Cross-Cultural Adaptation to Portuguese and Psychometric Validation of the DIVA Questionnaire (Day-to-Day Impact of Vaginal Aging)
Conditions: Vulvovaginal Atrophy, Genital Disorder, PROMs
Sponsor: Instituto Politécnico de Leiria

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RESEARCH PROJECT PROTOCOL 
For inclusion in the PhD project in Medicine 
Developed at the University of Minho | Institute for Life Sciences Research, in partnership 
with ciTechCare – Center for Innovation in Healthcare Technologies | Polytechnic of Leiria, 
funded by the Foundation for Science and Technology (2021.07973.BD) 
Title: 
Cross-Cultural Adaptation to Portuguese and Psychometric Validation of the DIVA 
Questionnaire (Day-to-Day Impact of Vaginal Aging) 
 
Short Title: 
Validation of the DIVA Questionnaire (Day-to-Day Impact of Vaginal Aging) 
for Portuguese Women 
Protocol ID: 6047/2022 Ethical Commission for Health of Regional Health Administration of 
Lisbon and Tagus Valley (CES ARS-LVT). 16/09/2022 
 
Responsible Investigator: 
Professor Patrício Costa 
Principal Investigator: 
Andreia Alexandra da Costa Azevedo Ribeiro da Rocha Antunes 
Largo Alexandre Herculano, nº6, 2410-083 Leiria 
Phone: 933266097 
 
Affiliation of Principal Investigator: 
Faculty of Medicine, University of Minho 
Institute for Life Sciences Research 
ciTechCare – Center for Innovation in Healthcare Technologies 
Polytechnic Institute of Leiria 

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Supervisor: 
Professor Cristina Isabel Nogueira da Silva 
Co-Supervisor: 
Professor Maria Pedro Sucena Guarino 
 
Institutions for Participant Recruitment: 
Study Centres: 
• 
Hospital Santo André (CHL, EPE) – Gynaecology Service 
• 
UCSP Sete Rios (ARS-LVT) 
• 
Hospital Dom Manuel de Aguiar, Leiria 
• 
Private Gynaecologic clinic at Braga 
 
Study responsible at UCSP Sete Rios:  
Dra. Maria Alexandra Colaço 
 
Key words:  
Dyspareunia 
Genitourinary syndrome of menopause (GSM) 
Female Genital Atrophy 
Female Genital Disorder 
Female Sexual Dysfunction (FSD) 
Vaginal dryness 
Vaginal Itching 
 
Start Date: 
2/10/ 2022 
End Date: 
22/01/ 2024 
 
 
 
 
 
 
 

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Protocol Index 
List of Abbreviations ................................................................................................... 4 
Introductory Note ....................................................................................................... 5 
Project Rationale ........................................................................................................ 5 
Introduction ................................................................................................................ 6 
General and Specific Objectives ................................................................................. 6 
Materials and Methods ............................................................................................... 6 
1. Study Type .......................................................................................................6 
2. Population and Study Location ...............…………………………………………….…….6 
3. Data Collection Instruments .......................................................................... 7 
4. Inclusion and Exclusion Criteria ………………………………….………………............ 8 
5. Recruitment Model .........................................................................................8 
6. Informed Consent ...........................................................................................8 
7. Participant Confidentiality ..............................................................................9 
8. Project Operationalization ……………………………………………………………………….9 
9. Data Collection Model ................................................................................... 10 
10. Participant Benefits ....................................................................................... 10 
11. Data Review and Database Management ……………………………………………….10 
 
12. Statistical Analysis ....................................................................................... 11 
 
13. Ethical Considerations ................................................................................. 11 
 
14. Results Publication ...................................................................................... 11 
 
15. Founding ...................................................................................................... 11 
 
16. Timeline ....................................................................................................... 12 
 
17. Bibliography ................................................................................................. 13 
 
18. Protocol Annexes ......................................................................................... 15 
Annex 1: DIVA Questionnaire (Portuguese Version) .......................................... 15 
Annex 2: Symptom Questionnaire ................................................................... 19 
Annex 3: Sociodemographic and Clinical Questionnaire…………………………. .... 21 
Annex 4: Original English Version of the DIVA Questionnaire ………………………… 25 
Annex 5: EQ-5D .............................................................................................. 28 
Annex 6: FSFI-6 .............................................................................................. 30 
Annex 7: Informed Consent for Participants ................. …………………………….…32 
 
