Supporting the translation of your PRO measure from development through to epro

Transcription

1 Supporting the translation of your PRO measure from development through to epro

2

3 Services We offer extensive expertise and experience in the following services: Translation and linguistic validation of PRO (patient reported outcome) measures Translatability assessments during PRO measure development to ensure future translations will be suitable for international adaptation epro migration and usability testing ensuring a smooth transition from source paper measures through to epro Clinician reviews of ClinROs PRO measure agreement and copyright management Medical translations About PharmaQuest PharmaQuest Ltd. are specialists in the translation and linguistic validation of PRO measures. We differentiate ourselves from our competitors by providing the responsive, personal and dedicated service you would hope for from a small company, and now as a proud member of the RWS group of companies, we can also offer the scope and resources of a global industry leader. Since our inception in 2005 we have developed a reputation for high quality work, the ability to meet tight deadlines and our flexible approach to our clients needs. Over the years we have successfully completed several thousand PRO translations and developed strong relationships with over 100 developers and copyright holders. Our extensive client base includes global pharmaceutical companies and we are listed as a preferred vendor for prestigious research bodies including the EuroQoL and EORTC Quality of Life groups. In April 2013 we were acquired by RWS Holdings plc, one of the world s largest translation groups. In collaboration with RWS s Medical Translation Division, PharmaQuest is able to cover the whole spectrum of clinical trial documentation. PharmaQuest is certified as meeting the requirements of ISO 9001:2008 and BS EN 15038:2006.

4 Translation and linguistic validation Translation and linguistic validation of PRO measures is our core specialism. We have translated numerous disease-specific measures, including the widely-used EORTC oncology modules, as well as generic quality of life measures such as the EQ-5D. Our carefully-developed methodology conforms to widely accepted industry standards and ensures that translations of a measure are accurate, culturally relevant and harmonised with each other. We particularly value and uphold the importance of maintaining a close working relationship throughout the process between our project manager, our in-country investigators, our qualified and experienced translators, the developer of the measure and the client. This enables us to draw on all of the expertise available to achieve the best wording solutions in each case. Methodology PharmaQuest s standard translation and linguistic validation methodology conforms to ISPOR* guidelines and the standards accepted by regulatory agencies. At the end of each project we produce a detailed report and provide our clients with certification letters to support ethics and regulatory submissions. Standard translation and linguistic validation methodology Concept Elaboration First Forward Translation First Back Translation Forward Translation Reconciliation Back Translation Review Second Forward Translation Second Back Translation Harmonisation Meeting Developer Review Independent Proofreading Pilot Testing and Review Investigator Proofreading Final Translation * The International Society for Pharmacoeconomics and Outcomes Research

5 Study team Project Manager Each project is run by a highly trained and experienced in-house project manager who supervises the project at every stage. This ensures quality control and accuracy and also provides clients with an approachable point of contact throughout every stage of the translation process. All our project managers are native speakers of English, which promotes faithful interpretations of source measures, down to the finest nuance. Investigator The investigator is the main translator on a project and works closely with the project manager from beginning to end. They are resident in the target country, native speakers of the target language, and typically have a background in health, linguistics, medicine or psychology. Translators and proofreaders Our translators and proofreaders are specialists in medical translation, with qualifications in translation and several years experience. They only work into their native language, ensuring the quality and cultural validity of the translations. Clinician During the course of a project, clients may require input from specialist clinicians. For such projects, we recruit relevant clinicians who are native speakers of the target language, based in the target country and have extensive experience in the relevant therapeutic area. Disease coverage PharmaQuest s extensive network of in-country investigators enables us to recruit patients from a diverse range of therapeutic areas for pilot testing and linguistically validating PRO measures. The disease areas we have worked in include: Alcohol abuse Amyotrophic lateral sclerosis Ankylosing spondylitis Asthma Brain cancer Breast cancer Bronchiectasis Cardiomyopathy Cataracts Chemotherapy-induced peripheral neuropathy Cholangiocarcinoma Chronic bronchitis Cystic fibrosis Chronic liver disease Chronic lymphocytic leukaemia Chronic myeloid leukaemia Chronic pain Clostridium difficile-associated diarrhoea Congestive heart failure Depression Dupuytren s contracture Endometriosis End-stage renal disease Epilepsy Erectile dysfunction Fatigue Gastric cancer Gastrointestinal neuroendocrine tumours Gout Haemophilia Head and neck cancer Hyperpigmentation Idiopathic pulmonary fibrosis Inflammatory bowel disease Juvenile idiopathic arthritis Lupus Melanoma Menopause Migraine Multiple myeloma Multiple sclerosis Myelodysplasia Obesity Ocular surface disease Oesophageal cancer Orthostatic hypotension Osteoarthritis Ovarian cancer Overactive bladder Parkinson s disease Peripheral arterial occlusive diseases Psoriasis Restless leg syndrome Rheumatoid Arthritis Rosacea Sexual interest/arousal disorder Sleep disorders Testicular cancer Type 1 diabetes Vulva cancer

