Introduction
Chronic pelvic pain (CPP) is a complex and multifactorial condition, defined by the
American College of Obstetricians and Gynecologist as pain in the pelvic area that
lasts for ≥ 6 months, is intermittent or constant, cyclic or noncyclic, and strong
enough to cause functional disturbances or require medical care.[1]
[2] It is a health problem estimated to affect between 6 and 27% of women worldwide.[3] This disease is responsible for 20% of gynecological consultations, and 45% of reduced
productivity at work leading to significant socioeconomic expenses and rates of up
to 66% of association with anxiety and 63% with depression.[4]
[5]
[6] Its etiology is quite complex due to the interaction between gynecological, gastrointestinal,
urological, musculoskeletal, and psychological disorders with potential mechanisms
that lead to sensitization of the nervous system.[7] It is estimated that only 30% of the etiologies attributed to CPP are primarily
gynecological,[2] with endometriosis as the main cause, with a rate of 24 to 40%.[8] However, CPP of unknown etiology accounts for up to 55% of cases.[5] Additionally, given the variable, multifactorial, and uncertain nature of the etiology
of this syndrome, the difficulty in accurately diagnosing it, and considering CPP
a condition with symptoms that are associated with behavioral, affective, social,
and cognitive consequences, it is of utmost importance to use a specific questionnaire
that addresses these domains and is aimed at comprehensively evaluating all aspects
related to CPP.[5]
[9]
The process of translating, adapting and cross-culturally validating a health questionnaire
to a new language, culture, or country, requires a unique method that maintains equivalence
between the original and the new version.[10]
[11] Recent reviews in the literature suggest that questionnaire translations should
be conducted through guidelines to ensure cultural and linguistic quality. However,
current guidelines focus exclusively on the translation and adaptation process, which
transforms the questionnaire, but does not cover the validation process that assesses
the quality of the questionnaire, which is considered a separate methodological process
although both seem to be conjoined.[12]
Moreover, Beaton et al. suggest a cross-cultural adaptation guideline based on the
first step of the three stages of the process adopted by the Society for Quality of
Life Assessment (IQOLA).These guidelines follow six phases that are very similar among
most authors: I – initial translation; II – synthesis of the translation; III – backtranslation;
IV – expert committee review; V – test of the prefinal version; VI –submission of
the document to the developers or coordination committee for appreciation of the adaptation
process.[11]
The validation stage of instrument formation tends to be more contested by reviewers.
Several instruments for measuring this validation process were created; however, they
were considered somewhat confusing and ended up being based on an empirical demonstration
of the adaptation of this instrument in the target population.[10]
Considering the complex nature of CPP, the importance of a precise diagnosis, and
the diverse multinational and multicultural characteristics of quality of life questionnaires
in their original languages, as well as the necessity to adapt these measures for
Brazilian research projects, we undertook the translation, adaptation, and validation
process of the Pelvic Health History Form, a quality of life questionnaire revised
in June 2019 by the International Pelvic Pain Society (IPPS), specifically for the
Portuguese language, aimed at facilitating the diagnosis of CPP within our settings,
which lack dedicated questionnaires available in Portuguese.
The objective of the present study was to carry out the translation, adaptation, and
validation of the quality of life questionnaire Pelvic Health History Form of the
IPPS into Portuguese.
Methods
A protocol was developed for the translation and validation of the QoL Pelvic Health
History Form questionnaire from the IPPS into the Portuguese language. The flowchart
outlines the steps involved in this process, with the original English version revised
in June 2019 serving as the foundation. Upon submission and approval of the project
by the Investigation Review Board (IRB) under CAAE 40166520.8.0000.5479, and with
consent from the IPPS, the methodology of "Cross-Cultural Adaptation" was employed
following six detailed phases as described below.[10]
[11] ([Flowchart 1]).
-
I – Initial translation: the instrument was translated into Portuguese by a bilingual
Brazilian translator with an American Translator Association (ATA) English to Portuguese
Certification #464880 who worked independently and had no understanding regarding
the purpose of the study, generating the Portuguese version (T1).
