Preventive Medicine 39 (2004) 404 – 412
www.elsevier.com/locate/ypmed
Distress after an abnormal Pap smear result: scale development and
psychometric validation
Eileen Shinn, Ph.D., a,* Karen Basen-Engquist, Ph.D., M.P.H., a Tao Le, B.S., a
Andrea Hansis-Diarte, M.P.H., a De’Shaunda Bostic, B.S., a Jodi Martinez-Cross, B.A., a
Annette Santos, B.A., a and Michele Follen, M.D., Ph.D. b,c
a
Department of Behavioral Science, M.D. Anderson Cancer Center, The University of Texas, Houston, TX 77030, USA
b
Biomedical Engineering Center, M.D. Anderson Cancer Center, The University of Texas, Houston, TX 77030, USA
c
Department of Obstetrics, Gynecology, and Reproductive Sciences at the University of Texas Health Science Center, Houston, TX 77030, USA
Available online 22 April 2004
Abstract
Background. Psychological distress is severe in women who receive a report of abnormal findings on Pap smear, and may be one reason
10 – 61% of such women fail to undergo follow-up testing.
Methods. Using the 14-question Psychosocial Effects of Abnormal Pap Smears Questionnaire (PEAPS-Q) as a basis, we developed the
23-question Cervical Dysplasia Distress Questionnaire (CDDQ), testing its internal consistency and validity with 661 women undergoing
colposcopy after an abnormal Pap smear finding in a three-phase analysis.
Results. Items were divided into two sets and factor analyzed separately: one addressed distress during medical procedures, and the other
concerned perceived consequences of an abnormal Pap smear. The medical procedures items yielded two factors: embarrassment regarding
the procedures and discomfort/tension with the procedures. Factor analysis of the second set also resulted in two factors: concern about
sexual and reproductive issues and concern about health consequences. Subscales created from items loading highly on each factor had high
internal consistency (a ranged from 0.76 to 0.90) and demonstrated good concurrent validity with other psychometrically validated measures
of distress.
Conclusions. The CDDQ is a reliable and valid questionnaire for measuring multiple domains of distress unique to women who test
positive on a cervical cancer screening test.
D 2004 The Institute For Cancer Prevention and Elsevier Inc. All rights reserved.
Keywords: Cervical intraepithelial neoplasia; Cervical cancer; Cervical smears; Cervix dysplasia; Distress; Papanicolaou smear; Psychometrics; Questionnaires
Introduction
Although rates for cervical cancer screening among
healthy women are high, failure to present for follow-up
evaluation after abnormal Papanicolaou (Pap) smear findings is a serious problem [1,2], particularly in women who
are low SES [3], inadequately insured, younger than 30 [4],
and African-American [5]. Recent reviews indicate that
nonadherence to initial colposcopy and subsequent treatment range from 10% to more than 40% [6,7]. One inner
city intervention study found even higher nonadherence
* Corresponding author. Department of Behavioral Science, M.D.
Anderson Cancer Center, University of Texas, 1515 Holcombe Boulevard,
Box 243, Houston, TX 77030-4009. Fax: +1-713-745-4468.
E-mail address: eshinn@mdanderson.org (E. Shinn).
rates to follow-up colposcopy, ranging from 39% to 61%
[8]. Although overall rates of cervical cancer deaths have
declined dramatically since the introduction of the Papanicolaou smear test, undergoing Pap smear tests is useless if
further diagnostic testing and treatment do not follow
abnormal screening results. Up to 15% of invasive cervical
cancer cases had not received proper follow-up for abnormal
Pap smear [9].
Three reasons for nonadherence to follow-up recommendations after an abnormal Pap test result are delays among
appointments, healthcare providers’ inadequate communication of the importance of follow-up care, and psychological distress. Multiple visits and delays of up to 6 months
between appointments are built into the standard evaluation
and treatment process after an abnormal test result. As a
result, many women report that forgetting their appointment
0091-7435/$ - see front matter D 2004 The Institute For Cancer Prevention and Elsevier Inc. All rights reserved.
doi:10.1016/j.ypmed.2004.02.004
E. Shinn et al. / Preventive Medicine 39 (2004) 404–412
is an influential factor in nonadherence [8]. Second, communication about the importance of follow-up care and the
meaning of the abnormal Pap test result is often inadequate
[6,10]. Third, psychological distress resulting from receiving an abnormal Pap result may act as a barrier to follow-up
care [11,12]. Several studies have documented high levels of
distress, intrusive thoughts, and avoidant coping after an
abnormal Pap smear result [13 –16]. The majority of women
interpret the abnormal result as a report of invasive cancer
[12,17]. Younger women report that the fear of loss of
reproductive functioning is as distressing as the prospect of
cancer [15,17]. Other feelings of distress may include a
sense of shame or guilt concerning their positive test result.
Increased public awareness about the role of the sexually
transmitted human papillomavirus (HPV) in cervical cancer
also negatively impacts patients’ feelings about their bodies
and their perceived feelings of responsibility in developing
cervical dysplasia [14]. For example, one study of 20 CIN
patients who completed semistructured interviews reported
that 60% of women reported a change in their sexual
activity; their most prevalent underlying reason was a sense
of contamination [14].
