ArticleTherapeutic innovation & regulatory science2020
Evaluation of the Content Validity and Cross-Cultural Validity of the Study Participant Feedback Questionnaire (SPFQ).
Article in Therapeutic innovation & regulatory science, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 20 papers.
What it found
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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.
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Who cites it
20 citing papers in PubMed, 27 citations in OpenAlex.
- Trial
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- Enterprise performance and talent innovation training in new enterprises based on social exchange theory and organizational psychology.Scientific reports · 2026Article
- The patient-centric development of an inclusive multi-arm multi-stage trial for Parkinson's disease.Brain communications · 2026Article
- Participant Experience, Acceptability and Feasibility of Virtual and Digitally Supported Visits in a Phase IIa COPD Trial.Journal of patient experience · 2026Article
- Assessing content validity of the Osteo-TAQ(Aus) using cognitive interviews: cross-jurisdictional evidence from UK osteopathic practice.BMC research notes · 2025Article
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- Perceived Quality-of-Life Importance Among Saudi Gynecologic Cancer Survivors: Latent Class Analysis.Current oncology (Toronto, Ont.) · 2025Article
- Sexual Satisfaction and Psychosocial Well-Being Among Saudi Survivors of Cervical and Breast Cancer: A Cross-Sectional Analysis.Healthcare (Basel, Switzerland) · 2025Article
- A prospective, multi-centre trial of PSMA-PET compared to FDG-PET for staging of newly diagnosed high risk prostate cancer.EJNMMI research · 2025Article
- Public Perception of Clinical Trials and Its Predictors Among Polish Adults.Journal of clinical medicine · 2025Article
- Multimodal exercise training to reduce frailty in people with multiple sclerosis: study protocol for a pilot randomized controlled trial.Pilot and feasibility studies · 2024Article
- Article
- Acceptability, fidelity and trial experience of four intervention components to support medication adherence in women with breast cancer: A process evaluation protocol for a pilot fractional factorial trial.NIHR open research · 2023Article
- Article
- Criminal law-based copyright protection with entrepreneurial spirit.Frontiers in psychology · 2022Article
- Sustaining Meaningful Patient Engagement Across the Lifecycle of Medicines: A Roadmap for Action.Therapeutic innovation & regulatory science · 2021Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
8 authors at 5 institutions in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectivesThe Study Participant Feedback Questionnaire (SPFQ) is a patient-completed tool designed to assess patient experiences and satisfaction with aspects associated with being involved in a clinical trial. Originally developed in oncology and among English-speaking participants, the aim of the current study was to evaluate the content and cross-cultural validity of the SPFQ in other indications and non-English-speaking countries.
methodsSemi-structured qualitative telephone interviews were conducted with 80 participants across eight non-English-speaking countries (in Europe, South America and Asia) who had received an investigational medicinal product as part of a clinical trial in the past three years. Interviews comprised concept elicitation to identify concepts of importance to participants' trial experiences, and cognitive debriefing to assess understanding and perceived importance of SPFQ instructions, items and response options.
resultsConcept elicitation findings supported the content validity of the SPFQ. During cognitive debriefing, SPFQ instructions and the majority of items were well understood by participants. Participants generally considered the SPFQ items important to their clinical trial experience, albeit a handful of items assessed concepts that had not been experienced by trial participants or were redundant with other SPFQ items. The instructions, response options and recall period of the SPFQ were generally well understood. No country-level differences in understanding or importance were apparent.
conclusionStudy findings provide evidence for the content and cross-cultural validity of the SPFQ and support implementation of the SPFQ as a means of obtaining participant feedback across global development programmes in a variety of indications.
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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.