Abstract
Introduction and hypothesis
Urinary incontinence (UI) is a common disorder in women that can affect a person’s quality of life. There are several instruments to assess the severity of urinary incontinence. One of the common tools is the Protection, Amount, Frequency, Adjustment, Body image (PRAFAB) questionnaire. Therefore, this study was performed with the aim of assessing the validity and reliability of the Persian version of the PRAFAB questionnaire.
Methods
First, the English version of the questionnaire was translated into Persian. Second, the psychometric properties of the Persian version were collected in 60 women with urinary incontinence referred to Al-Zahra Hospital by an expert team. Content validity (CV) was evaluated through CV index (CVI) and CV ratio (CVR). Construct validity was evaluated using exploratory factor analysis and reproducibility was tested based on test–retest reliability using intraclass correlation coefficient (ICC). Internal consistency was calculated using Cronbach's α.
Results
The results showed acceptable CVI in relevancy, clarity, and simplicity, acceptable CVR for all items, good internal consistency (Cronbach's alpha = 0.738) and excellent repeatability (ICC = 0.98).
Conclusion
The Persian version of the PRAFAB questionnaire has acceptable validity and reliability and in future it can be used as a suitable evaluation instrument to assess urinary incontinence in Iranian women.
Keywords: Persian version, PRAFAB, Reliability, Urinary incontinence, Validity
Introduction
Urinary incontinence (UI) is one of the most common pelvic floor disorders in the world. The general prevalence of UI in the world is estimated at 25 to 45% [1, 2] and 57.7% of adults in Iran [1]. Stress urinary incontinence (SUI) is the most common type of incontinence in women. About 50% of patients with UI have SUI, 16% have urgency UI (UUI), and 34% have mixed UI (MUI) [3]. UI affects a person’s quality of life. It is constantly associated with embarrassment, distress, and anxiety, which may negatively affect social participation, intimate relationships, and self-esteem [4–6]. There is a highly variable relationship between the severity of UI leakage and the effect of perceived symptoms [3].
The objective outcome measures based on pad weights and bladder volume are used to determine the severity of UI. However, today it is believed that these methods are time-consuming and not cost-beneficial for daily clinical use. So, subjective assessments using questionnaires are more common and applicable [7]. There are several questionnaires to assess the severity of UI, such as the International Consultation on Incontinence Questionnaire (ICIQ), the Incontinence Severity Index (ISI), the incontinence quality of life questionnaire (IQOL), the Protection, Amount, Frequency, Adjustment, Body image (PRAFAB), and the Patient Perception of Bladder Condition (PPCB).
Some of these questionnaires have been validated in different languages. The ICIQ and I-QOL have been validated in Persian [7–12]. The PRAFAB questionnaire is one of the QOL questionnaires used for determining the severity and impact of UI and is used by physiotherapists, researchers, general practitioners, urologists, and gynecologists [3, 13]. The PRAFAB questionnaire can determine the objective aspect of the severity of UI and the subjective aspect of its impact, just as the ICIQ questionnaire is quick and easy to implement. It also has added value, including the subjective aspect of the UI [3].
Hendriks et al. conducted a study on 87 women with UI and showed that the PRAFAB questionnaire scores had acceptable test–retest reliability, internal consistency, construct validity, and longitudinal validity [3]. In another study, Hendriks et al. investigated the cross-validity of PRAFAB in 279 patients with UI, and confirmed the internal consistency and construct validity of PRAFAB [13].
The original PRAFAB questionnaire contains five items: Protection (PR), Amount of urine loss (A), Frequency of UI (F), Adjustment of behavior owing to symptoms (A), and Body (self) image (B) [3]. Each item has a Likert score of 1 to 4 and the total score of the questionnaire will be between 5 and 20. This questionnaire discriminates between less or more than 2 g/h of urine loss on a pad-test, with a total score above 14 points [13]. The positive predictive value of “severe” urine loss was 83% and the negative predictive value was 61% [3, 13].
Up to now, the original English version of PRAFAB has been translated and adopted in Arabic and Dutch [13–15]. Psychometric properties and factorial validity and internal consistency of PRAFAB in Dutch were confirmed [3, 13]. Because PRAFAB is a brief questionnaire and assesses five different aspects of the severity of UI, with potential to support clinical decision-making and individual evaluation outcomes, most of the therapists prefer to use PRAFAB. This questionnaire has not been translated into Persian. The purpose of this study is to assess the structural validity and reliability of the Persian version of the PRAFAB questionnaire.
