Development and validation of the genitourinary syndrome of menopause symptoms and vaginal treatments acceptability questionnaire (GSM‐SVTAQ): An electronic patient‐reported outcomes measure

To develop and validate an electronic, patient‐reported outcomes measure (PROM) specific for genitourinary syndrome of menopause (GSM) patients. The PROM aimed to accurately assess the burden of GSM symptoms, their impact on health‐related and sexual quality of life, and the acceptability of vaginal treatments.


| INTRODUC TI ON
Genitourinary syndrome of menopause (GSM) (previously known as vulvovaginal atrophy, atrophic vaginitis, or urogenital atrophy) represents the clinical manifestations resulting from the hypoestrogenic state of perimenopause and menopause. 1,24][5] Management of GSM varies according to the severity of symptoms, but low-dose vaginal estrogen therapy is the reference standard. 1,6,7Increasing sexual activity and using vaginal lubricants and moisturizers are encouraged. 1 Vaginal vitamin D supplementation, [8][9][10][11] chamomile vaginal gel, 12 and vaginal vitamin E and hyaluronic acid suppositories have been investigated by a few studies. 13,146][17][18][19][20][21] However, there is no data on the prevalence in Arabic countries.GSM is a subjective condition that significantly impacts the well-being and sexual quality of life of postmenopausal women.
Both are important health outcomes that can be measured using patients' perceptions of their health status.However, perceptions of the severity of vaginal and climacteric symptoms and burden can differ between cultures and ethnic groups. 22[25] There are several patient-reported outcomes measures (PROMs) available to measure only one component of GSM, including the most commonly used ones such as the Vulvovaginal Atrophy Questionnaire, 26 the Female Sexual Function Index, 27 and the Menopause-Specific Quality of Life Questionnaire. 28ese existing PROMs, however, were not specifically designed for postmenopausal women with GSM; consequently, they fail to encompass the entirety of GSM's multifaceted impact on women's quality of life.Moreover, these tools do not adequately encapsulate the diverse experiences arising from varying cultural perspectives and practices.Furthermore, to date, there is no validated tool to measure vaginal treatment acceptance in this specific patient population.
[31][32][33] In the context of conditions like GSM, where patients' experiences are of paramount significance, the imperative for a tool that adeptly captures the nuanced subjective dimensions of their health status becomes all the more pronounced.A specific instrument not only empowers patients to articulate their condition comprehensively but also allows for a deeply personalized expression of their wellbeing.The objective of this study was to develop and validate an electronic PROM specifically tailored to GSM, which will evaluate the extent of GSM symptom burden, its influence on health-related quality of life, and the impact on sexual quality of life.Additionally, the study aimed to assess the acceptability to patients of using vaginal dosage forms for alleviating symptoms.

| MATERIAL S AND ME THODS
This study took place in the United Arab Emirates from October 2022 to March 2023.Ethical approval was obtained from the University Hospital Sharjah Research and Ethics Committee, Reference number (UHS-HERC-106-07092022). Informed consent was obtained from each participant who voluntarily agreed to take part in the study.5][36][37] Figure 1 depicts all the steps involved in the development and validation of the new PROM.