Research has indicated that psychological distress may
increase nonadherence to follow-up colposcopy by undermining coping strategies. Women with abnormal Pap smear
result report that anxiety and fear of the procedure as well as
fear of cancer and possible loss of reproductive functioning
are potential barriers to adherence for follow-up colposcopy
[12]. Women with high distress after an abnormal Pap were
more likely to exhibit avoidant rather than adaptive coping
strategies [15], making it more likely that nonadherence
would occur [14]. The distress associated with an abnormal
Pap smear result occurs among a wide range of specific
domains (cancer worries, reproductive worries, fears of the
medical follow-up procedures, and negative impact on
sexual self-schema), [15,17] making it more difficult for
women to cope effectively with the distress.
The first generation of descriptive studies used openended and semistructured interviews to reveal a complex
picture of high levels of distress in women related to several
specific domains after an abnormal Pap result [14,15,18].
Such research has been key in establishing the importance of
psychosocial functioning in these women. The next step in the
field is to measure not only the intensity of general distress,
but also to measure distress related to the areas of concern
specific to positive screenings for cervical cancer. There is a
need for a validated measure that can assess domains such as
fear of cancer and dying, fears of loss of reproductive
functioning, sexual concerns, and fear of diagnostic and
treatment procedures for cervical cancer. Previous research
in this area has tended to rely on such general measures of
psychological distress as the General Health Questionnaire
(GHQ) [16]. Other studies have investigated behavioral
factors in nonadherence to follow-up colposcopy using nonvalidated instruments [12]. One analytically derived measure
that was specifically developed for women who tested pos-
405
itive on cervical cancer screening, the Abnormal Smears
Questionnaire [13], provides subscale scores on procedural
distress, smear result distress, and negative cognitions. However, the items were generated during a single development
phase (40 colposcopy and laser excision patients participating
in semistructured interviews during their appointments) and
did not benefit from expert review [19]. Others have criticized
the study’s small validation sample size (n = 80) [20].
Another measure, the Psychosocial Effects of Abnormal
Pap Smears Questionnaire (PEAPS-Q), was developed in
Australia to measure distress in women undergoing follow-up
testing after an abnormal Pap test result [20]. The final
version of the scale, which was derived from factor analysis,
contains 14 items and four subscales: experience of medical
procedures, feelings about cervical abnormality/changes in
self, worry about infectivity (infecting others sexually), and
effect on sexual relationships. The PEAPS-Q was initially
drawn from a pool of more than 200 items generated from
individual interviews and from four focus groups of women
representing varying levels of age, education, and history of
ever having a Pap smear who were attending their first
colposcopy or attending follow-up colposcopy. Five independent expert researchers then culled out ambiguous or
repetitious items, resulting in 41 core items and five identified
domains of concern. The final version of the scale was
validated with the GHQ on a sample of 350 women who
had either received notification of an abnormal Pap result and
were attending their first colposcopy (n = 93), or women who
were attending follow-up colposcopy (n = 257). Test – retest
reliability over the overall scale was high (r = 0.88) and
internal consistency was good (a =0.84).
Interested in evaluating specific distress domains in
women with abnormal Pap smears, we identified the
PEAPS-Q [20] as a potential method for measuring their
distress during optical spectroscopy, which is an experimental technology used in screening and diagnosing cervical
cancer. In this study, women were assessed for distress
while undergoing follow-up procedures after abnormal
Pap, including optical spectroscopy, colposcopy, and biopsy.
Because the PEAPS-Q was developed in Australia, we
anticipated that some revisions would be necessary to make
it more understandable for a sample of U.S. and Canadian
women. Therefore, we undertook an effort to modify the
PEAPS questionnaire; after significant modifications, it was
renamed the Cervical Dysplasia Distress Questionnaire
(CDDQ). Here, we present information on the steps taken
to modify the PEAPS-Q as well as psychometric data on the
CDDQ’s internal consistency and validity.
Materials and methods
Background study
Data were collected as part of an NCI-funded program
project evaluating optical spectroscopy as a screening and
406
E. Shinn et al. / Preventive Medicine 39 (2004) 404–412
diagnostic tool for the diagnosis of cervical dysplasia. One
of the studies on the program project compared pain and
distress ratings for patients with abnormal Pap result during
each of the following procedures: optical spectroscopy, Pap
smear, and colposcopically directed biopsy.
Study design and sample
Participants (n = 661) were eligible for the present study
if they were (1) 18 years or older, (2) not pregnant, and (3)
referred for colposcopy because of an abnormal Pap smear,
or had received an abnormal Pap smear result in the last 12
months. The sample had the following ethnic breakdown:
46% were non-Hispanic White, 22% were African-American, and 28% classified themselves as Hispanic. The sample
was recruited from six clinical sites: the Gynecologic
Oncology Clinic at The University of Texas M.D. Anderson
Cancer Center (UTMDACC), the Harris County Hospital
District Lyndon B. Johnson Hospital Clinic (LBJ), the
Cancer Prevention Clinic at UTMDACC, Vancouver General Hospital Colposcopy Clinic, the Houston Medical
Center (HMC), and the Hermann Professional Building
(HPB). HMC and the UTMDACC clinics see primarily
white, insured patients, whereas HPB and LBJ Hospital see
a triethnic group of patients (white, African-American, and
Hispanic) who are typically uninsured or have Medicaid.
