Intra- and post-procedural patient-reported experience measures and their correlation with post-ERCP adverse events and unplanned healthcare utilization

Abstract

Background Post-endoscopic retrograde cholangiopancreatography (ERCP) adverse events (AEs) are common, as is unplanned healthcare utilization (UHU). We aimed to assess potential etiologic associations between intra-/post-procedural patient-reported experience measures (PREMs) and post-ERCP AEs and UHU.

Methods Prospective data from a multicenter collaborative were used. A 0–10 Likert-based PREM assessing intra- and post-procedural symptoms was applied to patients following ERCP, and follow-up was performed at 30 days to identify AEs and UHU for reasons not meeting the definitions of any AE. Multivariable logistic regression was conducted using PREM domains as exposures and AEs and UHU as outcomes, with a priori selected covariates. Odds ratios (ORs) and 95 %CIs for each PREM domain were reported.

Results From 2018 to 2023, 3434 patients were included. A post-procedural abdominal pain score > 3 was associated with pancreatitis (OR 3.71 [95 %CI 2.37–5.73]), while a score > 6 was associated with perforation (OR 9.54 [95 %CI 1.10–59.37]). Post-procedural pain was also associated with UHU within 30 days when used as a continuous exposure (OR 1.08 per point [95 %CI 1.01–1.16]), and when partitioned at a score > 3 (OR 1.79 [95 %CI 1.13–2.74]) and a score > 6 (OR 1.93 [95 %CI 1.02–3.46]). No other intra- or post-procedural PREMs were associated with any AEs or UHU.

Conclusions Patient-reported abdominal pain from a Likert-based PREM at the time of discharge from ERCP was associated with pancreatitis, perforation, and UHU within 30 days. Applying PREMs could potentially prevent UHU and/or facilitate earlier management and improved outcomes for patients with post-ERCP AEs.

Introduction

Endoscopic retrograde cholangiopancreatography (ERCP) is ubiquitously performed [1] but is associated with several adverse events (AEs) [2] [3] [4], which in turn are associated with significant morbidity and mortality. In addition to established AEs, there is also a high incidence of unplanned healthcare utilization (UHU) in the days and weeks following ERCP, with some of these encounters being for reasons that do not meet definitions of any AE [5].

Given the impact of post-ERCP AEs and UHU on patients, providers, and healthcare systems, the elucidation of factors potentially associated with these outcomes is crucial. Although the patient experience is a key component of overall healthcare quality [6], peri-procedural patient experiences have been relatively unstudied in endoscopy. Nurse- and provider-reported scales of patient tolerability exist for endoscopic procedures performed under conscious sedation [7] [8] [9], but true patient-reported experience measures (PREMs) in endoscopy are scarce [10]. Positive patient experiences have been linked to greater compliance with ongoing care plans [11] [12], improved perceived communication, and therefore lower rates of medicolegal action [13], as well as improved outcomes [14].

Despite our knowledge of the benefits of measuring patient experiences, there remains a knowledge gap regarding the potential associations between PREMs and post-procedural AEs and/or UHU in endoscopy. Understandably, for basic endoscopic procedures including gastroscopy and colonoscopy, the value of studying PREMs may be limited given the overall rarity of AEs [15] [16]. However, for advanced endoscopic procedures such as interventional endoscopic ultrasound and ERCP, the overall rates of AEs and UHU are markedly higher [2] [3] [17]. Of the limited evidence reporting on PREMs in the context of ERCP, none have investigated their association with AEs other than post-ERCP pancreatitis (PEP), and none have assessed PREMs specifically applied at the time of discharge from the endoscopy unit (i. e. in the immediate post-procedural setting). In this study, we explored the potential etiologic associations between PREMs recorded immediately following ERCP and ERCP-related AEs and UHU.