| Stage 1: Preliminary design of the PROM
The first stage was to identify the need for a new PROM.In October 2022, a thorough literature search was performed in MEDLINE (via PubMed), Cochrane Library databases, Web of Science, Google Scholar, and the Patient-Reported Outcome and Quality of Life Instruments Database (PROQOLID) to identify studies reporting the use of PROMs for GSM or vulvovaginal symptoms associated with menopause. 38The eligibility criteria for the included studies were that they must have measured at least one component of GSM, which includes vaginal, sexual, or urinary symptoms.Generic questionnaires assessing the quality of life without specific reference to menopausal symptoms were excluded.Additionally, the identified questionnaires had to be freely available and in English with high content validity and internal consistency.Keywords included atrophy, urogenital, urogenital atrophy, vaginal dryness, dyspareunia, incontinence, stress incontinence, sexuality, sexual dysfunction, menopause, and perimenopause.In addition to the literature search, we consulted with gynecologists to locate relevant questionnaires that may have been missed during the initial search.To achieve this, titles and abstracts of the identified publications were thoroughly reviewed by two panel members who categorized them as relevant, maybe relevant, or irrelevant.Citations designated as irrelevant by both reviewers were eliminated, and the remaining ones were evaluated.For this evaluation, relevance was defined Cronbach's α coefficient, dyspareunia, genitourinary syndrome of menopause, menopause, patient-reported outcome measures, reliability, scale validation, sexual activity based on the presence of information about symptoms, functional status, or health-related quality of life (HRQoL) using a PROM measure.
In parallel with the literature review, an expert panel was formed, comprised of a diverse group of experts including those with expertise in performance measurement, patient-reported outcomes, clinical and health service research, clinical pharmacists, patient representatives, and statisticians.The panel used a systematic and evidence-based approach to develop a set of methodologic best practices for guiding the development and evaluation of the new PROM in performance measurement.These best practices included guidance on the selection of appropriate domains, the development of items and response options, the evaluation of content validity, and the assessment of psychometric properties.Furthermore, the panel emphasized the importance of engaging patients and other stakeholders throughout the development and evaluation process to ensure that the PROM was relevant, acceptable, and understandable to those completing them.
The conceptual framework of the PROM was designed to capture the multidimensional nature of GSM symptoms and treatments and their impacts on women's quality of life.The framework included three main components: symptoms, impact domains, and treatment acceptability.The first component, symptoms, aimed to encompass the diverse range of GSM symptoms experienced by women, including vaginal dryness, pain during intercourse, urinary symptoms, and related discomfort.The second component, impact domains, delved into the wide-ranging consequences of GSM on various aspects of women's lives.This encompassed domains such as HRQoL and sexual quality of life.Notably, an essential component within the framework was the assessment of treatment acceptability of vaginal dosage forms.Recognizing the importance of evaluating the acceptability of treatment options, the PROM sought to capture patients' experiences and perspectives regarding the acceptability of, tolerability of, and satisfaction with vaginal treatments, so providing valuable insights for healthcare professionals and researchers in optimizing treatment approaches for GSM.Additionally, the conceptual framework of the PROM considered the incorporation of contextual factors.These factors recognized the influence of individual characteristics, sociocultural context, and other relevant contextual aspects that may shape the experiences and perspectives of women living with GSM.
The conceptual framework for the PROM for GSM was used to develop a set of qualitative semi-structured interviews for item generation.The interviews were designed to elicit women's experiences and perspectives on GSM symptoms, the impact of these symptoms on their daily lives, and their treatment preferences.
Between October and December 2022, we conducted qualitative semi-structured interviews with a purposive sample of 50 patients presenting with varying degrees of vulvovaginal symptoms associated with menopause and different demographic backgrounds to ensure that all relevant aspects of the condition were captured.
During the interviews, we asked open-ended questions to encourage patients to describe their experiences with vulvovaginal symptoms, including how these symptoms have affected their daily life and sexual life.We also asked patients to describe their treatment experiences, including self-care measures and treatment preferences.These questions allowed us to gain a deeper understanding of the patient experience and identify themes related to the impact of vaginal symptoms on sexual life and the interference of treatments on sexual activity.Qualitative interviews were analyzed using the thematic analysis software NVivo 20 to identify key themes for the PROM development.

| Stage 2: The five-step pre-validation methodology
To ensure that the developed PROM for GSM patients was comprehensive and relevant, we applied the five-step pre-validation methodology developed by Prior et al. 39

| Step 1-Item generation
We sourced items from both existing instruments in the menopause context that have been systematically identified from our literature review study using the following eligibility criteria: suitable for selfreport; validated in a population of postmenopausal women; and items and response options fully described in the text article reporting the instrument development and validation.We created an item pool with items grouped according to their category.This process resulted in a list of items that were then cross-checked against the key themes and codes obtained from the one-to-one interviews conducted with patients with vaginal symptoms.

