Development of an instrument to identify symptoms potentially indicative of ovarian cancer in a primary care clinic setting

doi:10.4236/ojog.2012.23037

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Open Journal of Obstetrics and Gynecology, 2012, 2, 183-191 OJOG

http://dx.doi.org/10.4236/ojog.2012.23037 Published Online September 2012 (http://www.SciRP.org/journal/ojog/)

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

Email: #[email protected]

Received 7 June 2012; revised 9 July 2012; accepted 17 July 2012

ABSTRACT

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

setting.

Keywords: Ovarian Cancer; Symptoms

1. INTRODUCTION

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.

OPEN ACCESS

M. R. Andersen et al. / Open Journal of Obstetrics and Gynecology 2 (2012) 183-191

184

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.

2. MATERIALS AND METHODS

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

Center.

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-

out.

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

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

assessments.

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. RESULTS

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)

Age

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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186

OPEN ACCESS

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

versus

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

Age

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%)

0.14

Race

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%)

0.001

GYNECOLOGICAL CONDITIONS

Endometriosis

Yes 11 11 (100%) 0

No 669 631 (94%) 38 (6%) 0.52

Fibroids

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

MEDICAL CONDITIONS

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

Diabetes

Yes 5 5 (100%) 0

No 675 637 (94%) 38 (6%) 0.99

Hypertension

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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188

OPEN ACCESS

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.

4. CONCLUSIONS

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-

cer.

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.

5. ACKNOWLEDGEMENTS

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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APPENDIX 1

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

symptom?

If so, how many days per month did

you experience this symptom?

How many mo nth s did this

symptom persist?

Symptom

No Yes 0 - 5 6 - 12 ≥13 <1 1 - 6 7 - 12≥13

Pain

Abdominal/pelvic pain 0 1 1 2 3 1 2 3 4

Eating

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

Abdomen

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.

M. R. Andersen et al. / Open Journal of Obstetrics and Gynecology 2 (2012) 183-191

191

APPENDIX 2

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.

OPEN ACCESS