The CDDQ was developed in three phases with three
separate samples. In the first phase, the original 14-item
PEAPS-Q was administered to assess distress in a sample of
253 colposcopy patients. Of these, 52 women who were
attending the colposcopy clinic for follow-up colposcopy
also completed a cognitive interview about the PEAPS-Q to
elucidate problems in interpretation of its questions or
response options. The actual cognitive interview process is
described in more detail in the next section, Data collection
procedures. Feedback from the participants’ cognitive interviews were then used to modify the original PEAPS-Q and to
generate 20 new items for the next phase of development.
The remaining 201 participants in phase 1 were participants
in the background spectroscopy study. As part of this
background study, these women completed additional pain,
anxiety, and distress questionnaires in addition to the
PEAPS-Q. Of these 201 women, 37% of the patients were
newly referred for colposcopy following an abnormal Pap
smear and 63% were women who had volunteered for the
background study and who had a history of abnormal Pap
smear within the past year. Unlike the referral patients,
women who volunteered for the study came to the clinic
voluntarily based on their response to media ads advertising
the study’s free diagnostic and follow-up care, and based on
the eligibility requirement of having a history of an abnormal
Pap smear within the past year.
For phase 2, the PEAPS-Q was modified based on results
from phase 1’s initial factor analysis and feedback from the
cognitive interviews. The modified PEAPS-Q was then
administered to a new sample of 89 colposcopy patients.
Of these, 60 women completed a cognitive interview about
the modified PEAPS-Q. These 60 women who completed
the cognitive interviews were patients who were attending
colposcopy clinic for follow-up colposcopy. The remaining
29 patients in phase 2 were enrolled into the background
spectroscopy study and thus completed the same pain,
anxiety, and distress questionnaires as in the previous phase.
Of these 29 women, 31% were newly referred colposcopy
patients and 69% were women with a history of abnormal
Pap attending colposcopy clinic for the background study.
For phase 3, the questionnaire items were modified again
based on the results from phase 2’s cognitive interviews,
and two of the new items were dropped since they were not
easily understood by patients in phase 2. The modified items
were administered to a new sample of 319 patients undergoing colposcopy. Of these, 143 women completed cognitive interviews about the modified items to assess further
concerns about the interpretability of the items. As with
phases 1 and 2, all women who completed the cognitive
interview were patients who were attending colposcopy
clinic for follow-up colposcopy. Of the 143 women completing cognitive interviews, 12 women who spoke Spanish
as a first language were given a Spanish translation of the
questionnaire. The cognitive interviews were conducted in
Spanish by two Spanish-speaking members of our research
team, resulting in minor changes in the Spanish wording of
the items. The remaining 176 patients in phase 3 were
enrolled into the background spectroscopy study and completed the pain, anxiety, and distress questionnaires in
addition to the modified questionnaire items. Of these 176
women, 70% were newly referred colposcopy patients and
30% were women with a history of abnormal Pap attending
colposcopy clinic for the background study.
Data collection procedures
After consenting to participation, all patients completed an
interview with a female interviewer to assess demographic
variables. Immediately following her colposcopy, the participant completed the questionnaire (either the PEAPS-Q or
modified versions of the PEAPS-Q, depending on the phase
of development for the CDDQ). It was at this time that she
also completed a cognitive interview, if applicable (i.e. she
was a follow-up colposcopy patient as opposed to a newly
diagnosed referral patient or a volunteer for the background
study). For the cognitive interviews, the participant was asked
to repeat each question of the questionnaire in her own words,
report any difficulties she experienced in responding, identify
words that were difficult to understand, provide specific
examples of actions implied by the responses, report how
difficult it was to generate a response, report alternatives that
would facilitate a clearer or easier response, and report any
other information that might elucidate understanding of the
question or the response process [21].
If the participant was enrolled in the background spectroscopy trial, the participant completed the state anxiety
and depression measures before the procedures. Then a
E. Shinn et al. / Preventive Medicine 39 (2004) 404–412
female interviewer accompanied the patient into the exam
room to assess the patient’s pain and anxiety ratings during
the Pap smear, colposcopy, spectroscopy, and biopsy procedures. Immediately following the examination, the participant completed measures of state anxiety, cancer worry, and
the PEAPS-Q (or CDDQ, depending on the phase of
development of the CDDQ).
Measures
For patients who completed the pain and distress procedures, pre- and postexam state anxiety was measured with
the Spielberger State-Anxiety Scale [22]. The pain and
anxiety ratings taken during the medical procedures were
rated on a 0- to 10-point scale. Such single-item scales have
been used in studies of distress during gynecologic exams
and they have been found to differentiate between experimental conditions designed to influence pain and anxiety
and are sensitive to changes in pain and anxiety over the
course of a colposcopic examination [23 – 25]. After the
procedures, widely used questionnaires with tested validity
and reliability were used to assess distress, including the
Spielberger State-Trait Anxiety Inventory [22] and Center
for Epidemiological Studies Depression Scale [26], and
Cancer Worry [27]. While other measures of Cancer Worry
exist, this particular measure represented the state of the
science at the time. Its brevity also ensured that it could be
easily integrated into the interview.
Measurement and analysis procedures
By the third phase of development, results from the
cognitive interviews indicated no further concerns about
the interpretability of the CDDQ items. Therefore, it was
decided that no additional changes to the items themselves
were needed. The factor analysis on this final set of
questionnaire items yielded the CDDQ and is presented in
the Results section.
