ArticleOncology nursing forum2011
Measuring the process and quality of informed consent for clinical research: development and testing.
Article in Oncology nursing forum, 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 10 papers.
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.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
10 citing papers in PubMed.
- Improving quality of the informed consent process: Developing an easy-to-read, multimodal, patient-centered format in a real-world setting.Patient education and counseling · 2019Trial
- Effectiveness and Validity of Informed Consent in Patients Undergoing Surgery in Cameroon: A Prospective Survey.The Journal of surgical research · 2026Article
- Article
- Health Communication and Decision Making about Vaccine Clinical Trials during a Pandemic.Journal of health communication · 2020Article
- Assessing usefulness and researcher satisfaction with consent form templates.Journal of clinical and translational science · 2017Article
- Article
- Current State of Electronic Consent Processes in Behavioral Health: Outcomes from an Observational Study.AMIA ... Annual Symposium proceedings. AMIA Symposium · 2017Observational
- ". . . I've Gone Through This My Own Self, So I Practice What I Preach . . . ".Journal of empirical research on human research ethics : JERHRE · 2016Article
- Improving the Proficiency of Research Consent Administrators.Clinical and translational science · 2015Article
- Audit of the informed consent process as a part of a clinical research quality assurance program.Science and engineering ethics · 2014Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
5 authors.
Funding
Abstract
PURPOSE/
objectivesTo develop and assess the reliability and validity of an observational instrument, the Process and Quality of Informed Consent (P-QIC).
designA pilot study of the psychometrics of a tool designed to measure the quality and process of the informed consent encounter in clinical research. The study used professionally filmed, simulated consent encounters designed to vary in process and quality.
settingA major urban teaching hospital in the northeastern region of the United States. SAMPLE: 63 students enrolled in health-related programs participated in psychometric testing, 16 students participated in test-retest reliability, and 5 investigator-participant dyads were observed for the actual consent encounters.
methodsFor reliability and validity testing, students watched and rated videotaped simulations of four consent encounters intentionally varied in process and content and rated them with the proposed instrument. Test-retest reliability was established by raters watching the videotaped simulations twice. Inter-rater reliability was demonstrated by two simultaneous but independent raters observing an actual consent encounter. MAIN RESEARCH VARIABLES: The essential elements of information and communication for informed consent.
findingsThe initial testing of the P-QIC demonstrated reliable and valid psychometric properties in both the simulated standardized consent encounters and actual consent encounters in the hospital setting.
conclusionsThe P-QIC is an easy-to-use observational tool that provides a quick assessment of the areas of strength and areas that need improvement in a consent encounter. It can be used in the initial trainings of new investigators or consent administrators and in ongoing programs of improvement for informed consent. IMPLICATIONS FOR NURSING: The development of a validated observational instrument will allow investigators to assess the consent process more accurately and evaluate strategies designed to improve it.
Indexed as
Identifiers
What 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.