The Effect of Pre-procedural Anxiety Level on Procedure Tolerability and Quality of ERCP in Consciously Sedated Patients

INTRODUCTION AND RATIONALE Endoscopic Retrograde Cholangiopancreatography (ERCP) is a specialized procedure combining upper gastrointestinal endoscopy and x-rays to treat hepatopancreaticobiliary diseases. Patient experiences after ERCP has been relatively understudied.

Patient-reported experience measures (PREMs) using questionnaires have been developed to capture patient experiences during clinical care. Most recent guidelines for performance measures for upper gastrointestinal endoscopy have included patient experiences as an important quality and performance measure. [1] It allows for the identification of areas of improvement, ensures the delivery of the procedure aligns with the patients' expectations while fostering a patient-centered and quality driven healthcare environment. [1] Studies have shown that better patient care experiences are correlated with favourable clinical outcomes and adherence to recommendations for future treatments. [2] The surgical literature has shown that high levels of pre-procedural or preoperative anxiety are strongly associated with poorer clinical outcomes, including increased postoperative pain, higher rates of complications, and longer hospital stays. [3] Many factors can influence preprocedural anxiety including demographic, psychological, medical, and social influences. [4] This prospective study aims to focus on pre-procedural anxiety and PREMs for patients specifically undergoing ERCP with conscious sedation and the impact on quality of the procedure

SUMMARY OF PRELIMINARY DATA The patient- reported scale for tolerability of endoscopic procedures (PRO-STEP) is a validated PREM. [5] In a study assessing patient reported experiences during ERCP, higher PRO-STEP scores were predictive of post procedure complications of pancreatitis and perforation. [6] Karpuzcu and colleagues determined that patient-reported anxiety pre-procedure was significantly associated with poor esophagogastroduodenoscopy outcomes [7]. Bal and colleagues found that state anxiety in patients undergoing diagnostic endoscopies was associated with difficulties in sedation regardless of baseline alcohol, opioid, and benzodiazepine use. [8] Studies are lacking looking specifically at anxiety levels and PREMs for ERCP. This is important as ERCP differs from other endoscopic procedures as it is more technically challenging and associated with higher adverse events. [9]

RESEARCH HYPOTHESIS AND SPECIFIC AIMS We propose to conduct a single-centre prospective cohort study to evaluate the effect of pre-procedural anxiety, measured by the State-Trait Anxiety Inventory (STAI-Y), on the tolerability of ERCP using conscious sedation measured by the patient- reported scale for tolerability of endoscopic procedures (PRO-STEP) and procedure cooperation measured by the Procedural Sedation Assessment Survey (PROSAS).

We hypothesize that higher preprocedural anxiety scores will lead to lower procedure tolerability scores and lower procedure cooperation.