Methods

Study design and population

This study was a post hoc analysis of a prospective data collection initiative across nine centers in Canada, the United States, and Europe [18]. As part of the protocol for this research collaborative, all outpatients are routinely administered a questionnaire at the time of discharge relating to their peri- and post-procedural experiences. For the present study, adult patients (age ≥ 18 years) undergoing ERCP for any indication between September 1, 2018 and October 31, 2023 were included only once (i. e. their first ERCP performed during the study period was the only one included). Each patient provided informed consent prior to inclusion in the study, with institutional research ethics board approval obtained at the coordinating center (the University of Calgary, REB18–0410) and locally at each subsite. This study followed the Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) reporting guideline (see Table 1 s in the online-only supplementary material).

Exposures of interest and covariates

The primary exposures of interest were case-by-case patient-reported results of the Patient-reported Scale for Tolerability of Endoscopic Procedures (PRO-STEP) questionnaire, a validated intra- and post-procedural PREM designed for application to outpatients undergoing endoscopic procedures [10]. PRO-STEP domains are summarized in [Table 1]. PRO-STEP is applied to outpatients at the expected time of discharge from the endoscopy unit once unit-specific discharge criteria (e. g. sufficient Aldrete scores [19]) are met, and consists of questions pertaining to both the intra-procedural and post-procedural experience. Questions in the intra-procedural domain assess awareness and discomfort or pain, both scored on a 0–10 Likert-based scale, while questions in the post-procedural domain assess abdominal pain, nausea, distension, and mouth or throat pain at the time of discharge, all also scored 0–10 [10].

Table 1 Patient-reported Scale for Tolerability of Endoscopic Procedures (PRO-STEP) domains and questions.

Intraprocedural domain (domain 1)
1) What was your level of awareness during the procedure
(if 0 is not aware at all and 10 is fully aware)
0 1 2 3 4 5 6 7 8 9 10
2) What was your level of discomfort or pain during the procedure?
(if 0 is none at all, and 10 is the worst possible)
0 1 2 3 4 5 6 7 8 9 10
Postprocedural domain (domain 2)
1) What is your level of NEW abdominal pain after the procedure?
(if 0 is none at all, and 10 is the worst possible)
0 1 2 3 4 5 6 7 8 9 10
2) What is your level of NEW nausea after the procedure?
(if 0 is none at all, and 10 is the worst possible)
0 1 2 3 4 5 6 7 8 9 10
3) What is your level of NEW bloating or distension after the procedure?
(if 0 is none at all, and 10 is the worst possible)
0 1 2 3 4 5 6 7 8 9 10
4) What is your level of NEW mouth or throat pain after the procedure?
(if 0 is none at all, and 10 is the worst possible)
0 1 2 3 4 5 6 7 8 9 10

Relevant patient- and procedure-related covariates were designated a priori prior to the analysis phase, and included age, sex, procedure time, baseline alcohol use, baseline opiate use, use and timing of per rectum nonsteroidal anti-inflammatory drugs (NSAIDs) for PEP prophylaxis, performance of a precut sphincterotomy, inadvertent pancreatic duct cannulation, pancreatic contrast injection, pancreatic stent placement, total number of cannulation attempts, and biliary stent placement.

Outcomes

Outcomes of interest included overall post-ERCP AE rates, UHU rates, and rates of other post-ERCP AEs including PEP, bleeding, cholangitis, and perforation, occurring within 30 days of the index procedure. AEs were defined according to accepted criteria [20], while UHU was defined as any emergency department presentation, unplanned admission, and/or unplanned repeat ERCP within 30 days following index ERCP but not meeting the definition(s) of any of the above AEs. Outcomes were prospectively identified by combination of comprehensive medical record review and patient phone interview using established follow-up protocols. Following this, the degree of relatedness between each AE or UHU and the index ERCP was assessed utilizing previously published consensus-based criteria, which subdivide events into definite, probable, possible, unlikely, unrelated, and unclassifiable categories [21]. Relatedness attribution was conducted independently by two independent reviewers who were blinded to procedural details, with all disagreements resolved by a third reviewer. AEs and UHU with an attribution of definitely or probably related to the index ERCP were retained for the primary analyses, with all others excluded.