-
II – Translation synthesis: the document was then reviewed by a specialist in the
field of chronic pelvic pain and gynecology (Ribeiro H. S. A. A.) who was aware of
the objective of the study and made her considerations based on her knowledge of the
subject in question.
-
III – Backtranslation: the revised version was backtranslated into English by two
other native Portuguese-speaking bilingual individuals, one of them mastering the
theme and object of the study in question and the other non-mastering, generating
two new versions in English (BT1 and BT2).
-
IV – Expert Committee: in the prefinal phase, a committee of experts formed by two
gynecologists with expertise in CPP (Ribeiro H. S. A. A. and Silva J. C. R.), a physiotherapist
(RFC) and two bilingual translators (Brito L. G. O. and Ribeiro P. A. A. G.) compared
all versions (T1, BT1, and BT2) with the original in English. Necessary adjustments
and adaptations were made to obtain the appropriate prefinal version of the questionnaire
in Portuguese.
-
V – Testing of the Prefinal version: this version of the questionnaire was applied
in a self-test format to a sample of 14 women, randomly selected at the Gynecological
Endoscopy and Endometriosis Division of Santa Casa de Misericórdia de São Paulo from
June 22 to June 29, 2022. Inclusion criteria were patients with complaints of pelvic
pain for > 6 months, aged between 18 and 45 years old, sexually active, and still
in menacme. Exclusion criteria included menopausal patients, prior hysterectomy patients,
and patients previously treated for pain with medication or surgery patients.
Flowchart 1 Detailed phases of the process.
To assess cultural adaptation and validation, each patient was led to a private room
and invited to participate in the study. Patients were explained the purpose of the
questionnaire followed by the signing of the informed consent form. The test was applied
individually so that the patient herself answered the questionnaire without help.
They were instructed to leave the topics they did not understand unanswered. Immediately
after each application, semistructured interviews were carried out for a careful analysis
of each item, including their responses addressing their understandings and difficulties
in interpretation and responses during the previous phase in order to evaluate the
semantic, idiomatic, conceptual, and experiential equivalence with the committee of
experts. For statistical purposes, positive responses were considered when the patients
had a good reaction to the question.
After this step, a statistical analysis of the response rates for each item and subitem
of the questionnaire was performed.[12]
[13] We evaluated the rate of nonresponses in each item and subitems in order to identify
which questions would be culturally incompatible (defined as those with ≥ 15% of nonresponses),
so that they could be adapted appropriately. These questions were selected and reviewed
by the expert committee to assess the increased rates of nonresponses, focusing on
adapting them culturally, while also preserving the same concept in a manner that
the structure and evaluation properties of these questions were not altered. After
conducting a comprehensive analysis, the committee of translation experts engaged
in insightful discussions to identify areas for enhancement and implement necessary
adaptations to the questionnaire. As a result, the final version was successfully
completed, ensuring semantic, grammatical, experiential, and conceptual equivalence
of the QoL questionnaire in Portuguese. The validated instrument was then submitted
to the IPPS for approval and recognition ([Supplementary Material Annex 1]).
Results
The demographic profile of the sample, as presented in [Table 1], indicated that the patients had a mean age of 34.5 years old (standard deviation
[SD]: 8.2), the majority of patients self-identified as white (42.9%) and were married
(42.9%), half of the patients reported being sexually active with men (50%), ∼ 70%
of the sample had completed high school and/or higher education, more than half of
the participants (57.1%) were employed outside the home, and an equal percentage (57.1%)
lived with a partner.
