Open Journal of Obstetrics and Gynecology, 2012, 2, 183-191 OJOG Published Online September 2012 (
Development of an instrument to identify symptoms
potentially indicative of ovarian cancer in a primary
care clinic setting*
M. Robyn Andersen1,2#, Barbara A. Goff2,3, Kimberly A. Lowe1,4
1Molecular Diagnostics Program, Fred Hutchinson Cancer Research Center, Seattle, USA
2School of Public Health, University of Washington, Seattle, USA
3Seattle Cancer Care Alliance, Seattle, USA
4Exponent Health Sciences, Seattle, USA
Received 7 June 2012; revised 9 July 2012; accepted 17 July 2012
Background: Several recently published studies sug-
gest that screening for symptoms could improve the
early diagnosis of ovarian cancer. This report de-
scribes the development of a simple and reliable
method of collecting symptom information in a pri-
mary care clinic. Methods: 1200 women, ages 40 - 87,
completed several versions of a draft symptom index
(SI) assessment form during their visits to a primary
care clinic. Factors associated with a positive SI result
were examined. Providers were surveyed about ac-
ceptability of the symptom screening procedures.
Findings: Variation in the instructions provided to
women influenced the rate at which women indicated
having symptoms indicative of a positive SI, 5% had
positive results when written instructions emphasized
listing only current symptoms. Women coming to
the clinic because of a current medical concern or
problem did have higher rates of positive SI results,
as did non-white women (p < 0.05). Acceptability by
providers was high. Patients could independently
complete the SI in 5 minutes. One patient with a
positive SI was diagnosed with ovarian cancer and
none with a negative SI developed cancer. Inter-
pretation: A quick paper and pencil form can be
used to identify women with symptoms potentially
indicative of ovarian cancer. Use of such a form for
ovarian cancer screening purposes is acceptable to
most women and providers in a primary care clinic
Keywords: Ovarian Cancer; Symptoms
Two recent prospective studies suggest that efforts to
identify women with symptoms and assure prompt as-
sessment for ovarian cancer using currently available
tests (CA-125 and TVS) could result in earlier diagnosis
of ovarian cancer [1,2]. Consistent with evidence to sug-
gest that women with ovarian cancer present with symp-
toms, even when the disease is in its early stages [3-8],
and advice from the Gynecologic Cancer Foundation, the
Society of Gynecologic Oncologists and the American
Cancer Society [9], and a statement by NICE (National
Institute for Health and Clinical Excellence) [10] en-
couraging follow-up of women reporting symptoms.
Studies using other methods also suggest that assessment
of women with symptoms could reduce time to diagnosis
[11,12]. Unfortunately, symptoms that may be indicative
of ovarian cancer can be caused by a variety of other
conditions. The key to identifying symptoms signaling
ovarian cancer appears to be that they are new to a
woman and occur frequently [13,14]. In an effort to iden-
tify women with symptoms that may be indicative of
ovarian cancer and create reliable algorithms for assess-
ment of symptoms necessary for serious study of their
potential, we have proposed a decision rule that we call a
“Symptom Index” [13,15].
The Symptom Index (SI) is considered positive if
women are currently experiencing any one or more of six
specific symptoms that are present for less than one year
and occur more than 12 times a month. These symptoms
include bloating, increased abdominal size, pelvic or
abdominal pain, difficulty eating, and feeling full quickly.
A case-control study has shown that 57% of women with
early stage ovarian cancer and 80% of women with ad-
vanced ovarian cancer report symptoms that follow this
distinctive pattern at the time of their diagnosis [13];
symptoms in conjunction with other bio-markers may
*This project was supported by grant number R21NR010571 from the
ational Institute of Nursing Research.
#Corresponding author.
M. R. Andersen et al. / Open Journal of Obstetrics and Gynecology 2 (2012) 183-191
have a role in earlier diagnosis of ovarian cancer [16].
This report provides preliminary results from a pilot
study using a standardized form to prospectively collect
SI information at a primary care clinic. The goals of this
pilot study were to determine valid methods for the pro-
spective collection of the SI and to assess the feasibility
and acceptability such assessments at a primary care visit.
We also sought to understand what factors other than
ovarian cancer may result in a positive SI.
