ArticlePharmacoEconomics2008
Perspectives on patient-reported outcomes : content validity and qualitative research in a changing clinical trial environment.
Article in PharmacoEconomics, 2008. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01880177 (A Study Designed to Develop and Validate a New Screening Measure for Identifying Undiagnosed At-Risk COPD Cases), which is not on this map. Cited by 112 papers, 2 of them syntheses that pooled 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.
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.
A Study Designed to Develop and Validate a New Screening Measure for Identifying Undiagnosed At-Risk COPD Cases
Who cites it
112 citing papers in PubMed, 2 syntheses or guidelines pooled it.
- Control of Allergic Rhinitis and Asthma Test for Children (CARATkids): A systematic review and meta-analysis of its measurement properties.Pediatric allergy and immunology : official publication of the European Society of Pediatric Allergy and Immunology · 2025Pooled it
- A meta-analytic review of measurement equivalence study findings of the SF-36® and SF-12® Health Surveys across electronic modes compared to paper administration.Quality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation · 2018Pooled it
- Small Social Incentives Did Not Improve the Survey Response Rate of Patients Who Underwent Orthopaedic Surgery: A Randomized Trial.Clinical orthopaedics and related research · 2019Trial
- Patient-reported Symptom Experiences in Patients With Carcinoid Syndrome After Participation in a Study of Telotristat Etiprate: A Qualitative Interview Approach.Clinical therapeutics · 2016Trial
- Development of a patient-reported outcomes registry for patients with brain tumours (BEACON).ESMO real world data and digital oncology · 2026Article
- Exit Interviews Examining Patient Experiences with Tirzepatide and Dulaglutide for Treatment of Type 2 Diabetes in the SURPASS-CVOT Trial.Diabetes therapy : research, treatment and education of diabetes and related disorders · 2026Article
- Development of the Pediatric Type 2 Diabetes Impact Measure (P-TIM).Journal of patient-reported outcomes · 2026Article
- Cross-cultural translation and content validity of the Determinants of Physical Activity Questionnaire (DPAQ) in a Dutch stroke rehabilitation population and their peers without stroke.Journal of patient-reported outcomes · 2026Article
- Content validation of the Myelofibrosis Symptom Assessment Form version 4.0 (MFSAF v4.0) in Janus kinase inhibitor-experienced patients with myelofibrosis.Journal of patient-reported outcomes · 2026Article
- Development of the Patient Satisfaction with Medication for Diabetes (PSMD) questionnaire.Journal of patient-reported outcomes · 2026Article
- Development of the Weight and Emotions Scale (WES).Obesity science & practice · 2026Article
- A comprehensive scoring system for defecation disorders derived by merging various validated patient-reported outcome measures for fecal incontinence, chronic constipation, and obstructed defecation.International journal of colorectal disease · 2026Observational
- Article
- Content Validity Assessment of the Insomnia Daytime Symptoms and Impacts Questionnaire (IDSIQ) Among Adults with Insomnia and Nocturia.The patient · 2025Observational
- Understanding the adult and adolescent patient experience with cyclic vomiting syndrome: a concept elicitation study.BMC gastroenterology · 2025Article
- Article
- A Review of Reviews of Patient-Reported Measures in Psychosis: Need to Consider Factors Affecting Equity and the Involvement of Patients.Schizophrenia bulletin open · 2025Review
- Development and validation of the "Adjustment Disorder Scale for Medically Ill Patients - ETAM".Frontiers in psychiatry · 2025Article
- Chronic rhinosinusitis with nasal polyps (CRSwNP) symptom verbal response scales: content validity testing for use in adults with CRSwNP.Journal of patient-reported outcomes · 2024Article
- Face and content validity of the EMPOWER-UP questionnaire: a generic measure of empowerment in relational decision-making and problem-solving.BMC medical informatics and decision making · 2024Article
52 more citing papers are in PubMed but not listed here.
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
2 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Patient-reported outcomes (PROs) represent the voice of the patient in drug and device evaluation. As such, the outcomes selected for evaluation must be relevant to the patient, and the instruments used to capture them must have sound measurement properties. This paper discusses the role of qualitative research methods in assuring PRO clarity and content validity in a clinical trial environment characterized by evolving regulatory policy, new advances in technology and increasingly diverse samples within global clinical trials. Three important PRO measurement issues influenced by these changes are addressed: (i) endpoint selection and instrument development; (ii) the adaptation of instruments for electronic administration; and (iii) conceptual equivalence of measures across diverse samples. These are viewed as interrelated issues of content validity that can be addressed through the appropriate and rigorous application of qualitative research methods. Focus groups, cognitive debriefing, user acceptance testing and translation methodologies are discussed as ways to address and document the content validity of PRO instruments and ensure the empirical data representing the voice of the patient is sound.
Indexed as
Identifiers
18429654What OpenQuestion holds
Registered trials
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.