Materials and Methods
A cross-sectional validation study was done to determine the structural validity and reliability of the Persian version of the PRAFAB questionnaire.
There were two phases. During the first phase, the translation process, the permission to translate PRAFAB into Persian was obtained from the developers. Forward Persian translation was done by two translators (a pelvic physiotherapist and a professional translator). The discrepancy between the two versions was solved through joint meetings and dialogs.
Another expert translator who is fluent in English translated the final Persian version into English. Expert panel consensus resolved discrepancies. Minor changes were made in the translated version. This group consisted of two urologists, three pelvic physiotherapists, two gynecologists, two English translators, and an epidemiologist.
The second phase concerned validity and reliability. The Persian version was studied for content validity, construct validity, internal consistency, and test–retest reliability.
Participants
The study was conducted in Al-Zahra hospital, Tabriz, Iran, from June to December 2021. Sixty women with UI participated in this study. All participating women filled out the final Persian version of the PRAFAB questionnaire, after the items were explained to them. They were asked to answer independently. For illiterate participants, an assistant filled out the questionnaire.
Inclusion criteria
Women with involuntary leakage of urine, aged over 18, were included.
Exclusion criteria
The patients with pregnancy, early postpartum, bladder cancer, diabetic nephropathy, previous central nervous system damage, congenital urological disorders, urinary tract infection, neurogenic bladder, severe cognitive impairment, and severe psychiatric illness were excluded [9–12]. The Ethics Committee of Tabriz University of Medical Sciences approved this validation study (code: IR.TBZMED.REC.1399.921).
Procedure
The PRAFAB questionnaire includes five items graded on a Likert score from 1 to 4. The English and the Persian versions of the PRAFAB questionnaire are shown in Figs. 1 and 2.
Fig. 1.
The Protection, Amount, Frequency, Adjustment, Body image (PRAFAB) questionnaire score
Fig. 2.
The Persian version of Protection, Amount, Frequency, Adjustment, Body image questionnaire
Content validity
The simplicity, comprehensibility, and accuracy of each item of the Persian version of PRAFAB was qualified by ten experts including urologists, gynecologists, and pelvic physiotherapists. The content validity was studied according to the content validity index (CVI) and the content validity ratio (CVR). The CVR was obtained by a three-point Likert scale including 1 (not necessary), 2 (useful but not necessary), and 3 (necessary). The CVI was determined by a four-point Likert scale for the simplicity, specificity, and clarity of each item.
Construct validity
Exploratory factor analysis (EFA) was conducted to measure the construct validity of the Persian version of PRAFAB. Based on the recommended sample size, there should be five to ten participants per measurement item [16]. According to the PRAFAB items, a minimum size of 25 to 50 subjects was required. Sixty women with UI symptoms were included to survey the EFA of the PRAFAB.
Reliability
Internal consistency shows the complementary nature of items and is calculated using Cronbach’s alpha. To determine the PRAFAB’s internal consistency, a correlation between the questionnaire’s items was investigated (item to total).
A test–retest method was used to evaluate external reproducibility. Intra-class correlation coefficient (ICC) was used to analyze the data. The test–retest examination was performed on 20 women with UI. The interval between the two tests was 2 weeks. Participants did not change their lifestyles or receive any treatment during the test–retest period. All patients were visited after 2 weeks and received their treatment.
Statistical analysis
Descriptive statistics were used to calculate the central indicators and dispersion of demographic characteristics. The content validity of the Persian versions of PRAFAB was obtained by calculating the CVR and the CVI. Because of the number of experts participating in this study (n=10), CVR >0.591 and CVI values >0.79 were acceptable. Maximum likelihood with Promax rotation was used to examine the nature of the interrelationship of the PRAFAB measurements and the group-correlated measurements. Bartlett’s test of sphericity and the Kaiser–Meyer–Olkin (KMO) test were used to assess the appropriateness of the factor analysis model and the sampling adequacy respectively. Statistical analyses to test the reliability and the internal consistency of the questionnaire were assessed by Cronbach’s alpha coefficient (item to total). An instrument will have good reliability and be considered satisfactory when the alpha is equal to or greater than 0.70. Reproducibility was examined by the test–retest method, which suggested a time interval between two tests of 2 weeks to 1 month [3]. The ICCs were interpreted according to the Landis and Koch criteria (0–0.2 as poor, 0.21–0.4 as fair, 0.41–0.7 as moderate, 0.71–0.80 as substantial, and 0.81–1 as almost perfect) [16]. Alpha coefficients >0.7 were satisfactory for all domains.