For the two sets of CDDQ items, distress and medical
procedures, the following procedures occurred. First, the
distributions of the items were examined, and items with
skewness values above 3.0 or kurtosis values greater than 10
were dropped. The items were then divided into two groups,
depending on whether they referred to distress resulting
from the colposcopy and related medical procedures, or
from concerns about the consequences of having an abnormal Pap smear. These two sets of items were factor analyzed
separately because we anticipated that they might be used
separately in different situations. Because the maximum
likelihood method produced a Heywood case (items with
communality greater than 1.0), alpha factoring extraction
was used instead, with oblique rotation. Items that had
factor loadings above 0.40 onto the factors were retained
in the final solution.
In the factor analysis process, items with low communality (<0.30) were dropped, as were items that loaded
407
heavily on more than one factor. Such items were dropped
one at a time, until a solution was reached in which all
communalities were above 0.30 and all items loaded at least
0.40 on only one factor. The number of factors chosen for
the final solution was based on the criteria that all factors
should account for at least 10% of the variance and that the
percentage of residuals above 0.10 in absolute value would
be 10% or less.
To assess the concurrent validity of the CDDQ, Pearson
correlation coefficients were calculated between the subscales generated by the factor analysis in phase 3 and the
CES-D, Spielberger State Anxiety Scale, Cancer Worry
Scale, and the one-item Pain and Anxiety ratings. Cronbach’s alpha was used to assess the internal consistency of the
CDDQ subscales.
Results
Item and factor analyses
Phase 1
Results from the initial factor analysis of the original 14item PEAPS-Q did not replicate the four-factor structure of
Bennetts et al. [20] (experience of medical procedures,
beliefs/feelings about cervical abnormality and changes in
the perception of self, worry about infectivity, and effects on
sexual relationships). Instead, a three-factor solution was
found to be the best fit to the data (experience of medical
procedures, distress about health consequences, and distress
about sexual consequences). The reliability of these subscales had moderate to high internal consistency (Cronbach’s a = 0.73 – 0.87), but the results of the cognitive
interviews indicated problems with the interpretation of
certain questions, particularly those from the experience of
medical procedures subscales. For example, when asked,
‘‘Did you find the procedures uncomfortable?’’ some participants interpreted ‘‘uncomfortable’’ to mean emotionally
uncomfortable, while others interpreted it to mean painful or
in a physically uncomfortable position.
Phase 2
To remedy the problems with question interpretation, we
composed 20 additional questions for each of the three
factors. The questions were developed based on the phase 1
participants’ rewording of the original questions and additional concerns they identified, such as issues of being
emotionally upset by the medical procedures (as opposed
to physical discomfort), attractiveness to sexual partners,
and specific worry about the test results, cancer, and the
possibility of dying from cervical cancer. These were
administered to 89 patients undergoing colposcopy, with
60 completing a cognitive interview as well. The main issue
identified in this phase was that some patients did not
understand the use of the term test to refer to parts of the
examination, and so the word exam, which they did under-
408
E. Shinn et al. / Preventive Medicine 39 (2004) 404–412
stand, was substituted. In addition, two of the new questions
were not easily understood by patients and so were dropped.
Phase 3
The third phase of the pilot test enrolled 319 colposcopy
patients and demographics of this sample are presented in
Table 1. Although we did not collect data on the socioeconomic status of the sample, we did collect information on
educational level as a proxy measure, and approximately
half (48%) of the sample had 12 years of formal education
or less. Twenty percent of the sample did not attain a GED
level of education: 12% women completed at least some
high school and 8% dropped out before the ninth grade.
Women who volunteered for the screening and diagnostic
trial were more likely to be college educated (79%) compared to the women who were referred to the colposcopy
clinic (47%). However, the ethnic breakdown of the volunteer and referred samples was similar. One hundred and
forty-three colposcopy patients completed the questionnaire
items and a cognitive interview, and 176 colposcopy
patients completed the questionnaire items in addition to
an interview about the optical spectroscopy procedure. No
major concerns about the interpretation of the questions
arose in phase 3.
In the analysis of the resulting pool of questionnaire
items, we decided to do separate factor analyses on items
Table 1
Demographic profile of sample
Characteristic
Frequency
%
Age (years)
18 – 29
30 – 39
40 – 49
50 – 59
60 – 69
70 – 79
80 – 89
125
78
76
27
6
5
1
39.2
24.5
23.8
8.5
1.9
1.6
0.3
Ethnicity
White
African-American
Asian/Pacific Islander
American Indian
White Hispanic
Black Hispanic
Other
147
70
7
1
88
2
2
46.2
21.9
2.2
0.3
27.7
0.6
0.6
24
38
90
89
77
7.5
11.9
28.3
28.0
24.2
71
163
71
13
22.3
51.1
22.3
4.1
Education
Elementary school (grades 1 – 8)
Some high school (grades 9 – 11)
Grade 12 or GED
Some college (1 – 3 years)
College and above (4 years or more)
Marital status
Never married
Married or living with partner
Divorced or separated
Widowed
relating to distress regarding the colposcopy examination
procedures (medical procedures) and worry about the consequences of having an abnormal Pap smear (distress)
because the two sets of items might be used at different
times for different purposes.