This pilot effort was conducted at a Women’s Health
clinic in an urban setting as part of an integrated system
of medical centers. This clinic provides both primary
care and referral for a group of neighborhood clinics. The
clinic performs approximately 24,000 visits annually for
11,500 unique patients. Women were eligible for the
study if they were 40 years of age or older, not pregnant
at the time of their clinic visit, and had not participated in
the study within a 12 months period.
All study activities were reviewed and approved by
the institutional review boards of the University of
Washington and the Fred Hutchinson Cancer Research
2.1. Procedures
A research nurse identified all women over 40 years of
age with scheduled clinic appointments as potentially
eligible to participate. Informed consent was obtained
from eligible and interested women. In the first phase of
the study, 419 women completed an initial version of an
SI assessment form with the assistance of the research
nurse. Feedback from women participating during this
stage of the project was used to understand how women
respond to questions about symptoms which allowed us
to understand potential false positive or negative re-
sponses to the SI, and to improve the design of the data
collection instrument.
In the second phase of the study, 781 women were
asked to complete one of three versions of the SI data
collection form under development. Our goal was to de-
velop an accurate method of symptom data collection
that would require minimal implementation effort from
clinic staff. After appropriate written instructions were
developed, a second format was examined to assess pos-
sible differences in the results or the completeness of
women’s self-reports associated with questionnaire lay-
2.2. Measuring the Symptoms
Initially a tabular form for data collection was used and
women were asked “Have you experienced any of the
following symptoms?” (Appendix 1). With extended use
of the SI, it became apparent that the time frame women
should use to answer questions about symptoms was
unclear. Some women who reported symptoms had ex-
perienced them frequently at some point in the past year
but those symptoms had since resolved. Reports of such
symptoms would increase the false positive rate of the SI
because the symptoms are of potential importance only
for women who are currently symptomatic. The spoken
instructions were changed to clarify that the symptoms
reported should be occurring at the present time. A total
of 101 women completed study forms with spoken in-
struction to indicate their current symptoms. After IRB
approval was sought to change the written instructions,
the next 258 participants completed the tabular form with
new instructions asking “Are you currently experiencing
any of the following symptoms frequently?” These in-
troductory instructions resulted in fewer requests for
clarification. Differences in the rates of positive results
associated with the change in both spoken and written
instructions versus the earlier version of the question-
naire were evaluated.
Two different page layouts of the symptoms questions
were also tested. During initial pilot testing the question-
naire was presented using a tabular layout but women
frequently left portions blank requiring the nurse to ask if
blank spaces indicated no symptoms. In an effort to re-
duce such difficulties, a second layout was tested using
separate questions for each set of symptoms and a more
explicit flow pattern (Appendix 2). Statistical compari-
sons of the two formats examining the effect of the ques-
tionnaire layout on the rate of SI completion and on SI
results were also performed.
2.3. Coding of the Symptom Index
Women were considered to be positive for symptoms if
any of the six symptoms occurred 13 or more times per
month and were present for less than one year.
2.4. Assessing Other Variables of Interest
In addition to the symptoms question, women completed
a questionnaire allowing us to assess age, race/ethnicity,
menopausal status, reason for clinic visit, and a variety of
general medical conditions that might cause similar
symptoms. Women also provided information about any
gynecological or medical conditions diagnosed in the
past. Gynecological conditions reported included endo-
metriosis, fibroids, and ovarian cysts. General medical
conditions included irritable bowel syndrome (IBS), uri-
nary tract infections, acid reflux, diabetes, hypertension,
heart disease, and thyroid disease.
2.5. Statistical Methods
STATA statistical software package [version 10.0, Stata
Copyright © 2012 SciRes. OPEN ACCESS
M. R. Andersen et al. / Open Journal of Obstetrics and Gynecology 2 (2012) 183-191 185
Corporation, College State, TX] was used for these
analyses. The characteristics of the study population (n =
1200) were assessed using descriptive statistics, which
included the median and range for continuous variables
and the frequency and percent for categorical variables.
Associations between the instruction or format of the
symptoms questions and the results of the Index were
assessed using the Fisher’s exact test. Exploratory ana-
lyses examining the association of symptom index results
with demographic characteristics and with self-reported
health problems were conducted. All statistical tests were
two-sided and considered to be statistically significant at
p 0.05.
