Informed consent for digestive endoscopy in adults aged >85 years: documentation gaps and ethical implications

Technical Summary: Informed Consent for Digestive Endoscopy in Adults Aged >85 Years

Problem Statement
Informed consent (IC) is a foundational element of clinical ethics, grounded in the principles of autonomy, beneficence, non-maleficence, and justice. However, in adults aged ≥85 years, the validity of IC is frequently compromised by cognitive and functional vulnerabilities, particularly in the context of urgent clinical decisions required for invasive procedures like digestive endoscopy. While professional societies (ESGE, ASGE) mandate robust, patient-centered, and well-documented consent processes, there is a lack of empirical data regarding how these standards are implemented and recorded in very old adults. Specifically, it remains unclear whether routine documentation captures the essential elements of capacity, disclosure, understanding, and voluntariness, or if the process is reduced to a mere signature. This study addresses the gap between ethical guidance and actual practice by auditing IC documentation for upper gastrointestinal (GI) endoscopy in this vulnerable demographic.

Methodology
The authors conducted a retrospective, cross-sectional observational study at a 900-bed tertiary university hospital in Barcelona, Spain. The study population consisted of 106 adults aged ≥85 years who underwent an upper GI endoscopy between January 1 and December 31, 2022. Patients were admitted via the emergency department or inpatient wards; outpatient and day-hospital cases were excluded.

Data were abstracted from electronic medical records (EMRs) using a standardized form. The study variables included:

• Demographics and Social Context: Age, sex, living arrangement, and caregiver involvement.
• Clinical Status: Functional status (Barthel Index), cognitive status (Global Deterioration Scale [GDS] and dementia diagnosis), and endoscopy indications.
• IC Documentation Metrics: Presence of any IC document, presence of an endoscopy-specific IC form, identity of the signer (patient vs. proxy), narrative documentation of the consent process (searched via keywords in physician and nursing notes), and the presence of advance directives.

Statistical analysis involved descriptive statistics, Chi-square or Fisher's exact tests for categorical variables, and non-parametric tests for continuous variables. An exploratory logistic regression was performed on the subset of patients with any IC record (n=80) to identify predictors of proxy signing, specifically examining Barthel scores and dementia.

Key Results
The study revealed significant deficits in the documentation of the informed consent process:

• Documentation Gaps: 25% (26/106) of patients had no consent document on record. Only 40% (42/106) possessed an endoscopy-specific IC form.
• Process Recording: The narrative description of the IC process (discussions, information provided, or signature justification) was documented in only 22% (23/106) of charts. When present, these notes were almost exclusively found in nursing records (91%), with minimal documentation in physician notes.
• Signatory Patterns: Among the 80 patients with at least one consent form, 94% were self-signed, and 6% were proxy-signed. Proxy signing was strongly associated with clinical vulnerability: it occurred almost exclusively in patients with severe or total functional dependence (60% of proxy cases) and advanced dementia (GDS 5–7).
• Advance Directives: No patient in the cohort had documented advance directives.
• Case Analysis: The five instances of proxy signing involved patients with high levels of dependency and cognitive impairment, often living with caregivers. In one case, the proxy-signed document was for "Hospital at Home" admission rather than the specific endoscopy procedure.

Key Contributions
This study provides a granular audit of informed consent practices specifically for the "oldest old" (≥85 years) undergoing endoscopy. Its primary contributions include:

1. Quantifying Documentation Deficits: It demonstrates that a substantial portion of this vulnerable population undergoes invasive procedures without any recorded consent or specific procedural forms.
2. Linking Vulnerability to Proxy Consent: It establishes a clear correlation between functional dependence, dementia, and the reliance on proxy signatures, highlighting that the most vulnerable patients are the least likely to have self-signed documentation.
3. Highlighting the "Process" Gap: The study distinguishes between the presence of a form and the documentation of the process (discussion and understanding), finding that the latter is rarely recorded, particularly by physicians.
4. Identifying the Absence of Advance Care Planning: It notes the complete lack of advance directives in a cohort with high rates of frailty and cognitive decline, representing a missed opportunity for autonomy preservation.

Significance and Claims
The authors claim that the observed documentation patterns reveal ethically relevant gaps in safeguarding patient autonomy. The findings suggest that current practices often fail to meet the standards set by the ESGE and ASGE, which call for individualized, well-documented consent.

The paper argues that the absence of process notes and capacity assessments undermines the transparency and accountability of clinical care. It posits that for very old adults, especially those with dementia, the consent process must move beyond a transactional signature to a deliberative conversation. The authors propose that bridging the gap between ethical guidance and practice requires:

• Capacity-informed consent checks (e.g., teach-back techniques) when risk factors are present.
• Explicit documentation of the rationale for proxy involvement and the proxy's legal status.
• Standardized notes summarizing risks, benefits, and alternatives.
• Integration of EMR prompts to facilitate advance care planning and consent process documentation.

The study concludes that while endoscopic procedures can be appropriate for this age group, the current documentation landscape is insufficient to demonstrate that autonomy is genuinely respected, necessitating structural and educational interventions to support capacity-sensitive consent.