Results
Content validity
An expert panel (n=10) was formed to confirm the content validity of PRAFAB. The CVI and CVR results are shown in Table 1.
Table 1.
The content validity index (CVI) and content validity ratio (CVR) of the Persian version of the Protection, Amount, Frequency, Adjustment, Body image questionnaire (n=10)
| Questions (items) | CVR (necessity) | CVI (relative) | CVI (clarity) | CVI (simplicity) | |
|---|---|---|---|---|---|
| Protection | Never | 0.81 | 1 | 1 | 1 |
| Sometimes | 1 | 1 | 1 | 1 | |
| Normally | 1 | 1 | 1 | 1 | |
| Always | 0.81 | 1 | 1 | 1 | |
| Amount | Just a drop or less | 0.81 | 0.95 | 1 | 1 |
| Sometimes a trickle | 0.63 | 1 | 0.9 | 0.95 | |
| Wets noticeably | 1 | 0.95 | 1 | 1 | |
| Soaked or leaks | 1 | 1 | 1 | 1 | |
| Frequency | Once a week or less | 0.81 | 0.95 | 1 | 1 |
| More than once a week but less than three times a week | 1 | 0.95 | 1 | 1 | |
| More than three times a week, but not every day | 1 | 1 | 1 | 1 | |
| Every day | 1 | 1 | 1 | 1 | |
| Adjustment | Not hampered in daily activities | 0.63 | 1 | 1 | 0.95 |
| Stopped some physical activities | 0.81 | 1 | 1 | 1 | |
| Stopped most physical activities | 0.63 | 1 | 1 | 1 | |
| Almost never go out | 0.63 | 1 | 1 | 1 | |
| Body image | Bot bothered | 0.63 | 1 | 1 | 1 |
| Annoying and troublesome, but not greatly bothered | 0.63 | 1 | 1 | 1 | |
| Feel dirty | 0.63 | 1 | 1 | 1 | |
| Disgusted by myself | 0.63 | 1 | 0.95 | 1 | |
Construct validity
In this study, 60 samples with chief complaints of UI (mean age=54.78 ± 9.27 years) participated, and completed the Persian version of the PRAFAB questionnaire. The maximum likelihood of Promax rotation showed that the measurement items loaded to one component (variance=53%). The study sample was adequate based on the Kaiser–Meyer–Olkin test and Bartlett’s test of sphericity (0.69). The correlation matrix was suitable for factor analysis (Chi-squared=14.965 and p=0.011; Table 2).
Table 2.
The factor loading of the Protection, Amount, Frequency, Adjustment, Body image questionnaire in the maximum likelihood factoring and rotated using Promax (N = 60)
| Items | Component 1 |
|---|---|
| Protection | 0.966 |
| Amount | 0.76 |
| Frequency | 0.548 |
| Adjustment | 0.4 |
| Body image | 0.34 |
Reliability
The result of internal consistency (alpha coefficients) for questionnaire items was 0.738 (N=60).
Test–retest reliability
Test–retest reliability (n=20) of PRAFAB showed excellent reliability. The total ICC was 0.98 with a 95% CI of 0.94 to 0.99 (Table 3).
Table 3.
The results of test–retest analysis for the Protection, Amount, Frequency, Adjustment, Body image questionnaire (n=20)
| Item | ICC | CI |
|---|---|---|
| Protection | 0.95 | 0.87–0.98 |
| Amount | 0.97 | 0.94–0.99 |
| Frequency | 1 | 1 |
| Adjustment | 0.92 | 0.8–0.96 |
| Body (or self) image | 0.87 | 0.67–0.94 |
| Total | 0.98 | 0.94–0.99 |
ICC intraclass coefficient, CI confidence interval
Discussion
Urinary incontinence is one of the most common problems for women that has negative effects on their quality of life. The availability of short and simple questionnaires that reduce the scoring burden on clinicians, is likely to increase the implementation of these questionnaire in clinical practice.
In evaluating the performance of questionnaires and comparing their settings, high internal and external responsiveness can be seen for the I-QOL, the PRAFAB, and the ICIQ questionnaires. Therefore, these questionnaires, especially the PRAFAB questionnaire, are suitable for studies evaluating the effects of a conservative treatment for UI in women. Strong evidence of high methodological quality is recommended in support of the use of the PRAFAB questionnaire [17].
Several quality-of-life questionnaires are available in the Persian language (for example, the ICIQ and the I-QOL) for UI. Considering the brevity and comprehensiveness of the PRAFAB questionnaire, the Persian version of this questionnaire may be more useful for Iranian women with UI. Through a few short questions, the PRAFAB questionnaire assesses several UI-related variables, from the amount of protection used to body image perception, which may provide clinicians with a quick overview of the condition.