Medical procedures
Of 15 questions about the patient’s experience of the
medical procedures, four were dropped because of their
distributions being highly skewed (skewness > 3.0), making
them inappropriate for factor analysis. The remaining 11
items were factor analyzed using the alpha factoring extraction method with oblique rotation. Three additional questions (‘‘Did you feel you had control over the things that
were done to you during the exam?’’ ‘‘Was your body
relaxed?’’ and ‘‘Did you feel you were in a helpless or
vulnerable condition?’’) were dropped one at a time from
the factor analytic model because of low correlation with the
overall solution (communalities for all three items were
below 0.30).
A final solution of two correlated factors was selected as
the most parsimonious and best fit to the data. The twofactor solution resulted in just 10.7% of the fitted residuals
with values greater than 0.10. All items had loadings above
0.40 on either factor 1 or factor 2. The two factors were a
six-item ‘‘discomfort and tension’’ factor (factor 1) and a
two-item ‘‘embarrassment’’ factor (factor 2). Factor 1
accounted for 42.9% of the variance and factor 2 accounted
for an additional 11.5% of the variance. Table 2 presents the
results of the two-factor solution for the medical procedures
items. Both the factor pattern, which includes the item
loadings, and the factor structure are presented. The structure matrix takes into account the interrelatedness of the two
factors, which resulted from the oblique rotation. The two
factors had a substantial intercorrelation coefficient of 0.46.
Distress items
None of the 17 questions about distress due to an
abnormal Pap smear were dropped from the analysis for
reasons of skewness, as all items’ distributions had skew
values below 3. The 17 items related to distress about the
consequences of having abnormal Pap smear findings were
also factor analyzed using the alpha factoring extraction
method with oblique rotation. One of the questions (‘‘Do
you feel your health keeps getting worse?’’) had to be
dropped because of its low communality. In the analysis
of the remaining 16 questions, a solution with two correlated factors was selected as the most parsimonious and best
fit to the data. Each factor accounted for >10% of the
variance, and only 7.6% of the residuals were greater than
0.10. An additional item, ‘‘Have you had the feeling that
you are not as healthy as you thought you were?’’ was
dropped from the model because of low, equal loadings on
both factors, resulting in 15 remaining questions.
In the final two-factor solution, nine items loaded onto
the first factor (factor 1) describing concerns about sexual
409
E. Shinn et al. / Preventive Medicine 39 (2004) 404–412
Table 2
Factor loadings and communality estimates for the medical procedures items
Questions
Factor pattern
Factor structure
Factor 1, tension
and discomfort
Tension and discomfort
Did you find the exams uncomfortable?
Did you find the exams emotionally upsetting?
Did the exams make you nervous?
Did the exam hurt?
Did you feel tense?
Were you nervous?
Embarrassment
Were you uncomfortable being partly undressed?
Were you embarrassed having your private parts
touched by the doctor or nurse?
Factor 2,
embarrassment
Factor 1, tension
and discomfort
Factor 2,
embarrassment
Communality
estimates
0.66
0.57
0.82
0.68
0.79
0.73
0.07
0.03
0.04
0.03
0.01
0.03
0.70
0.58
0.80
0.66
0.80
0.72
0.38
0.30
0.33
0.28
0.38
0.38
0.50
0.34
0.63
0.44
0.64
0.51
0.06
0.07
0.92
0.67
0.36
0.38
0.89
0.70
0.80
0.50
and reproductive consequences, which accounted for 36.7%
of the variance. One item, ‘‘How worried are you that you
will lose your chance to have a baby?’’ had low loadings on
the two factors (0.29 and 0.20, respectively), but was kept
in the analysis since it was the only item in the sample pool
which addressed reproductive concerns. Furthermore, it
would not necessarily be expected that this item would
load highly onto either of the two factors since the sexual
items addressed concerns about decline in sexual functioning and attractiveness, and the health concerns were cancer-
related. The remaining six items had high loadings on a
second factor (factor 2) about concerns with health consequences and accounted for an additional 11.4% of the
variance. Table 3 presents the results of the two-factor
solution for the distress items. Both the factor pattern,
which includes the item loadings, and the factor structure
are presented. The structure matrix takes into account the
interrelatedness of the two factors, which resulted from the
oblique rotation. The correlation between the two factors
was 0.49.
Table 3
Factor loadings and communality estimates for the distress items
Question
Factor pattern
Factor 1, sexual
consequences
Sexual and reproductive consequences
How worried are you that you would lose your chance to
have a baby?
Have you been worried that you could give the problem
to a sexual partner?
Have you been worried whether a sexual partner will
think they can catch the problems from you?
Have you been worried whether you should continue
having sex?
Have you been worried that this problem might affect
how attractive you are to your sexual partner?
Have you been worried whether having sex will make
the problem worse?
Have you been worried whether others think you have had
more sexual partners than you should?
Have you been worried about sex being more painful now?
Have you been worried that this problem might affect how
much you enjoy sex?
Health consequences
How worried are you that cancer will appear in your body?
Have you worried about the test results?
Have you worried that you may have cancer?
How worried are you that you might die?
Have you been worried that your problem may turn into cancer?
How worried are you that you might die from cervical cancer?