Statistical analysis

Baseline patient demographic and clinical characteristics were reported as means or proportions. Multivariable logistic regression was performed to investigate the potential etiologic associations between individual PRO-STEP scores, as both continuous and binary variables using prespecified cutoffs (> 3 and > 6), and post-ERCP outcomes as described. Adjusted odds ratios (ORs) were calculated along with their respective 95 %CIs. In a sensitivity analysis, outcomes deemed possibly related to the index ERCP were considered as legitimate post-ERCP events alongside the definitely and probably related events used for the primary analyses. In another sensitivity analysis, multiple imputation by chained equations was utilized to handle missing PRO-STEP score data, as opposed to case deletion. A third sensitivity analysis excluded patients undergoing ERCP with general anesthesia, retaining only those undergoing the procedure with conscious sedation. Given that abdominal pain is part of the definition of PEP, a final sensitivity analysis was performed restricting patients to those with post-procedural abdominal pain scores ≤ 3 and ≤ 6 to see whether any other symptoms were associated with eventual development of PEP.

All statistical tests were two sided with a statistical significance threshold of P < 0.05. All statistical analyses and visualizations were carried out in R version 4.0.2 (R Group for Statistical Computing, Vienna, Austria).

Results

A total of 3434 patients from the multicenter collaborative with complete peri-procedural, PRO-STEP, and follow-up/outcomes data were included. Patients undergoing ERCP had a mean age of 62.4 years (SD 22.8 years), and 1789 (52.1 %) were female. The mean procedure time was 22.5 minutes (SD 15.4 minutes). A total of 1407 patients (41.0 %) received peri-procedural NSAIDs for PEP prophylaxis. Pancreatic and biliary stents were placed in 281 (8.2 %) and 1116 (32.5 %) patients, respectively.

With regard to post-ERCP AEs, the most common AE was PEP, occurring in 147 patients (4.3 %). Cholangitis occurred in 56 patients (1.6 %), and clinically significant bleeding in 37 patients (1.1 %). Perforation was uncommon, occurring in 9 patients (0.3 %). UHU not meeting the definitions of any of the above AEs occurred in 139 patients (4.0 %). Characteristics of patients, ERCP procedures, and outcomes included in the study cohort are provided in [Table 2] and [Table 3].

Table 2 Baseline demographic characteristics of patients undergoing endoscopic retrograde cholangiopancreatography.

	Patients (n = 3434)
Age, mean (SD)	62.4 (22.8)
Male sex, n (%)	1645 (47.9)
Procedure indication, n (%)
Suspected CBD stones	1340 (39.0)
Stent removal	462 (13.5)
CBD obstruction	401 (11.7)
Stent exchange	210 (6.1)
Other	1021 (29.7)
Mode of anesthesia/sedation, n (%)
General endotracheal anesthesia or monitored anesthesia care	141 (4.1)
Conscious sedation	3293 (95.9)
Medications administered (conscious sedation patients only), mean (SD)
Midazolam, mg, IV	4.96 (19.0)
Fentanyl, μg, IV	99.4 (43.7)
Dimenhydrinate, mg, IV	46.5 (12.4)
Diphenhydramine, mg, IV	47.2 (8.86)
Baseline alcohol use, n (%)1
None	749 (21.8)
Former	967 (28.2)
Occasional	1147 (33.4)
Moderate	439 (12.8)
Heavy	132 (3.8)
Baseline opioid use, n (%)
None	2975 (86.6)
Oral opioid use	459 (13.4)

CBD, common bile duct; IV, intravenously.

¹Alcohol use defined as none (no previous use), former (previous use, with no current use), occasional (1–2 drinks per week), moderate (up to 14 drinks/week for males, 7 drinks/week for females), or heavy ( > 14 drinks/week for males, > 7 drinks/week for females).

Table 3 Characteristics of endoscopic retrograde cholangiopancreatography procedures.

