Evidence map›Paper›PMID 15804318›Full record

GuidelineValue in health : the journal of the International Society for Pharmacoeconomics and Outcomes Research

Principles of Good Practice for the Translation and Cultural Adaptation Process for Patient-Reported Outcomes (PRO) Measures: report of the ISPOR Task Force for Translation and Cultural Adaptation.

Diane Wild, Alyson Grove, Mona Martin, Sonya Eremenco, Sandra McElroy, Aneesa Verjee-Lorenz, Pennifer Erikson, ISPOR Task Force for Translation and Cultural Adaptation

20 registry-linked trialsAbstract readGuideline
PubMed Publisher
In one paragraph

Guideline in Value in health : the journal of the International Society for Pharmacoeconomics and Outcomes Research. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 20 registered trials, which are not on this map. Cited by 2,295 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
2,295citing papers in PubMed, 1 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT03347682 completednot on this map

Reliability and Construct Validity of the Turkish Version of the Prosthesis Donning and Doffing Questionnaire in Transtibial Amputees.

TypeobservationalSponsorMarmara UniversityRan2017 to 2019Enrolled30ConditionsAmputation, Traumatic, Leg, LowerArmsSatisfaction with Prosthesis -SATPRO, Nottingham Health Profile-NHP, Prosthesis donning and doffing questionnaire
NCT03837912 naunknown statusnot on this map

Intervention Based on the Use of Patient Feedback Collected for Improving Patient Safety in Spanish Primary Care (PC) Centres

TypeinterventionalSponsorFundació d'investigació Sanitària de les Illes BalearsRan2019 to 2021Enrolled1,248ConditionsPatient SafetyArmsPatient reported safety experiences fed back to PC providers
NCT03855618 enrolling by invitationnot on this map

Translation and Validation of the Evaluation Scale Fugl-Meyer in Italian Language

Typeobservational_patient_registrySponsorFondazione Don Carlo Gnocchi ETSRan2019 to 2025Enrolled10ConditionsValidation Fugl Meyer Scale in Italian
NCT04090177 naunknown statusnot on this map

Evaluation of a Peer-led eHealth Wheelchair Skills Training Program: Training to Enhance Adaptation and Management for Wheelchair Users

TypeinterventionalSponsorUniversity of ManitobaRan2021 to 2024Enrolled54ConditionsMobility LimitationArmsTEAM Wheels
NCT04117997 recruitingnot on this map

Validation of the Evaluation Scale Fugl-Meyer in Italian Language

TypeobservationalSponsorFondazione Don Carlo Gnocchi ETSRan2022 to 2025Enrolled70ConditionsValidation Fugl-Meyer Scale in Italian
NCT04165473 completednot on this map

A Training Program for Developing Social- and Personal Resources and Its Effects on Emotional, Physical and Social Wellbeing in Adults

TypeobservationalSponsorMedical University of ViennaRan2023 to 2024Enrolled223ConditionsStress, Psychological, Stress, Emotional, Health Behavior, Satisfaction, PersonalArmsTraining Program for Developing Social- and Personal Resources
NCT04501848 completednot on this map

The Impact of Sleep Disordered Breathing on Parental Quality of Life

TypeobservationalSponsorWestern Galilee Hospital-NahariyaRan2018 to 2020Enrolled45ConditionsSleep Apnea SyndromesArmsadenotonsillectomy
NCT04541290 phase1 / phase2completednot on this map

Tacrolimus as Treatment of Breast Cancer-Related Lymphedema

TypeinterventionalSponsorOdense University HospitalRan2020 to 2022Enrolled20ConditionsBreast Cancer LymphedemaArmsProtopic 0.1 % Topical Ointment
NCT04557982 completednot on this map

Creating a Czech Version of the Simplified Faces Pain Scale and the Simplified Concrete Ordinal Pain Scale

TypeobservationalSponsorPalacky UniversityRan2020 to 2021Enrolled135ConditionsPain MeasurementArmsA painful procedure (peripheral venepuncture)
NCT04583670 completednot on this map

How Point-of-care Ultrasound Affects the Diagnostic and Therapeutic Process in General Practice. A Prospective Follow-up Study in France

TypeobservationalSponsorSorbonne UniversityRan2023 to 2024Enrolled655ConditionsPoint of Care Ultrasound
NCT04710147 completednot on this map

Cross-cultural Adaptation to the Spanish Population and Validation of Community Balance & Mobility Scale in Persons With Acquired Brain Injury in Subacute and Chronic Phase

Typeobservational_patient_registrySponsorUniversity of Castilla-La ManchaRan2021 to 2022Enrolled100ConditionsBrain Injury, Chronic
NCT05782166 naunknown statusnot on this map

Cross-Cultural Adaptation of a Betel Quid Cessation Program and Evaluation of Its Effectiveness in a Malaysian High-Risk Community

TypeinterventionalSponsorUniversity of MalayaRan2024 to 2024Enrolled92ConditionsBetel Nut Chewer, Tobacco CessationArmsBetel Quid Educational Booklet, Betel Quid Cessation Intervention Module
NCT05923164 unknown statusnot on this map

Reliability And Validity Study Of MAP-BC Evaluation Tool In Turkish Language To Detect Myofascial Adhesions Among Women Under Breast Cancer Treatment