Structure pattern
Factor 2, health
consequences
Factor 1, sexual
consequences
Factor 2, health
consequences
Communality
estimates
0.29
0.20
0.39
0.35
0.19
0.74
0.04
0.72
0.32
0.52
0.70
0.07
0.66
0.27
0.45
0.75
0.02
0.74
0.35
0.55
0.56
0.14
0.63
0.41
0.41
0.67
0.09
0.72
0.42
0.52
0.46
0.08
0.50
0.31
0.26
0.63
0.69
0.06
0.05
0.60
0.67
0.25
0.30
0.36
0.45
0.13
0.11
0.02
0.02
0.06
0.07
0.81
0.64
0.83
0.76
0.85
0.74
0.30
0.40
0.41
0.37
0.47
0.41
0.73
0.70
0.85
0.76
0.88
0.75
0.54
0.49
0.72
0.57
0.78
0.57
410
E. Shinn et al. / Preventive Medicine 39 (2004) 404–412
Table 4
Descriptive statistics, reliability, and validity of the CDDQ
Scale
Mean
Discomfort and tension during medical
procedures
Embarrassment due to medical procedures
Concerns related to sexual consequences
Concerns related to health consequences
SD
Reliability
Correlation with
Pain during
colposcopy
Anxiety during
colposcopy
Preexam
anxiety
Postexam
anxiety
Cancer
worry
Depression
2.14
0.74
0.86
0.38***
0.55***
0.36***
0.54***
0.27**
0.30**
1.54
1.52
2.26
0.82
0.63
0.87
0.76
0.85
0.90
0.14
0.22*
0.11
0.19*
0.19*
0.30***
0.26***
0.27***
0.48***
0.32***
0.22**
0.43***
0.29***
0.38***
0.68***
0.23**
0.23**
0.38***
* P < 0.05.
** P < 0.01.
*** P < 0.001.
Formation of subscale scores, internal consistency, and
concurrent validity of scales
Medical procedures subscales
When the six items on the discomfort and tension factor
(factor 1) were combined, the resulting scale had a high
internal consistency (Cronbach’s a = 0.86). As shown in
Table 4, the discomfort and tension factor correlated most
highly with conceptually related variables, namely, pain and
anxiety ratings during colposcopy (r = 0.38 and 0.55,
respectively), and with pre- and postexam state anxiety
(r = 0.36 and 0.54). Other significant but smaller correlations
were with cancer worry (r =0.27) and depression (r =0.30).
The two items that loaded heavily on factor 2 were related to
embarrassment during the exam. The resulting embarrassment subscale had an internal consistency of 0.76. Correlations of the embarrassment factor with conceptually related
variables are also presented in Table 4. The embarrassment
factor showed significant but small correlations with anxiety
ratings taken during the colposcopy procedure (r =0.19) as
well as state anxiety assessments taken before (r =0.26 and
after the exam (r =0.32). The embarrassment factor also
showed significant but small correlations with cancer worry
(r =0.29) and with depression (r =0.23).
Distress items subscales
The sexual consequences subscale had high internal
consistency (Cronbach’s a = 0.85) and the health consequences subscale had good internal consistency as well (a =
0.90). As with the two medical procedures distress subscales, we examined correlations with conceptually related
variables to evaluate the validity of the distress subscales
(Table 4). The sexual consequences factor correlated most
highly with cancer worry (r = 0.38). Other significant but
small correlations were with preexam anxiety (r = 0.27),
depression (r = 0.23), anxiety during colposcopy (r = 0.19),
and with postexam assessments of state anxiety (r = 0.27).
As would be expected, the health consequences factor
Table 5
Mean subscale scores and standard deviations by demographic group
Discomfort
Means
Marital status
Education
Age
Ethnic group
a
Never Married (n = 71)
Married (n = 163)
Divorced or Separated (n = 69)
Widowed (n = 13)
Grades 1 – 8 (n = 23)
Grades 9 – 11 (n = 38)
Grade 12 or GED (n = 90)
College 1 – 3 years (n = 88)
College z 4 years (n = 77)
Vmedian age of 33 (n = 161)
>median age of 33 (n = 155)
White (n = 146)
Black (n = 70)
White Hispanic (n = 87)
a
2.36
2.05a
2.12
2.10
2.03
2.27
2.09
2.23
2.05
2.24d
2.02d
2.12
2.08
2.22
SD
0.75
0.68
0.80
0.76
0.53
0.76
0.80
0.74
0.69
0.75
0.71
0.73
0.71
0.78
Embarrassment
Sexual consequences
Health consequences
Means
Mean
SD
Mean
SD
0.74
0.61
0.49
0.38
0.58
0.72
0.64
0.54
0.66
0.69
0.48
0.58
0.61
0.16
2.42
2.23
2.17
2.26
2.78c
2.57c
2.18c
2.24c
2.07c
2.29
2.22
2.19
2.15
2.51
0.71
0.88
0.86
0.93
1.03
1.01
0.84
0.85
0.72
0.81
0.93
0.77
0.87
1.01
1.51
1.50
1.58
1.92
1.63
1.67
1.63
1.45
1.44
1.50
1.58
1.43
1.66
1.68
SD
0.80
0.73
0.94
1.20
0.98
0.94
0.89
0.72
0.73
0.70
0.93
0.72
0.93
0.91
b
1.75
1.48b
1.43b
1.21
1.52
1.70
1.48
1.47
1.55
1.71e
1.32e
1.48
1.52
1.61
Women who were never married reported more discomfort with the medical procedures compared to women who were married, P < 0.05.