List of Abbreviations 

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ARS-LVT – Regional Health Administration of Lisbon and Tagus Valley 
ciTechCare – Center for Innovative Care and Health Technology 
COSMIN – Consensus-based Standards for the Selection of Health Measurement 
Instruments 
DIVA – Day-to-day Impact of Vaginal Aging 
EQ-5D – EuroQol Group 5-Dimension Quality of Life Questionnaire 
EQ-VAS – Visual Analog Scale associated with the EQ-5D questionnaire 
FMUM – Faculty of Medicine, University of Minho 
FDD – Digital Data File 
FSFI – Female Sexual Function Index 
HDMA – Hospital Dom Manuel de Aguiar 
HSA – Hospital Santo André 
CHL – Hospital Center of Leiria 
ICVC – Institute for Health Sciences Research 
IPL – Polytechnic Institute of Leiria 
SGUM – Genitourinary Syndrome of Menopause 
UCSP – Personalized Health Care Unit 
UM – University of Minho 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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This study protocol is part of a PhD project in Medicine to be developed in partnership 
between the University of Minho, ciTechCare, and the company DRT Molds. The project has 
been awarded a PhD scholarship by FCT (ref. 2021.07973.BD). The title of the project is 
"Regenerative Treatment for Vulvo-Vaginal Atrophy". To assess pre- and post-therapy, it was 
necessary to include clinical assessment instruments, which, in the case of genital atrophy, 
include self-assessment questionnaires and the perception of the impact that this clinical 
problem has on a woman's life. As there are no validated questionnaires in European 
Portuguese, it is intended to proceed with the cultural adaptation of a questionnaire 
developed in another sociodemographic context. The DIVA (Day-to-Day Impact of Vaginal 
Aging) questionnaire was selected because it was designed and constructed according to 
the guidelines of the COnsensus-based Standards for the selection of health Measurement 
INstruments (COSMIN), and the construct validity showed adequate values with a 
comparative fit index of 0.987 and Cronbach's alpha values ranging from 0.82 to 0.93. 
We began by informing the authors of the DIVA questionnaire that we would initiate this 
cultural and linguistic adaptation process, emphasizing that the authors state in the original 
publication that formal authorization is not required, but they wish to be informed of the 
results of the translation and cultural adaptation process. 
Before the start of this research protocol, a translation process into Portuguese was carried 
out according to the principles of good practice, which included the following steps: 1) 
translation by two independent researchers, 2) reconciliation, 3) back translation by two 
certified translators fluent in English, 4) unification and harmonization of the translated 
version in Portuguese, 5) evaluation by a group of specialists in gynaecology and sexology, 
and 6) pre-test in a group of patients with the final cultural adaptation of the DIVA scale 
translated into European Portuguese. 
 
 
Project Rationale 
Symptoms that cannot be directly quantified but have an impact on quality of life can be 
assessed through self-perception health questionnaires1. These clinical instruments play a 
key role, not only in identifying the clinical problem but also in assessing the individual 
impact of the problem on various psychological and physical dimensions, helping to 
identify the impact of therapeutic strategies on the improvement of these subjective 
symptoms2. For research to be valid, these instruments must be appropriate and accurate 
to ensure the quality of the results3,4. 
Aging has a significant impact on women's genital health, which results in a set of 
symptoms and signs known as the Genitourinary Syndrome of Menopause (GSM)5. This 
clinical issue affects approximately 50% of postmenopausal women. While the urinary 
component of GSM can be quantified through validated diagnostic tests, the vulvovaginal 
atrophy component is not quantifiable by diagnostic tests. It has an increasing severity with 
age, impacting self-esteem, well-being, and sexuality, yet remains a stigma for women and 
is poorly perceived by doctors6. It is in this context that the DIVA7 questionnaire (Day-to-day 
Impact of Vaginal Aging) was developed, as it brings together characteristics that make it 
practical for use in population studies, transforms subjective measures into objective, 
quantifiable, and analysable data, and assesses the relative strength of each domain or 

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component of female genital atrophy on quality of life. Other advantages of this 
questionnaire include being a well-studied and validated index with the ability to evaluate 
therapeutic interventions8. It has also been adapted into other languages besides English9 
– including Spanish10, Italian5, German11, and Turkish12 – and has been validated in these 
cultural contexts. 
The DIVA questionnaire analyses and quantifies the impact of female genital aging. It 
consists of 23 items grouped into 4 constructs, which include the dimensions of daily 
activities, emotional well-being, sexual function, and self-esteem and body image. There 
are two versions of the questionnaire: the full version with 23 items, which includes 4 items 
on sexual function that can only be evaluated in sexually active women, and a shorter 
version with 19 items that can be applied regardless of sexual activity. Each item is rated on 
a 5-point Likert scale, with the dimension value obtained by calculating the average of the 
corresponding items. Higher values indicate a greater adverse impact of atrophy 
symptoms. 
 
Project Objectives: 
General Objective: To determine the reliability, consistency, and validity of the 
psychometric properties of the Portuguese version of the DIVA questionnaire, adapted for 
our culture, in peri- and postmenopausal women. This validation will provide the foundation 
for using this questionnaire both in research and clinical practice with Portuguese women. 
Specific Objective: To assess the discomfort of genital atrophy symptoms in the study 
participants and the impact of this problem on the quality of life of peri- and 
postmenopausal women in the Portuguese context. 
Materials and Methods: 
Study Type: 
This will be an observational, cross-sectional, and descriptive study, conducted and guided 
by investigators with the appropriate professional qualifications to carry out the research 
protocol, in a clinical and human environment suitable for the study. The study will be 
conducted in accordance with Law No. 21/2014 of April 16 (amended by Law No. 73/2015, 
July 27) and Decree-Law No. 145/2009 of June 17. 
Population and Study Location: 
Participants will include woman that had at least one complaint of vaginal atrophy (dryness, 
itching, burning, irritation, discomfort, or pain when urinating or during intercourse, or 
bleeding during intercourse, affecting the external genitalia: vulva or vagina). 
For the normative convenience sample from the general population, participants will be 
users of a large urban health centre, the Personalized Health Care Unit (UCSP) of Sete Rios, 
Lisbon. For the clinical convenience sample, participants will be users of a general 
gynaecology consultation at a private hospital (Hospital Dom Manuel de Aguiar) and the  
gynaecology consultation at a public hospital (Hospital Santo André), both located in an 
urban centre  in Leiria, another group of participants came from a private gynaecologic 
consultation of north of Portugal, at Braga city, aiming to gather 230 valid tests, following 
COSMIN13 recommendations, to allow for an assessment of invariance correlation. 