| Step 2-Item deduplication
Item deduplication was a crucial step in ensuring that the final version of the PROM was comprehensive and relevant.The expert panel played a critical role in validating the final item pool, evaluating each item based on several criteria, including clarity of expression, face validity, and appropriateness for measuring the intended construct.During this process, the panel was vigilant in identifying any potential issues with item redundancy or content overlap with existing generic instruments.Any items found to be literal duplications or those whose content overlapped with other instruments were deleted to prevent redundancy and ensure the instrument's uniqueness.Moreover, the panel reviewed the final item pool to ensure that it covered all relevant domains and that the items' wording was appropriate for the target population.They also reviewed the items' response options to ensure that they were clear, unambiguous, and comprehensive.Any issues identified during this process were addressed through revisions and refinements to the item pool.

| Step 3-Item reduction
Adhering to the Patient-Reported Outcomes Measurement Information System (PROMIS) guidelines, we conducted a thorough evaluation of all remaining items to ensure their relevance and appropriateness for measuring the intended construct.Items were discarded if they were found to be semantically redundant with a previous item, inconsistent with the PROM domain definition, inappropriate or unclear, or too narrow to have universal applicability. 40ter discarding irrelevant items, the remaining ones were used to create the first draft of the PROM.

| Step 4-Assessment of content coverage
To ensure that the PROM accurately captured the experiences of patients with GSM, we evaluated each item's content coverage against the Theory of Unpleasant Symptoms for GSM symptoms and the Theoretical Framework of Acceptability for the assessment of vaginal therapy acceptability. 41The Theory of Unpleasant Symptoms is a middle-range nursing theory that provides a comprehensive framework for examining the subjective, self-reported symptoms related to urogenital atrophy, including the cluster of urologic, genital, and sexual symptoms experienced by women. 42The theoretical framework of acceptability, developed by Sekhon et al., 41 aims to measure the extent to which an intervention is perceived as acceptable by individuals or groups.It provides a systematic approach to understanding the factors that influence the acceptability of a particular intervention or innovation within a specific context.Using both frameworks as a guide, we conducted a thorough examination of the symptom experiences of women with GSM, identifying the specific symptoms that were most relevant to our target population and gaining insights into the factors that affect the acceptability of vaginal interventions.

| Step 5-Exploratory pilot testing
We used an "item-centered" coding scheme based on the Cognitive Aspect of Survey Methodology Framework of Tourangeau to identify "problem" items (i.e.those with which participants had difficulty following instructions or problems with comprehensibility, acceptability, relevance, or answerability). 43The "think aloud" interviews are useful tools for assessing the clarity and importance of items for patients. 44A deliberate selection of 12 patients diagnosed with GSM was made for the study.These patients were requested to share their thoughts aloud (think aloud) while they completed a preliminary version of the PROM questionnaire, and this was done in the presence of a researcher.The researcher also probed the patients for feedback on specific items, as well as their overall opinion about the PROM draft.The entire interview process was recorded and later transcribed verbatim.To identify any potential impact of item interpretation on written responses, the verbal responses provided by each participant for every item were recorded in a tabular format alongside their written responses.One researcher (M.M.H.) coded all the transcripts and disagreements were resolved by consensus of the "think aloud" research team (M.M.H., H.Z.H., K.B.).

