Pelvic floor dysfunction (PFD) in women consists of urinary incontinence (UI), fecal incontinence (FI) and pelvic organ prolapse (POP). Clinically, PFD presents as a group of disease symptoms, the severity of which and the impact on quality of life (QoL) are closely, but not exclusively, related to anatomical changes. Questionnaires have become an important tool to evaluate PFD symptoms and quality of life in PFD diagnosis and treatment studies.
I. The value of questionnaires in female PFD studies
The clinical symptoms of PFD vary, and the quantitative staging of POP cannot explain all the symptoms and the degree of impact on the patient’s QoL, and the perception of symptoms by patients and physicians is often subjective, so it is difficult to define and quantify them by anatomical or other objective indicators. In addition, although PFD rarely causes serious morbidity and mortality, it can significantly affect the patient’s QoL, so treatment of PFD should focus first on symptom relief and QoL improvement, and second on anatomical recovery.QoL measurement allows clinicians to more accurately determine whether treatment is truly beneficial to the patient. Therefore, the assessment of QoL is an essential component and indicator in the overall evaluation of PFD. However, the reality is that the impact of PFD on QoL is also influenced by a variety of factors such as patient status, age, emotional intelligence, occupation, hygiene practices, and culture, which requires questionnaire tools that reflect the condition to assess the patient. Current studies have shown that objective indicators commonly used in clinical practice, such as urine pad tests, urodynamic tests, and POP staging, do not correlate exactly with patients’ QoL, i.e., the same symptoms may affect different patients to different degrees, and vice versa. Thus, as early as 1995, organizations such as the UK Medical Research Council and European Cancer Research and Treatment have recognized the importance of QoL assessment in health research and mandated its inclusion as a component of clinical trial indicators.
Most current experts believe that questionnaires provide the most valid evaluation of clinical symptoms as well as QoL in patients with PFD. This is mainly due to the fact that such questionnaires are mostly designed by experts in the field, with well-targeted and structured questions; secondly, they are easy to understand and implement; and they are subjected to rigorous psychological tests with reliable results. The so-called psychological tests are the science used to measure reactions to human phenomena that are not easily quantifiable. Valid questionnaires for practical application need to have three important psychometric properties: (1) validity, i.e., the ability to detect the problem to be measured; (2) reliability, i.e., the repeatability of the measurement; and (3) sensitivity, i.e., the ability to detect the overall effect of the treatment as well as clinically meaningful changes. Otherwise, it is an invalid questionnaire, and the resulting survey data may provide incorrect information.
II. Current status of questionnaires in female PFD research
Currently, most international studies of high-quality PFD diagnosis and treatment apply questionnaires, thus enabling a uniform standard for comparative evaluation between different studies. In order to further standardize the use of questionnaires, the International Continence Advisory Committee (ICS) developed recommended ratings for UI questionnaire criteria in 2001 and revised them in 2004 due to the increasing number of questionnaires for UI and PFD. There are now two recommended classifications, A for highly recommended questionnaires and B for recommended questionnaires, with the new A for highly recommended questionnaires and C for questionnaires lacking good psychological testing. Therefore, they are mostly B and C level questionnaires. A recent study of randomized trials of incontinence treatment in the United States from 2001 to 2004 showed that about 50% of the 130 trials assessing UI used A-level questionnaires, only 2 of the 9 trials assessing FI used B-level questionnaires, and the rest were C-level questionnaires, while in the 11 studies assessing PFD, although 6 trials used questionnaires to assess prolapse patients’ symptoms and QoL, none of the questionnaires were recommended for use. The variety of questionnaires currently available on UI is large and largely adequate for the study. However, more specific questionnaires need to be designed for certain special populations, such as children or those with spinal cord or nerve damage. For FI and PFD, the corresponding assessment questionnaires are far inferior to those for UI in terms of number and grade, and no A-level questionnaires are available yet.
The domestic research on female PFD started late, but has developed rapidly in recent years. In China, Song Yanfeng et al. mainly used the Bristol female lower urinary tract symptom questionnaire (BFLUTS) and the incontinence quality of life questionnaire (I-QoL) in their study of UI. questionnaire (I-QoL), and other foreign recommended A-level questionnaires. This has greatly facilitated the development of domestic PFD studies and the exchange with international ones.