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Data Collection Instruments: 
 
The methodological approach is a cross-sectional descriptive study of qualitative and 
quantitative data, including dependent and independent variables organized into a self-
administered form completed by the participants. This form includes 5 questionnaires: 
1. Symptom Questionnaire: This questionnaire will screen participants to be 
included in the study who must report at least one symptom associated with genital 
atrophy. The symptoms include dryness, itching, burning, irritation, discomfort or 
pain when urinating or during intercourse, or bleeding during intercourse, with each 
symptom rated on a 5-point Likert scale from 0 (no discomfort) to 4 (extreme 
discomfort) (Annex 2). 
2. Sociodemographic and Clinical Questionnaire: This questionnaire will 
characterize the study participants. The sociodemographic section will include 
variables related to biological profile, such as gender and birth date, as well as 
socioeconomic variables like marital status, education, and professional activity. 
Finally, it will cover clinical variables related to gynaecological function, 
comorbidities, and treatments (Annex 3). 
3. DIVA Questionnaire (Day-to-day Impact of Vaginal Aging): This questionnaire 
assesses the impact of vaginal aging on daily life. The original version was 
developed by Alison J. Huang (Annex 4), Director of the Department of Medicine at 
the University of California, San Francisco. It included 745 postmenopausal 
women, from 2008 to 2012, of multiethnic backgrounds with at least one complaint 
of genital atrophy (dryness, burning, irritation, and itching) or pain during sexual 
intercourse. The questionnaire is constructed with a multidimensional scale 
covering 4 domains: (1) daily activities, (2) emotional well-being, (3) sexual function, 
and (4) self-esteem and body image. The full version consists of 23 items, with a 
version for women without sexual activity that includes a "not applicable" option for 
the sexual function domain. The items are scored between 0 and 4, and the overall 
score is the average of the scores in each domain, with higher scores indicating a 
greater impact and severity of genital atrophy symptoms. The internal consistency 
of the original scale in English ranged from 0.47 to 0.72, with Cronbach’s alpha 
between 0.82 and 0.93. Confirmatory factor analysis showed appropriate structural 
validity with a comparative fit index of 0.987 and a standardized root mean square 
residual (SRMR) of 0.038. A measurement property assessment of this symptom 
evaluation questionnaire identified it as one of the best quality and reliable tools for 
assessing female genital atrophy (Annex 1 and 4). 
4. EQ-5D is a generic instrument for measuring health-related quality of life, which 
generates an index representing an individual's health state. Developed by the 
EuroQoL group since 1987 and made public in 1990, it is based on a classification 
system that describes health in five dimensions: mobility, self-care, usual activities, 
pain/discomfort, and anxiety/depression. Each dimension has three associated 
severity levels: no problems (level 1), some problems (level 2), and extreme 
problems (level 3) experienced by the individual. Another measure used is the EQ-
VAS, a 20 cm vertical visual analog scale (VAS) ranging from 0 to 100, where 0 is the 
worst and 100 the best imaginable health. This measure of self-perceived health is 

8 
 
evaluated independently for the subject’s self-perception. It is available in over 130 
languages in various application formats and was validated for European 
Portuguese in 2013 by Ferreira14. It is considered reliable and valid, showing 
moderate to high correlations with other health status and quality of life measures 
for various diseases, and the purpose of using this questionnaire is to verify the 
concurrent validity of DIVA (Annex 5). 
5. FSFI-6 (Female Sexual Function Index) is an instrument developed by Isidori, 
based on the longer version of the original questionnaire but designed for easier 
clinical use, as it is quick to complete but still maintains good internal consistency 
(Cronbach’s alpha of 0.79) and excellent accuracy for differentiating clinical 
populations, with sensitivity and specificity above 94%. It was validated in the 
Portuguese population by Pechorro15, including 6 items that evaluate 6 domains of 
sexuality: desire, satisfaction, excitement, lubrication, orgasm, and pain. This scale 
will be used for convergent assessment of the sexual domain of DIVA (Annex 6). 
4. Inclusion and Exclusion Criteria: 
Inclusion Criteria: Women who agree to participate in the study after giving their informed 
consent (Annex 7) and who report at least one symptom related to genital atrophy, such as 
dryness, itching, burning, irritation, discomfort, or pain when urinating or during 
intercourse, or bleeding during intercourse, affecting the external genitalia (vulva or vagina). 
Exclusion Criteria: Pregnancy, neoplasms under treatment, inability to speak Portuguese, 
or any mental or physical disability that prevents coherent responses to the questionnaire. 
 
5. Recruitment Model: 
The recruitment for the project will be conducted by the researchers involved, and the 
selection of participants will be voluntary and carried out on a convenience basis, in a non-
random manner. 
In all cases, the referred participant must give prior informed consent for referral, by signing 
the informed consent form and verifying that they meet the inclusion criteria and none of 
the exclusion criteria. 
 
6. Informed Consent: 
In accordance with the provisions of the Clinical Research Law (Law No. 21/2014 of April 
16, amended by Law No. 73/2015, July 27), the researcher will provide the informed consent 
document to the volunteer. The information will be provided verbally and in writing, in 
accessible language, and the volunteer will be given time to read the document and ask any 
questions. 
It will be ensured that the participant receives the appropriate information to consent to the 
research procedures, preserving their autonomy and decision-making power regarding 
participation. All information about the project, including its objectives, procedures, 
participant duties and rights, risks and benefits, data handling, civil liability insurance, as 
well as the contact person’s details, will be included. 

9 
 
 
The informed consent will be signed by the volunteer if they agree to participate, and by the 
researcher, in duplicate, with one copy for the participant and another for the researcher. 
The participant can withdraw their informed consent for participation in the project at any 
time, by notifying a member of the research team, preferably in writing, without the need for 
justification, without incurring any form of liability, and without suffering any harm. If the 
participant withdraws their consent, all data collected about that participant will be 
excluded, respecting the right to be forgotten. 
 