Clinic providers also completed a brief questionnaire
assessing the acceptability of the SI assessments being
conducted in the clinic, how assessment of symptoms
may have influenced their interactions with patients and
clinic flow, and their satisfaction with the results of the
Finally, the names of all participating women were
matched to the local cancer registry in an effort to deter-
mine whether any of them developed ovarian cancer in
the 12 months following their participation in this study.
3.1. Eligibility and Enrollment Information
Approximately 72% of women approached about the
study completed eligibility and interest form and re-
turned it to the clinic or to study staff. Of those complet-
ing forms, 74% indicated that they were eligible to par-
ticipate. Of those women indicating eligibility, 80% were
interested in volunteering to participate in the study and
completed study procedures during their clinic visit.
3.2. Characteristics of the Study Participants
The characteristics of the study participants are summa-
rized in Table 1. The average age was 55 years (35% of
the participants were ages 40 - 49 and 64% were >50
years). More than half of the study population reported
being post-menopausal. Approximately 87% of the par-
ticipants in the pilot study were white. Almost half of the
clinic appointments for study enrollees were either for
evaluation of a current health concern (26%) or for rou-
tine follow-up of a health problem reported at an earlier
clinic visit (21%). The remaining visits were reported as
routine screening appointments; for women over the age
of 40, the screening visits were primarily associated with
routine screening mammography.
Two (0.17%) of the enrolled women reported a prior
history of ovarian cancer but still had an intact ovary, and
were retained in all study analyses as they remained at
risk for ovarian cancer (data not shown). An additional
Table 1. Patient characteristics.
Total (n = 1200)
Mean (SD) 54.6 (9.4)
40 - 49, n (%) 423 (35%)
50+, n (%) 764 (64%)
Not reported 13 (1%)
Menopausal status
Pre 277 (23%)
Peri 164 (14%)
Post 636 (53%)
Not reported 123 (10%)
Ethnic background
White 1,041 (87%)
Non-white 148 (12%)
Not reported 11 (1%)
Reason for visit
Routine screen 608 (51%)
Routine follow-up 252 (21%)
I’m concerned about something 310 (26%)
Not reported 30 (2%)
Gynecological condition
Endometriosis 18 (2%)
Fibroids 108 (9%)
Ovarian cysts 67 (5%)
Other gynecological problems 84 (7%)
More than 1 of these conditions 101 (8%)
Not reported 822 (69%)
Medical conditions
Irritable bowel disease 27 (2%)
Urinary tract infections 17 (1%)
Interstitial cystitis 2 (<1%)
Acid reflux 73 (6%)
Diabetes 13 (1%)
Hypertension 72 (6%)
Heart disease 9 (<1%)
Thyroid disease 73 (6%)
More than 1 condition 315 (26%)
None of the listed conditions 336 (28%)
Not reported 263 (22%)
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M. R. Andersen et al. / Open Journal of Obstetrics and Gynecology 2 (2012) 183-191
Copyright © 2012 SciRes.
5.58% of women reported a personal history of breast
cancer and these women were also deemed eligible to
participate and retained in the study sample. All women
were able to complete the SI in less than 5 minutes
(average 1.5 minutes).
3.3. Effects of Differences in Written and Verbal
Instructions and Form Layout on the
Results of the Symptom Index
Table 2 summarizes the rate of positivity we observed
using the different SI forms. Using the initial symptom
data collection instrument and written instructions, ap-
proximately 9.3% (95% CI: 6.4% - 11.9%) of the women
reported having at least one of the symptoms more than
13 times per month, resulting in a positive Index score.
When the spoken instructions were changed and included
asking women to describe their current symptoms with-
out a change in the written instructions, the rate of posi-
tive index results was 7.9% (95% CI: 2.6% - 13.2%).
Although it appears that asking women about their “cur-
rent” symptoms as part of the verbal but not written in-
structions reduced the rate of positive index results, the
rate of positive index results was not statistically signifi-
cant between the two groups (p = 0.85).
After changes in the written instructions, no further
spoken instruction was deemed necessary. Two hundred
and fifty-eight women responded to the written instruc-
tions, “Are you currently experiencing any of the fol-
lowing symptoms frequently?” The rate of positive index
results in this group was 5.4% (95% CI: 2.7% - 8.2%).
