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Linguistic validation is the process of investigating the reliability, conceptual equivalence, and content validity [1] of translations of patient-reported outcome (PRO) [1] measures.
Most usually, linguistic validation refers to a process whereby translated text is actively tested with patients in the target population and target language group through cognitive debriefing [1] interviews. For example, if the PRO instrument is intended to measure the symptoms of diabetes in a trial in Denmark, the linguistic validation interviews would be conducted with diabetic patients in Denmark, who speak Danish as their mother tongue. This interview exercise ensures that items are appropriate for use in the target population, are clearly expressed and understood. [2] The exercise is also an important tool for demonstrating content validity when compared with the source. During the interview, the respondents complete the questionnaire, and then answer a series of open-ended questions on its content and explain what they think each item means in their own words. The results of this cognitive debriefing exercise should therefore show the respondents' understanding of the translation, and alterations can be made after this stage if nuances of meaning in the source text have not been clearly expressed in the translation and understood by the respondents. The process also ensures multi-lingual harmonization of the translations, by making sure that the questionnaire is understood in the same way by target populations across all language groups, thus ensuring that the resulting quantitative data can be compared across language groups.
An alternative method of conducting linguistic validation is to ask a clinician who specialises in working with the target population to review the text, to ensure that it is clearly understandable. The clinician's understanding and knowledge of the usual terminology and phrases used by the patient group can be utilised, thus ensuring that the wording used in the translation reflects that which would be used by the target patient group themselves. Some parties feel that this step is sufficient to validate a PRO translation. However, regulatory authorities consider it preferable to validate measures through the above-mentioned cognitive debriefing with the patients in the target population where possible, and clinician reviews are more usually reserved for clinician-reported measures, or for particular circumstances in which testing with patients in the target population is particularly problematic (Wild et al. 2005). [3]
Some companies use the term 'linguistic validation' to refer to the entire process for the translation of PRO measures as described in the 'Principles of Good Practice' (Wild et al. 2005), [3] and the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) Task Force report (Wild et al. 2009), [4] even if this process does not include patient interviews or a clinician review. The recommended methodology utilises double, independently created translations into the target language, which are then combined into a 'reconciled version' which uses the best of both forward translations. The reconciled version, or harmonization, is then back translated (back translation) by two individual blinded translators who have no previous knowledge of the original questionnaire. The back translations are used as a window into the translated version, so that the project manager can assess whether the translated version accurately assesses the concepts measured by the source questionnaire. This stage is described as the back translation review. Ideally, it would be followed by patient interviews or a clinician review. Please note however, PROs should not be confused with PCOs, or patient-centered outcomes. PCOs implies the use of a questionnaire covering issues and concerns that are specific to a patient.
A comprehensive linguistic validation process including cognitive debriefing is vital to demonstrate content validity in translations for use in a U.S. Food and Drug Administration (FDA) submission.
Questionnaire construction refers to the design of a questionnaire to gather statistically useful information about a given topic. When properly constructed and responsibly administered, questionnaires can provide valuable data about any given subject.
Survey methodology is "the study of survey methods". As a field of applied statistics concentrating on human-research surveys, survey methodology studies the sampling of individual units from a population and associated techniques of survey data collection, such as questionnaire construction and methods for improving the number and accuracy of responses to surveys. Survey methodology targets instruments or procedures that ask one or more questions that may or may not be answered.
A questionnaire is a research instrument that consists of a set of questions for the purpose of gathering information from respondents through survey or statistical study. A research questionnaire is typically a mix of close-ended questions and open-ended questions. Open-ended, long-term questions offer the respondent the ability to elaborate on their thoughts. The Research questionnaire was developed by the Statistical Society of London in 1838.
Response bias is a general term for a wide range of tendencies for participants to respond inaccurately or falsely to questions. These biases are prevalent in research involving participant self-report, such as structured interviews or surveys. Response biases can have a large impact on the validity of questionnaires or surveys.
Personality Assessment Inventory (PAI), developed by Leslie Morey, is a self-report 344-item personality test that assesses a respondent's personality and psychopathology. Each item is a statement about the respondent that the respondent rates with a 4-point scale. It is used in various contexts, including psychotherapy, crisis/evaluation, forensic, personnel selection, pain/medical, and child custody assessment. The test construction strategy for the PAI was primarily deductive and rational. It shows good convergent validity with other personality tests, such as the Minnesota Multiphasic Personality Inventory and the Revised NEO Personality Inventory.
For cognitive interview to retrieve memories from crime scene eyewitnesses and victims, see Cognitive Interview.
A patient-reported outcome (PRO) is a health outcome directly reported by the patient who experienced it. It stands in contrast to an outcome reported by someone else, such as a physician-reported outcome, a nurse-reported outcome, and so on. PRO methods, such as questionnaires, are used in clinical trials or other clinical settings, to help better understand a treatment's efficacy or effectiveness. The use of digitized PROs, or electronic patient-reported outcomes (ePROs), is on the rise in today's health research setting.
A depression rating scale is a psychometric instrument (tool), usually a questionnaire whose wording has been validated with experimental evidence, having descriptive words and phrases that indicate the severity of depression for a time period. When used, an observer may make judgements and rate a person at a specified scale level with respect to identified characteristics. Rather than being used to diagnose depression, a depression rating scale may be used to assign a score to a person's behaviour where that score may be used to determine whether that person should be evaluated more thoroughly for a depressive disorder diagnosis. Several rating scales are used for this purpose.
