Study Type: This is an observational study
Study Groups/Sites: 5-15 sites within each non-English language sphere
Study Period: One year: From the approval of the specific language translation program, teams will be given 18 months to complete the translation/back translation, cognitive testing, and validation phases. Data analysis, feedback to program teams and finalization of reports will take place within 3 months of full data set submission by the MDS Translation Steering Committee.
Study Population: Parkinson's disease patients whose native language is not English.
Primary Study Objective: To develop and validate Non-English translations of the MDS-NMS, MDS-UPDRS and/or UDysRS
Requirements for Participation:
Local translation/back-translation program will include two teams. One team will develop the forward translation (English to selected native language) and a second team will independently conduct a back-translation (native language translation to English). Both teams operate under one or two Primary Investigators (also referred to as Translation Leads), but otherwise are independent for this phase of the program.
For each team, at least one movement disorder specialist is required who is fluent in English and the native language. Other specialists (professional translator, linguist, cultural expert etc.) are optional.
The proposed list of these two teams and the raters who will participate in the validation phase will be submitted to the Chair of the MDS Clinical Outcome Assessments (COA) Program, Dr. Sheng Luo. This will be shared with members of the MDS Translation Steering Committee. Current members of the Translation Steering Committee include: Christopher Goetz, Glenn T. Stebbins, Pablo Martinez-Martin, Sheng Luo, Monica M. Kurtis, and Michelle H. S. Tosin. The Translation Steering Committee will grant approval to initiate the translation program.
The PI for each language group will agree on behalf of the team to publication guidelines which are as follows:
- Investigators will have the responsibility to summarize their findings and submit them to the MDS.
- They will be encouraged to submit findings for peer-review publication and will determine authorship independently of the Translation Steering Committee or MDS. Authors are encouraged to submit to the MDS journals, Movement Disorders or Movement Disorders - Clinical Practice, although acceptance is not guaranteed. They will agree to acknowledge the MDS COA Program, copyright ownership of the translated scale as belonging to MDS and list the members of the Translation Steering Committee along with other people who participated in the program.
- The Chairs of the MDS COA Committee and Dr. Goetz will have final approval of the list of acknowledgments.
- A copy of the final publication will be submitted to MDS and the Chairs of the COA Program.
- Investigators understand that the Translation Program is on behalf of MDS and all translations remain under the copyright ownership of MDS.
- Investigators agree that only the Official MDS Translation will be distributed once developed. Individuals interested in using the translation for a study will be directed to the MDS Permission Request Form to seek permissions from the Society. Licensing fees for funded research apply. Translation Teams will be provided 5 free uses of the scale within funded research after which a licensing fee will apply. Request for free use must be submitted by the Translation Lead.
Translation and back-translation
A forward translation will be developed by an independent translation team. Translations should be developed with an emphasis on meaning as opposed to a word by word literal translation. Following completion, a second team will independently translate the scale from the native language into English. A review and reconciliation between the forward and back-translation should be conducted and any discrepancies should be reviewed and corrected. Please ensure that this review includes examination of spelling and grammar. The translation must include all pages of the scale including the introductory page and corresponding score sheet. It is recommended that the English scale be used as a template for the new language translation so that the appearance and format of the scales are uniform.
MDS does not develop translations for a specific dialect or region. All language translations should be conducted to provide facile tools that can be used in any population utilizing a given language based on standard grammar and terminology. For these programs, the translation development team should consider the international representation of a given language to make it broadly applicable.
Once completed, the final translation (including updates from the reconciliation process), the fully completed forward translation, the fully completed back translation, and a reconciliation report, which lists the items that were examined and what decision was made along with the rationale (example: the word for X was replaced with Z as it portrays a more accurate meaning), will be submitted to Dr. Luo, Dr. Stebbins and the MDS Secretariat. The MDS Translation Steering Committee will review the submitted materials with attention to the back-translation and reconciliation report. If needed, independent reviewers will be requested to conduct a review of the final translation. A report will then be provided to the Translation Steering Committee.
The Translation Steering Committee will review the original submission and the critique of the back translation. Based on this review, revisions will be requested or the documents will be approved for Cognitive Testing.
During the review process, translation teams are requested to begin translation of the Cognitive Pre-testing documents. This form will be provided by MDS. Please see item two under Phase II: Cognitive Pre-Testing for more information.
The translation should be provided to the MDS Secretariat for a format review at this stage. The MDS copyright statement, “Copyright © [year] International Parkinson and Movement Disorder Society (MDS). All rights reserved.” will be included by the MDS Secretariat if it is not already present and the provisionally approved translation will be returned to the local translation team. A translation of the copyright statement can be provided.
Once approved, the final translation may be used in Phase II: Cognitive Pre-testing.
The provisionally approved translation will be administered in a set of approximately 10 PD patients for cognitive pre-testing. This phase will identify potentially culturally sensitive or complex items.
Questions will be asked to the patients and examiners after each targeted item in order to assess patient and examiner understanding and comfort, using a cognitive pre-testing guide (in English) prepared by a cognitive specialist (Nancy LaPelle). This guide should be translated into the native language by the translation team. The guide does not need to be back translated into English.
The translated cognitive pretesting forms should then be administered following administration of the scale. The rater administering the scale will be requested to complete a cognitive pre-test questionnaire and the patient will also be required to complete a cognitive –pre-test questionnaire. Please test the translation in patients that speak different dialects and consider the global nature of the language population. Collaborations with other centers can be conducted for this purpose. Please note that collection of data for the “Subject Registration Form” required in phase III is not required in this phase.
