Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT03302468 |
| Other study ID # |
EHP30 traditional Chinese |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
August 6, 2015 |
| Est. completion date |
July 31, 2023 |
Study information
| Verified date |
August 2023 |
| Source |
Chinese University of Hong Kong |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
Endometriosis and adenomyosis can impact on the quality of life including the physical,
psychological and social aspects. It is important to include quality of life measurements in
evaluating the disease severity and response to any given treatment. The 30-item
Endometriosis Health Profile (EHP-30), derived from in-depth interviews of patients with
endometriosis, is currently the most reliable questionnaire for health-related quality of
life measurement in women with endometriosis. It includes specific questions addressing the
problems faced by patients with endometriosis.
Unfortunately, this widely accepted tool does not have a traditional Chinese version for the
measurement of health-related quality of life of endometriosis in Hong Kong. Furthermore,
adenomyosis and endometriosis share similar histological and clinical symptomatology, but
application of EHP-30 to adenomyosis has never been studied.
The aims of the present study are to translate the EHP-30 English version into traditional
Chinese version and to evaluate its psychometric properties in endometriosis and adenomyosis.
The hypothesis of this study is that EHP-30 (Hong Kong) traditional Chinese questionnaire has
high internal consistency, construct validity, reproducibility as the original English
version and can be applicable to Hong Kong Chinese women with endometriosis and adenomyosis.
Description:
Endometriosis is a chronic condition caused by the presence of ectopic endometrial tissue
outside the uterus, affecting the fallopian tubes, ovaries, pelvic peritoneum or even the
urinary and gastrointestinal tracts. Adenomyosis is characterized by the presence of ectopic
endometrial gland and stroma in the myometrium with associated myometrial hypertrophy and
hyperplasia. Adenomyosis has been reported to occur in 30-60% of the hysterectomy
specimen.Endometriosis causes painful symptoms including dysmenorrhoea, pelvic pain,
dyspareunia and infertility. Adenomyosis also causes clinically significant symptoms include
dysmenorrhoea, pelvic pain and heavy menstrual flow.
Both conditions can impact on the quality of life including the physical, psychological and
social aspects. It is important to include quality of life measurements in evaluating the
disease severity and response to any given treatment. The 30-item Endometriosis Health
Profile (EHP-30), derived from in-depth interviews of patients with endometriosis, is
currently the most reliable questionnaire for health-related quality of life measurement in
women with endometriosis. It includes specific questions addressing the problems faced by
patients with endometriosis. It also exhibits good reliability, validity and
interpretability.
The EHP-30 has recently been translated into simplified Chinese version and evaluated with
psychometric tests which showed the simplified Chinese version is a valid, reliable and
acceptable tool for the measurement of the health-related quality of life of women with
endometriosis in mainland China. Unfortunately, this widely accepted tool does not have a
traditional Chinese version for the measurement of health-related quality of life of
endometriosis in Hong Kong. Furthermore, adenomyosis and endometriosis share similar
histological and clinical symptomatology, but application of EHP-30 to adenomyosis has not
been studied. The aims of the present study are to translate the EHP-30 English version into
traditional Chinese version and to evaluate its psychometric properties in endometriosis and
adenomyosis.
EHP-30 consists of 30 items in English, grouping into five subscales measuring pain (11
items), control and powerlessness (6 items), emotions (6 items), social support (4 items) and
self-image (3 items) in part one. Part two consists of 23 items, grouping into six subscales
may not be applicable to all adenomyosis patients: work (5 items), relationship with children
(2 items), sexual intercourse (5 items), medical profession (4 items), treatment (3 items)
and infertility (4 items). Participants choose their response from a five point likert scale
from 0 to 4. Items within each subscale will be added up to generate a subscale score. Then,
the subscale score is divided by maximum possible score and multiply by 100 to give a health
status score which 100 represent worst health and 0 represent best health status.
Firstly, approval to use EHP-30 will be obtained from the original author, Dr Georgina Jones.
We will adhere to the Good Practice for the Translation and Cultural adaptation process for
patient-reported outcomes measures guideline. 6 The EHP-30 will be evaluated by 2 bilingual
researchers in the fields of gynaecology independently and decide if any item will be
regarded as inappropriate. They will then perform the forward translation of the EHP-30 to
traditional Chinese independently. After that, they will review the two versions of
translation and hold a meeting for discussion on items of discrepancy, in order to produce
one version. Back-translation will be performed by another 2 persons who are professional in
Chinese-English translation, after the iterative evaluation of forward translation process.
The original and back-translated versions will be compared for accuracy and comprehension by
another two monolingual researchers. If substantial differences existed between the two
original and the back-translated versions, the translation-back translation process are
repeated until a questionnaire representative of the original is obtained. Finally, the
back-translated version will be sent to Dr Georgina Jones and the colleagues. Comments on the
back-translated version will be obtained from them.
Pilot phase of the translated questionnaire Chinese women attending the Gynaecology clinic of
New Territories East Cluster with pelvic painful symptoms will be invited to join the study.
Exclusion criteria include an age of less than 18 years, mental incapacity that would
preclude completion of the questionnaire and those who refuse to join. Written consent will
be obtained from them by a research assistant. They will be asked to complete the EHP-30 and
SF-36 at the specialty clinic. After filling in the questionnaires, they will be asked to
give comments on the questionnaire.
Any patient attending the gynaecology clinic who fulfills the inclusion criteria and without
any exclusion criteria will be invited for participation in the study. If the patient is
willing to participate, written consent will be obtained from the patient. The study
investigators will record demographic features and characteristics of the disease. The
patient will be asked to complete the traditional-Chinese version of EHP-30 and
traditional-Chinese version of the Medical Outcomes Study Short Form 36-item health survey
(SF-36). 11-13 Demographic data collected include age, height, weight, education level,
marital status, monthly household income and employment status. Disease characteristics for
endometriosis include intensity of painful symptoms by visual analog scale (VAS), menstrual
blood loss by pictorial blood loss assessment chart (PBAC) and intraoperative scoring of the
severity of endometriosis. Disease characteristics for adenomyosis include VAS scores on
painful symptoms, size of uterus and size of adenomyosis and menstrual blood loss by
pictorial blood loss assessment chart (PBAC).
Exploring the impact of quality of life is important to clinical practice. The Medical
Outcomes Study Short Form 36-item health survey (SF-36) is a generic type of Health Related
Quality of Life (HRQoL) assessment tool widely used in different disease conditions.
Questionnaire which assesses eight dimensions of QoL of an individual. A higher score means a
better quality of life. It has been used to study QoL in normal populations as well as
patients suffering illnesses and estimating the relative burden of different diseases. 11-13
All patients are expected to spend within 30 minutes on questionnaire survey.
In order to study for test-retest reliability, patient with endometriosis and adenomyosis
scheduled for operation will be asked to complete the first set of questionnaires, EHP-30 and
SF-36, when they attend for the pre-operative assessment clinic. The same set of EHP-30 will
be completed when they are admitted for operation. In order to study the measurement
properties of the questionnaire, the same set of EHP-30 and SF-36 will be given at the usual
postoperative follow up visit which is usually scheduled 3-6 months later.
In order to study for test-retest reliability, patient with endometriosis and adenomyosis not
scheduled for operation will be asked to complete the first set of questionnaires, EHP-30 and
SF-36, at recruitment and a set of EHP-30 will be completed 2 weeks later and return by the
return envelope provided. In order to study the measurement properties of the questionnaire,
the same set of EHP-30 and SF-36 will be given at the usual gynaecology follow up visit which
is usually scheduled 3-6 months after treatment.
All patients will be asked to report any important health or life changes that occur between
the questionnaires.