7. Participant Confidentiality: 
The participant will not be identified by any of their personal data. To ensure the 
anonymization of the data collected during the study, each participant will be assigned an 
identification number, consisting of an alphanumeric code with 3 digits: the first digit 
corresponds to one of three letters identifying the interview location: A (HDM), B (HSA), C 
(CS7R), while the last two digits correspond to a sequential number for the participant, 
starting from 01. In the case of participants being "re-tested," the code will include an 
apostrophe after the letter. 
In all documents, databases, or others, the participant’s information will only be identified 
by this alphanumeric code. 
Only the Principal Investigator will have access to the list that links the identification 
number to the participant's personal data. This list will be in electronic format with 
restricted access permissions, preventing unauthorized individuals from accessing, 
printing, forwarding, or copying confidential information. 
 
8. Process Implementation: 
• 
Provision of "Link" at the selected data collection units the materials 
(questionnaires, informed consents, and envelopes). 
• 
Distribution of data collection materials to data collection units by colleagues 
interested in collaborating. 
• 
Identification of participants in the clinic, either because they express complaints 
or through regular medical history taken during consultation. 
• 
Invitation to identified participants to complete the questionnaire in the nearest 
waiting room, in a more private space designated for the process. 
• 
Sealing of the envelope in person in the consultation room and placing it in a 
closed box with a slot for insertion. 
• 
Return of completed questionnaires to the Principal Investigator. 
 
9. Data Collection Method: 

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After voluntary recruitment and confirmation of inclusion criteria and the absence of 
exclusion criteria, the possibility of inclusion in the study and the volunteer’s willingness to 
participate will be certified. The Informed Consent Form will be provided for the participant 
to read carefully, while being verbally informed about the details of the study. Once consent 
is obtained, the participant will complete the form, which will include the participant ID 
according to a sequential number assigned to each participant. A researcher will be 
available for any clarification needed during the self-completion of the form. 
 
10. Participant Benefits: 
The participant will not receive any individual benefits apart from the opportunity to 
participate in the study and the chance to raise and clarify any concerns regarding this 
specific and sensitive health issue (female genital atrophy). However, their participation in 
this research project may help other patients receive better healthcare in the future. 
The participant will have the right to request, in writing, the final publication results from the 
Principal Investigator. 
 
11. Data Review and Database Management: 
This project complies with the legal provisions and regulations applicable, namely, the 
Clinical Research Law No. 21/2014 of April 16 in its current version, Law No. 12/2005 of 
January 26 ("Genetic and personal health information"), the General Data Protection 
Regulation, as well as international Good Clinical Practice (GCP) guidelines (International 
Conference on Harmonization). 
 
Signed informed consents will be stored in a secure physical location with restricted access 
specifically for that purpose. The student/Principal Investigator will be responsible for 
entering data into the digital data files (DDF), which will be stored in a specific physical 
location with restricted access. The data from the DDF will be transferred by the 
student/Principal Investigator into a global electronic database, which is secure and has 
restricted access, ensuring that the data is entered completely and accurately. 
Personal data collected within the framework of this research project and shared between 
FMUM/ICVC, IPL/ciTechCare, and the Sete Rios Health Center will be kept in secure files, 
with restricted access, whether electronic or physical, for 15 years after the completion of 
the study, in compliance with current legislation. The personal data identifying the 
participants (list linking the participant’s name to the alphanumeric identification code) will 
only be kept by the Principal Investigator in a secure location, and only the investigator will 
have access to their identity. 
 
The personal data of participants and researchers and the electronic databases will only be 
accessible to authorized members of the research team. Additionally, study data may be 
communicated to the competent Ethics Committees and other entities under the relevant 
clinical trial legislation, who may have access to this data. It will be ensured that all 
individuals or entities with access to personal data are bound by confidentiality 
agreements. 

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The electronic data will have restricted access permissions to prevent unauthorized 
persons from accessing, printing, forwarding, or copying confidential information. 
12. Statistical Analysis: 
An anonymized data sheet will be constructed for statistical treatment to validate the 
questionnaire by determining its reliability and validity using appropriate statistical 
methods. 
 
13. Ethical Considerations: 
This study will be approved by the Administration Council and the Ethics Committee of 
CHL-HSA, the clinical directors of HDMA and UCSP Sete Rios, as well as the Ethics 
Committee of the Lisbon and Tagus Valley Regional Health Administration. 
This clinical study has been designed, and will be implemented, executed, and reported in 
accordance with the current and future amendments of the International Conference on 
Harmonization – Good Clinical Practice (ICH-GCP) guidelines, laws, regulations, and 
ethical codes applicable to the locations where the clinical study is conducted, including 
but not limited to Law No. 21/2014, of April 16, and all decisions and instructions from 
relevant 
authorities, 
boards 
of 
directors, 
and/or 
ethics 
committees. 
All participants will be informed and clarified about the procedures, study objectives, and 
data confidentiality. It will be ensured, prior to data collection, that participation in the study 
is voluntary and informed, and that all participants will be guaranteed the right to withdraw 
from the study at any time, without any penalties. All participants will sign the Informed 
Consent Form, which will be provided in duplicate, one for the participant and the other for 
inclusion in the project. To ensure ethics in data collection, the questionnaires used in the 
study will be given to participants in envelopes, which will be sealed in the participant's 
presence. 
It is emphasized that there are no direct risks from participating in the study that need to be 
disclosed. 
 
