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Procedural Framework to Facilitate Hospital-Based Informed Consent for Dementia Research
Holden TR, Keller S, Kim A, Gehring M, Schmitz E, Hermann C, Gilmore-Bykovskyi A, Kind AJH.. Journal of the American Geriatrics Society, 2018-09-24
Topic: Risk, prevention and care in population studies
Improving quality and delivery of care for people with Alzheimer disease and related dementias (ADRD) requires a comprehensive research agenda that encompasses the entire care continuum. Logistical and ethical challenges of informed consent for research participation of persons with ADRD include determination of capacity to consent, surrogate consent when capacity to consent is compromised, timely identification of the legally authorized representative (LAR) providing surrogate consent, and balancing residual autonomy with surrogate consent. Short stays; limited access to patients, caregivers, and LARs; and fluctuating influences of acute illness on capacity determination compound these challenges in the acute care setting. To address these challenges, we worked with the University of Wisconsin Health Sciences Institutional Review Board to develop a procedural framework for obtaining informed consent from hospitalized individuals with ADRD and their caregivers to participate in a minimal risk care intervention. The framework is specially designed for minimal risk situations in which rapid enrollment is a necessity and uses rapid identification of surrogates to consent for patients who lack legal capacity to make medical decisions, indicated by an activated healthcare power of attorney, and individualized formal assent procedures for patients who lack capacity to consent. These methods were proven effective in facilitating hospital-based recruitment in an ongoing randomized controlled trial and provide a basis for increasing access to acute care clinical research for persons with ADRD. Bolstering research participation through more easily used consent procedures during acute illness is critical to fostering improvements in the delivery of high-quality care to persons with ADRD. J Am Geriatr Soc 66:2243-2248, 2018.
Key findings
- Short stays; limited access to patients, caregivers, and LARs; and fluctuating influences of acute illness on capacity determination compound these challenges in the acute care setting.
- To address these challenges, we worked with the University of Wisconsin Health Sciences Institutional Review Board to develop a procedural framework for obtaining informed consent from hospitalized individuals with ADRD and their caregivers to participate in a minimal risk care intervention.
- The framework is specially designed for minimal risk situations in which rapid enrollment is a necessity and uses rapid identification of surrogates to consent for patients who lack legal capacity to make medical decisions, indicated by an activated healthcare power of attorney, and individualized formal assent procedures for patients who lack capacity to consent.
- These methods were proven effective in facilitating hospital-based recruitment in an ongoing randomized controlled trial and provide a basis for increasing access to acute care clinical research for persons with ADRD.
- Bolstering research participation through more easily used consent procedures during acute illness is critical to fostering improvements in the delivery of high-quality care to persons with ADRD.
Why it matters
This paper describes a procedural framework for obtaining informed consent from hospitalized people with dementia for a minimal risk care intervention. It does not test any treatment for Alzheimer's disease.
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Study details
- Study designrandomized controlled trial
- Evidence strengthHigh
How this study scored 53/100
Published in a peer-reviewed journal, and it is a randomised controlled trial. Scored zero for sample size, effect reported and studied in people because the record does not state it.
| Component | Points | Why |
|---|---|---|
| Journal tier | 7 / 10 | Tier 3 — peer-reviewed journal (Journal of the American Geriatrics Society) |
| Journal's citation record | 3 / 4 | Journal of the American Geriatrics Society: journal h-index 344 (OpenAlex, 2026-10-29) |
| Study design | 11 / 12 | A randomised controlled trial |
| Strength of evidence | 5 / 5 | Rated “high” in our summary |
| Peer-review validation | 10 / 10 | Peer-reviewed. Published as an article in a named peer-reviewed journal. |
| How recent | 2 / 5 | 2018 — within 10 year(s) of the newest study here |
| Sample size | 0 / 4 | Participant count not stated — scores zero (not stated in the record — scored 0) |
| Effect reported | 0 / 3 | No effect size reported — scores zero (not stated in the record — scored 0) |
| Studied in people | 0 / 3 | Not stated whether this was studied in people — scores zero (not stated in the record — scored 0) |
| Randomised / blinded | 1 / 2 | Randomised (as stated in the record) |
| Times cited | 3 / 7 | Cited 21 times (OpenAlex, 2026-10-10) |
| Citations per year | 1 / 5 | 2.1 citations a year over 10 year(s) since 2018 |
| Impact for its field and year | 2 / 6 | Cited 2.4× the average for papers of its field and year (OpenAlex FWCI) |
| Cited by studies here | 0 / 6 | No other study in this library cites it |
| Still being cited | 1 / 4 | Cited 5 times in 2024–2026 (2026 still in progress; OpenAlex) |
| Senior author's track record | 2 / 4 | Last-listed author Amy Kind: h-index 47 (OpenAlex, whole career) |
| Institution's track record | 2 / 3 | Washington University in St. Louis: institution h-index 1,962 (OpenAlex) |
| Multi-centre collaboration | 1 / 3 | OpenAlex lists 3 institution(s) in 1 country |
| Indexed in PubMed | 2 / 2 | Indexed in PubMed (PMID 30246863) |
| Free to read | 0 / 2 | Behind a paywall — scores zero |
| Total | 53 / 100 | — |
What each of these 20 components measures, and what this score is not →
Read the original
Full text: free to read — PubMed Central lists this copy as free to read: the link above (checked 10 Oct 2026).
Cite this study APA, Vancouver, BibTeX · download .bib or .ris
Built from the record alzhub holds for this paper, not looked up. Volume, issue and page numbers are not held in the record. The record names 8 authors; APA and Vancouver show the first six, BibTeX and the downloads carry all of them. Check the citation against the original before you use it.
APA 7th
Holden, T. R., Keller, S., Kim, A., Gehring, M., Schmitz, E., Hermann, C., et al. (2018). Procedural Framework to Facilitate Hospital-Based Informed Consent for Dementia Research. Journal of the American Geriatrics Society. https://doi.org/10.1111/jgs.15525
Vancouver
Holden TR, Keller S, Kim A, Gehring M, Schmitz E, Hermann C, et al. Procedural Framework to Facilitate Hospital-Based Informed Consent for Dementia Research. Journal of the American Geriatrics Society. 2018. doi:10.1111/jgs.15525. PMID: 30246863.
BibTeX
@article{holden2018-30246863,
author = {Holden, T. R. and Keller, S. and Kim, A. and Gehring, M. and Schmitz, E. and Hermann, C. and Gilmore-Bykovskyi, A. and Kind, A. J. H.},
title = {{Procedural Framework to Facilitate Hospital-Based Informed Consent for Dementia Research}},
journal = {Journal of the American Geriatrics Society},
year = {2018},
doi = {10.1111/jgs.15525},
pmid = {30246863},
url = {https://doi.org/10.1111/jgs.15525}
}
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