	ERCP procedures (n = 3434)
Pre-cut sphincterotomy, n (%)
None	2995 (87.2)
Needle-knife papillotomy	228 (6.6)
Suprapapillary fistulotomy	107 (3.1)
Transpancreatic sphincterotomy	104 (3.0)
Pancreatogram, n (%)
None	3304 (96.2)
Partial	130 (3.8)
Pancreatic stent placement, n (%)
None	3153 (91.8)
Plastic stent	258 (7.5)
Zimmon stent	23 (0.7)
Total number of CBD cannulation attempts, n (%)
None	65 (1.9)
1–2	2009 (58.5)
3–5	709 (20.6)
6–10	293 (8.5)
> 10	358 (10.4)
Main PD cannulation, n (%)	665 (19.4)
Rectal NSAIDs given, n (%)
None	2027 (59.0)
Prior to procedure	930 (27.1)
Intra-procedural	38 (1.1)
Post-procedural	439 (12.8)
Biliary stent placement, n (%)
None	2318 (67.5)
Metal	357 (10.4)
Plastic	759 (22.1)
Procedure time in minutes, mean (SD)	22.5 (15.4)
Post-ERCP events, n (%)1
Pancreatitis	147 (4.3)
Bleeding	37 (1.1)
Perforation	9 (0.3)
Cholangitis	56 (1.6)
UHU	139 (4.0)

AE, adverse event; CBD, common bile duct; ERCP, endoscopic retrograde cholangiopancreatography; NSAID, nonsteroidal anti-inflammatory drug; PD, pancreatic duct; UHU, unplanned healthcare utilization.

¹Events deemed definitely, probably, and possibly related to the index ERCP.

Responses to the PRO-STEP PREM across the study cohort are provided in [Table 4], expressed both as means and proportions above the a priori cutoffs. Patient-reported intra-procedural discomfort and awareness were both low, with mean scores of 1.05 (SD 2.31) and 1.53 (SD 2.89), respectively, out of 10. ERCP resulted in low overall patient-reported post-procedural symptoms at the time of discharge from the endoscopy unit, with the following scores for distension (mean 0.30, SD 1.14), mouth/throat pain (mean 0.45, SD 1.32), nausea (mean 0.41, SD 1.49), and abdominal pain (mean 0.82, SD 2.02). However, a minority of patients experienced significant post-ERCP symptoms including abdominal pain (143, 4.2 %), nausea (75, 2.2 %), mouth/throat pain (37, 1.1 %), and distension (31, 0.9 %).

Table 4 Patient-reported experience measures per PRO-STEP criteria for patients undergoing endoscopic retrograde cholangiopancreatography (n = 3434).

	Intraprocedural domains		Post-procedural domains
	Self-reported awareness	Discomfort level	Abdominal pain	Nausea level	Distension level	Mouth/throat pain
Mean (SD)	1.53 (2.89)	1.05 (2.31)	0.82 (2.02)	0.41 (1.49)	0.30 (1.14)	0.45 (1.32)
Score > 3, n (%)	661 (19.2)	479 (13.9)	359 (10.5)	168 (4.9)	122 (3.6)	153 (4.5)
Score > 6, n (%)	358 (10.4)	206 (6.0)	143 (4.2)	75 (2.2)	31 (0.9)	37 (1.1)

PRO-STEP, Patient-reported Scale for Tolerability of Endoscopic Procedures.

Multivariable analyses assessing the etiologic associations between PREMs (adjusting for patient- and procedure-related covariates selected a priori) demonstrated a statistically significant association between post-procedural abdominal pain and multiple post-ERCP AEs, as demonstrated in [Table 5]. Post-procedural abdominal pain was associated with PEP, both as a continuous exposure variable (OR 1.19 for each additional point out of 10 [95 %CI 1.12–1.28) and a dichotomous exposure, partitioned both at any score > 3 (OR 3.71 [95 %CI 2.37–5.73]) and any score > 6 (OR 2.22 [95 %CI 1.14–4.09]). Similarly, post-procedural abdominal pain was associated with perforation when scored continuously (OR 1.32 for each additional point [95 %CI 1.01–1.70]); however, post-procedural abdominal pain with a score > 6 was more strongly associated with perforation (OR 9.54 [95 %CI 1.10–59.37]). Post-procedural abdominal pain was also associated with UHU within 30 days when used as a continuous exposure variable (OR 1.08 [95 %CI 1.01–1.16]), and when partitioned at a score > 3 (OR 1.79 [95 %CI 1.13–2.74]) and a score > 6 (OR 1.93 [95 %CI 1.02–3.46]). No other intra- and post-procedural PREMs were statistically significantly associated with any post-ERCP AEs or UHU (Table 2 s). Similarly, no statistically significant associations between other intra- and post-procedural PREMs and outcomes were observed when limiting the cohort to patients with a post-procedural abdominal pain score of ≤ 3. However, post-procedural nausea was associated with an increased risk of PEP (OR 1.16 for each additional point [95 %CI 1.05–1.27]) in the subset of patients with a post-procedural abdominal pain score of ≤ 6 (Table 3 s). All statistically significant associations between PREMs and UHUs were re-demonstrated in a priori planned sensitivity analyses with a more liberal attribution of adverse outcomes, with no new significant findings (Table 4 s).

