- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06525038
PRISMA 7 and SARC-F in Predicting Emergency Department Readmission and Mortality
PRISMA 7 (for Frailty Assessment) and SARC-F (for Evaluation of Sarcopenia Risk) in Predicting Emergency Department Readmission and Mortality
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Aim Most screening tools for frailty and sarcopenia are complex and thus impractical for emergency physicians. They require more time. Administering them to patients in limited time and in emergencies is difficult as it requires most equipment. Among these methods, PRISMA-7 and SARC-F can be applied in the ED as they are practical, fast, and convenient.
This prospective study evaluates the ability of PRISMA-7 and SARC-F to predict hospitalization after ED admission, readmission to the hospital ED at 1, 3, and 6 months, and mortality at 6-month follow-up.
- Materials and Methods 2.1 Study Design and Compliance Criteria This study was approved by the Non-Interventional Research Ethics Committee of Firat University and conducted by the Faculty of Medicine, Department of Emergency Medicine. 150 patients aged ≥65 who presented to the emergency department (ED) in a 6-month period from January 2023 to July 2023 were included in this study. The patient's gender, comorbidities, and reasons for admission were examined. The admission dates to the ED were recorded. Patients and their relatives were informed about the study to obtain written informed consent.
Patients meeting the inclusion criteria and providing written consent to participate in this study were included. The patients were consecutively included in the study. Patients with no spontaneous heartbeat or breathing at the time of ED arrival, the ones refusing to participate in the study, and whose information could not be retrieved were excluded. The patients' SARC-F and PRISMA-7 scores were calculated at the first ED presentation. Later, the same patients were evaluated via the electronic hospital system and called by phone. Their status was assessed regarding the recurrent ED visits, hospitalization, and mortality at 1, 3, and 6 months. Patients were divided into four groups. Group 1: risk of sarcopenia (-) and risk of frailty (-), Group 2: risk of sarcopenia (+) and risk of frailty (-), Group 3: risk of sarcopenia (-) and risk of frailty (+), and Group 4: risk of sarcopenia (+) and risk of frailty (+).
2.2 Frailty and Sarcopenia Assessment PRISMA-7 assessment included seven yes/no questions. The questionnaire interrogated patients' demographic characteristics (age and gender), physical ability, limiting medical problems, and dependency on others. The questionnaire was scored between 0 and 7 points, where higher scores indicated higher severity of frailty. A score of ≥3 suggested further assessment and that the patient had a frailty risk. Turkish validity and reliability studies of this questionnaire were conducted.
The SARC-F for sarcopenia assessment had five questions. Each question was scored between 0 and 2. The questionnaire interrogated patients' strength, assistance in walking, climbing stairs, rising from chairs, and falling status. The questionnaire was scored between 0 and 10 points. A score of ≥4 demonstrated possible sarcopenia risk and indicated the need for the patient's further examination. It was susceptible for detecting sarcopenia risk in older adults.
2.3 Follow-up Evaluation and Outcome Criteria Patients or their immediate relatives were contacted at 1, 3, and 6 months for the follow-up interviews. The information included hospitalization, readmission to ED, and mortality status. The mortality and ED readmissions of patients with and without frailty and sarcopenia were compared.
2.4 Statistical Analysis The data analysis was carried out using SPSS version 22. Kolmogorov-Smirnov test determined whether the numerical data were normally distributed. The numerical parameters exhibiting normal distributions were presented as mean (standard deviation), while those without normal distribution were shown as median (minimum-maximum). Non-quantitative parameters were analyzed using the Chi-square test and expressed as numbers and percentages. Student's t-test compared the numerical parameters with normal distribution between the groups, while the Mann-Whitney U test compared the non-parametric groups. Kruskal-Wallis and Bonferroni-adjusted Mann-Whitney U tests were conducted for the post hoc analysis. ANOVA and Tukey or Tamhane tests compared the means in more than two groups (according to the sarcopenia risk and frailty status). Spearman correlation test examined the relationship between numerical parameters. According to the Spearman test, the rho coefficient <0.4 was considered a weak correlation, 0.4 and 0.59 a moderate correlation, 0.6 and 0.79 a strong correlation, and 0.80 and above a very strong correlation. ROC analyses examined the potential of PRISMA-7 and SARC-F scores in predicting long-term mortality. The cut-off points were assessed using the ROC curve analysis. The best points for both scores (PRISMA-7 and SARC-F) were calculated using the Youden index. The significance level was considered as 0.05.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Elazig, Turkey, 23119
- Firat University School of Medicine
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Patients aged over 65 years
Exclusion Criteria:
- Patients with no spontaneous heartbeat or breathing at the time of ED arrival
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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Risk of sarcopenia (-) and risk of frailty (-)
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All groups were observed for clinical end-points (mortality, readmission to emergency service) described in the study protocol.
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Risk of sarcopenia (+) and risk of frailty (-)
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All groups were observed for clinical end-points (mortality, readmission to emergency service) described in the study protocol.
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Risk of sarcopenia (-) and risk of frailty (+)
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All groups were observed for clinical end-points (mortality, readmission to emergency service) described in the study protocol.
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Risk of sarcopenia (+) and risk of frailty (+)
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All groups were observed for clinical end-points (mortality, readmission to emergency service) described in the study protocol.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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Mortality
Time Frame: up to 6 months
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up to 6 months
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Readmission to the Emergency Department
Time Frame: up to 6 months
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up to 6 months
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- FiratU-EM-MCG-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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