| Content validity
We evaluated the content of the items to ensure that they accurately represented the theoretical construct of our model.The panel assessed the adequacy of the chosen items and determined whether they were sufficient to measure the variables in the domain, using a validation form.The content validity index (CVI) was measured for each item and each scale.A panel of six experts was asked to rate each item on a four-point Likert scale, where 1 represented "irrelevant," 2 represented "somehow relevant," 3 represented "quite relevant," and 4 represented "very relevant."The item-CVI (I-CVI) was calculated by dividing the total number of experts who scored an item as 3 or 4 by the total number of experts.
The scale-CVI (S-CVI) was calculated as the average of the I-CVIs for all items in the scale.For the I-CVI, items with a score greater than 0.79 were considered relevant, items with scores between 0.70 and 0.79 needed revision, and items with scores below 0.7 were eliminated. 45

| Face validity
To ensure the linguistic and analytical validity of the questionnaire and the understandability of its items, a rigorous face validity study was conducted.The expert panel was asked to evaluate each item's clarity and relevance to the construct being measured.Furthermore, to assess face validity, a group of carefully selected respondents was recruited to evaluate the items.The respondents were selected based on their familiarity with GSM symptoms and their ability to provide insightful feedback.They were asked to evaluate the items' feasibility, style, formatting, readability, and clarity of language.The respondents were instructed to indicate their understanding of each item using a dichotomous scale of either "yes" or "no" to signify whether they found the item favorable or unfavorable, respectively.

| Reliability
Cronbach's α coefficients were calculated to assess the internal consistency of questionnaire domains.A Cronbach's α of 0.70 or greater was considered to establish sufficient internal consistency.

| Identified PROMs from the literature review
We identified 12 specific questionnaires written in English used in studies involving postmenopausal women.The three most commonly used in literature were the Day to Day Impact of Vaginal Aging, 46 and Female Sexual Function Index and the Menopause Rating Scale. 27,47Less commonly cited included the Vulvovaginal Atrophy Symptoms Questionnaire, 26 Menopause-Specific Quality of Life, 28 Female Sexual Distress Scale, 48 McCoy Female Sexuality Questionnaire, 49 Menopausal Sexual Interest Questionnaire. 50Urogenital Atrophy Questionnaire, 51 the MenoScores questionnaire, 52 Fallowfield's Sexual Activity Questionnaire, 53 and the Overactive Bladder Symptom and health-related quality of life questionnaire. 54r literature review revealed that although the identified PROMs were valuable in capturing some aspects of the GSM, they were insufficient on their own to gather comprehensive data on the three components of GSM.

| Identified themes from the qualitative study
We identified the main themes related to decreased sexual desire, inability to experience pleasure, and delayed orgasm, which were common among all women.These themes were used to build the related constructs of the PROM instrument, ensuring that the instrument is comprehensive and addresses the unique sexual aspects of GSM.The first and most commonly encountered theme was the impact of vulvovaginal symptoms on sexual activities and performance, as well as the after effects of vaginal treatments on sexual activity.Women described their symptoms using phrases such as "decreased desire," "inability to experience pleasure," and "delayed orgasm."They also discussed their feelings about managing their therapies and what mattered to them most.Some of the women expressed that vaginal treatments helped to relieve irritation and improve their sex lives, but at the same time decreased sensitivity.Others mentioned the importance of feeling healthy and being able to enjoy sexual relations comfortably.These findings highlight the significant impact of vulvovaginal symptoms on sexual function and the importance of considering sexual health in the management of menopausal symptoms.The study also sheds light on women's priorities when it comes to treatment acceptability, which can inform healthcare providers in their decisionmaking and communication with patients.

| Item reduction
A literal de-duplication phase resulted in the removal of eight items.
Decisions on which content themes were not relevant for inclusion in the PROM were informed by the literature and by two consultant gynecologists on the research team.Excluded content themes were all in the treatment acceptability domain.