This study was aimed at measuring the different aspects of validity and reliability of the Persian version of the PRAFAB questionnaire and if this version is acceptable, we will be able to use this Persian version for Persian-speaking women.
Our results were consistent with the previous reports showing that internal consistency, test–retest reliability, and validity of the PRAFAB were satisfactory [3, 13]. The findings showed acceptable content validity for the Persian version. The content validity of the translated questionnaire was more than 0.63 and CVI >0.95 respectively. Therefore, the validity of the Persian version of PRAFAB seems acceptable in that the items were clear enough to be understood by Persian-speaking participants. The CV of PRAFAB using the maximum likelihood with Promax rotation showed that the measurement items loaded to one component variance were 53%.
The Persian version of PRAFAB showed good internal consistency (item to total) for the translated questionnaire score (0.738). This is in line with the results of other studies [3, 13]. In a study on 279 women with UI it was found that the internal consistency of PRAFAB in the whole population was good (Cronbach’s α>0.70). In this study, participants were divided into two groups and Cronbach's α was 0.92 for domain A and 0.86 for domain B [3].
Test–retest reliability analysis shows excellent reproducibility (ICC: 0.98) for the Persian version of the PRAFAB. Also, the Dutch version of PRAFAB showed excellent test–retest reliability (ICC: 0.86) [3]. KMO index and Bartlett test were also significant at 0.69, which indicates that the sample size is sufficient in this study.
The present study showed that the Persian version of the PRAFAB questionnaire could be used as a valid and reliable tool to assess the severity of leakage, the effect of perceived symptoms, and QOL in Iranian women with UI.
However, documenting the impact of UI on a patient's quality of life is important to evaluate the effectiveness of interventions and treatment options, especially because these interventions and treatment options often fail to completely cure UI [18].
Based on the studies, clinical changes in patients can be related to changes in the scores of this report. Hendriks et al.'s study indicated that the differences between SUI and UUI groups can be largely explained by the smaller amount of change on the PRAFAB questionnaire items, specifically “protection,” “frequency,” and “adjustment” in the UUI group [13].
As the degree of generalization of our findings to patients who refer to different nonconservative interventions is not known and our samples may not be representative of the entire population of different types of UI, in the next studies, it could be suggested that the Persian version of the PRAFAB questionnaire might be used on a larger number of samples and in different types of UI (SUI, UUI, and MUI) to determine the amount of changes in the overall score and the score of each item of this questionnaire in each type of UI.
This study was conducted during the COVID-19 pandemic; thus, there was no access to a larger number of patients and it was carried out with a statistically acceptable sample size. It is suggested that in the future, a study with a larger number of samples considering a correlation between the Persian version of the PRAFAB questionnaire and another valid Persian questionnaire such as the ICIQ SF might be performed.
Conclusion
As the PRAFAB questionnaire is short and easy to implement, and the reliability and validity of the Persian version of the PRAFAB questionnaire are acceptable, in the future it can be used as a suitable tool to assess UI in Iranian women. The availability of PRAFAB in a variety of languages would make it feasible and easy to compare the results with other research.
Acknowledgements
The authors are grateful to Dr. Erik Hendriks et al. for their original work and the permission to use their data. We also thank the participants and staff of Al-Zahra Hospital for their kindly cooperation.
Authors’ contributions
Fariba Ghaderi: protocol development, writing manuscript, editing; Naser Havaei: data analysis; Mahdieh Hamedfar: data collection; Bary Berghmans: writing manuscript, editing; Zahra Chakeri: protocol development, writing manuscript, editing.
Funding
This study was funded by the Vice Chancellor for Research of Tabriz University of Medical Sciences.
Data Availability
Data available on request from the correspond auther. The data are not publicly available due to privacy or ethical restriction.
Declarations
Conflicts of interest
None.
Footnotes
Publisher's note
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Contributor Information
Fariba Ghaderi, Email: ghaderimailbox@gmail.com.
Naser Havaei, Email: naser_havaei@yahoo.com.
Mahdieh Hamedfar, Email: mahdieh.hamedfar.pt@gmail.com.
Bary Berghmans, Email: bary.berghmans@maastrichtuniversity.nl.
Zahra Chakeri, Email: z.chakeri@gmail.com.
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Associated Data
This section collects any data citations, data availability statements, or supplementary materials included in this article.
Data Availability Statement
Data available on request from the correspond auther. The data are not publicly available due to privacy or ethical restriction.