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European Journal of Obstetrics & Gynecology and Reproductive Biology 193 (2015) 8891

Contents lists available at ScienceDirect

European Journal of Obstetrics & Gynecology and


Reproductive Biology
journal homepage: www.elsevier.com/locate/ejogrb

Response validity of Persian version of P-QOL questionnaire in patients


with prolapse
Negar Morovatdar a,1, Ladan Hghighi b,2, Zahra Najmi b,3, Atiyeh Hashemi c,4,
Marzieh Nojomi d,*
a
Health System Research Committee, Treatment Affairs of Vice Chancellery, Mashhad University of Medical Sciences, Mashhad, Iran
b
Department of Obstetrics and Gynecology, Akabr-Abadi Hospital, Iran University of Medical Sciences, Tehran, Iran
c
Department of Community Medicine, Iran University of Medical Sciences, Tehran, Iran
d
Department of Community Medicine, School of Medicine, Iran University of Medical Sciences, Tehran, Iran

A R T I C L E I N F O A B S T R A C T

Article history: Background and objective: Pelvic organ prolapse (POP) refers to drop of any pelvic organs into or outside of
Received 13 April 2015 the vaginal canal or anus. This is a disabling condition that results in limitations in all aspects of womens
Received in revised form 27 May 2015 lives, especially quality of life. The evaluation of quality of life in women with POP requires the use of a
Accepted 23 July 2015
valid and reliable measure. An important aspect of validity is responsiveness. The aim of current study is
to evaluate the responsiveness of P-QOL questionnaire in patients with prolapse.
Keywords: Methods: Women with conrmed diagnosed POP by gynecologist who were scheduled to undergo POPs
Prolapse
treatment enrolled in the study. Quality of life as an outcome measure was evaluated before and six
P-QOL
Quality of life
month after treatment besides assessing of physical index of treatments effect (pelvic organ prolapse
Responsiveness quantication; POP-Q). Responsiveness was evaluated using calculation of standardized response mean
(SRM) and effect size (ES).
Results: Fifty women were evaluated in current study. Mean age was 43.5  11.8 years old. The range of
Cronbachs alpha was between 0.60 and 0.89 for all domains of P-QOL. The range of SRM for all domains was
between 0.60 and 0.88. The range of ES was between 0.54 and 0.96. Score of all domains of P-QOL was
statistically different between pre and post-treatment (P < 0.0001).
Conclusion: The ndings of current study showed the P-QOL questionnaire has a good responsiveness in
Persian language and could use to assess the impact of interventions on quality of life in patients with
prolapse.
2015 Elsevier Ireland Ltd. All rights reserved.

Introduction anterior vaginal wall, posterior vaginal wall, cervix, or vaginal apex
drops into or out of the vagina. Prevalence of POP has been reported
Pelvic organ prolapse (POP) is a common, distressing and between 5 and 10 percent [2].
disabling condition that results in limitations in social, physical, The evaluation of quality of life in women with POP requires
mental, and occupational aspects of a womens lives [1]. In POP the using a valid and reliable questionnaire as a part of any assessment,
management and follow-up of treatment. A measure that uses
commonly to assess the quality of life of women with prolapse is
prolapse quality of life (P-QOL) questionnaire. This questionnaire
* Corresponding author at: Department of Community Medicine, School of has been validated in English speaking patients [1] and also in
Medicine, Mental Health Research Center, Iran University of Medical Sciences,
several other languages including Dutch [3], Thai [4], Slovakian [5],
Crossroads of Hemmat and Chamran Expressways, 15875-6171 Tehran, Iran.
Tel.: +98 21 88602225/09121095773; fax: +98 21 88602217. Portuguese [6], German [7], Japanese [8], Turkish [9], Italian [10],
E-mail addresses: negarmorovat@gmail.com (N. Morovatdar), and recently in Farsi speaking patients in Iran [11]. Majority of
haghighi.l@iums.ac.ir (L. Hghighi), zahranaj@yahoo.com (Z. Najmi), these studies have not assessed the responsiveness of the P-QOL.
Ati_hashemi@yahoo.com (A. Hashemi), mnojomi@iums.ac.ir (M. Nojomi). The Dutch study [3] and a study conducted on Brazilian patients
1
Tel.: +98 09122027604.
2
Tel.: +98 09121388780.
[12] were assessed the responsiveness of P-QOL beside other
3
Tel.: +98 09122415398. aspects of validity. Both two mentioned studies have concluded
4
Tel.: +98 09122214528. that the questionnaire has an acceptable responsiveness.