| Content coverage
The evaluation of each item's content coverage against the Theory of Unpleasant Symptoms was a critical step in developing a comprehensive and relevant PROM for GSM patients.This process ensured that the instrument accurately reflected the symptom experiences the target population and effectively captured the full spectrum of symptoms related to urogenital atrophy.Overall, the use of the Theory of Unpleasant Symptoms as a guiding framework allowed us to develop a PROM that was grounded in the most relevant symptom domains, ensuring that the instrument effectively measured the patient-reported outcomes related to GSM.The rigorous evaluation of each item's content coverage against the Theory of Unpleasant Symptoms was instrumental in developing a high-quality instrument that can be used to improve patient care and treatment outcomes for women with GSM.

| The think-aloud interviews (pilot-testing)
The findings from the think-aloud study have led to modifications to the wording of the remaining items.These changes aimed to improve the consistency of item wording and reduce the burden on participants.For instance, to enhance understanding among respondents who expressed confusion, the term "vulvovaginal" was replaced with "vulvar and vaginal" for simplicity.Furthermore, in the initial version of the PROM, a word difficulty issue arose in one of the questions where the response options contained the term "grade overall severity of symptoms."To address feedback suggesting unnecessary repetition and annoyance, the word difficulty was eliminated from the response options.As a result, the wording of the responses changed to "none, mild, moderate, severe, and extremely severe."

| Content validity
We assessed the content validity by calculating the S-CVI and I-CVI using the responses from the panel experts.All items in the GSM symptom burden domain had CVI scores greater than 0.80, and the S-CVI was 0.926.The HRQoL had an S-CVI of 0.875.Eight items in the treatment acceptability domain had an I-CVI of 0.666 and were eliminated.The treatment acceptability domain had an S-CVI of 0.824.

| Face validity
The face validity study was crucial in ensuring the comprehensibility and relevance of the questionnaire items.By involving both an expert panel and carefully selected respondents, we were able to capture a diverse range of perspectives and ensure that the questionnaire items were understandable, relevant, and appropriate for the target population.Overall, the rigorous face validity study allowed us to refine the questionnaire items and ensure their linguistic and analytical validity.

| Reliability testing
We conducted a reliability test to assess the consistency of responses obtained from the participants using the newly developed questionnaire.Reliability testing was performed in a population similar to the intended population of the study in terms of the constructs being measured and all other characteristics.A total of 72 participants were included in the reliability testing.The results indicated a high level of internal consistency with a Cronbach's α of 0.85.
The GSM symptom burden domain with an α coefficient of 0.939, HRQoL with α coefficient of 0.947, and the treatment acceptability domain with α coefficient of 0.855.Participants' characteristics are detailed in Table 1.

| The final validated PROM
The final PROM developed in this study, named GSM-SVTAQ, encompasses three distinct domains: GSM symptom burden, HRQoL and sexual quality of life, and vaginal treatment acceptability.Each of the three GSM symptom clusters, namely vaginal, sexual, and urinary, covers the dimensions of symptom burden, including frequency, severity, and perception of distress. 55

| Domain A: GSM symptom burden
Within the vaginal symptoms cluster, the GSM-SVTAQ addresses various issues such as vaginal dryness, vulvar and vaginal itching and burning, vaginal discharge, and pelvic pain or pressure.
Sexual symptoms included and encompassed reduced or loss of vaginal lubrication during sexual intercourse, loss of libido, pain, or discomfort during or after sexual intercourse, as well as bleeding during or after sexual intercourse.Additionally, urinary symptoms covered by the GSM-SVTAQ consist of pain or burning sensation during urination, urinary urgency, increased frequency of urination, and nocturia.Symptom frequency was evaluated using a five-point scale, ranging from "almost always or always" to "almost never or never," providing a comprehensive assessment of how often the symptoms occurred.The severity of symptoms was measured on a five-point scale, ranging from "none" to "extremely severe," allowing for an assessment of the intensity of the symptoms experienced.Perception of symptoms was determined by identifying the single most bothersome symptom reported by the patient.This approach aimed to capture the patient's subjective evaluation of symptom importance and the level of disturbance or concern caused.It was recognized that the most intense or frequent symptoms might not necessarily be the highest priority for the patient, as individual perceptions of bothersome symptoms may vary.Less intense or more frequent symptoms could still be perceived as bothersome due to the differential in the perceived importance of these symptoms. 56 Domain B: HRQoL and sexual quality of life A secondary scale was implemented to comprehensively evaluate the repercussions of vulvovaginal symptoms on multiple dimensions of daily functioning.This scale measured physical status and functional abilities, psychological status, and emotional well-being.
Additionally, the assessment extended its scope to thoroughly examine the effects of symptoms on sexual quality of life.These items probed into essential aspects such as sexual desire, interest, lubrication, and pleasure.