Changing the symptom data collection instrument
from a tabular form to one with individual questions
about each symptom and a skip pattern did not change
the percentage of women judged to be positive from that
of the prior group, given the same written instructions (p
= 0.99). The rate of women with positive symptoms in
the group receiving the flow chart form was 5.7% (95%
CI: 3.5% - 7.9%). It should be noted, however, that this
test had power to detect only differences of 10% or more.
When a statistical test was performed comparing the
third and fourth groups of women combined (that is to
say, all women receiving the written instructions asking
for current symptoms) with that of the women provided
the initial written instructions, the rate of symptom posi-
tive results was lower than in the first two groups of
women (those who did not receive written instructions
specifying interest in current symptoms only [p< 0.05]).
These results are also presented in Table 2.
3.4. Differences in the Clinical Characteristics of
Women with and without Positive SI Results
In order to describe the clinical characteristics of women
with and without symptoms, the bivariate associations of
SI results with the age, race, menopausal status, gyneco-
logical and other conditions, and type of clinic visit were
explored for all those completing a form that included
the written instructions to report only “current” symp-
toms (n = 680) (Table 3). SI results did not demonstrate
statistically significant differences according to partici-
pant’s age, or menopausal status, although younger and
premenopausal women were somewhat more likely to
have a positive result.
The rate of positive SI results did demonstrate a statis-
tically significant bivariate association with race, with
non-white women approximately twice as likely to report
symptoms and receive a positive SI result when com-
pared with white women (11% versus 5% respectively, p
= 0.05). When the non-white group was examined in its
sub-categories of Black, Asian, Other, and more than one
race, the elevation was not isolated to any specific
non-white racial group (data not shown), and, the differ-
ences between groups were no longer statistically sig-
nificant. Women visiting the clinic for a current concern
were more likely to have a positive SI result than those
coming for follow-up or routine screening (14% versus
6%, and 2% respectively). Non-gynecological conditions
were not associated differences in the rates of SI positive
results, although 14% of women with IBS and 13% of
Table 2. Description of the study participant groups and percentage of SI positivity within each group.
Group Description n % SI Positive (95% CI)p values
Group 1
Participants completed the symptom
index with the assistance of the
research nurse.
419 (35%) 9.3 (6.4 - 11.9)
Group 2 Participants completed the symptom
index independently. 101 (8%) 7.9 (2.6 - 13.2)
Group 1 versus
Group 2 N.S.
Group 3
Participants were instructed to
complete the symptom index based
on their current symptoms.
258 (22%) 5.4 (2.7 - 8.2)
Group 4
Participants completed a new version
of the symptom index that used
a larger format.
422 (3%) 5.7 (3.5 - 7.9)
Group 3 versus
Group 4 N.S.
Groups 1 & 2
Groups 3 & 4
(9.0% versus 5.5%,
p < 0.05)
M. R. Andersen et al. / Open Journal of Obstetrics and Gynecology 2 (2012) 183-191 187
Table 3. Relationship between patient characteristics and results of the symptom index in women who reported “current” symptoms
(Groups 3 & 4, n = 680).
Patient characteristic and health condition Total Negative SI Positive SI p value
40 - 49 214 198 (93%) 16 (7%) 0.16
50+ 463 441 (95%) 22 (5%)
Menopausal status
Pre 144 133 (92%) 11 (8%)
Peri 100 98 (98%) 2 (2%)
Post 372 349 (94%) 23 (6%)
White 602 572 (95%) 30 (5%)
Non-white 72 64 (89%) 8 (11%) 0.05
Reason for visit
Routine screen 366 360 (98%) 6 (2%)
Routine follow-up 125 117 (94%) 8 (6%)
I’m concerned about something 177 153 (86%) 24 (14%)
Yes 11 11 (100%) 0
No 669 631 (94%) 38 (6%) 0.52
Yes 56 52 (93%) 4 (7%)
No 624 590 (95%) 34 (5%) 0.54
Ovarian cysts
Yes 32 29 (91%) 3 (9%)
No 648 613 (95%) 35 (5%) 0.42
Other gynecological condition
Yes 44 37 (84%) 7 (16%)
No 636 605 (95%) 31 (5%) 0.008
More than 1 of these conditions
Yes 57 46 (81%) 11 (19%)
No 623 596 (96%) 27 (4%) <0.001
Irritable bowel syndrome
Yes 14 12 (86%) 2 (14%)
No 666 630 (95%) 36 (5%) 0.18
Urinary tract infections
Yes 8 8 (100%) 0
No 672 634 (94%) 38 (6%) 0.99
Acid reflux
Yes 39 34 (87%) 5 (13%)
No 641 608 (95%) 33 (5%) 0.06
Yes 5 5 (100%) 0
No 675 637 (94%) 38 (6%) 0.99
Yes 43 42 (98%) 1 (2%)
No 637 600 (94%) 37 (6%) 0.50
Heart disease
Yes 6 5 (83%) 1 (17%)
No 674 637 (95%) 37 (6%) 0.29
Thyroid disease
Yes 45 41 (91%) 4 (9%)
No 635 601 (95%) 34 (5%) 0.31
More than 1 of these conditions
Yes 186 172 (92%) 14 (8%)
No 494 470 (95%) 24 (5%) 0.19
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M. R. Andersen et al. / Open Journal of Obstetrics and Gynecology 2 (2012) 183-191
Copyright © 2012 SciRes.
