Validation of The Proxy Test for Delirium (PTD) Among delirious patients in King Khalid University Hospital (KKUH) in Riyadh, Saudi Arabia. Principle Investigator: Dr. Fahad Alosaimi. Co-Investigator(s): Dr. Bandar Althomali, Dr. Ayedh Alghamdi, Dr. Fadi Aljamaan, Amjad Albatili, Ghadah Alhammad, Latifah Albatly, Raya Alsuhaibani. Collage of Medicine - King Saud University.

Introduction "Delirium is a serious neuropsychiatric syndrome characterized by acute and fluctuating in attention, other cognitive deficits and alternation in level of consciousness”.

Delirium is being misdiagnosed and undetected in the Intensive Care Unit (ICU) sittings. To overcome this problem validated highly sensitive tools are needed. The Proxy Test for Delirium (PTD) is a new tool to detect delirium in patients admitted to the ICU.

Research Question Is the Proxy Test for Delirium (PTD) more sensitive and specific than the Confusion Assessment Method (CAM) in screening for delirium?

Objective and Hypothesis To validate PTD as a screening tool to detect delirium in patients admitted to the ICU by comparing it with Confusion assessment method (CAM) and clinical neuropsychiatric evaluation based on DSM-5 criteria performed by psychosomatic medicine specialist. Null hypothesis: PTD is as sensitive and specific in screening of delirium as CAM. Alternative hypothesis: PTD is superior to CAM in practicability and easy to use by nurse.

Methodology (I) Study design: A cross-sectional approach. Study setting: Intensive care unit at King Khalid University Hospital. (KKUH) Sampling (size, type): 288 patients – 50 were collected in convenient sample.

Sample Inclusion criteria: ICU Patients who are 18 years and above. Exclusion criteria: Patients unwilling to participate. Patient cannot communicate in Arabic or English. Patients “too sick” to participate.

PTD CAM Methodology (II) Data collection tools: Three different delirium scales. PTD Score (6-24)= delirium 5 and less is not delirium CAM Delirium Not Delirium Doctor’s assessment Delirium Not Delirium

All enrolled patients were separately and blindly screened for symptoms of delirium within 24 hours time limit: The patient's primary nurse performed the PTD at the end of their shift (were trained in advance of the start of the study). A trained research assistant (one of the medical students, the co-investigators) performed CAM (were trained in advance of the start of the study). A clinical neuropsychiatric evaluation based on DSM-5 criteria performed by Psychosomatic Medicine specialist.

Methodology (III) Data management: Ethical considerations: The data was analyzed using SPSS and MedCalc programs. Descriptive statistic. Sensitivity, Specificity, PPV, NPV. ROC curve analysis. Ethical considerations: 1. IRB committee approval. 2. Written informed consent.

Result (I) 53.33% Sensitivity Total Disease - Disease + CAM 100.00% Table 1 (The relation between The Confusion Assessment Method (CAM) and the doctor’s assessment) 53.33% Sensitivity Total Disease - Disease + CAM 100.00% Specificity 8 CAM+ 1 PPV 42 35 7 CAM- 0.833 NPV 50 15

ROC curve analysis * Criterion corresponding with highest Youden index Cut-off Score Criterion Sensitivity 95% CI Specificity +LR -LR >=0 100.00 78.2 - 100.0 0.00 0.0 - 10.0 1.00 >0 73.33 44.9 - 92.2 57.14 39.4 - 73.7 1.71 0.47 >0.5 60.00 42.1 - 76.1 1.83 0.44 >1 66.67 38.4 - 88.2 77.14 59.9 - 89.6 2.92 0.43 >2 82.86 66.4 - 93.4 3.89 0.40 >3 32.3 - 83.7 88.57 73.3 - 96.8 5.25 0.45 >5 * 94.29 80.8 - 99.3 10.50 0.42 >6 53.33 26.6 - 78.7 97.14 85.1 - 99.9 18.67 0.48 >7 90.0 - 100.0 >22 0.0 - 21.8  * Criterion corresponding with highest Youden index Area under the ROC curve (AUC) = 0.776 95% confident interval = 0.636 to 0.882 Significance level P (area = 0.5) = 0.0010

Result (II) 60.00% Sensitivity Total Disease - Disease + Cut off 5 Table 2 (The relation between The Proxy Test for Delirium (PTD) and the doctor’s assessment) 60.00% Sensitivity Total Disease - Disease + Cut off 5 94.29% Specificity 11 2 9 PTD + 0.818 PPV 39 33 6 PTD - 0.846 NPV 50 35 15

Result (III) The result shows that the sensitivity of CAM was 53.33% and the specificity was 100.00%. The positive predictive value and the negative predictive value were 1 and 0.833, respectively. (table 1) Using a cutoff score more than 5, the PTD has sensitivity of 60.00%, specificity of 94.29%, positive predictive value of 0.818 and negative predictive value of 0.846. (table 2)

Result (IV) Thus using PTD in detecting delirium cases in ICU patients is more sensitive and clinically significant in minimizing the misdiagnosed and undetected cases. In the other hand, CAM shown to be more specific and reliable in detecting delirium in ICU sittings which might help in confirming the diagnosis.

The basic socio-demographic and clinical data were collected from patient’s chart, patient himself and/or family member if available. Gender Age Height and weight Marital Status Education level Type of ICU Place of Residence Smoking and other substance Reason of Admission Medications Vital signs and Lab results Medical and psychiatric illnesses

Age Mean Std. deviation 56.32 17.325

Conclusion The PDT tool is a comprehensive, based on the Diagnostic and Statistical Manual for Mental Disorders-5 (DSM-5), yet easy to use. It eliminates the problem of a patient's lack or inability to cooperate with the examination. Using an observation based tools, such as the PTD, may help in early detection and diagnosis of delirium.

Limitations: Recommendations: The shortage of ICU patients at King Khalid University Hospital (KKUH). This is could be due to shortage of beds and long hospitalization stay. We are planning to continue sampling until 2017, aiming to reach 288 participants. Recommendations: We recommend that future studies be carried out in multi-centers ICU settings to get more generalizable data.

Acknowledgements Dr. Fahad Alosaimi, Associate professor, Psychiatry & Psychosomatic medicine consultant, department of Psychiatry. Dr. Fadi Aljamaan, Assistant Professor in Critical Care Department, ICU consultant, Mr. Zakria Almasri, Nurse educator, nursing department. ICU Nurse staff.

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