Women who were never married were more likely to report concerns about sexual and reproductive consequences than women who were married, divorced,
or widowed, P < 0.05.
c
Women with a high school education and above were less likely to report concerns about health consequences, compared to women who did not complete
high school, P < 0.05.
d
Women aged 33 and below reported more discomfort with the medical procedures compared to women above the median age of 33 P < 0.01.
e
Women aged 33 and below were more likely to report concerns about sexual and reproductive consequences than women who were above age 33, P < 0.001.
b
E. Shinn et al. / Preventive Medicine 39 (2004) 404–412
correlated highest with cancer worry (r = 0.68) and was
highly correlated with state anxiety ratings taken before (r =
0.48) and after the exam (r = 0.43). It showed smaller but
significant correlations with anxiety during colposcopy (r =
0.30) and with depression (r = 0.38).
In Table 5, the four mean subscale scores and standard
deviations are presented by demographic group. Differences
in subscale scores were tested with ANOVA, and significant
differences were analyzed post hoc with a Tukey’s HSD
correction. Women above the median age of 33 were less
likely to report discomfort with the medical procedures
compared to younger women ( P < 0.01), and they were
also less likely to report distress about sexual and reproductive concerns ( P < 0.05). Women who had never
married were more likely to report concerns about sexual
and reproductive issues compared to married, divorced, or
widowed women (all comparisons, P < 0.05), and more
discomfort with the medical procedures compared to married women ( P < 0.05).
Discussion
The CDDQ is a 23-item questionnaire that was factoranalytically developed in three consecutive phases with 661
women referred for colposcopy after an abnormal finding on
a Pap test. The CDDQ can be used to measure the
participant’s perception of diagnostic procedures themselves, the participant’s distress concerning the consequences of testing positive on a screen for cervical dysplasia, or
both. Furthermore, as we study the psychosocial and behavioral consequences of providing women with results on
HPV testing, optical spectroscopy, and other diagnostic
procedures, the CDDQ’s distress regarding sexual consequences subscale may be a useful assessment tool since
there is no other comparable instrument to measure this
domain. The need for a validated instrument is underscored
by studies which investigated behavioral factors for nonadherence to colposcopy with a nonstandardized instrument
[12]. Furthermore, careful and objective assessment of
specific domains of distress can guide targeted intervention
to address potential sources of nonadherence to follow-up
procedures following abnormal Pap smear result.
All four subscales generated by the factor analysis
demonstrated good internal consistency. The two subscales
associated with the medical procedures items, embarrassment and discomfort/tension, demonstrated overall good
concurrent validity with conceptually related constructs.
The embarrassment subscale was expected to be correlated
with anxiety, but not pain. This was supported for pain
during colposcopy, and modestly so with anxiety (for which
there were significant but moderate correlations ranging
from 0.26 to 0.32). The relatively small correlation between
anxiety and embarrassment may be because the two concepts are related but not similar. The discomfort and tension
subscale was expected to be related to pain and anxiety
411
during colposcopy, and pre- and postexam anxiety. This was
confirmed, and this subscale was moderately correlated with
depression and cancer worry as well. We expected both of
the distress subscales related to sexual consequences and
health consequences to have high correlations with cancer
worry and general psychological distress, but lower correlations with pain and anxiety measured during the exam. In
general, these hypotheses were verified, as shown in Table 4
supporting the convergent validity of the subscales.
The 23-item CDDQ is a reliable and valid questionnaire
for measuring multiple domains of distress that are unique
to women who have tested positive for a screening for
cervical cancer. Consistent with past research, our study
demonstrated that women’s distress after receiving an abnormal Pap test result can be assessed with four specific
domains (although in our study, the domains were discomfort and embarrassment about medical procedures, and
worries about sexual and health consequences). The CDDQ
evolved according to extensive feedback provided by cognitive interviewing, which asks research participants to state
their interpretation of each item’s meaning, and any difficulties in understanding the wording of the item. Based on
the identification of additional specific concerns uncovered
in the cognitive interviews, more items were added assessing participants’ emotional reaction to medical procedures,
and with their concerns about sexual attractiveness to
partners, worries about developing cancer and its consequences. In addition, the CDDQ was developed with a
diverse sociodemographic group, with sizable representation of African-American and Hispanic ethnic groups.
Limitations
Future research is needed to distinguish the CDDQ’s
ability to distinguish between psychological distress and
other unrelated constructs in women undergoing diagnostic
testing for cervical cancer. The CDDQ’s subscales would
also benefit from further reliability testing. The design of the
current study did not allow us to assess test –retest reliability. Furthermore, the factor analysis was exploratory, and
further replications in different samples are necessary to
confirm the factor structure found in our analysis. Finally, it
would be interesting to see how the CDDQ would perform
in analyzing differences in adherence to follow-up diagnostic testing in women with abnormal Pap tests results.
Conclusion
The CDDQ is a reliable and valid questionnaire for
measuring multiple domains of distress that are unique to
women who have tested positive for a screening for cervical
cancer. There is a need for a validated measure of the
specific domains of distress that many women experience
after receiving a positive screening result for cervical cancer.
Careful and objective assessment of these separate domains
can provide useful information in the development of
412
E. Shinn et al. / Preventive Medicine 39 (2004) 404–412
targeted intervention programs to increase adherence to
follow-up procedures after abnormal Pap smear result.