14. Publication of Results: 
The dissemination of the study results is part of the research project process, with the 
confidentiality and privacy of the participants' personal data ensured, guaranteeing that 
their identification will not be possible, regardless of the form of result dissemination. This 
is an academic study of a non-commercial nature. 
 
15. Funding: 
The research project budget will be funded by financial instruments in the health sector, 
which are being identified for application, with funding already guaranteed for materials, 
data transportation logistics, and postage. No additional costs are expected for the involved 
entities, including UCSP Sete Rios, HSA, or HDMA, particularly no extra costs for the 
working hours of the staff involved in the study. 
 

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16. Timeline: 
The proposed work plan for this research project, to be carried out in the year 2022, 
involves the following work plan and schedule: 
Tasks 
• 
Literature Review  
2022 
2023 
2024 
2025 
 
• 
Translation and Cultural Adaptation: January to April 2022 
• 
Presentation of the Study to Participating Health Units: April to June 2022 
• 
Protocol Instruction to the Ethics Committees: June to September 2022 
• 
Conducting the Study with Participants: October 2022 to January 2024 
• 
Development of the Digital Database and Statistical Data Analysis: 
2023 
2024 
2025 
 
• 
Scientific Dissemination of the Data: From 2025 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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Bibliography 
 
1.  
Mattos S, Moreira T, Pereira D, et al. INSTRUMENTS FOR MEASURING SELF-PERCEPTED 
HEALTH AMONG ADULTS: A SCOPING REVIEW. Psicol Saúde Doença. 2020;21(03):878-
895. doi:10.15309/20PSD210328 
2.  
Calvert M, King M, Mercieca-Bebber R, et al. SPIRIT-PRO Extension explanation and 
elaboration: guidelines for inclusion of patient-reported outcomes in protocols of 
clinical trials. BMJ Open. 2021;11(6). doi:10.1136/BMJOPEN-2020-045105 
3.  
Eremenco S, Pease S, Mann S, Berry P. Patient-reported outcome (PRO) consortium 
translation process: Consensus development of updated best practices. J Patient-
Reported Outcomes. 2018;2. doi:10.1186/S41687-018-0037-6 
4.  
Mckown S, Acquadro C, Anfray C, et al. Good practices for the translation, cultural 
adaptation, and linguistic validation of clinician-reported outcome, observer-reported 
outcome, and performance outcome measures. doi:10.1186/s41687-020-00248-z 
5.  
Nappi RE, Palacios S, Bruyniks N, Particco M, Panay N. The burden of vulvovaginal 
atrophy on women’s daily living: implications on quality of life from a face-to-face real-
life survey. Menopause. 2019;26(5):485-491. doi:10.1097/GME.0000000000001260 
6.  
Nappi RE, Palacios S, Panay N, Particco M, Krychman ML. Vulvar and vaginal atrophy in 
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7.  
Huang AJ, Gregorich SE, Kuppermann M, et al. Day-to-Day Impact of Vaginal Aging 
questionnaire: a multidimensional measure of the impact of vaginal symptoms on 
functioning and well-being in postmenopausal women. Menopause J North Am 
Menopause Soc. 2015;22(2):144-154. doi:10.1097/gme.0000000000000281 
8.  
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menopause: a systematic review. Menopause. 2019;26(11):1342-1353. 
doi:10.1097/GME.0000000000001390 
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Hunter MM, Guthrie KA, Larson JC, et al. Convergent-Divergent Validity and Correlates 
of the Day-to-Day Impact of Vaginal Aging Domain Scales in the MsFLASH Vaginal Health 
Trial. J Sex Med. 2020;17(1):117-125. doi:10.1016/J.JSXM.2019.10.010 
10.  
Moral E, Delgado JL, Carmona F, et al. The impact of genitourinary syndrome of 
menopause on well-being, functioning, and quality of life in postmenopausal women. 
Menopause. 2018;25(12):1418-1423. doi:10.1097/GME.0000000000001148 
11.  
Gabes M, Stute P, Apfelbacher C. Validation of the German Day-to-Day Impact of Vaginal 
Aging (DIVA) Questionnaire in Peri- and Postmenopausal Women. Sex Med. 
2021;9(4):100382. doi:10.1016/j.esxm.2021.100382 
12.  
Sert B, Özgül S. Turkish day-to-day impact of vaginal aging questionnaire: reliability, 
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online January 27, 2022:1-10. doi:10.1007/S00192-022-05085-W 
13.  
Mokkink Cecilia AC Prinsen Donald L Patrick Jordi Alonso Lex M Bouter LB, Mokkink CL. 
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instruments. Accessed May 15, 2022. www.cosmin.nl 

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Ferreira PL, Ferreira LN, Pereira LN. Contribution for the Validation of the Portuguese 
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Santos Pechorro P, Monteiro Pascoal P, Monteiro Pereira N, Poiares C, Neves Jesus S, 
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Annex 1: Portuguese Version of DIVA Questionnaire 
QUESTIONÁRIO DE IMPACTO DO ENVELHECIMENTO VAGINAL NO DIA-A DIA       
COD:................ 
Estamos interessados em entender o impacto dos sintomas vaginais como: secura 
vaginal, dor, irritação e comichão no seu dia-a-dia. Para cada pergunta abaixo, marque a 
resposta que melhor descreve como as suas atividades, relacionamentos e sentimentos 
foram afetados por qualquer um destes sintomas durante as últimas 4 semanas. 
Parte A. Durante as últimas 4 semanas, quanto é que os sintomas vaginais como: 
secura, ardor, irritação ou comichão, foram desconfortáveis ou interferiram na sua 
capacidade de: 
1. Andar á velocidade habitual? 
□0 Nada       □1 Um pouco    □2 Moderadamente        □3 Bastante        □4 
Extremamente 
  