TypeobservationalSponsorSultan Abdulhamid Han Training and Research Hospital, Istanbul, TurkeyRan2023 to 2024Enrolled88ConditionsBreast Cancer, Upper Extremity Dysfunction, Tissue AdhesionArmsMAP-BC (Myofascial Adhesions in Patients after Breast Cancer) Evaluation Tool, Patient And Observer Scar Assessment Scale ( Observer Subscale)
NCT05935943 completednot on this map

Reliability and Validity of the Spinal Cord Injury Secondary Conditions Scale Among the Turkish Population With Spinal Cord Injury

TypeobservationalSponsorFatih Sultan Mehmet Training and Research HospitalRan2022 to 2023Enrolled93ConditionsSpinal Cord Injuries, Reliability, Validity
NCT05947903 unknown statusnot on this map

Validation of the European Oncology Quality of Life Toolkit. A European Pilot Survey.

TypeobservationalSponsorFondazione IRCCS Istituto Nazionale dei Tumori, MilanoRan2024 to 2024Enrolled4,000ConditionsCancer, Survivorship, Palliative CareArmsAdministration of the EUonQoL-Kit - Active Treatment questionnaire, Administration of the EUonQoL-Kit - Survivors questionnaire, Administration of the EUonQoL-Kit - Palliative Care questionnaire
NCT06373588 narecruitingnot on this map

Co-design and Evaluation of a Patient Navigator Intervention for Migrant Children and Youth with Special Healthcare Needs (CYSHCN) Experiencing Care Transitions (MiNav Trial)

TypeinterventionalSponsorMcGill University Health Centre/Research Institute of the McGill University Health CentreRan2024 to 2027Enrolled324ConditionsPatient NavigationArmsPatient Navigator
NCT07476976 enrolling by invitationnot on this map

Characteristics of the Functional State of the Musculoskeletal System, Body Awareness, and Quality of Life in Individuals With Joint Hypermobility, Their Associations, and Guidelines for Intervention.

TypeobservationalSponsorLithuanian University of Health SciencesRan2026 to 2029Enrolled511ConditionsJoint HypermobilityArmsNo intervention
NCT07653074 recruitingnot on this map

Functional Vision and Quality of Life in a Modern Society - With Emphasis on Myopia and Cerebral Visual Impairment Among Youth

Typeobservational_patient_registrySponsorRegion Örebro CountyRan2024 to 2029Enrolled300ConditionsMyopia, Quality of LifeArmsophthalmological examination
NCT07673874 not yet recruitingnot on this map

Turkish Cross-Cultural Adaptation, Validity, and Reliability of the "Brief Inventory of Treatment Expectations in Chronic Pain" (BITEC) Scale

TypeobservationalSponsorHacettepe UniversityRan2026 to 2027Enrolled250ConditionsChronic PainArmsSurvey Assessment Battery
NCT07673926 not yet recruitingnot on this map

Turkish Cultural Adaptation and Psychometric Properties of the Pain and Smoking Inventory in Individuals With Chronic Pain

TypeobservationalSponsorHacettepe UniversityRan2026 to 2027Enrolled200ConditionsChronic Pain
3 · Its place in the literature

Who cites it

2,295 citing papers in PubMed, 1 synthesis or guideline pooled it.

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  20. Greek Translation and Preliminary Test-Retest Reliability of the AQUA CHILD Questionnaire in Children With Developmental Disabilities.Physiotherapy research international : the journal for researchers and clinicians in physical therapy · 2026
    Article

2,235 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

8 authors.

Diane WildOxford Outcomes Ltd., Cassington, Oxford, UK. Diane.wild@oxfordoutcomes.com
Alyson Grove
Mona Martin
Sonya Eremenco
Sandra McElroy
Aneesa Verjee-Lorenz
Pennifer Erikson
ISPOR Task Force for Translation and Cultural Adaptation

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

In 1999, ISPOR formed the Quality of Life Special Interest group (QoL-SIG)--Translation and Cultural Adaptation group (TCA group) to stimulate discussion on and create guidelines and standards for the translation and cultural adaptation of patient-reported outcome (PRO) measures. After identifying a general lack of consistency in current methods and published guidelines, the TCA group saw a need to develop a holistic perspective that synthesized the full spectrum of published methods. This process resulted in the development of Translation and Cultural Adaptation of Patient Reported Outcomes Measures--Principles of Good Practice (PGP), a report on current methods, and an appraisal of their strengths and weaknesses. The TCA Group undertook a review of evidence from current practice, a review of the literature and existing guidelines, and consideration of the issues facing the pharmaceutical industry, regulators, and the broader outcomes research community. Each approach to translation and cultural adaptation was considered systematically in terms of rationale, components, key actors, and the potential benefits and risks associated with each approach and step. The results of this review were subjected to discussion and challenge within the TCA group, as well as consultation with the outcomes research community at large. Through this review, a consensus emerged on a broad approach, along with a detailed critique of the strengths and weaknesses of the differing methodologies. The results of this review are set out as "Translation and Cultural Adaptation of Patient Reported Outcomes Measures--Principles of Good Practice" and are reported in this document.

Indexed as

Sickness Impact ProfileTranslatingAdvisory CommitteesAttitude to HealthCultureHealth Services ResearchHumansOutcome Assessment, Health CarePsychometricsQuality of LifeReproducibility of ResultsSurveys and Questionnaires

Identifiers

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

and 14 more above

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.