Clinical Outcomes – Glossary of terms

COA

The term Clinical Outcome Assessment or COA covers a number of health outcomes assessment instruments (questionnaires), including Patient Reported Outcome (PRO) measures (or PROMs, as used in the UK); Clinician Reported Outcome (ClinRO) measures; Performance Outcomes measures (PerfO’s) and Observer-Reported Outcome (ObsRO) measures. Most of the health outcome measurement instruments that we manage and support are PRO measures.

The vast majority of medical interventions intend to maintain or improve patient functioning and well-being. Consequently, the intervention should have a positive impact upon the quality of life of the individual. Despite the obvious patient-centric perspective to the assessment of well-being, the medical profession has not traditionally undertaken systematic evaluation of patient-based reports. Medical professionals have tended to rely on questions such as ’how does the patient feel’ or asking them to describe symptoms. However, clinicians and medical researchers are increasingly measuring quality of life alongside lab data. For this reason, Patient Reported Outcome (PRO) measures are used to quantify the quality of life or other outcome from the patient’s perspective as part of the medical evaluation.

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eCOA/ePRO

The collection of PRO data using electronic data capture modes of administration is defined as an ePRO. ePRO modes of administration include but are not limited to:

  • PC/Laptops (including web-based capture and data collection)
  • Tablets
  • Mobile Phones /Smartphones
  • Palms
  • Telephone – Voice recognition
  • Bespoke devices

Compared to paper-based PRO measures, ePROs may lead to less administrative burden, high patient acceptance, higher levels of administrations, avoidance of secondary data entry errors, easier implementation of skip patterns, and more accurate and complete data.

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Copyright Licence Agreement

An agreement between Licensor (OUI) and Licensee to grant permission to use a COA. Its essential component parts are Grant of Licence (the permissions given, i.e. non-exclusive rights, with limited sub-licensing for the agreed purpose, for an digitally delivered COA (eCOA) or a paper and pen version); Intended Use (i.e. Commercial or non-Commercial academic research, Clinical use in a Publicly or Privately Funded Healthcare Provider); Study reference (our licences tend to be study-specific); Term (the duration of the study or period of intended use); Number of Subjects and Administrations (to evaluate impact and calculate Licence Fees if appropriate); Territory (the location/s of the Study, no use is permitted outside agreed territories without permission); Supporting Materials (e.g. linguistically validated translations, user manuals, scoring instructions, concept elaboration documents); Licence Fee (this will normally be generated as a multiplier of Number of Subjects times Administrations times per copy fee, if the Intended Use is Commercial in nature); Other Fees (these will depend on the Supporting Materials selected); Other Terms and Conditions (typically defining any reporting obligations, our mutual obligations on confidentiality, liabilities and warranties and legal jurisdiction). Submission of an online licence request constitutes a legally binding acceptance of these standard licence terms.

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Cognitive Debriefing

Pilot Testing of the non-finalised translation with at least 5 participants who are suffering from the specific condition the COA is targeted to assess. The participants of the pilot testing should be in the target country and native speakers of the target language. The interviews should preferably be performed face-to face.

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Concept Elaboration

A document approved by the developer which includes the definition of terms and concepts within the Clinical Outcome Assessment in use to be provided to the translators and reviewers of the instrument.

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Country-specific translation

The preferred translation approach at Clinical Outcomes at Oxford University Innovation which creates individual translations for countries sharing the same language (e.g. Russian for Russia, Russian for Ukraine, Lithuania etc); it focuses on accurately replicating the diversity of languages and cultural identity of the target populations.

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Forward translation

Translation of an instrument from the source language to the target language by two different translators. Each forward translator being a native speaker in the target language but fluent in English (or parent language if not English), with3 years of experience in medical translations and ideally with experience of translating COAs.

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Forward Translation Reconciliation

Comparison of the two forward translation in a merged best-of-both version which most accurately represents the concepts within the source version and which is also culturally relevant and meaningful for use in the target country.

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Back-translation

The process of translating an already translated instrument back to the English – performed by two translators working independently of each other. Each back-translator being a native English speaker but fluent in target language, with 3 years of experience in medical translations and ideally with experience of translating COAs.

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In Country Review

The in-country investigator reviews the existing language version (optimised to another country using the same language) in terms of its cultural relevance for use in the target country and changes any text that requires an adaption to make it more suitable in the target country.

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Linguistic Validation

The translation process which assesses and confirms conceptual equivalence and content validity of translations of Clinical Outcome Assessment. OUI considers a fully validated measure, the one that has been translated following a minimum of dual forward and back translation and that has been tested with patients in the target language and population through cognitive debriefing.

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Universal translation

This approach is not recommended by Clinical Outcomes and we do not generally create Universal versions for our COAs (including Patient, clinician, observer reported outcomes) but it is a recognised approach which can be discussed on a case by case basis. This is based on language commonalities and will develop one version suitable for use in all countries sharing the same language (Universal Russian to be used in Russia, Ukraine, Lithuania etc).

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