http://dx.doi.org/10.1016/j.ejogrb.2015.07.013
0301-2115/ 2015 Elsevier Ireland Ltd. All rights reserved.
N. Morovatdar et al. / European Journal of Obstetrics & Gynecology and Reproductive Biology 193 (2015) 8891 89

A common method to assess responsiveness is, anchored-based subgroups according to changes in POP-Q score. A change between
approach. This method compares the changes in health related 0.33 and 0.66, and more than 0.66 were considered as moderate,
quality of life (HRQoL) comparing to other clinically meaningfully and large improvement respectively. A change less than 0.33 was
markers or anchors. considered as no improve. At stage 3, we assessed responsiveness
The aim of current study is to determine the responsiveness of to change using a statistical indicator, the standardized response
P-QOL in patients with prolapse who have taken a treatment for mean (SRM) and effect size (ES). The SRM calculated by the change
prolapse using a prospective study. in score divided by the standard deviation of the change. The ES
calculated by the mean change in scores divided by the standard
Materials and methods deviation of the baseline. The SRM and ES were calculated for all
subgroups of patients based on P-QOL Score. For both statistics, a
Subjects and patient recruitment value of 0.20.49 was considered as small, between 0.5 and 0.79
was interpreted as moderate, and more or equal 0.80 was
Participants were enrolled form a teaching hospital of Iran considered as large [14]. We compared changes of domains of
University of Medical Sciences (Akbar-Abadi Hospital, Tehran, P-QOL and POP-Q scales across before and post treatment using
Iran) in a prospective time series study before and after treatment Wilcoxon signed rank test. Cronbachs alpha was calculated to
for POP. The study carried out between March 2012 and March conrm reliability of questionnaire in current study. Statistical
2013. All women had a conrmed diagnosis of POP by a level was set at 0.05.
gynecologist. All patients in the study were scheduled to undergo
POPs treatment. Women were excluded if they were mentally or Results
physically incapable of completing the P-QOL and if they had
comorbidity or any concomitant severe diseases. Pregnant Fifty patients completed their data in this time series study.
women were not included too. There was no age restriction. Mean age and mean weight were 43.5  11.8 and 72  11 years old
Women were included in the study before beginning the respectively. Other demographic and medical characteristics of
treatment. We received a written informed consent from all patients are summarized in Table 1.
patients before recruitment. Treatment included cystocele and/or For all domains, Cronbachs alpha was more than 0.70 but for
rectocele repair. severity measures. The range of Cronbachs alpha was between
Follow-up appointment took place at six months after 0.60 and 0.89 for severity measures and social limitation
treatment. For the aim of assessing the responsiveness of P-QOL, respectively.
patients who had had their six months follow-up were eligible. For evaluation of responsiveness of P-QOL questionnaire, in rst
An examination using pelvic organ prolapse quantication step we compared partial frequency of stage of POP-Q examination
(POP-Q) was performed for each woman at the time of enrollment. in pre and post-treatment phases. Table 1 shows, in pre-treatment
Also, P-QOL was offered to each woman to assess HRQoL. Both phase, 88% of women had stages of two and three. In post
measures was repeated six months after treatment to determine treatment phase, 6% of women had stage two and there was not
any changes in clinical signs and quality of life. We used anchored- any woman with stage three and more. Eight (16%) and 42 (84%)
based approach, and POP-Q was considered as an anchor or women had moderately and largely changes after treatment
marker. The P-QOL was lled up by an educated staff in hospital. All respectively. There was not any woman with less than 33% change
patients were examined by a gynecologist to determine POP-Q in POP-Q scale.
score. Of 59 eligible patients, 9 patients failed to complete both Table 2 illustrates SRM and ES for all domains of P-QOL. The
questionnaires at both measurements (85% responsiveness). A range of SRM for all domains was between 0.60 and 0.88. It shows
total of 50 patients were included in the rst and last analyses. moderately responsiveness for all domains but prolapse impact
The current study received the ethical approval of institutional and personal relationships. For these two domains, SRM was 0.88
review board of Iran University of Medical Sciences. and 0.81 respectively (large responsiveness). For ES, the range was
between 0.54 and 0.96. Also, shows moderately responsiveness.
P-QOL instruments Scores of all domains was changed after treatment statistically
signicant (P < 0.0001) (Table 2).
The P-QOL is a disease specic instrument to measure the
HRQoL in women with prolapse. It has 20 items representing nine
quality of life domains including general health, prolapse impact, Table 1
role, physical and social limitations, personal relationships, Demographic and clinical characteristics of the patients (n = 50).
emotional problems, sleep/energy disturbances, and severity Pre-treatment Post-treatment
measures. The responses in the P-QOL questionnaire ranged from
Age (years)
none/not at all to slightly/a little to moderately to a lot. A
Less than 35 13 (26)
four point scoring system for each item and a total score for each 3649 24 (48)
domain with score ranging between 0 and 100 were used for +50 13 (26)
severity measurement of prolapse symptoms. A higher score Parity
indicated a greater deterioration of quality of life [1]. Less than 2 14 (28)
34 25 (50)
+5 11 (22)
Statistical analyses History of pelvic surgery
Positive 42 (84)
Data analysis was performed by SPSS version of 18.0 (SPSS Inc., Negative 8 (16)
POP-Q ndings P value = 0.0001*
Chicago, IL, USA). We used three steps recommended by Revicki
Stage 0 0 (0) 20 (40)
et al. [13] to assess the responsiveness of the P-QOL. First (step 1), Stage 1 2 (4) 27 (54)
we selected a criterion to identify clinical change of prolapse in Stage 2 16 (32) 3 (6)
patients over time. This criterion was POP-Q that could be Stage 3 28 (56) 0
considered as an anchor to show objective changes in prolapse Stage 4 4 (8) 0