Commonly used questionnaires for female PFD studies
The questionnaires currently used in clinical research on PFD in women can be broadly classified into three categories according to their design purposes: PFD symptoms, quality of life and sexual function questionnaires. In addition to these, there is also an overall index to assess the overall health status of the patient.
(i) Female PFD symptom questionnaire
Symptom questionnaires for women with PFD are divided into UI, FI and pelvic floor disorder symptom questionnaires. The currently used UI symptom questionnaires mainly include the incontinence severity index (ISI, level A), the international consultation on incontinent questionnaire (ICIQ, level A), and the genitourinary incontinence questionnaire (level A). (ICIQ, Level A), the urogenital distress inventory (UDI, Level A) and its short form (UDI-SF, Level A), the Bristol Female Lower Urinary Tract Symptoms Questionnaire (BFLUTS, Level A), and the King’s health questionnaire (KHQ, Level A), etc. Current UI symptom questionnaires are mostly gender or population specific, e.g., for those with SUI or UI only, whereas the ICIQ is applicable to different ages, genders, and causes of UI, and it can assess both UI symptoms and their impact on QoL, thus serving as a standard epidemiological tool as well as a baseline measure for clinical studies. The validity of other language versions of this questionnaire has also been confirmed. the BFLUTS questionnaire, unlike other questionnaires, covers a comprehensive range of symptoms and can evaluate both the effectiveness of treatment on the improvement of lower urinary tract symptoms and the impact of these symptoms on sexual function and QoL, and is one of the classic UI symptom questionnaires commonly used in China and abroad.
Symptom questionnaires for evaluating FI are still immature and mainly include Wexner scale (C scale), fecal Incontinenc severity index (FISI) and Clevelend clinic fecal incontinence score. Although widely used, the Wexner scale has not been subjected to rigorous psychological performance testing and is a level C questionnaire. The symptom questionnaire for full pelvic floor disorders includes two kinds of pelvic floor distress inventory (PFDI, level B) and its short form (pelvic floor distress inventory short form, PFDI-SF, level B). PFDI is based on UDI with the addition of The PFDI is based on the UDI with the addition of the POP and colon and rectal function components, and is used to assess symptomatic distress in total pelvic floor disorders, but the length of the questionnaire limits its clinical use. The development of a simplified questionnaire (PFDI-SF) based on the original one compensates for this deficiency, and the two versions of the questionnaire are well correlated in terms of length. The choice of the two depends on the purpose of use. The short form is more often used in clinical practice and in studies using multiple questionnaires and where there is a need to reduce overhead, but if detailed information is needed, the original form may be more appropriate.
(ii) General and specific disease quality of life questionnaire
The health related quality of life (HRQOL) refers to people’s overall perception of health, including social, physical and emotional health. The former is used for large diseases and populations and for comparison of different subgroups or diseases, but lacks sensitivity to the effect of a particular aspect of a particular disease on QoL. The latter is used for special disease populations and is more sensitive to changes in symptoms, with the disadvantage that it cannot be compared with normal populations.
The two more widely used general HRQOL questionnaires are the SF-36 (Level A) and the European quality of life questionnaire (EQ-5D, Level A), available in multiple languages and at the highest evidence-based level of psychological testing. the SF-36 questionnaire focuses on 3 aspects of functional status, well-being and overall health assessment, with a total of 36 items, which is the most commonly used questionnaire of its kind. The Chinese quantitative standard of the SF-36 was studied by the West China Medical University in 2001, which emphasized that the Chinese quantitative standard should be used in the Chinese population. the EQ-5D was designed by the European Quality of Life Group (EQ) in 1987 as a multi-country, multi-lingual, multi-center participatory project, completed using design sharing and local trials. The EQ-5D provides a simple description of health and a single index that can be used in clinical and economic evaluations of health care and population health surveys, and is one of the methods recommended by the Washington Group on Health and Medical Cost Effectiveness for cost-effectiveness analysis. One of the methods recommended by the Washington Group on Health and Medical Cost Effectiveness for cost-benefit analysis. However, it has also been pointed out that there is no worst or best HRQOL questionnaire of its kind, and the decision of which questionnaire to use or the combination of certain questionnaires needs to be based on a combination of factors such as the purpose of the study, the characteristics of the population, and the implementation setting. Since these two questionnaires are designed for the general population, they are not specific for patients with PFD.
