SynthesisPloS one2014
Systematic evaluation of the patient-reported outcome (PRO) content of clinical trial protocols.
Synthesis in PloS one, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 48 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.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
48 citing papers in PubMed, 2 syntheses or guidelines pooled it.
- [Extensions of guidelines for reporting types of study in medicine].Revista medica del Instituto Mexicano del Seguro Social · 2022Pooled it
- Pooled it
- Web-Based Cancer Symptom Self-Management System: A Randomized Clinical Trial.JAMA network open · 2025Trial
- Trial
- A review of rate control in atrial fibrillation, and the rationale and protocol for the RATE-AF trial.BMJ open · 2017Trial
- Trial
- A 360 Degree Qualitative Ethical Assessment of Reporting Patient Reported Outcomes.Journal of empirical research on human research ethics : JERHRE · 2026Article
- The importance of patient-reported outcomes: A call for their integration in the routine care of patients with multiple sclerosis.Multiple sclerosis (Houndmills, Basingstoke, England) · 2025Review
- Establishing the content validity of patient-reported outcome measures used in neuro-oncology based on the WHO ICF framework: Part of the RANO-PRO initiative.Neuro-oncology · 2025Article
- Health status, respiratory symptom and dyspnea trajectories in subjects with chronic obstructive pulmonary disease: a seven-year observation in clinical practice.Journal of patient-reported outcomes · 2025Observational
- Patient reported outcomes in the FDA approved drugs for systemic rheumatic diseases (2013-2024).Health and quality of life outcomes · 2025Review
- SPIRIT 2025 explanation and elaboration: updated guideline for protocols of randomised trials.BMJ (Clinical research ed.) · 2025Article
- Breast-cancer specific comprehensive archive of Patient-Reported Outcome Measures (PROMs) for clinical research and clinical practice in oncology: Results from the PRO4All project.Breast (Edinburgh, Scotland) · 2024Article
- Enhancing reporting through structure: a before and after study on the effectiveness of SPIRIT-based templates to improve the completeness of reporting of randomized controlled trial protocols.Research integrity and peer review · 2024Article
- Review
- Closing the value-based circle in shared decision-making: a digital framework for informing the shared decision-making process through patient reported outcome and experience measures.Frontiers in public health · 2024Article
- Assessing patient-reported outcomes (PROs) and patient-related outcomes in randomized cancer clinical trials for older adults: Results of DATECAN-ELDERLY initiative.Journal of geriatric oncology · 2024Review
- Ethical and practical considerations related to data sharing when collecting patient-reported outcomes in care-based child health research.Quality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation · 2023Article
- Comparison of Predictive Properties between Tools of Patient-Reported Outcomes: Risk Prediction for Three Future Events in Subjects with COPD.Diagnostics (Basel, Switzerland) · 2023Article
- Reminding Peer Reviewers of Reporting Guideline Items to Improve Completeness in Published Articles: Primary Results of 2 Randomized Trials.JAMA network open · 2023Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
11 authors.
Funding
Abstract
backgroundQualitative evidence suggests patient-reported outcome (PRO) information is frequently absent from clinical trial protocols, potentially leading to inconsistent PRO data collection and risking bias. Direct evidence regarding PRO trial protocol content is lacking. The aim of this study was to systematically evaluate the PRO-specific content of UK National Institute for Health Research (NIHR) Health Technology Assessment (HTA) programme trial protocols. METHODS AND
findingsWe conducted an electronic search of the NIHR HTA programme database (inception to August 2013) for protocols describing a randomised controlled trial including a primary/secondary PRO. Two investigators independently reviewed the content of each protocol, using a specially constructed PRO-specific protocol checklist, alongside the 'Standard Protocol Items: Recommendations for Interventional Trials' (SPIRIT) checklist. Disagreements were resolved through discussion with a third investigator. 75 trial protocols were included in the analysis. Protocols included a mean of 32/51 (63%) SPIRIT recommendations (range 16-41, SD 5.62) and 11/33 (33%) PRO-specific items (range 4-18, SD 3.56). Over half (61%) of the PRO items were incomplete. Protocols containing a primary PRO included slightly more PRO checklist items (mean 14/33 (43%)). PRO protocol content was not associated with general protocol completeness; thus, protocols judged as relatively 'complete' using SPIRIT were still likely to have omitted a large proportion of PRO checklist items.
conclusionsThe PRO components of HTA clinical trial protocols require improvement. Information on the PRO rationale/hypothesis, data collection methods, training and management was often absent. This low compliance is unsurprising; evidence shows existing PRO guidance for protocol developers remains difficult to access and lacks consistency. Study findings suggest there are a number of PRO protocol checklist items that are not fully addressed by the current SPIRIT statement. We therefore advocate the development of consensus-based supplementary guidelines, aimed at improving the completeness and quality of PRO content in clinical trial protocols.
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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.