2. Usar a roupa e lingerie que quer?  
□0 Nada       □1 Um pouco    □2 Moderadamente        □3 Bastante        □4 
Extremamente 
 
3. Usar a casa de banho ou limpar-se após o uso desta? 
□0 Nada       □1 Um pouco    □2 Moderadamente        □3 Bastante        □4 
Extremamente 
 
4. Ficar sentada mais de 1 hora?  
□0 Nada       □1 Um pouco    □2 Moderadamente        □3 Bastante        □4 
Extremamente 
 
5. Ter uma boa noite de sono? 
□0 Nada       □1 Um pouco    □2 Moderadamente        □3 Bastante        □4 
Extremamente 
 
Parte B. Durante as últimas 4 semanas, com que frequência os sintomas vaginais 
como: secura, ardor, irritação ou comichão, fizeram com que se sentisse: 
6. Deprimida ou em baixo? 
□0 Nunca      □1 Raramente      □2 Às vezes        □3 Frequentemente   □4 Quase 
sempre 
 
7. Embaraçada? 
□0 Nunca      □1 Raramente      □2 Às vezes        □3 Frequentemente    □4 Quase 
sempre 
 

16 
 
8. Frustrada ou ressentida? 
□0 Nunca    □1 Raramente       □2 Às vezes        □3 Frequentemente    □4 Quase 
sempre 
 
9. Mal consigo própria? 
□0 Nunca    □1 Raramente       □2 Às vezes        □3 Frequentemente    □4 Quase 
sempre 
 
 
Parte C. As perguntas que se seguem são sobre o impacto dos seus sintomas, nas 
relações sexuais e outros tipos de atividade sexual, como autoestimulação ou 
masturbação. Durante as últimas 4 semanas, sintomas vaginais como: secura, ardor, 
irritação ou comichão, afetaram: 
 
10. O seu desejo ou interesse em ter relações sexuais ou outros tipos de atividade sexual 
(autoestimulação ou masturbação)? 
□0 Nada       □1 Um pouco    □2 Moderadamente        □3 Bastante        □4 
Extremamente 
□ Não aplicável- não tive atividade sexual de nenhum tipo recentemente. 
 
11. A frequência com que teve relações sexuais, ou outros tipos de atividade sexual 
(incluindo autoestimulação ou masturbação)?  
□0 Nada       □1 Um pouco    □2 Moderadamente        □3 Bastante        □4 
Extremamente 
□ Não aplicável- não tive atividade sexual de nenhum tipo recentemente. 
 
12. A sua capacidade de ficar excitada durante a atividade sexual (incluindo 
autoestimulação ou masturbação)? 
□0 Nada       □1 Um pouco    □2 Moderadamente        □3 Bastante        □4 
Extremamente 
□ Não aplicável- não tive atividade sexual de nenhum tipo recentemente. 
 
13. A sua capacidade de espontaneamente se dedicar á atividade sexual (incluindo 
autoestimulação e masturbação)? 
□0 Nada       □1 Um pouco    □2 Moderadamente        □3 Bastante        □4 
Extremamente 
□ Não aplicável- não tive atividade sexual de nenhum tipo recentemente. 
 

17 
 
14. A sua capacidade de relaxar e desfrutar da atividade sexual (incluindo 
autoestimulação ou masturbação)? 
□0 Nada       □1 Um pouco    □2 Moderadamente        □3 Bastante        □4 
Extremamente 
□ Não aplicável- não tive atividade sexual de nenhum tipo recentemente. 
 
15. O nível de prazer que experienciou durante a atividade sexual (incluindo 
autoestimulação ou masturbação)? 
□0 Nada       □1 Um pouco    □2 Moderadamente        □3 Bastante        □4 
Extremamente 
□ Não aplicável- não tive atividade sexual de nenhum tipo recentemente. 
 
 
16. O seu desejo ou interesse em ter um relacionamento sexual? 
□0 Nada       □1 Um pouco    □2 Moderadamente        □3 Bastante        □4 
Extremamente 
□ Não aplicável- não tive atividade sexual de nenhum tipo recentemente. 
 
17. A sua confiança em ser capaz de satisfazer sexualmente um parceiro(a)? 
□0 Nada       □1 Um pouco    □2 Moderadamente        □3 Bastante        □4 
Extremamente 
□ Não aplicável- não tive atividade sexual de nenhum tipo recentemente. 
 
18. A sua satisfação geral com a sua vida sexual? 
□0 Nada       □1 Um pouco    □2 Moderadamente        □3 Bastante        □4 
Extremamente 
□ Não aplicável- não tive atividade sexual de nenhum tipo recentemente. 
 
Parte D. As afirmações que se seguem descrevem a forma pela qual os seus 
sintomas vaginais podem ter afetado o que sente por si e pelo seu corpo. Por favor, 
indique o quão verdadeira cada uma das seguintes afirmações foi para si durante as 
últimas 4 semanas. 
19. Os meus sintomas vaginais fazem sentir-me como se estivesse a envelhecer. 
□0 Nada       □1 Um pouco    □2 Às vezes       □3 Muitas vezes        □4 Sempre 
 
20. Sinto-me indesejável devido aos meus sintomas vaginais. 

18 
 
□0 Nada       □1 Um pouco    □2 Às vezes       □3 Muitas vezes        □4 Sempre 
 
21. Quando penso nos meus sintomas vaginais, sinto como se tivesse perdido algo. 
□0 Nada       □1 Um pouco    □2 Às vezes       □3 Muitas vezes        □4 Sempre 
 