| Domain C: Vaginal treatment acceptability
The third and final domain measured vaginal treatment acceptability.
Items were developed following the Theoretical Framework of Acceptability. 41The domain included a total of 13 items assessing the acceptability of treatment and covered components of the Theoretical Framework of Acceptability including affective attitude, burden, ethicality, intervention coherence, opportunity cost, perceived effectiveness, and self-efficacy.Table 2 shows elements included in the vaginal treatment acceptability domain.

| DISCUSS ION
Our study represents the first-ever electronic PROM that fully encompasses the GSM patient experience, providing valuable insights into the complexities of this condition.We recognize that previous PROMs had limitations in addressing the full spectrum of GSM and its impact on sexual quality of life and each should be used in conjunction with other assessments to provide a comprehensive evaluation.For instance, the Menopause Rating Scale only focused on the physical and psychological aspects of menopause, vasomotor symptoms, and vulvovaginal symptoms, while ignoring changes in social functioning and quality of life. 47In contrast, the Day-to-Day Impact of Vaginal Aging questionnaire covered most aspects of GSM but failed to include urinary symptoms and contained explicit questions that could be inappropriate for some patients' cultures. 46Our study aimed to overcome these limitations by developing a comprehensive  Previous surveys that investigated GSM's prevalence and impact on postmenopausal women used structured questionnaires.
However, there was no data on their validation or reliability.These surveys were descriptive in nature.Although they did not attempt to draw any causal relationships between the data variables collected, they provided a good perspective on the GSM symptoms and their effect on postmenopausal women's lives.The REVIVE, CLOSER, and EMPOWER studies provided data on postmenopausal women's knowledge of the GSM symptoms and awareness about the treatment options available.They all concluded that most postmenopausal women did not recognize their GSM symptoms failed to discuss them with their healthcare providers. 16,18,57e involvement of patients with GSM was a crucial and necessary step in the development of the GSM-SVTAQ.PROMs are developed to improve the detection of the patient's subjective experience. 58,59M is a highly subjective condition that has a significant impact on the quality of life, particularly sexual activity, which can be a private and personal matter perceived differently by different women.Relying solely on existing literature when developing the PROM would limit the validity of its constructs.Only women with symptoms can provide valuable insights into which health outcomes are most important to them and how they experience and manage their symptoms.With direct input from patients, their perspectives can help ensure that the PROM adequately captures the breadth and complexity of their experiences, unlike PROMs that are developed conventionally. 60,61e initial domain of the GSM-SVTAQ aimed to assess the symptom burden associated with GSM.Symptom burden, as described in the existing literature by Lenz et al. 55 and Cleeland, 62 encompasses the combined impact of symptom frequency, severity, and distress or perception.In this domain, we also recognized the interconnectedness of GSM symptoms, where certain symptoms, such as vaginal dryness and pain during sexual intercourse, can mutually exacerbate or alleviate each other.Consequently, each item was represented as a symptom cluster, defined as a group of two or more related symptoms that co-occur.These symptom clusters consist of stable sets of symptoms, relatively independent from other clusters, and can reveal distinct underlying dimensions of symptoms. 62,63It is important to note that the single most bothersome symptom may not align with its severity alone.The measurement of the most bothersome symptom assesses the perceived significance of a symptom when it troubles and disturbs patients.