Table 5 Associations between post-procedural patient-reported abdominal pain and 30-day outcomes for patients undergoing endoscopic retrograde cholangiopancreatography (n = 3434).

	Association between pain and 30-day outcomes, OR (95 %CI)
	Pancreatitis (n = 147)	Bleeding (n = 37)	Perforation (n = 9)	Cholangitis (n = 56)	UHU (n = 139)
Patient-reported abdominal pain score
Continuous	1.19 (1.12–1.28) P < 0.001	1.07 (0.92–1.22) P = 0.31	1.32 (1.01–1.7) P = 0.03	0.97 (0.82–1.11) P = 0.68	1.08 (1.01–1.16) P = 0.02
Score > 3 (n = 359) vs. ≤ 3 (n = 3075)	3.71 (2.37–5.73) P < 0.001	1.34 (0.46–3.3) P = 0.55	4.34 (0.71–22.21) P = 0.09	0.9 (0.32–2.08) P = 0.82	1.79 (1.13–2.74) P = 0.01
Score > 6 (n = 143) vs. ≤ 6 (n = 3291)	2.22 (1.14–4.09) P = 0.01	1.38 (0.29–4.47) P = 0.64	9.54 (1.10–59.37) P = 0.02	0.84 (0.13–2.91) P = 0.82	1.93 (1.02–3.46) P = 0.04

OR, odds ratio; UHU, unplanned healthcare utilization.

Sensitivity analysis demonstrated that post-procedural abdominal pain remained significantly associated with post-ERCP PEP, perforation, and UHU in patients who underwent ERCP with conscious sedation alone (Table 5 s). Similar associations were also seen in the sensitivity analysis that used multiple imputation by chained equations rather than a case deletion approach to handle missing PRO-STEP scores (Table 6 s).

Discussion

In this large multicenter study, patient-reported abdominal pain at the expected time of discharge following ERCP was associated with presentations for PEP and perforation. In particular, values > 3 were associated with PEP and values > 6 were associated with perforation. Interestingly, the presence of abdominal pain was also associated with UHU within 30 days in the absence of any post-ERCP AEs.

PREMs and patient-reported outcome measures are scarce in endoscopy. Thiruvengadam et al. assessed the ability of PAN-PROMISE, a patient-reported outcome measure specifically developed and validated for patients with acute pancreatitis, to predict post-ERCP morbidity and outcomes [22]. Close to 20 % of patients self-reported abdominal symptoms unrelated to PEP at 7 days following ERCP, and higher PAN-PROMISE scores correlated with both direct and indirect healthcare costs [22]. However, to our knowledge, PRO-STEP is the only PREM validated for use immediately following ERCP [10], and no existing studies have assessed associations between the scores with such a tool and clinically important outcomes following ERCP.

The spectrum of AEs following ERCP is incompletely understood, and even less is known with respect to overall UHU following ERCP. Using data from over 600 centers, Huang et al. reported a 30-day post-ERCP UHU rate of 4.2 % for high-volume facilities performing in the top 5th percentile and a staggering 25.2 % for facilities performing in the bottom 5th percentile [5]. Reasons for UHU outside of AEs might include abdominal pain or nausea with no discernible cause or diagnosis, or those that relate to missed pathology from the original procedure such as residual choledocholithiasis. In our study, we carefully separated AEs from UHU for other reasons, but made sure that for both AEs and UHU, that either a probable or definite causal attribution to the index ERCP was established [21]. By doing so, we are confident that all outcome events included herein represent true post-ERCP events rather than unrelated presentations, which are more difficult to exclude in some study designs.