stages over time. Second (step 2), patients were classied into *
Using Wilcoxon signed rank test.
90 N. Morovatdar et al. / European Journal of Obstetrics & Gynecology and Reproductive Biology 193 (2015) 8891

Table 2
Responsiveness to treatment: Mean change in prolapse quality of life domain scores after treatment, effect size (ES) and standardized response mean (SRM).

Prolapse quality of life domain Pre-treatment Post-treatment Mean change ES SRM P value*
mean (SD) score mean (SD) score in score (SD)

General health perceptions 44 (24) 28 (21) 16 (22) 0.66 0.72 0.0001


Prolapse impact 69 (31) 39 (31) 30 (34) 0.96 0.88 0.0001
Role limitations 41 (34) 19 (27) 22 (29) 0.64 0.75 0.0001
Physical limitations 37 (33) 15 (24) 22 (28) 0.66 0.78 0.0001
Social limitations 23 (26) 7 (14) 16 (25) 0.61 0.64 0.0001
Personal relationships 48 (40) 18 (28) 30 (37) 0.75 0.81 0.0001
Emotions 51 (33) 28 (34) 23 (40) 0.69 0.57 0.0001
Sleep/energy 35 (35) 16 (28) 19 (32) 0.54 0.6 0.0001
Severity measures 30 (23) 10 (16) 20 (28) 0.86 0.71 0.0001
*
Wilcoxon signed rank test.