22. Os meus sintomas vaginais fazem-me sentir como se o meu corpo se estivesse a 
deteriorar 
□0 Nada       □1 Um pouco    □2 Às vezes       □3 Muitas vezes        □4 Sempre 
 
23. Sinto-me menos sexualmente atraente (sexy) devido aos meus sintomas vaginais. 
□0 Nada       □1 Um pouco    □2 Às vezes       □3 Muitas vezes        □4 Sempre 
 
Agradecemos as suas respostas. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

19 
 
Annex 2: Symptom Questionnaire 
Objective: To correctly identify your genital discomfort (vagina and vulva). Please describe 
the discomfort caused by each of the following symptoms. If you do not have this 
complaint, please mark as "no discomfort". 
Symptom Classification: 
□ 1 - No Discomfort 
□ 2 - Mild Discomfort 
□ 3 - Moderate Discomfort 
□ 4 - Intense Discomfort 
 
1. Vaginal or Vulvar Dryness 
□ 1 No Discomfort 
□ 2 Mild Discomfort 
□ 3 Moderate Discomfort 
□ 4 Intense Discomfort 
2. Vaginal or Vulvar Irritation 
□ 1 No Discomfort 
□ 2 Mild Discomfort 
□ 3 Moderate Discomfort 
□ 4 Intense Discomfort 
3. Vaginal or Vulvar Itching 
□ 1 No Discomfort 
□ 2 Mild Discomfort 
□ 3 Moderate Discomfort 
□ 4 Intense Discomfort 
4. Vaginal or Vulvar Burning or After Sexual Intercourse 
□ 1 No Discomfort 
□ 2 Mild Discomfort 
□ 3 Moderate Discomfort 
□ 4 Intense Discomfort 
5. Vulvar or Vaginal Discomfort or After Sexual Intercourse 
□ 1 No Discomfort 
□ 2 Mild Discomfort 
□ 3 Moderate Discomfort 
□ 4 Intense Discomfort 
6. Pain During Sexual Intercourse 
□ 1 No Discomfort 
□ 2 Mild Discomfort 
□ 3 Moderate Discomfort 
□ 4 Intense Discomfort 
7. Bleeding or Unpleasant Odor During or After Sexual Intercourse 
□ 1 No Discomfort 

20 
 
□ 2 Mild Discomfort 
□ 3 Moderate Discomfort 
□ 4 Intense Discomfort 
 
Of these 7 symptoms, the one that bothers you the most or disturbs your life the most 
is: 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

21 
 
Annex 3: Sociodemographic and Clinical Questionnaire 
Questionnaire: ____________ 
Age: _______ years    Height: ________ cm    Weight: _________ kg 
1. Ethnicity: 
o 
White (European, Hispanic, North African, Middle Eastern) 
o 
Black (African, Caribbean, African American) 
o 
South Asian (Indian, Pakistani, Bangladeshi) 
o 
East Asian (Chinese, Japanese, Korean) 
o 
Other 
2. Marital Status: 
o 
Single 
o 
Cohabiting 
o 
Married 
o 
Divorced 
o 
Widowed 
3. Education Level: 
o 
Up to 4th grade 
o 
5th to 9th grade 
o 
10th to 12th grade 
o 
Bachelor's degree 
o 
Master's/Doctorate 
4. Employment Status: 
o 
Employed 
o 
Retired 
o 
Unemployed 
5. Current Occupation (or previous occupation if retired): 
o 
Executive/Manager 
o 
Specialist in intellectual and scientific professions 
o 
Technicians and intermediate-level professionals 
o 
Administrative and similar staff 
o 
Service personnel and salespeople 

22 
 
o 
Industrial workers, agriculture, cleaning 
6. Profession: _____________________________ 
7. Do you smoke? 
o 
Yes 
o 
No 
8. Do you drink wine weekly (more than 3 glasses)? 
o 
Yes 
o 
No 
9. Type of residence: 
o 
Owned 
o 
Rented 
o 
Shared 
o 
Apartment 
o 
House 
o 
Nursing home 
10. Menopausal status: 
o 
Perimenopausal 
o 
Don't know 
o 
Postmenopausal 
Age of menopause: _______ years 
11. Ner of pregnancies: _____Ner of vaginal births: _____ Ner of caesarean sections: 
________ 
 
12. Gynecological surgeries: 
o 
No 
o 
Yes 
If yes, which ones: _______________________________ 
13. Hormonal treatments (creams or vaginal suppositories): 
o 
No 
o 
Yes 
If yes, which one: ____________ 
14. Do you use vaginal lubricants? 
o 
No 
o 
Yes 

23 
 
Do you use vaginal moisturizers? 
o 
No 
o 
Yes 
14. Contraceptive treatments (pills, patches, implants, devices): 
o 
No 
o 
Yes 
15. Hormonal treatment for menopause: 
o 
No 
o 
Yes 
If yes, which one: ________________________ 
16. Current sexual activity: 
o 
Yes 
o 
No 
Number of years without intercourse: ________ 
17. Do you leak urine when coughing? 
o 
No 
o 
Yes 
18. Do you feel that the walls of your vagina are prolapsed or loose? 
o 
No 
o 
Yes 
19. Do you have diabetes? 
o 
No 
o 
Yes 
 
Do you take medication for diabetes? 
o 
Yes 
o 
No 
20. Do you have high blood pressure? 
o 
No 
o 
Yes 
Do you take medication for high blood pressure? 
o 
Yes 

