NEQOL Survey Spanish Validation in a Hispanic Clinic Based Population

August 7, 2018 updated by: Carlos Robles-Medranda

Quality of Life Among Patients With Chronic Esophageal Disorders : Spanish Translation and Validation of the Survey "Northwestern Esophageal Quality of Life Scale" in Hispanics

Chronic esophageal disorders affect approximately one third part of global population, with a deleterious impact in the quality of life of patients. Measured of health related quality of life in chronic esophageal conditions such as gastroesophageal reflux disease and achalasia are widely used to measure this important patient-reported outcome. The Northwestern Esophageal Quality of Life (NEQOL) is a hybrid measure of esophageal illness, allowing for broad use across esophageal diseases while maintain sensitivity to nuances of a specific condition. The NEQOL is a reliable and valid hybrid measure of disease specific health related quality of life across several chronic esophageal conditions. The Ecuadorian Institute of Digestive Diseases aims to translate and validate this survey into Spanish for its use in a Hispanic population. This cross-sectional study aims to translate, apply and validate the NEQOL in the patients attending in the esophageal division of the institute.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Methods: An authorization for translating the survey into Spanish was obtained from the survey authors. The translation and cross-cultural adaptations were carried out based on guidelines and international criteria proposed by Sperber. The NEQOL was translated independently from English into Spanish by two professional translators. Each one provided a written report, which was combined by the authors in a new version that contained the most reliable translation for each question. The new version was back translated to English by two different professional translators, who were blinded to the original version of the NEQOL. A new English version was developed by combining the written reports. The aim of the back translation was to compare each item of the new English version with the original NEQOL. Each item of the new English version was compared with the original questionnaire by 30 native English speakers. The success of the translation was evaluated using two scales of comparison: comparability of language and similarity of interpretability. Each one used Likert scales ranging from 1 (extremely comparable/ extremely similar) to 7 (not at all comparable/ not at all similar). A mean score for each question was obtained. Questions with mean scores of three or less were included in the Spanish version. The Spanish version of the NEQOL was tested on 10 subjects diagnosed with GERD, each subject provided feedback on the survey content, which was used to make final corrections. The questionnaire contains fourteen questions; every statement refers to the impact of the esophageal condition in the quality of life. There are five options ranking from not at all true to very true, with every option meaning a numerical value, a higher grade in the questionnaire will express a better quality of life and a low impact in the health-related quality of life.

Patients above 18 years old with chronic esophageal disorders, that require a functional esophageal test such as ph-impedanciometry and/or high-resolution manometry, will be included. Written informed consent will be obtained. All participants will complete the questionnaire before performing the functional esophageal tests and a gastroenterologist specialized on functional esophageal pathology will perform the esophageal tests and analyze the results. Finally, the data from the questionnaire will be compared with the esophageal tests results in order to stablish if there is a correlation between the impact in the quality of life measured by the questionnaire and the tests results.

Statistical analysis: Base line characteristics will be analyzed using Chi-square o Fisher Test for categorical variable, and the Mann-Whitney Test for continuing variables. Continuous variables will be expressed as mean +/- standard deviation. The sensitivity, specificity, predictive values and accuracy will be calculated with the 95% Confidence Interval (95% CI). A P value of less than 0.05 was considered to be statistically significant. All the statistical analysis was performed using SPSS software suite v.22.

Study Type

Observational

Enrollment (Actual)

385

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Ecuador
    • Guayas
      • Guayaquil, Guayas, Ecuador, 090505
        • Ecuadorian Institute of Digestive Diseases, Omnihospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Hispanic patients above 18 years old with chronic esophageal disorders, that require a functional esophageal test such as ph-impedanciometry and/or high-resolution manometry

Description

Inclusion Criteria:

  • Written informed consent obtained
  • Ability to complete the survey
  • Hispanic patients above 18 years old with chronic esophageal disorders, that require a functional esophageal test such as ph-impedanciometry and/or high-resolution manometry

Exclusion Criteria:

  • Not able to complete the survey
  • Not in the range of age acceptable for inclusion

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To measure the disease related quality of life and its impact among patients with chronic esophageal disorders by translating and validating into Spanish the Northwestern Esophageal Quality of Life Scale survey.
Time Frame: 9 month
9 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Carlos Robles-Medranda

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

October 1, 2016

Primary Completion (ACTUAL)

October 1, 2017

Study Completion (ACTUAL)

November 1, 2017

Study Registration Dates

First Submitted

November 7, 2016

First Submitted That Met QC Criteria

November 8, 2016

First Posted (ESTIMATE)

November 9, 2016

Study Record Updates

Last Update Posted (ACTUAL)

August 9, 2018

Last Update Submitted That Met QC Criteria

August 7, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NOV-7-2016

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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