Table 1
Demographic dada
|
n
|
%
|
Mediam/SD/Min-Max
|
|
Age (years old)
|
12
|
–
|
34,5 (8,2) (21-44)
|
|
Ethnicity
|
–
|
–
|
–
|
|
White
|
6
|
42.9
|
–
|
|
Black
|
5
|
35.7
|
–
|
|
Other
|
3
|
21.4
|
–
|
|
Marital status
|
–
|
–
|
–
|
|
Single
|
2
|
14.3
|
–
|
|
Married
|
6
|
42.9
|
–
|
|
Widowed
|
1
|
7.1
|
–
|
|
Stable relationship
|
4
|
28.6
|
–
|
|
No answer
|
1
|
7.1
|
–
|
|
Sexual practice
|
|
|
–
|
|
Sexually active with men
|
7
|
50.0
|
–
|
|
Sexually active with women
|
3
|
21.4
|
–
|
|
Abstinent
|
3
|
21.4
|
–
|
|
No answer
|
1
|
7.1
|
–
|
|
Level of Education
|
|
|
–
|
|
< 12 years of study
|
2
|
14.3
|
–
|
|
Complete high school
|
5
|
35.7
|
–
|
|
Complete university education
|
5
|
35.7
|
–
|
|
No answer
|
2
|
14.3
|
–
|
|
Type of work
|
|
|
–
|
|
Unemployed
|
3
|
21.4
|
–
|
|
Works outside home
|
8
|
57.1
|
–
|
|
Homemaker
|
3
|
21.4
|
–
|
|
Coexistence
|
|
|
–
|
|
Alone
|
1
|
7.1
|
–
|
|
Partner
|
8
|
57.1
|
–
|
|
Relatives
|
3
|
21.4
|
–
|
|
Another family member
|
2
|
14.3
|
–
|
Abbreviation: SD, standard deviation.
Following the administration of the instrument and conducting individual interviews
for questionnaire analysis, we obtained positive and satisfactory results. Most patients
showed good acceptance of the instrument as indicated by their favorable evaluation
of the concepts addressed. These findings are summarized in [Table 2], which was created based on the analysis of the questions asked during the semistructured
cognitive interviews.
Table 2
Evaluation of positive responses per item n (%) of patients with chronic pelvic pain
at the gynecological endoscopy and endometriosis outpatient clinic
|
Question
|
n (%)
|
|
1. Does the questionnaire represent the pain you feel?
|
14 (100%)
|
|
2. Has everything you feel been addressed? Or was something missing?
|
14 (100%)
|
|
3. Do you believe that the instrument will help health professionals to better understand
your pain?
|
14 (100%)
|
|
4. Did you understand everything that was asked? If not, what did you not understand?
|
9 (64.3%)
|
|
5. Did you have difficulty with any answers?
|
3 (21.4%)
|
|
6. Did you have difficulty with any specific words or interpretations?
|
13 (92.9%)
|
|
7. Were you embarrassed to answer?
|
14 (100%)
|
|
8. Did you find it time consuming? And how long do you think it took to respond?
|
4 (28.6%)
|
|
9. Do you think the questionnaire could be shortened?
|
8 (57.1%)
|
|
10. What did you think of the questionnaire? Do you believe it will be useful in helping
your diagnosis?
|
14 (100%)
|
Among the questions that did not receive 100% positive responses, we noticed that
in item 4, which asked if patients understood everything they were asked, the majority
(64.3%) understood most of the questionnaire. However, some patients highlighted flaws
and left certain questions blank (items 11 and 12) due to confusion caused by the
translated image tables. Regarding item 5, which asked if there were difficulties
with any response, 21.4% of the participants experienced difficulties with the response
format for item 11, which was based on the McGill pain quality approach. In item 6,
which inquired about difficulties with specific words or interpretations, 7.1% of
the participants had trouble understanding the word vesicais (item 14), which addressed infecções urinárias frequentes. Moreover, these observations provide valuable feedback on areas that may require
further clarification or refinement in the translated instrument. Regarding the time
to complete the form, when asked in question 8 if they found it time-consuming and
how long they estimated it took to answer, only 35.7% of the patients did not consider
it time-consuming, while 28.6% thought it was time consuming, and 35.7% thought it
was just a bit time consuming. Overall, patients were dissatisfied with the time it
took to complete the questionnaire. The perception of time varied from 10 to 60 minutes
(median of 32.5 minutes), while the reality of scheduled time ranged from 31 to 75 minutes
(median of 58.0 minutes). The comparison between the perceived time and the actual
scheduled time was assessed using the p-value obtained from the Wilcoxon test, as
presented in [Table 3].