women with Acid reflux disease were index positive, in a
larger population these differences might have achieved
statistical significance.
None of the individual gynecological conditions named
on our survey were associated with an elevated fre-
quency positive SI results. However, women reporting
any of a variety of “other” gynecological conditions (16%
versus 5%; p < 0.01) and those with more than one gy-
necologic condition were more likely to have a positive
results (19% versus 4%; p < 0.01).
3.5. Multivariate Analyses
Multivariate analyses were then conducted on an ad-hoc
basis in order to explore whether the statistically signifi-
cant bivariate association of race and symptoms might be
related to differences in personal characteristics or health
status. When a multivariate logistic regression model of
SI positivity that included race, age, more than one gy-
necological condition, fibroids, and IBS was tested, the
association of race with positive results for symptoms
was reduced in size and was not statistically significant.
Differences in the rate of SI positivity associated with
race may be due to other characteristics of our sample.
3.6. Acceptability to Providers
A survey of the physicians, physician assistants (PAs),
and nurses working in the clinic (n = 10) revealed that
they felt the SI was “very acceptable” (5.0, sd = 0 among
physicians and PAs, and 4.5, sd = 0.58 among nurses).
This represented the answers on a Likert scale running
from 1 to 5, where 1 was “not at all acceptable” and 5 =
“very acceptable”. These clinic staff also felt the SI
added 1 - 2 minutes to the patient visit, in the 10% to
20% of patients for whom they judged it added any time
at all. They also indicated that the symptom information
provided was useful to them in their practice (4.3, sd =
0.82 for physicians and PAs and 4.3, sd = 0.58 among
nurses). This on a Likert scale running from 1 to 5 where
1 was “not at all useful” and 5 = “very useful”.
Participating patients were also linked to the Western
Washington SEER registry to determine if they had de-
veloped any cancer in the 12 months following study
participation. One new case of ovarian cancer was iden-
tified. The participant had a positive SI and was diag-
nosed with ovarian cancer shortly after participating. In
this sample no other participants with a positive SI de-
veloped ovarian cancer and no patients with a negative
SI developed ovarian cancer in this sample.
Recently, many lay media outlets have encouraged
women to keep diaries of symptoms as a possible method
of early detection for ovarian cancer. In the Diagnosing
Ovarian Cancer Early (DOvE) study conducted in Can-
ada, women were recruited though a public media cam-
paign utilizing newspaper, radio, television, and fliers to
attract symptomatic women to participate. Remarkably,
through this approach, investigators diagnosed ovarian
cancer in one per 132 women, which is ten times higher
than reported in other studies. Comparison of DOvE pa-
tients to those in the general population found a complete
resection rate of cancer to be 73% compared to 44%, p =
0.075. While this was not statistically significant in this
pilot study, the trend was encouraging and suggests that a
valid tool to assess symptoms associated with ovarian
cancer could be important.
