Conducting and reporting trials for older people

Area of Science:

• Geriatric Medicine
• Clinical Trials Methodology

Background:

• Randomized controlled trials (RCTs) are crucial for healthcare intervention evidence.
• Older adults are frequently underrepresented in RCTs, creating knowledge gaps regarding treatment efficacy and safety.
• Clinical geriatrics journals play a vital role in promoting the inclusion and rigorous reporting of trials involving older individuals.

Purpose of the Study:

• To provide practical guidance on reporting RCTs specifically targeting older populations.
• To highlight generic and specific reporting considerations for geriatric RCTs.
• To emphasize the importance of transparency and quality in reporting trials involving older adults.

Main Methods:

• The article offers practical advice for reporting RCTs in older people.
• It emphasizes the need to record and report basic characteristics of participants, including physical function, cognition, comorbidity, and frailty.
• Adherence to the CONSORT (CONsolidated Standards Of Reporting Trials) guidelines is recommended.

Main Results:

• Exclusion of older adults from RCTs leads to uncertainty about treatment risks and benefits.
• Proper reporting of participant characteristics is essential for interpreting external validity.
• Consideration of common geriatric issues, such as falls, in adverse event reporting is vital.

Conclusions:

• Rigorous reporting of RCTs involving older adults is essential for clinical practice.
• Detailed participant characterization and attention to geriatric-specific outcomes enhance trial interpretability.
• Following CONSORT guidelines improves the transparency and quality of published research on older populations.