Comments responsiveness too [6,12]. They concluded a very good validity of


this instrument to assess quality of life. Also, Dutch version of this
It has been shown a symptomatic POP could cause substantial measure has a good to excellent responsiveness [3]. They assessed
discomfort, decrease quality of life and reduce activities of daily responsiveness of P-QOL instruments by comparing pre and
living in women [2]. The severity of symptoms in patients with POP postoperative intervention in 45 patients. Finally, they concluded
and its impact on their quality of life is an important issue in P-QOL is valid, reliable, and responsive to evaluate quality of life
assessing efciency of various treatments for this problem. symptoms in patients with urogenital prolapse.
Therefore, it is important to develop a valid and reliable instrument It is important to detect how changes in the P-QOL scores over
to evaluate quality of life as an important patient oriented time reect true underlying change in women with prolapse.
outcome. One aspect of validity of any instruments is its Clinicians like to know if the difference in P-QOL scores over time
responsiveness. Assessing responsiveness is known as a nal step could signify a clinically important change. This information is
in validating a measure. The responsiveness of an instrument has important in guiding clinical decisions making for patients. When a
an important effect on the conclusion of clinical trials. Respon- true change occurs in a clinical trial a responsive measure could
siveness is an important psychometric measure that is often show it.
neglected in the literature [3]. Responsiveness could consider as an It has been recommended that a questionnaire to evaluate
aspect of construct validity. quality of life in women with POP should be routinely applied in
It has been shown using poor responsiveness measure will the clinical practice to better detect those women who need
increase the risk of type two errors and underestimate the effect of treatment. Also, it is stated to assess the surgical outcomes through
treatment [15]. a comparison of pre- and post-treatment scores of quality of life
The current study was aimed to evaluate the responsiveness of questionnaire [10].
Persian version of P-QOL questionnaire. The other aspects of Therefore determination of the degree of prolapse before and
validity and reliability of this version was shown before [11]. This after the treatment alone is insufcient for the evaluation of the
measure in Persian version had a good reliability with a outcome [1719]. The current study conrmed these recommen-
Chronbachs alpha between 0.78 and 0.97 for all domains. Also dations and showed the P-QOL is sensitive to physical changes. The
it had a ne and acceptable discriminant validity to assess quality P-QOL is a specic measure for assessing quality of life of women
of life of women with POP [11]. with prolapse. Change in quality of life over time and after
Reliability of this version in current study was conrmed again treatment is easier to detect using disease specic measure than
(as in previous study;[11]). All just one domains (severity measure) generic questionnaire. We found this disease specic measure is
had Cronbachs alpha more than 0.70. Although, the severity closely related to changes in clinical status of patients.
measure had a reliability of 0.6, is considered acceptable. This The strength of current study was to determine responsiveness
nding was shown for other versions languages of this instrument of P-QOL that is very useful to help physician to evaluate quality of
too [3,12]. It means this version was reliable and has a good life as a patient oriented outcome in Iranian trials on urogenital
consistency to assess quality of life of patients with prolapse. prolapse. The Persian version of P-QOL as a device to measure the
Recently, the Polish version of P-QOL is created too. The effect of treatment of prolapse could ideally detect any clinically
authors illustrated this version is also a valid, reliable, and easily signicant change in current study.
comprehensive measure to assess quality of life in women with There was not any woman with minimal change in POP-Q scale
POP [16]. after intervention in our study. Therefore, we could not detect
In this study we found that P-QOL measure was responsive to responsiveness of P-QOL with mall physical change. It could be
clinical change as an anchor. We showed POP-Q stage of majority consider the main limitation of current study and may be it was
of women had a dramatic change after intervention. Eighty four due to small sample size. Having enough sample size provide a
percent of women had a large change after treatment in POP-Q wide range of clinical stages of prolapse to detect any small change
scale. It means that intervention had a good effect on this outcome. too.
If we consider, POP-Q scale as a disease oriented outcome, In conclusion, we showed the Persian version of P-QOL
therefore, intervention had a remarkable effect on this variable. questionnaire has a good responsiveness to assess changing
Also, we illustrated a dramatic and signicant change in all quality of life after treatment. Therefore, we recommended using
domains of P-QOL after treatment. We showed a SRM and ES more this instrument as an outcome measure after any intervention in
than 0.50 for all domains of P-QOL too. It means, the Persian patients with urogenital prolapse.
version of this instrument has an acceptable and moderate to
excellent responsiveness to assess the effect of interventions. This Conict of interest
nding conrmed in other version of this questionnaire. The
Brazilian and Portuguese versions of the P-QOL showed a great There was no conict of interest for all authors.
N. Morovatdar et al. / European Journal of Obstetrics & Gynecology and Reproductive Biology 193 (2015) 8891 91

[9] Cam C, Sakalli M, Ay P, Aran T, Cam M, Karateke A. Validation of the prolapse


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