UI QoL questionnaires include the incontinence impact questionnaire (IIQ, level A) and its short form (IIQ-SF, level A), the incontinence quality of life questionnaire (I- QoL, Level A), King’s health questionnaire (King’s health questionnaire, Level A), and urge incontinence impact questionnaire (U-IIQ, Level A), all Level A. The IIQ was designed by Shumaker et al. The IIQ-SF was designed by Shumaker et al. in 1994 to assess the impact of UI on women’s activities, roles, and emotions, etc. The IIQ-SF reduced the content of the IIQ from 30 items to 7 items, and the two are highly correlated, and the IIQ-SF is easier to apply because of its short structure. The I-QoL is gender neutral in measuring the impact of UI on QoL. Current studies on the Iranian and 15 other language versions of the questionnaire confirm that the other language versions also have good psychometric properties and are the most frequently used quality of life questionnaire for urinary incontinence after the IIQ. And it has been shown that the I-QoL has the highest response rate in clinical trials evaluating the measurement performance of the I-QoL versus other questionnaires.The KHQ questionnaire was designed by Kelleher et al. at the Gynecological Urology Centre, King’s Hospital, London, in 1997 and consists of three parts: first, general health problems and the impact of UI; second, UI symptoms; and third, six aspects involving QoL: role , physical, social, personal-emotional, sleep, and energy. The KHQ-SF is a short form of the KHQ questionnaire, which maintains the first and second parts of the original version, while only one of the six aspects in the third part is selected and combined, with the same good psychometric properties.
The main QoL questionnaires for fecal incontinence are the fecal incontinence quality of life scale (FIQL, Level B) and the Manchester health questionnaire (Level B). Although FI is a common problem from childhood to old age, the FIQL is primarily intended for the adult FI population, as the questions about sexual activity are not appropriate for children. Therefore, if applied to children with FI, the relevant content of the questionnaire needs to be revised and reassessed psychologically. The Manchester Health Questionnaire was developed by Bugg et al. at the University of South Manchester Medical School in 2001 by adapting the KHQ questionnaire for assessing QoL in women with UI, taking into account the similarity in symptomatology between FI and UI due to pelvic floor denervation and myogenic injury after childbirth. This questionnaire can be used both to assess the effect of FI on QoL and to study FI in women after childbirth. The modified Manchester Health Questionnaire (i.e., using American English and a telephone survey) is also psychometrically sound.
The main QoL questionnaires for pelvic floor disorders are the pelvic floor impact questionnaire (PFIQ, level B) and its short form (pelvic floor impact questionnaire short form, PFIQ-SF, level B). the PFIQ is based on the IIQ, with The PFIQ is based on the IIQ with the addition of POP and anal and rectal function. Both versions have good psychometric properties.
(iii) Sexual function questionnaire
Sexual function has an important impact on the QoL of sexually active individuals and needs to be taken into account when evaluating the treatment of PFD. 14 questionnaires assessing male and female sexual function were established by Daker-White in 2002, and only the McCoys female sexual function questionnaire (MoCoys female sexual function questionnaire, MFSQ) and the PFIQ were used. Only the McCoys female sexual function questionnaire (MFSQ) and the female sexual function index (FSFI) meet the highest standards and are recommended for use. The only questionnaire for POP or UI female sexual function is the prolapse and incontinence sexual function questionnaire (PISQ). The current studies on sexual function in patients with UI, FI or POP are grouped into two main categories, namely the analysis of vaginal anatomy and the analysis of sexual satisfaction. Many researchers have evaluated surgical repair considering only the anatomical findings without considering the sexual function of the patient, paying too much attention to the length and diameter of the vagina used to satisfy sexual intercourse and not to the sexual satisfaction of the woman after the repair. Obviously, it is not enough to evaluate the effect of pelvic floor reconstruction on female sexual function by considering anatomical findings only. Common sexual function questionnaires, although they can also be used for specific populations in some studies, may not detect differences before and after treatment. For this reason, Rogers et al. in 2001 designed a special questionnaire used to evaluate sexual function in sexually active women with PFD, the PISQ questionnaire. This questionnaire addresses behavioral or emotional, physical, and partner-related questions, and is graded primarily on the frequency or impact of the questions. Before using this questionnaire, it is necessary to confirm whether the study population is sexually active women and the composition of the study population to ensure the validity of the PISQ questionnaire in this study population. The prolapse and incontinence sexual function questionnaire short form (PISQ-SF) is a short form of the PISQ developed by Rogers et al. in 2003 and correlates well with the original version. Recent studies on the PISQ and the Spanish version of the PISQ-SF have confirmed that the questionnaire has good psychometric properties.