The translated cognitive pretesting guide will be used in conjunction with the translated scale to create language specific cognitive pretesting packets to be used during cognitive pretesting. These packets will be reviewed by the Translation Steering Committee.
Once data has been collected for 10 patients, please send the completed Cognitive Pre-testing forms and collected scale data for each participant to Dr. Luo and the MDS Secretariat. Please ensure that all data is de-identified. After statistical review by Dr. LaPelle of the data collected from the PD population, recommendations regarding problem areas will be sent to the translation team. In the event that major issues are identified, changes to the translation may be needed. For minor issues, a response from the translation team (in English) to Dr. Luo and Dr. Stebbins should be submitted and will be reviewed by the Translation Steering Committee for provisional approval of the translation. Following approval, the translation will be fully tested (Phase III).
If major problems are identified during the first round of cognitive pretesting, additional rounds may be required.
Once the translation is completed and approved, it will be termed the “Official Working Document”. The MDS Secretariat may license the scale to clinical trials interested in using the MDS Official Working document with the understanding that the scale has only completed the cognitive pre-testing phase. Changes to the translation should not be made following approval of the Official Working Document.
Large-scale validation testing.
Each translation team will administer the MDS-UPDRS to 350 PD patients (250 patients for the UDysRS and 300 patients for the MDS-NMS) on one visit. These patients should be native speakers of the language being tested and should represent a wide demographic of native language speakers. The patient sample should include samples from different ages, genders, severities of PD (determined by the patients Hoehn and Yahr score), geographical regions and educational levels.
Data entry and analysis: Sites will be encouraged to collect data through the score sheet of the scale and a Subject Registration Form which collects demographic/disease-related variables. A unique patient identifier should be used per patient and recorded on the Score Sheet and corresponding Subject Registration Form. S. Scanned copies of the data collection sheets should be created into a single PDF file and submitted via a secure server to Dr. Luo. Alternatively, paper copies can be mailed if needed.
Statisticians in this program will provide the analyses required for verification of the translation. Other analyses that individual groups from each country wish to conduct can be handled by the team for each country and are not part of this program. Questions regarding individual sub-analyses and access to data will be directed to Dr. Luo and Dr. Stebbins.
Primary outcome for designation of approval: For the MDS-UPDRS, confirmatory factor analysis will be run against the established English version factor structure by each part. To be designated as an official translation, Comparative Fit Index (CFI) of the final model for each part of MDS-UPDRS must be ≥ 0.9 relative to the English version.
For the UDysRS, confirmatory factor analysis will be run against the established Spanish version factor structure by each part. To be designated as an official translation, Comparative Fit Index (CFI) of the final model for the entire UDysRS must be ≥ 0.9 relative to the Spanish version.*
For the MDS-NMS, confirmatory factor analysis will be run against the established English version factor structure by each part. To be designated as an official translation Comparitive Fit Index (CFI) from the confirmatory factor analysis (CFA) based on the score of nine domains (13 original subscale domains, A to M, excluding E, G, H, and I) of MDS-NMS must be ≥ 0.9 relative to the English version.
Once the translation has been completed and approved by the Translation Steering Committee, the statement “MDS Official Translation” will also be included in the footer of the translation and it will be posted on the MDS website. Permission to use the translation is required.
*The first large scale field testing for the UDysRS began with the Spanish translation.
Sample Size: For the MDS-UPDRS, there will be 350 subjects from each translation program spread among several sites. This calculation is based on the need for 5 subjects per item of the questionnaire in order to perform the statistical tasks needed to validate the instrument. There are 65 items on the MDS-UPDRS.
For the UDysRS, there will be 250 subjects from each translation program spread among several sites. This calculation is based on the need for 5 subjects per item of the questionnaire in order to perform the statistical tasks needed to validate the instrument. There are 26 items on the UDysRS.
For the MDS-NMS, there will be 300 subjects from each translation program spread among several sights. This calculation is based on the need for 5 subjects per item of the questionnaire in order to perform the statistical tasks needed to validate the instrument. There are 61 items on the MDS-NMS.
Inclusion Criteria: Patients with Parkinson’s disease fluent in the native language of the site. Given that dyskinesia does not occur in all PD patients, up to 10% of the UDysRS cohort (25 patients) are allowed to be enrolled if they do not report dyskinesia and therefore have potential entries of uniform zeroes.
Exclusion Criteria: Patients cannot be included if they do not have Parkinson’s disease. Further, they cannot be included if the language translation being tested is not the native language of the patient.
Study Intervention: None
Primary Outcome Measure: The MDS-UPDRS factor scores and CFI of the final model for each part of the MDS-UPDRS. The UDysRS factor scores and CFI of the final model for the entire UDysRS. The MDS-NMS factor scores and CFI based on the scores of nine domains (13 original subscale domains, A to M, excluding E, G, H, and I) of MDS-NMS.
Statistical Analysis: For the MDS-UPDRS, a confirmatory factor analysis will be run against the established English-version factor structure, by part. This will be done by Dr. Luo’s team. Similarly, for the UDysRS, Dr. Luo’s team will run a confirmatory factor analysis against the established Spanish-version factor structure, by part. For the MDS-NMS, a confirmatory factor analysis will be run on the nine domains against the established English-version factor structure. This will be done by Dr. Luo’s team as well.
Caveats: Translation Leads are invited to serve on the MDS Translation Committee. From time to time, additional review of the translation may be requested. Translation committee members are requested to assist with translation specific inquiries from the MDS Secretariat. Translation leads may be requested to assist with future language translations of other MDS-owned scales as members of the MDS Translation Committee.