Table 3
Assessment of perception of time in minutes by patients with chronic pelvic pain
|
n
|
median (min–max)
|
p-value
|
|
Perception
|
12
|
32.5 (10–60)
|
< 0.001[**]
|
|
Real time
|
13
|
58.0 (31–75)
|
** p-value obtained by the Wilcoxon test.
A little over half of the participants (57.1%) expressed that, despite its length,
the questionnaire should not be shortened. They believed that all the questions included
were important, which was evident when asked if they thought the questionnaire could
be shortened. During the statistical analysis of the questionnaire responses, we examined
a total of 42 items/subitems. Among these, we identified 18 that were deemed culturally
inappropriate, based on the criterion of response absence rate > 15%. These findings
are depicted in [Fig. 1].
Fig. 1 Percentage of responses per item.
Discussion
Our study was inspired by the understanding of the complexity of CPP and the realization
that there is no extensive questionnaire available that could guide us more easily
towards the diagnosis of the disease. Therefore, we chose to carry out the translation,
adaptation, and validation into Portuguese of the quality of life questionnaire Pelvic
Health History Form of the International Pelvic Pain Society revised in June 2019.
The process of cross-cultural adaptation and validation is indeed lengthy, but it
holds significant importance in adapting multinational/cultural quality questionnaires
and promoting the use of these measurements in Brazilian research projects.
As the literature suggests, the guidelines used in the questionnaire translation process
were based on the cross-cultural adaptation of the medical, sociological, psychological,
and methodological literature, resulting in a complete adaptation process that conferred
a semantic, idiomatic, experiential, and conceptual equivalence between the source
country (USA) and target country (Brazil) questionnaires, as well with several other
already recognized questionnaires.[10]
[11]
[12]
[14]
[15]
[16]
[17]
[18]
[19]
The backtranslations demonstrated a high level of agreement with the original English
version. Cognitive interviews conducted with semistructured questions indicated excellent
acceptability and comprehension of the questionnaire, consistent with previous findings
by other researchers ([Table 2]).[18]
[19] All respondents regarded the items as relevant (questions 1, 2, and 3), non-offensive
(question 7), and useful (question 10). Approximately 64% of the patients found the
questions to be easily understandable (question 4), and there were minimal difficulties
encountered regarding specific terminology or the interpretation of questions and
answers (questions 5 and 6). None of the participants suggested any modifications
to the instrument, although over half of them (64.3%) acknowledged that the questionnaire
could be perceived as “time-consuming” or “slightly time-consuming"; however, they
did not think it should be reduced (57%).
An important consideration is the method of questionnaire administration. In the literature,
we observed that the SF-36 questionnaire was designed to be a straightforward instrument,
with clear and easily understandable direct questions, typically administered in a
self-report format. A crucial characteristic of a questionnaire is its reasonable
application time. In comparison with the translation and validation study of the SF-36,
which reported an average application time of 7 minutes, our study recorded an average
time of 58 minutes. This discrepancy may explain the higher rate of unanswered questions
as the patients did not exhibit difficulties with the questions during the interviews
themselves.
The translated questionnaire utilized simple language, making it easy to understand
and easy to self-administer. Although a few items analyzed showed a higher rate of
unanswered response (above or equal to the acceptable threshold of 15%), primarily
in questions related to contact information (item 1), professional contact information
(item 2), clinical history (item 4) and surgical history (item 5), menstrual history,
birth control, and STIs (items 6A, 6B, 6C, 6D, and 6H), allergies and medications
(items 7A and 7B), obstetric history (8B), history, description, and contributing
factors of pain (10A , 10B, and 10D), location of pain, intensity scales and treatments
performed (11A, 11B, 11D, and 11F), most of these instances were due to a lack of
attention, often precipitated by the lengthy completion time of the questionnaire.
As identified through the cognitive interview, there was no need to modify the content
of the questions or answers, hence only minor text formatting corrections were made.
During the cognitive interview, a comprehensive analysis of all items in the translated
questionnaire was conducted, comparing the findings with the completion statistics.
The most significant observations were carefully examined and discussed. Regarding
item 1, which focused on contact information, although all participants indicated
their understanding of the question, many were reluctant to provide personal identification,
even though they were assured of data confidentiality. This justified the slightly
higher response rate, which remained above the recommended threshold of 15%. Additionally,
in this item, it was decided to adapt the response options by including "Portuguese"
as an answer choice for preferred language of communication.