In general, quality of life is the perceived quality of an individual's daily life, that is, an assessment of their well-being or lack thereof. This includes all emotional, social and physical aspects of the individual's life. In health care, health-related quality of life (HRQoL) is an assessment of how the individual's well-being may be affected over time by a disease, disability or disorder.
Behavioral health outcome management (BHOM) involves the use of behavioral health outcome measurement data to help guide and inform the treatment of each individual patient. Like blood pressure, cholesterol and other routine lab work that helps to guide and inform general medical practice, the use of routine measurement in behavioral health is proving to be invaluable in assisting therapists to deliver better quality care.
The CRAFFT is a short clinical assessment tool designed to screen for substance-related risks and problems in adolescents. CRAFFT stands for the key words of the 6 items in the second section of the assessment - Car, Relax, Alone, Forget, Friends, Trouble. As of 2020, updated versions of the CRAFFT known as the “CRAFFT 2.1” and "CRAFFT 2.1+N" have been released.
An electronic patient-reported outcome (ePRO) is a patient-reported outcome that is collected by electronic methods. ePRO methods are most commonly used in clinical trials, but they are also used elsewhere in health care. As a function of the regulatory process, a majority of ePRO questionnaires undergo the linguistic validation process. When the data is captured for a clinical trial, the data is considered a form of Electronic Source Data.
The Health Dynamics Inventory (HDI) is a 50 item self-report questionnaire developed to evaluate mental health functioning and change over time and treatment. The HDI was written to evaluate the three aspects of mental disorders as described in the Diagnostic and Statistical Manual of Mental Disorders (DSM): "clinically significant behavioral or psychological syndrome or pattern...associated with present distress...or disability". This also corresponds to the phase model described by Howard and colleagues Accordingly, the HDI assesses (1) the experience of emotional or behavioral symptoms that define mental illness, such as dysphoria, worry, angry outbursts, low self-esteem, or excessive drinking, (2) the level of emotional distress related to these symptoms, and (3) the impairment or problems fulfilling the major roles of one's life.
The Patient-Reported Outcomes Measurement Information System (PROMIS) provides clinicians and researchers access to reliable, valid, and flexible measures of health status that assess physical, mental, and social well–being from the patient perspective. PROMIS measures are standardized, allowing for assessment of many patient-reported outcome domains—including pain, fatigue, emotional distress, physical functioning and social role participation—based on common metrics that allow for comparisons across domains, across chronic diseases, and with the general population. Further, PROMIS tools allow for computer adaptive testing, efficiently achieving precise measurement of health status domains with few items. There are PROMIS measures for both adults and children. PROMIS was established in 2004 with funding from the National Institutes of Health (NIH) as one of the initiatives of the NIH Roadmap for Medical Research.
The Ankylosing Spondylitis Quality of Life (ASQoL) questionnaire is a patient-reported outcome (PRO) measure which assesses the quality of life of patients with ankylosing spondylitis. The ASQoL is based on the needs-based quality of life model. It is a self-administered questionnaire which contains 18 items and takes up to four minutes to complete.
EQ-5D is a standardised measure of health-related quality of life developed by the EuroQol Group to provide a simple, generic questionnaire for use in clinical and economic appraisal and population health surveys. EQ-5D assesses health status in terms of five dimensions of health and is considered a ‘generic’ questionnaire because these dimensions are not specific to any one patient group or health condition. EQ-5D can also be referred to as a patient-reported outcome (PRO) measure, because patients can complete the questionnaire themselves to provide information about their current health status and how this changes over time. ‘EQ-5D’ is not an abbreviation and is the correct term to use when referring to the instrument in general.
The Pittsburgh Sleep Quality Index (PSQI) is a self-report questionnaire that assesses sleep quality over a 1-month time interval. The measure consists of 19 individual items, creating 7 components that produce one global score, and takes 5–10 minutes to complete. Developed by researchers at the University of Pittsburgh, the PSQI is intended to be a standardized sleep questionnaire for clinicians and researchers to use with ease and is used for multiple populations. The questionnaire has been used in many settings, including research and clinical activities, and has been used in the diagnosis of sleep disorders. Clinical studies have found the PSQI to be reliable and valid in the assessment of sleep problems to some degree, but more so with self-reported sleep problems and depression-related symptoms than actigraphic measures.
The Hypomania Checklist (HCL-32) is a questionnaire developed by Dr. Jules Angst to identify hypomanic features in patients with major depressive disorder in order to help recognize bipolar II disorder and other bipolar spectrum disorders when people seek help in primary care and other general medical settings. It asks about 32 behaviors and mental states that are either aspects of hypomania or features associated with mood disorders. It uses short phrases and simple language, making it easy to read. The University of Zurich holds the copyright, and the HCL-32 is available for use at no charge. More recent work has focused on validating translations and testing whether shorter versions still perform well enough to be helpful clinically. Recent meta-analyses find that it is one of the most accurate assessments available for detecting hypomania, doing better than other options at recognizing bipolar II disorder.
ISPOR—The Professional Society for Health Economics and Outcomes Research, better known as ISPOR, is a nonprofit global professional organization in health economics and outcomes research. It was founded in 1995 as an international multidisciplinary professional organization that advances the policy, science, and practice of pharmacoeconomics and outcomes research. The society's mission is to promote health economics and outcomes research to improve decision making for health globally.
The Somatic Symptom Disorder - B Criteria Scale (SSD-12) is a brief self-report questionnaire used to assess the B criteria of DSM-5 somatic symptom disorder, i.e. the patients’ perceptions of their symptom-related thoughts, feelings, and behaviors.