External Validation of the Falls Decision Rule to Exclude Intracranial Bleeding Without Head CT in Geriatric Patients Presenting to the Emergency Department With A Fall
Conditions: Intracranial Hemorrhages
Sponsor: Marmara University

NCT06525727 
 
14.02.2025 
1. Methods 
Study design and settings 
This prospective cohort study was conducted at a single center, Marmara University Pendik Training and 
Research Hospital, a Level 1 trauma center with an annual ED visit frequency approximating 200,000. Marmara 
University Clinical Research Ethics Committee approved the study protocol (protocol number: 09.2024.48, date 
12.01.2024]), and the research was carried out in accordance with the ethical principles delineated in the 
Declaration of Helsinki.  
In reporting the study, the Standards for Reporting of Diagnostic Accuracy Studies (STARD) guidelines were 
followed, and the corresponding flow diagram was utilized to ensure clarity and transparency in the presentation 
of diagnostic accuracy results [1].  
Study participants 
The study prospectively enrolled all consecutive geriatric patients (aged >65 years) who presented to the 
emergency department of XXX (blinded) Hospital within 48 hours following a ground-level fall. In alignment with 
the derivation study, this encompassed patients who had fallen from a standing position as well as those who 
had fallen from a toilet, chair, or bed. Patient enrollment commenced on January 20, 2024, and persisted until 
the required sample size was attained on October 1, 2024. Exclusions were made for patients who had previously 
enrolled in the study, those who left the hospital against medical advice prior to the completion of the diagnostic 
and treatment protocols, individuals with incomplete data, those transferred from another facility, and foreign 
patients not registered in the national database (as they could not be monitored for long-term outcomes). 
Patient assesment and data collection  
This observational study was conducted devoid of any external intervention. Each patient included in the 
investigation was managed and treated by their primary emergency physician, who autonomously determined 
the necessity for a head CT at the time of presentation. 
Demographic information (e.g., age, sex), history of antiplatelet or anticoagulant utilization, particulars of the 
fall, and clinical frailty scores  were gathered by the research personnel through self-reports from patients, their 
relatives, and/or from patient medical records after obtaining consent to participate in the study [2]. In instances 
where the treating physician mandated laboratory testing, results such as hemoglobin and platelet levels were 

NCT06525727 
 
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documented. The determination to perform a head CT and the subsequent results were also recorded. Outcomes 
including the requirement for surgical intervention, and mortality were tracked. 
Patients were observed for delayed intracranial bleeding over a period of 42 days, adhering to the protocol 
established by the derivation study [3]. During this follow-up interval, any subsequent hospital visits were 
identified via the national healthcare system (e-pulse), and those who presented again were assessed for 
evidents of intracranial bleeding. 
Outcome definition and test methods 
Since this is an external validation study, the outcome definitions used in the validation study were applied 
exactly as originally defined. The definition of clinically important intracranial bleeding (CIIB) was defined to 
include any intracranial bleeding requiring medical or surgical intervention within follow-up period or resulting 
in death within temporal scope. Medical intervention was defined as either the temporary or permanent 
cessation of antiplatelet or anticoagulant therapy, administration of antifibrinolytics, reversal of anticoagulation, 
hospital admission, or surgical procedures [3]. 
An ED Specialist and a radiologist were evaluated all head CT scans independently and blindedly to the 
demographic and clinical particulars of the patients. In case of disagreement, a third reviewer (radiologist) 
assessed the images to achieve consensus.  
Patients were followed for 42 days after their ED visit. If they sought care at another healthcare facility during 
this period, their clinical status and test results were reviewed to evaluate for intracranial bleeding. In alignment 
with the derivation study, patients who did not develop symptoms warranting a hospital visit and did not die 
during the follow-up period were considered negative for CIIB. Given that previous studies have demonstrated 
the poor sensitivity (37%, 95% confidence interval [CI] 21-56%) of patient-reported intracranial bleeding, patients 
who neither revisited the hospital nor died were not actively contacted, adhering to the original derivation 
protocol [3, 4]. In the event of patient death, the cause of death was determined through follow-up with family 
members via telephone and a review of medical records. Death reports and related documentation were also 
examined. All available clinical data were collectively reviewed by the research team, and final CIIB classification 
was determined by consensus. 
Index test (The Falls Decision Rule and The Focused Falls Decision Rule) 
This study assessed two clinical decision instruments: the Falls Decision Rule and the Focused Falls Decision Rule, 
both conceived by de Wit and colleagues. According to the Falls Decision Rule, a head CT scan is deemed 

NCT06525727 
 
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unnecessary if all of the subsequent criteria are satisfied: (1) the patient did not hit their head during the fall, as 
determined through patient history or witness accounts; (2) no novel abnormalities detected on neurological 
examination; (3) the patient retains memory of the events surrounding the fall; and (4) the Clinical Frailty Scale 
score is below 5. 
The Focused Falls Decision Rule, a simplified variant of the original tool, includes only the first two criteria: the 
absence of head impact during the fall and no new neurological abnormalities upon examination. 
Sample size 
The sample size for this diagnostic accuracy study was calculated to validate the Falls Decision Rule. Based on the 
incidence, sensitivity, and specificity values reported by the de Wit et al., the minimum required sample size was 
determined to be 663 participants, assuming 80% power and a 0.05 margin of error [3]. To account for potential 
data loss and measurement errors, the target sample size was increased by 15%, resulting in a minimum of 763 
participants. The sample size calculation was performed utilizing G*Power version 3.1.9.2 [5]. 
References 
[1] 
Cohen JF, Korevaar DA, Altman DG, Bruns DE, Gatsonis CA, Hooft L, et al. STARD 2015 
guidelines for reporting diagnostic accuracy studies: explanation and elaboration. BMJ Open. 
2016;6(11):e012799. https://doi.org/10.1136/bmjopen-2016-012799. 
[2] 
Rockwood K, Song X, MacKnight C, Bergman H, Hogan DB, McDowell I, et al. A global clinical 
measure 
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[3] 
de Wit K, Mercuri M, Clayton N, Mercier É, Morris J, Jeanmonod R, et al. Derivation of the Falls 
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[4] 
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patient-reported outcome measures: Hemorrhage, anticoagulant, antiplatelet medication use. Res 
Pract Thromb Haemost. 2021;5(4):e12501. https://doi.org/10.1002/rth2.12501. 
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