Furthermore, in item 6D, where participants were asked about the duration of their
menstrual cramps, it was found that 64.3% did not provide a response. Many participants
explained that they experienced pain but not specifically cramps. Therefore, it was
determined to modify the term to "menstrual pain" instead of "menstrual cramps" to
better align with participants' experiences. Regarding the item addressing ethnicity
(item 3), although it was considered culturally appropriate based on the response
rate, it was decided to adapt it according to the race classification defined by the
Brazilian Institute of Geography and Statistics (IBGE, in the Portuguese acronym)
to ensure consistency with the categorization of the population. These adaptations
and modifications were made to enhance the clarity, relevance, and cultural appropriateness
of the questionnaire based on the cognitive interview feedback.
The study findings indicated that the utilization of simple, objective, and direct
questions with minimal descriptors was associated with a lower rate of unanswered
responses. Notably, items 8A, 10E, 10G, 10H, 10I, 10K, and 10L achieved a complete
response rate of 100% without any reported difficulties by the participants
The assessment of pain location, intensity, and characteristics, as well as psychological
aspects, were based on questionnaires already recognized, translated, and validated
into Portuguese. These included the short version of the McGill Questionnaire, the
Visual Analogue Scale (VAS), the short form of the Pain Intensity Scale, the Sexual
Function Profile PROMIS version for women, men, and global health, and the Pain Catastrophizing
Scale (PCS) and the DASS-2.
Regarding the characteristics of pain in the short version of the McGill questionnaire
contained in item 11B, 9 patients (64.3%) did not provide a response. This observation
raises several considerations. Notably, the patients encountered the greatest difficulty
in answering this particular item, likely due to the complex evaluation format employed
in the original proposed form. In addition, the example formatting was less prominent,
and there was a formatting error in the answer table, which led to confusion and subsequent
difficulty in understanding and responding. In comparison, the other scales mentioned
in this form were found to have clearer questions and answers, resulting in a higher
response rate (items 11C/D/E and 15). However, since there was no semantic and conceptual
difficulty, it was decided to keep the translation according to the original McGill
content and highlight only its presentation form to facilitate understanding. The
McGill Questionnaire (MPQ) was initially developed in 1970 and has since been considered
as an important tool for the quantitative assessment of subjective pain experiences.
Its shorter version was developed a decade later (Sort Form-MPQ), consisting of 15
descriptors (11 sensory and 4 affective) and complemented with the VAS and the verbal
scale of pain in the present moment (present pain intensity [PPI]). In our questionnaire,
derived from this instrument, we maintained the anatomical map from the original version,
along with the 15 descriptors and their qualitatively classified intensities (mild,
moderate, and severe). Additionally, items were included to assess the duration of
the pain, the guided location using the anatomical map, and the VAS. The purpose of
this item is to evaluate the location, duration, type, and qualitative intensity of
pain. However, the formatting of this item was found to be generalized and visually
complex, leading to some confusion during its completion, even among the expert professionals
who assisted in validating the questionnaire. Despite this issue, it was determined
that the official translation provided by Menezes Costa et al. in 2011, which had
already undergone validation, would be retained for consistency.[20]
[21]
As mentioned in the translation and validation study conducted by Flynn et al. in
2013, the subitem 11D of our questionnaire includes the SexFS Version 1.0 from PROMIS.
This questionnaire was specifically designed to assess sexual function and satisfaction
in both males and females, comprising a total of 81 items.[22] The psychometric properties of this instrument were evaluated using both quantitative
(development scales) and qualitative (psychometric evaluation) measures, providing
researchers with information regarding its reliability and validity as a measure of
sexual function and satisfaction for both genders. However, it is worth noting that
a criticism of this study is the lack of testing the male version on male participants.