6 PRO measure translatability assessments Developers can make their measures more suitable for international use by making sure the content and wording is easy to adapt, not only into other languages but also for other cultures. PharmaQuest can help to achieve this aim by conducting translatability assessments while a measure is still in development. This eliminates any problematic wording and ensures the final measure lends itself to consistent translations, regardless of the language involved. We highly recommend this as part of any PRO development project. Our translatability assessments of PRO measures include the following steps: 1 Concept Elaboration Clarification of the source wording to ensure that the concepts are clear for reviewers. The concept elaboration is sent to the instrument developer for their feedback and approval. 2 Translatability Assessment Experienced medical translators in a variety of countries analyse the measure to identify any phrases or concepts that may not easily transfer to their language or culture. 3 Review of the Translatability Assessment PharmaQuest collate the results of the translatability assessment into one report and summarise the findings, highlighting the words and phrases that were difficult to translate and for which alternative wording may be preferable. 4 Teleconference with PRO Developer A teleconference is held by the project manager to discuss the results of the translatability assessment with the PRO developer and to put forward recommendations on the acceptability of the wording from a translatability perspective. 5 Final Report PharmaQuest prepares a final report following the completion of the translatability assessment and teleconference. This documents the methodology conducted and will also contain all the discussions that took place at every stage of the project.

7 epro migration and usability testing PharmaQuest provides expertise in assessing the linguistic equivalence of an epro version against the source paper version, to ensure that patients interpret items in the same way and that the resulting data collected is valid. epro migration and usability testing includes the following steps: Review of the draft epro version: to review any format or content changes to the measure and to ensure that these changes are acceptable and do not alter the meaning or tone of the questions. The usability of the epro platform is also assessed. Development of an interview schedule: to capture both the patients understanding of the items within the epro measure and the usability of the epro format. Pilot testing: two levels of evidence are required when making minor modifications to paperbased PRO measures for administration as epros. 1. Cognitive Debriefing: a think aloud approach during which patients from the target population complete the epro measure and describe in their own words what the instructions, questions and response options mean to them. 2. Usability Testing: to examine whether patients from the target population are able to use the device and software, follow the instructions clearly and complete the measure correctly using the epro platform. Pilot testing review: review of all comments and feedback to assess linguistic equivalence with the paper-based PRO measure and usability. Final report and certification letter. We also offer translation of the final epro version into the target languages required. PRO measure agreement and copyright management To simplify the management of translation projects for our clients, we offer a comprehensive PRO measure agreement and copyright management service. On translation and linguistic validation projects, we will liaise with the developers and copyright holders of the measures on behalf of our clients, completing the necessary paperwork and agreements to allow for the measures to be administered in the appropriate clinical trials. This service removes the stress of contacting numerous developers for permission to use a portfolio of measures in a clinical trial. It also improves continuity as we have early contact with the developers and can inform them of the translation and linguistic validation methodology and discuss their role in the process. Clinician reviews of ClinROs PharmaQuest s expertise extends to ClinROs (clinician-reported outcome measures) as well as PROs. We work with a network of specialised clinicians to conduct expert reviews as part of the ClinRO translation process and can source reviewers from any relevant specialist area.

8 Medical translations In addition to our core services, PharmaQuest works with the specialist Medical Translation Division at RWS to offer a comprehensive medical translation service for the pharmaceutical industry. We have the capacity to translate a wide range of medical documents, including: Brochures Case report forms Contracts Informed consent forms Investigator CVs Journal articles Marketing Authorisation Procedures Medical device instructions Patents Patient diaries Patient information sheets Protocols Public health leaflets Screening questionnaires Surveys Training manuals User manuals Video role play scripts Our translators are all qualified and experienced, specialising in medical and pharmaceutical translations and working only into their native language. We can provide translations for over 60 languages and can work either from English or into English. Contact us Our specialist team of project managers, translation coordinators and quality control staff can help guide you through all of our services with expertise and efficiency. You can rely on us to provide you with a personal service and above all, work of the highest possible standard. If you would like to get in touch with us about a potential translation project or to find out more about us, why not visit our website or contact Rebecca Two, our Head of Operations, on rebecca.two@pharmaquest-ltd.com or +44 (0) We look forward to hearing from you! PharmaQuest Ltd. Bloxham Mill Business Centre Barford Road, Bloxham Banbury OX15 4FF UK Tel: +44 (0) Fax: +44 (0) Web: