Development and Validation of EHP-30 (Hong Kong Chinese Version) for Patients With Endometriosis and Adenomyosis

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Brief Title

Development and Validation of EHP-30 (Hong Kong Chinese Version) for Patients With Endometriosis and Adenomyosis

Official Title

Development and Validation of the Endometriosis Health Profile-30 Traditional Chinese (Hong Kong) Version in Endometriosis and Adenomyosis

Brief 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.
    

Detailed 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.
    


Study Type

Observational


Primary Outcome

Validation of Endometriosis health profile-30 (EHP-30) traditional Chinese (Hong Kong) version


Condition

Endometriosis



Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information



Estimated Enrollment

444

Start Date

August 6, 2015

Completion Date

December 31, 2022

Primary Completion Date

December 31, 2022

Eligibility Criteria

        Inclusion Criteria:

          -  Premenopausal

          -  Hong Kong Chinese women

          -  diagnosed with endometriosis or adenomyosis.

        Exclusion Criteria:

          -  uterine fibroid more than 5 cm

          -  other premalignant or malignant conditions
      

Gender

Female

Ages

18 Years - 55 Years


Contacts

Wen Ying Fung, 852-35052748, [email protected]

Location Countries

Hong Kong

Location Countries

Hong Kong

Administrative Informations


NCT ID

NCT03302468

Organization ID

EHP30 traditional Chinese


Responsible Party

Principal Investigator

Study Sponsor

Chinese University of Hong Kong


Study Sponsor

Wen Ying Fung, Principal Investigator, 852-35052748


Verification Date

October 2021