The four subscales had good internal consistency (a
ranged from 0.75 to 0.86) and demonstrated good concurrent validity with other well-known psychometrically validated measures of distress. By providing a measure which
presents specific types of distress both about follow-up
procedures and about consequences related to an abnormal
Pap, the CDDQ can be used in future research to provide
further investigation into how specific domains of distress
may influence nonadherence to follow-up after abnormal
Pap smear result.
Acknowledgments
This work, which was initiated and analyzed by its
authors, was supported by NCI Grant P01-CA-82710,
Michelle Follen, MD, PhD, Principal Investigator, and
NCI Grant R25 CA57730, Robert M. Chamberlain, PhD,
Principal Investigator.
References
[1] Stewart DE, et al. The effect of educational brochures on follow-up
compliance in women with abnormal Papanicolaou smears. Obstet
Gynecol 1994;83(4):583.
[2] Massad LMP. Predicting compliance with follow-up recommendations after colposcopy among indigent urban women. Obstet Gynecol
1999;94(3):371 – 6.
[3] Michielutte R, et al. Noncompliance in screening follow-up among
family planning clinic patients with cervical dysplasia. Prev Med
1985;14:248 – 58.
[4] Peterson N, Han J, Freund K. Inadequate follow-up for abnormal pap
smears in an urban population. J Natl Med Assoc 2003;95:825 – 32.
[5] Carey P, Gjerdingen D. Follow-up of abnormal Papanicolaou smears
among women of different races. J Family Pract 1993;37:583 – 7.
[6] Khanna N, Phillips MD. Adherence to care plan in women with
abnormal Papanicolaou smears: a review of barriers and interventions.
J Am Board Fam Pract 2001;14(2):123 – 30.
[7] Yabroff KR, Kerner JF, Mandelblatt JS. Effectiveness of interventions
to improve follow-up after abnormal cervical cancer screening. Prev
Med 2000;31:429 – 39.
[8] Miller S, et al. Enhancing adherence following abnormal Pap smears
among low-income minority women: a preventive telephone counseling strategy. J Natl Cancer Inst 1997;89:703 – 8.
[9] Janerich D, et al. The screening histories of women with invasive
cervical cancer, Connecticut. Am J Public Health 1995;85:791 – 4.
[10] McKee MD, et al. Barriers to follow-up of abnormal Papanicolaou
smears in an urban community health center. Arch Fam Med
1999;8:129 – 34.
[11] Lerman C, et al. Adverse psychologic consequences of positive
cytologic cervical screening. Am J Obstet Gynecol 1991;165:
658 – 62.
[12] Brooks S, et al. Association of knowledge, anxiety, and fear with
adherence to follow up for colposcopy. J Low Genit Tract Dis 2002;
6:17 – 22.
[13] Richardson PH, et al. Evaluation of cognitive – behavioral counseling
for the distress associated with an abnormal cervical smear result. Br J
Health Psychol 1996;1:327 – 38.
[14] Palmer AG, et al. Understanding women’s responses to treatment
for cervical intra-epithelial neoplasia. Br J Clin Psychol 1993;32:
101 – 12.
[15] Beresford JM, Gervaize PA. The emotional impact of abnormal pap
smears on patients referred for colposcopy. Colposcopy Gynecol Laser Surg 1986;2(2):83 – 7.
[16] Boag FC, et al. Assessment of psychiatric morbidity in patients attending a colposcopy clinic situated in a genitourinary medicine
clinic. Genitourin Med 1991;67:481 – 4.
[17] McDonald TW, et al. Impact of cervical intraepithelial neoplasia diagnosis and treatment on self-esteem and body image. Gynecol Oncol
1989;34:345 – 9.
[18] Lauver DR, Baggot A, Kruse K. Women’s experiences in coping with
abnormal Papanicolaou results and follow-up colposcopy. J Obstet
Gynecol Neonatal Nurs 1999;28(3):283 – 90.
[19] Doherty I, et al. The assessment of the psychological effects of an
abnormal cervical smear result and subsequent medical procedures.
J Psychosom Obstet Gynaecol 1991;12:319 – 24.
[20] Bennetts A, et al. PEAPS-Q: a questionnaire to measure the psychosocial effects of having an abnormal pap smear. J Clin Epidemiol
1995;48(10):1235 – 43.
[21] Warnecke RB, et al. Measuring quality of life in culturally diverse
populations. J Natl Cancer Inst Monogr 1996;20:29 – 38.
[22] Spielberger CD, et al. State-trait anxiety inventory for adults: sampler
set manual, test, scoring key, vol. 1. Palo Alto, CA: Consulting Psychologists Press; 1983. p. 70.
[23] Miller SM, Mangan CE. Interacting effects of information and coping
style in adapting to gynecologic stress: should the doctor tell all?
J Pers Soc Psychol 1983;45(1):223 – 36.
[24] Clifton PA, Shaughnessy AF, Andrews S. Ineffectiveness of topical
benzocaine spray during colposcopy. J Fam Pract 1998;46(3):242 – 6.
[25] Rodney WM, et al. Colposcopy in family practice: pilot studies of pain
prophylaxis and patient volume. Fam Pract Res J 1992;12(1):91 – 8.
[26] Radloff LS. The CES-D scale: a self-report depression scale for
research in the general population. Appl Psychol Meas 1977;1(3):
385 – 401.
[27] Lerman C, et al. Attitudes about genetic testing for breast – ovarian
cancer susceptibility. J Clin Oncol 1994;12(4):843 – 50.