24 
 
o 
No 
21. Do you have difficulty sleeping? 
o 
No 
o 
Yes 
Do you have anxiety? 
o 
No 
o 
Yes 
22. Have you had cancer? 
o 
No 
o 
Yes 
If yes, where: ______________________________________ 
23. Have you undergone chemotherapy/radiotherapy? 
o 
No 
o 
Yes 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

25 
 
Annex 4 – DIVA English Version 
 

26 
 
 

27 
 
 
 
 
 
 
 
 

28 
 
Annex  5: EuroQol 5D 
 
 
 

29 
 
 

30 
 
Annex 6; Female Sexual Function Index (short version 6) 
1. Over the past 4 weeks, how often did you feel sexual desire or interest?  
Please circle your response and enter the score below  
5 = Almost always or always  
4 = Most times (more than half the time)  
3 = Sometimes (about half the time)  
2 = A few times (less than half the time)  
1 = Almost never or never  
Score:_____  
2. Over the past 4 weeks, how often did you feel sexually aroused “turned on” during 
sexual activity or intercourse?  
 
Please circle your response and enter the score below  
0 = No sexual activity  
5 = Almost always or always  
4 = Most times (more than half the time)  
3 = Sometimes (about half the time)  
2 = A few times (less than half the time)  
1 = Almost never or never  
Score:_____ 
 
3. Over the past 4 weeks, how often did maintain your lubrication (“wetness”) until 
completion of sexual activity/ intercourse?  
Please circle your response and enter the score below  
0 = No sexual activity  
5 = Almost always or always  
4 = Most times (more than half the time)  
3 = Sometimes (about half the time)  
2 = A few times (less than half the time)  
1 = Almost never or never  
Score:_____  

31 
 
4. Over the past 4 weeks, when you had intercourse, how difficult was it for you to reach 
orgasm (climax)?  
 
Please circle your response and enter the score below  
0 = No sexual activity  
1 = Extremely difficult or impossible 
2 = Very difficult  
3 = Difficult  
4 = Slightly difficult  
5 = Not difficult  
Score:_____  
 
5. Over the past 4 weeks, how satisfied have you been overall with your sex life?  
Please circle your response and enter the score below  
5 = Very satisfied  
4 = Moderately satisfied  
3 = About equally satisfied and dissatisfied  
2 = Moderately dissatisfied  
1 = Very dissatisfied  
Score:_____ 
 
6. Over the past 4 weeks how often did you experience pain or discomfort during 
vaginal penetration?  
Please circle your response and enter the score below  
0 = Did not attempt intercourse  
1 = Almost always or always  
2 = Most times (more than half the time)  
3 = Sometimes (about half the time)  
4 = A few times (less than half the time)  
5 = Almost never or never  
Score:_____ 
 

32 
 
Annex 7 – Informed Consent 
INFORMED, FREE, AND VOLUNTARY CONSENT FOR PARTICIPATION IN RESEARCH 
You are being invited to participate in the study: "Cross-cultural adaptation to Portuguese 
and psychometric validation of the DIVA questionnaire (Day-to-day Impact of Vaginal 
Aging) - Impact of vaginal aging on daily life." This study is being conducted by Dr. Andreia 
Antunes as part of her PhD project at the University of Minho, involving several healthcare 
professionals, such as doctors and researchers. The aim of this research is to validate a 
clinical questionnaire for the Portuguese population to identify complaints related to genital 
atrophy and how it impacts the quality of life of women. Self-administered questionnaires 
will be used, but you may clarify any doubts with the person handing you the questionnaire. 
You are expected to respond to the following questionnaires: 
1. Genital Symptoms Questionnaire 
2. Sociodemographic and Clinical Data Questionnaire, which will evaluate possible 
factors associated with genital atrophy. 
3. DIVA Questionnaire (Day-to-day Impact of Vaginal Aging), which evaluates the 
impact of genital atrophy symptoms on: 
o 
(1) Daily activities, 
o 
(2) Emotional well-being, 
o 
(3) Sexual functioning, 
o 
(4) Self-esteem and body image. 
4. EQ-5D, which evaluates your general quality of life. 
5. Female Sexual Function Index (FSFI-6), which evaluates female sexual function. 
The total time for completing the questionnaires will be approximately 20 minutes. You may 
feel discomfort in responding to the questionnaires, and certain questions may evoke 
unpleasant memories due to potential references to anatomical or functional changes. To 
minimize discomfort, the questionnaire will be completed individually. Participation in the 
study is voluntary and can be withdrawn at any time without any penalty. There is no cost or 
risk involved in participating. 
The data collected will be used exclusively for this study, ensuring anonymity and 
confidentiality. The identification of participants will not be disclosed. The researcher is 
available for any clarifications. 
After reading and understanding this document, I declare that I agree to participate in this 
study and allow the use of the data I voluntarily provide. The informed consent will be 
completed in duplicate, one for inclusion in the project and the other for the participant. 
 
 
PARTICIPANT IDENTIFICATION AND CONSENT 
Full Name: _____________________________________________ 

33 
 
ID Number: _____________________________________________ 
 
POST-INFORMED CONSENT: 
I declare that, on //____, I agreed to participate as a subject in the research project entitled 
“Cross-cultural adaptation to Portuguese and psychometric validation of the DIVA 
questionnaire (Day-to-day Impact of Vaginal Aging) - Impact of Vaginal Aging on Daily 
Life” after being fully informed about the study’s objectives, purpose, and terms of my 
participation. The information provided to the researchers will be used solely for the 
objectives and purposes of the research project, ensuring my identification remains 
confidential under the responsibility of the project proponents (Andreia Antunes, email: 
id10188@alunos.uminho.pt). 
I will not receive any compensation, nor will I incur any financial costs as a result of my 
voluntary consent to participate in this research project.