ArticleTherapeutic innovation & regulatory science2025
An Evaluation of Time Spent Completing Electronically Collected Patient-Reported Outcomes in Clinical Trials.
Article in Therapeutic innovation & regulatory science, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 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
5 citing papers in PubMed.
- Determining the quality of life-aged care consumer threshold to identify good quality of life in older adults in long-term care.Quality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation · 2026Article
- International Consensus-Driven Recommendations for Patient-Reported Outcome Research Objectives in Early Phase Dose-Finding Oncology Trials: OPTIMISE-ROR.Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2026Article
- Development of a Novel Patient-Reported Outcome Diary to Capture and Monitor Home-Managed Pain Crises in Patients with Sickle Cell Disease.Advances in therapy · 2026Article
- Development of the Nephrotic Syndrome Symptom and Impact Patient Reported Outcome (NephroSSI-PRO) measure for use in adults and adolescents with primary glomerulopathies.Journal of patient-reported outcomes · 2025Article
- A Hybrid Technology-Enabled Financial Navigation Model to Combat Financial Toxicity in Cancer Care.Cancer control : journal of the Moffitt Cancer CenterArticle
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
No grant is acknowledged in the PubMed record.
Abstract
objectivesPatient-reported outcomes (PROs) are important measures of efficacy in the context of clinical trials but are sometimes identified as time and resource intensive to study participants and site personnel. The objective of this research was to evaluate the amount of time that participants spend completing PROs via an electronic device in phase 2 and 3 clinical trials across several disease areas.
methodsThe electronic Clinical Outcome Assessment (eCOA) data were obtained from Johnson & Johnson clinical trials across various disease areas from 2016 to 2023. Data were acquired from internal and external sources including clinical trial sites and eCOA partners. In total, 82 trials were analyzed, containing data from 33,633 unique participants, and 1,083,994 measurements of completed electronic PRO instruments. After data cleaning, descriptive and multivariate analyses were performed. Electronic PRO completion time was examined in two ways: by time-per-item and time-per-instrument for each PRO.
resultsOn average, participants spend about 16 s per item and an average of 2 min to complete a PRO instrument electronically. The average time to complete PRO instruments varied significantly by disease area and most eCOA were completed on study site tablets (68%) or personal handheld devices (31%).
conclusionsOverall, patients spend an average of 16 s per item and 2 min per PRO instrument in clinical trial studies. PROs are a crucial component of clinical trial outcomes data and can be efficiently completed electronically by participants in clinical trials in a short amount of time.
Indexed as
Identifiers
40056370What 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.