The most intense or frequent symptom may not necessarily be the highest priority for patients due to differences in perceived importance or the level of bother.Conversely, a less intense or more frequent symptom may be perceived as highly bothersome. 64 developing a new patient-reported outcome measure for vaginal therapies, the framework of acceptability developed by Sekhon et al. 41 was used as a guide.The seven domains of acceptability were carefully considered to ensure that the measure effectively captured the acceptability of vaginal therapies among postmenopausal women with GSM.For instance, the affective attitude domain was considered when selecting appropriate language and phrasing in the measure to ensure that patients could easily understand and respond to the questions.The burden domain was considered when evaluating the impact of vaginal therapies on patients' daily lives, such as their ability to carry out daily activities and engage in sexual activity.Ethicality was considered by ensuring that the measure did not discriminate against any particular group of patients and was culturally sensitive.
A 3-month recall period was determined to be reasonable for several reasons.First, vulvovaginal symptoms in GSM are characterized as chronic and persistent, with less variability over time.Sexual and vaginal symptoms such as vaginal dryness or pain during intercourse are more likely to be more consistent over time and women may have a better recollection of their experiences if they are asked to recall them over a longer period.Therefore, a longer recall period of 3 months was deemed appropriate and feasible for capturing patients' responses to treatment.Furthermore, the GSM-SVTAQ demonstrated high internal validity, providing support for the decision to maintain the 3-month recall period. 65er the past two decades, the utilization of PROMs has significantly increased. 29,30The primary objective has been the development of electronic PROMs as a replacement for traditional paper-based assessments.Technological advancements have increased interest in employing electronic PROMs to monitor patients' conditions. 66,67ectronic PROMs allow patients to input their data conveniently, at a time and place of their choosing, through a user-friendly platform.The significance of these advancements lies in the fact that patients often experience low levels of comfort when discussing symptoms and experiences related to their condition.In this context, using a PROM like the developed GSM-SVTAQ PROM can play a crucial role in enhancing patient engagement and facilitating effective patient-clinician communication.On a different level, the GSM-SVTAQ implemented a display logic feature that allowed respondents who were not sexually active or without a partner to skip questions related to sexual activities and their impact on sexual quality of life, enhancing the relevance and customization of the survey for individual participants.[70][71] A potential limitation of our study is the absence of a test-retest analysis, as GSM symptoms can fluctuate over time due to factors such as hormone levels, medications, and lifestyle changes, potentially impacting the reliability of this method.Additionally, treatment acceptability may be influenced by factors like cost, availability, and individual preferences, which can also change over time, making consistent results difficult to obtain.Longitudinal studies could provide a more accurate assessment of the impact of GSM on women's health.In developing the GSM-SVTAQ, responsiveness was not measured because the PROM was intended to capture symptoms at a specific point in time rather than changes over time. 72 conclusion, the GSM-SVTAQ is a new electronic disease-specific PROM that was developed and validated to assess various aspects of GSM, including its symptoms, impact on HRQoL, sexual functions and quality of life, and the acceptability of vaginal treatments.By

F I G U R E 1
Process of development and validation of the PROM.

TA B L E 2
Elements of the vaginal treatment acceptability domain.Being comfortable using vaginal treatments The treatment information provided was clear and easy to follow Using vaginal treatments made much sense Being confident applying the treatment correctly Improvement of vaginal symptoms with the treatment Improvement of sexual desire with the treatment Bothered by the side effects of the treatment Bothered by the time and effort required for the treatment application Bothered by the changes in sexual activity Bothered by the changes in vaginal hygiene routine Benefits of vaginal treatment outweighed any potential risks Being comfortable discussing personal aspects associated with the treatment with healthcare practitioner Worried about how partner feels about treatment electronic PROM that encompasses all components the syndrome and evaluates the acceptability of vaginal therapies.

TA B L E 1
Characteristics of participants (validation survey).a