Observational studyScandinavian journal of trauma, resuscitation and emergency medicine2020
Barriers and challenges in the process of including critically ill patients in clinical studies.
Observational study in Scandinavian journal of trauma, resuscitation and emergency medicine, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03405766 (Barriers in the Process of Achieving Informed Consent From Critically Ill Patients), which is not on this map. Cited by 10 papers, 1 of them a synthesis 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.
Barriers in the Process of Achieving Informed Consent From Critically Ill Patients
Who cites it
10 citing papers in PubMed, 1 synthesis or guideline pooled it, 22 citations in OpenAlex.
- Views on consent approaches used in emergency and critical care research: a rapid, systematic review.Trials · 2026Pooled it
- Nociception and pain assessment during suctioning procedures in mechanically ventilated patients in the intensive care unit: A validation study of the Nociception Level index (NOL™).Canadian journal of pain = Revue canadienne de la douleur · 2026Article
- The POETIC (PrOcess Evaluation of Trials In Critical care) Framework: A Structured Approach for Designing and Conducting Process Evaluations in Critical Care Trials.Critical care explorations · 2025Article
- Research Ethics Challenges, Controversies and Difficulties in Intensive Care Units-A Systematic Review of Theoretical Concepts.Nursing reports (Pavia, Italy) · 2025Review
- Patient and public involvement and engagement in critical care research in low and middle-income countries: challenges and solutions.Critical care science · 2025Article
- [Proposal for participation in intensive care and emergency medicine studies for patients unable to give informed consent (Cologne Model)].Medizinische Klinik, Intensivmedizin und Notfallmedizin · 2024Review
- Optimising clinical outcomes with innovative research in the intensive care unit.Indian journal of anaesthesia · 2022Article
- Educational Intervention for Management of Acute Trauma Pain: A Proof-of-Concept Study in Post-surgical Trauma Patients.Frontiers in psychiatry · 2022Article
- Article
- Recent Randomized Trials of Antithrombotic Therapy for Patients With COVID-19: JACC State-of-the-Art Review.Journal of the American College of Cardiology · 2021Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
4 authors at 2 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundClinical research in severely ill or injured patients is required to improve healthcare but may be challenging to perform in practice. The aim of this study was to analyse barriers and challenges in the process of including critically ill patients in clinical studies.
methodsData from critically ill patients considered for inclusion in an observational study of venous thromboembolism in Norway were analysed. This included quantitative and qualitative information from the screening log, consent forms and research notes.
resultsAmong 279 eligible critically ill patients, 204 (73%) were omitted from the study due to challenges and barriers in the inclusion process. Reasons for omission were categorised as practical in 133 (65%), medical in 31 (15%), and legal or ethical in 40 (20%) of the patients. Among 70 included patients, 29 (41%) consents were from patients and 41 (59%) from their next of kin. Several challenges were described herein; these included whether patients were competent to give consent, and which next of kin that should represent the patient. Furthermore, some included patients were unable to recall what they have consented, and some appeared unable to separate research from treatment.
conclusionsBarriers and challenges in the inclusion process led to the omission of near three out of four eligible patients. This analysis provided information about where the problem resides and may be solved. The majority of challenges among included patients were related to issues of autonomy and validity of consent.
trial registrationClinicalTrials.gov (NCT03405766).
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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.