Any presence of abdominal pain following ERCP should intuitively alert practitioners to possible AEs. However, it can be difficult to determine which patients should be monitored and/or investigated and which can be safely discharged. Jeurnink et al., using established health status tools [23], reported that 30 %–50 % of patients experienced some degree of pain or discomfort either during or immediately following ERCP [24]. Reasons for such symptoms could include gas pain, discomfort from instrumentation, and/or presence of newly inserted prostheses, among others. The issue is that PEP, perforation, or even cholangitis could also present with pain, so knowing whom to investigate can be challenging. We demonstrated that PRO-STEP scores of > 3 were associated with PEP and scores of > 6 were associated with perforation. Therefore, these cutoff points could theoretically be used as a screening tool in combination with a patient’s overall clinical picture. Ensuing possibilities could include closer monitoring via phone calls in the 1–2 days following the procedure for patients suspected of being at higher risk. This approach could then enable earlier evidence-based management and lower the risk of severe outcomes [25].

We also found that self-reported abdominal pain at the expected time of discharge was associated with UHU within 30 days for reasons unrelated to defined AEs. This interesting and novel finding should be made the basis of future research. The potential reason(s) behind this association are currently unknown, but could include pre-existing anxiety and/or “state anxiety,” apprehension relating to the procedure and/or its outcomes [26]. Future research should assess whether there are possible interventions that can potentially prevent these types of UHUs, including scheduled follow-up phone calls after the procedure to discuss potential symptoms, answer questions, and/or provide reassurance. Resource considerations and cost thresholds associated with such initiatives also require investigation to ensure they would result in net cost savings by preventing UHU [22].

Our study has several strengths. First, we used high-fidelity, multicenter, prospective data across a mix of community and academic centers to inform our analyses, thereby maximizing generalizability. ERCPs were observed in real time, significantly mitigating risks of several biases, and yielding accurate classification of measured confounders. Additionally, protocolized 30-day follow-up occurred, in addition to adjudication and attribution of AEs as discussed above, meaning we had high confidence in both the definitions and relatedness of outcomes labeled as AEs or UHU.

There are also important limitations associated with our study. First, despite the inclusion of over 3400 patients, some AEs were only encountered in relatively small numbers, resulting in a potential lack of power to detect some associations. Second, the possible contribution of unmeasured confounding needs to be acknowledged given the lack of a randomized design for our etiologic question. Third, although our study included patients undergoing ERCP with multiple sedation plans, the majority underwent ERCP under endoscopist-directed conscious sedation, partially limiting generalizability. Finally, although the rate of PEP in our cohort was relatively low, this can be explained both by a cohort of patients with a generally low–average risk (as exemplified by close to 20 % stent removals or exchanges) and the rigorous attribution criteria employed. This low-risk cohort also partially explains the relatively low use of recommended strategies to mitigate the risk of PEP [27] [28], although the roughly 40 % use of NSAIDs and 7 % use of prophylactic stenting, both of which have been demonstrated to be efficacious in preventing PEP [29] [30], are in line with the established use of these strategies in the “real world” [31] [32].

In conclusion, we demonstrated associations between post-ERCP PREMs and outcomes within 30 days. In particular, self-reported abdominal pain at the expected time of discharge was shown to be associated with PEP when scored at > 3, and perforation when scored at > 6. Post-ERCP abdominal pain was also associated with UHU within 30 days, though the reasons are unclear and should be made the focus of future research. Overall, practitioners should consider the use of validated peri-procedural PREMs in ERCP to potentially improve patient outcomes.

Competing interests

The authors declare that they have no conflict of interest.

^‡ Alessandra Ceccacci and Mehul Gupta contributed equally to this work.

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Publication History

Received: 15 April 2024

Accepted after revision: 19 September 2024

Accepted Manuscript online:
19 September 2024

Article published online:
06 November 2024