (RSOM-31). Am J Rhino1 1995;9:297-306. (grade A)
l 1. Juniper EF, Guyatt GH. Development and testing of a new mea-
sure of health status for clinical trials in rhinoconjunctivitis.Clin
Exp Allergy 1991;21:77-83. (grade A)
12. Lund VJ, Holmstrom M, Scadding GK. Functional endoscopic
sinus surgery in the management of chronic rhinosinusitis. An
objective assessment. J Laryngol Otol 1991;105:832-5. (grade
C)
13. Benninger MS. The development of the Rhinosinusitis
Disability Index. Arch Otolaryngol Head Neck Surg. In press.
(grade A)
14. Gill TM, Feinstein AR. A critical appraisal of the quality of
quality-of-life measurements. JAMA 1994;272:619-26. (grade
A)
15. Tugwell R Bombardier C, Buchanan WW, et al. The MACTAR
patient preference disability questionnaire--an individualized
functional priority approach for assessing improvement in phys-
ical disability in clinical trials in rheumatoid arthritis. J
Rheumatol 1987;14:446-51. (grade A)
16. Guyatt GH, Bombardier C, Tugwell PX. Measuring disease-
specific quality of life in clinical trials. Can Med Assoc J
1986;134:889-95. (grade C)