When symptoms are collected prospectively in a clinic
setting using the SI, it appears that 5.5% of women re-
port current symptoms associated with a positive result,
although as many as 9.7% of women may report having
had these symptoms frequently in the past. Thus, it is
important to direct women to report only symptoms they
are currently experiencing frequently. Predictors of
symptoms appear to include the nature of the clinic visit
with women reporting current concerns more likely than
those visiting for a routine screening appointment to re-
port symptoms. Women with a personal history of gyne-
cological conditions, particularly those with more than
one gynecological condition, are also more likely to re-
port currently experiencing symptoms. Those with a di-
agnosis of acid reflux disease or IBS may also be more
likely to report symptoms, although this study did not
have power to fully assess this. Further studies are
needed to better understand racial or ethnic differences in
the reporting of symptoms associated with ovarian can-
Study Limitations and Considerations
As expected the low incidence of ovarian cancer led to
only one patient in the population developing ovarian
cancer. Although this patient was symptom positive, the
sensitivity and specificity of the SI tool cannot be as-
sessed in the current study.
The value of this report needs to be understood in
context. There have been several efforts to develop algo-
rithms for assessing ovarian cancer symptoms [11-13,17,
18], but few have reported results from use of their index
in a study group other than the one in which it was
developed , and differences associated with methods of
administration of self-report questionnaires have not
been previously examined. The symptom index [13] pro-
vides a considerably more specific result than other
indexes with similar sensitivity and is the first to report
results from prospective use in a clinic population. If
ovarian cancer screening using symptoms is widely
M. R. Andersen et al. / Open Journal of Obstetrics and Gynecology 2 (2012) 183-191 189
adopted, maximizing the specificity of screening pro-
grams will be important. Until better biomarkers are iden-
tified and tested collecting information about symptoms
appears to have promise. The Symptom Index (SI) can
be easily used in a primary care clinic setting and is
acceptable to providers and patients and identifies
women with symptoms that are worthy of concern with
minimal false-positive results.
This project was supported by grant number R21NR010571 from the
National Institute of Nursing Research. The contents are solely the
responsibility of the authors and do not necessarily represent the offi-
cial views of the National Institute of Nursing Research or the National
Institutes of Health.
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M. R. Andersen et al. / Open Journal of Obstetrics and Gynecology 2 (2012) 183-191
Symptom Questionnaire
Have you experienced any of the following symptoms? Check the box Yes or No. If yes, also check the box for number
of days per month and the box for the number of months you experienced each symptom.
Have you had this
If so, how many days per month did
you experience this symptom?
How many mo nth s did this
symptom persist?
No Yes 0 - 5 6 - 12 13 <1 1 - 6 7 - 1213
Abdominal/pelvic pain 0 1 1 2 3 1 2 3 4
Feeling full quickly 0 1 1 2 3 1 2 3 4
Unable to eat normally 0 1 1 2 3 1 2 3 4
Abdominal bloating or Increased abdomen size 0 1 1 2 3 1 2 3 4
8 None of the above symptoms
FOR STAFF USE ONLY. SI Negative: 0; SI Positive: 1.
Copyright © 2012 SciRes. OPEN ACCESS
M. R. Andersen et al. / Open Journal of Obstetrics and Gynecology 2 (2012) 183-191
Copyright © 2012 SciRes.
Symptom Questionnaire
Are you currently experiencing any of the following symptoms frequently? Check the box Yes or No. If yes, also check
the box for number of days per month and the box for the number of months you experience each symptom.
1) Pain: abdominal/pelvic pain
0 No
1a. If yes, how many days per month do you experience this symptom?
0 - 5 days 6 - 12 days More than 13 days
1 2 3
1b. If yes, how long have you had this symptom?
Less than 1 month 1 - 6 months 7 - 12 months More than 1 year
1 Yes
1 2 3 4
2) Eating: feeling full quickly or unable to eat normally
0 No
2a. If yes, how many days per month do you experience this symptom?
0 - 5 days 6 - 12 days More than 13 days
1 2 3
2b. If yes, how long have you had this symptom?
Less than 1 month 1 - 6 months 7 - 12 months More than 1 year
1 Yes
1 2 3 4
3) Abdomen: abdominal bloating or increased abdomen size
0 No
3a. If yes, how many days per month do you experience this symptom?
0 - 5 days 6 - 12 days More than 13 days
1 2 3
3b. If yes, how long have you had this symptom?
Less than 1 month 1 - 6 months 7 - 12 months More than 1 year
1 Yes
1 2 3 4
FOR STAFF USE ONLY. SI Negative: 0; SI Positive: 1.