(iv) Global Indices (GI)
The GI is a questionnaire that asks individual patients to rate their response to treatment for the severity of a particular condition or their own condition, and is an overall assessment of a composite phenomenon rather than a single component of it, usually only a single item. and specificity. One GI that has recently been shown to be effective in evaluating UI is the Patient Gobal Impression of Improvement (PGI-I), which consists of single-item questions that ask patients to rate their improvement after treatment.The sensitivity of the PGI-I confirms its usefulness in terms of urine pad test, frequency of UI, and change in I- QoL scores after UI treatment. QoL score changes were significantly correlated. Thus, this simple tool appears to provide a valid overall evaluation of UI-treated patients.
IV. Selection, implementation and translation of questionnaires in PFD
(i) Questionnaire selection: The first step is to determine whether the questionnaire truly reflects the test index, the second is to assess the psychometric properties of the questionnaire, and the last is to determine whether the length and structure of the proposed questionnaire are easy to implement in practice. As far as possible, classical questionnaires that have been widely adopted and tested by time and practice should be used.
(ii) Specific implementation methods of the questionnaire: The implementation method of the questionnaire determines the response rate and response content, and is divided into two methods: self-administration by the patient or implementation with the participation of the researcher. Jones et al. reported good clinical response rates for electronic personal assessment questionnaires on the pelvic floor. However, it has also been reported in the literature that electronic questionnaires on sexual function were rejected by the participants, not because the survey involved the privacy of sexual life, but because the population surveyed was unfamiliar with the electronic questionnaire format due to old age. The involvement of researchers in the implementation of the method may increase the response rate but may be limited by the reluctance of patients to disclose sensitive issues face-to-face. A systematic review of questionnaire response rates found that short questionnaires are easy to follow up, while completion of the survey through motivational and humane requests can lead to increased response rates. In many studies, Internet-based questionnaires were found to have lower response rates than mail-based surveys, depending on the respondents’ familiarity with Web-based technologies. In conclusion, a survey prior to the implementation of the questionnaire to the target population is necessary and will help avoid unnecessary errors from occurring.
(iii) Translation of questionnaires: At present, domestic studies on female PFD mostly use classic foreign questionnaires, such as BFLUTS and ICIQ questionnaires. However, the validity and reliability of the questionnaire in the domestic population may be potentially affected by the translation errors of the questionnaire. Both one-way and bilingual expert translations may have inherent biases due to language and cultural differences. A better translation method would be simultaneous design of the questionnaire in multiple languages and back translation method. The former is used sparingly but allows different versions to be evaluated simultaneously; the latter is used more often, with the bilingual experts translating the original questionnaire into the required language version and a second group of experts retranslating that version back to the original and comparing it in terms of accuracy and comprehension. This process can be repeated until the requirements are met. Nevertheless, the newly translated questionnaire still needs to be evaluated psychologically in the study population.
Although anatomical measures of PFD have an irreplaceable place in the evaluation of treatment outcomes, with the development of female pelvic floor medicine, it has become increasingly important to evaluate precise quantification and appropriate measures of patients’ subjective symptoms and their impact on quality of life. Currently available questionnaires are still under further clinical and research scrutiny, and the development of newer, more comprehensive questionnaires is underway, such as the revised IIQ and UDI questionnaires for the assessment of urge urinary incontinence (UUI): U- IIQ and U-UDI, more targeted questionnaires designed for overactive bladder A more specific questionnaire for overactive bladder, as well as high-quality questionnaires for FI and other PFD questions are under development.
In conclusion, questionnaires are an important tool in the study of female pelvic floor dysfunction, and as research progresses, existing questionnaires will be improved and new ones will be developed and applied in clinical practice.