The Global Health Scale v1.1, developed by PROMIS, is notable for its ability to assess
overall perceptions of physical, mental, and social health using a limited number
of items. This scale consists of a total of 10 items and can be completed in a short
time, ∼ 2 minutes. The scale has been previously translated and validated by Zumpano
et al. in 2017. In our questionnaire, the eight items used for scoring are included
from this instrument, as well as the item Global 07 from the original scale. However,
there are no fields or cutoff points provided for evaluating the results. It should
be noted that the global nonscoring question 08, which asks about fatigue, is absent
in our version, which may be considered a limitation of the original IPPS questionnaire.[23] The DASS-21 questionnaire, a shortened version of the DASS questionnaire, is included
in our questionnaire as item 15. It consists of three subscales, each containing seven
items that assess emotional aspects such as depression, anxiety, and stress. The questionnaire
consists of a total of 21 items that are rated on a 4-point Likert scale. The translation
and adaptation of the DASS-21 to Brazilian Portuguese was conducted by Vignola et
al. in 2014,[24] following a methodology similar to the cross-cultural method used in our study.
The translation process involved multiple iterations of translation, revision, backtranslation,
and finalization. It takes approximately 30 minutes to complete the DASS-21 questionnaire.
It should be noted that in the original IPPS questionnaire, the last item of the DASS-21
questionnaire was replicated, while the last item of the original DASS-21 version
contains a different statement. This discrepancy may indicate a potential flaw in
the original version of the questionnaire. It was observed that, despite all these
QoL questionnaires having their scales and classification scores already predefined,
none of these questionnaires (items 11A/D/E and 15) contained in the form provide
fields for calculating points, scores, or reference cutoffs to evaluate the results.
During the review of the completed questionnaires, it was noticed that several items,
although considered completed, were incomplete, with only the affirmative answer “yes”
marked, while the negative response "no" was ignored when the participant did not
identify with the question (items 5, 11F, 13, and part of 14) in contrast to Cicconelli,
1997, who suggests that a questionnaire should preferably be presented in a simple
format and language, being easy to apply and understand.[15] This may indicate that the extensive format of the form, possibly leading to fatigue,
despite being well accepted, and the inclusion of multiple questionnaires within it
contribute to the increased completion time.
To assess the acceptability and understanding of the questionnaire, similar to the
present study, Hasvik et al. and Zumpano et al. also conducted semistructured cognitive
interviews regarding the general meaning of the questionnaire, the explanatory text,
the pain descriptors, and the answers (numerical classification).[19]
[23] The number of patients tested with the prefinal version was also quite variable,
ranging from just 5 to even using 100 patients in the surveyed literature.[16]
[23]
Systematic reviews on the methodological studies related to the development and validation
of questionnaires have concluded that there is no established set of criteria to determine
the quality of property measures. The literature in this field is highly variable,
often relying on expert opinions, even if based on literature reviews.[12]
[25]
These reviews suggest that if the content validity of a questionnaire is adequate,
it can be considered usable, and it is sufficient to test the translated instrument
against the original questionnaire for validation purposes. In the case of this questionnaire,
which includes several previously translated and validated instruments (SF-McGill,
PCS, VAS, PROMIS sexual function, global health, and DASS-21) in Portuguese, we can
consider it validated. Therefore, there was no evaluation of the psychometric properties
conducted in the present study. However, it is important to acknowledge that this
may be considered a weakness of the instrument.
Cicconelli (1997) emphasizes the importance of reproducibility in evaluation instruments,
requiring consistent results across multiple administrations for the same patient,
assuming their general clinical state remains unchanged. In the present study, the
evaluation of reproducibility was not conducted since the questionnaire serves as
an identification form and initial anamnesis, rather than a comprehensive instrument
intended for repeated administration in the same patients. Furthermore, Cicconelli
emphasizes that a measure is considered valid when it effectively measures what it
intends to measure. Considering the systematic review by Terwee, which highlights
content validity as a crucial property measure, and the absence of a gold standard
instrument for criterion validity comparison, face and content validity were thoroughly
assessed using a subjective and reliable format, ultimately consolidating the validity
of this instrument.
The Pelvic Health History Form in Portuguese will significantly contribute to the
diagnosis and appropriate treatment of CPP, leading to improved quality of life for
women with CPP. Moreover, its availability will foster research endeavors in Brazil.
