A 12-month follow-up study of discharged patients with acute pancreatitis: An acute condition with prolonged sequela

To the Editor: Acute pancreatitis (AP) is the most common gastrointestinal condition that leads to acute hospitalization.[1] The incidence of AP has increased in recent decades, with a current global incidence of 34/100,000, probably due to a rising trend of obesity and gallstone disease. AP is associated with remarkable pain, reduced quality of life (QoL), and even death, thus posing a heavy socioeconomic burden. In addition, approximately 22% of AP patients experience recurrent AP (RAP) and 10% of AP patients progress to chronic pancreatitis.[2] Petrov and Yadav[3] have, therefore, argued that AP should not be considered an acute and self-limiting disease. Treatment and long-term care after AP have drawn widespread attention, which has improved patients' physical and mental health. Some studies have investigated the factors influencing long-term QoL in patients with AP. Although RAP and AP have different characteristics, few studies have considered recurrence status when following up on QoL in patients with AP. Therefore, in this study, we conducted a longitudinal study to observe the changes in QoL in consideration of recurrence status and explore factors related to recurrence and QoL in patients with AP after discharge. This study was approved by the Ethics Review Board of the Peking Union Medical College Hospital (No. ZS-1413), and has been registered in the Clinical Trials (NCT04222075). All participants provided informed consent. In this 12-month, longitudinal observational study, we recruited AP patients from July 2018 to July 2021, from the Peking Union Medical College Hospital. All patients were diagnosed with AP based on the Atlanta criteria. Patients aged <18 years or >75 years were not included in the study. Data on baseline characteristics, including age, sex, medical history (history of diabetes mellitus, hypertension, hypertriglyceridemia, and pancreatitis), and alcohol and tobacco consumption, were collected at the first visit. Clinical data on the etiology of AP, ICU admission, percutaneous or endoscopic drainage, infected necrosis, and sterile necrosis were collected. In addition, patients were classified and scored using the Revised Atlanta Classification (RAC), the Acute Physiology and Chronic Health Assessment II (APACHE-II), the Modified Marshall Score, and the Sequential Organ Failure Assessment (SOFA) systems. The lengths of ICU and hospital stay were also collected. New-onset diabetes were extracted after one year from the clinical system of hospital. Eligible patients received the online questionnaire upon discharge and at the 1st, 3rd, 6th, and 12th months after discharge. The online questionnaire contained the recurrent status and the Chinese versions of the EuroQol-5 Dimensions-3 Levels (EQ-5D-3L) and 36-Item Short Form Survey (SF-36). In the online questionnaire, patients were asked to report their subsequent clinic visits and the reason for the visit. Online questionnaire has some checkpoints to control the quality. If patients claimed the recurrence, relevant clinical data were reviewed to determine in hospital's electronic system. The five responses to the EQ-5D-3L were converted into health utility using the Chinese value set.[4] The EQ-VAS is a visual analog scale ranging from 0 (worst imaginable health) to 100 (best imaginable health). The SF-36, a patient-reported survey of patient health, was scored according to the official scoring instructions. In this study, two summary components, the physical component summary (PCS) scores and the mental component summary (MCS) scores, were calculated according to the Chinese scoring algorithm.[5] We used descriptive statistics to compare the demographic characteristics of AP patients with and without recurrence within 12 months. We compared the two groups using the chi-squared test, Fisher's exact test for categorical variables, and the two-sample t-test for continuous variables. Mann–Whitney tests were used to compare the QoL between the patients with and without recurrence. In addition, we adopted Friedman's test and Wilcoxon signed-rank tests to compare the QoL between the different follow-up time points. To identify factors associated with recurrence, we used univariate and multiple logistic regression analyses with backward selection. To measure the factors influencing QoL during the 12-month follow-up period, we used multiple linear mixed models. The dependent variables were health utility, the EQ-VAS scores, the PCS scores, and the MCS scores. The fixed factors were age, sex, smoking history, drinking history, chronic diseases (diabetes mellitus and hypertension), etiology of AP, the RAC, and recurrent status. The individual was a random factor that allowed for heterogeneity among individuals. Values of P <0.05 were considered statistically significant. An online questionnaire was administered via the Wenjuanxing website (https://www.wjx.cn/m/44343257.aspx). IBM SPSS Statistics 25 (Chicago, IL, USA) was used for all data analyses. Figures were generated using Microsoft Excel 365 (Redmond, WA, USA) and SAS 9.4 (Cary, NC, USA). A total of 116 patients were invited, 109 of whom completed the online questionnaires (response rate, 94.0%). There were no statistically significant differences in the demographic and clinical characteristics between the participants and non-participants, indicating no selection bias. Of the participants, 43.1% were male, and the mean (± standard deviation) age of the participants was 43.2 ± 14.1 years. Of the patients, 35.8% had a history of AP; 19.3%, of diabetes; 27.5%, of hypertension; and 40.4%, of hypertriglyceridemia. A total of nine patients experienced new-onset diabetes within one year (10.2%). The causes of AP included biliary (35.8%), idiopathic (4.6%), alcoholic (6.4%), hypertriglyceridemia (45.9%), other causes (4.6%), and more than one cause (2.8%). According to the RAC system, 53.2% of the patients had mild acute pancreatitis (MAP), 30.3% had moderately severe acute pancreatitis (MSAP), and 16.5% had severe acute pancreatitis (SAP). Among all participants, 37/109 (33%) reported recurrence of AP within 12 months. Supplementary Table 1 [https://links.lww.com/CM9/B746] shows the characteristics of the patients with AP with or without recurrence. The risk of developing recurrence was highest in patients with a history of pancreatitis (56.8% vs. 25.0%, P = 0.001) or hypertriglyceridemia (54.1% vs. 33.3%, P = 0.037). Hypertriglyceridemia was found to be the cause of AP in 59.5% and 38.9% of patients with and without recurrence, respectively. According to the results of the logistic regression, a history of pancreatitis had a significant interaction with hypertriglyceridemia etiology. When compared with patients with biliary etiology and no history of pancreatitis, patients with hypertriglyceridemia etiology and a history of pancreatitis (adjusted odds ratio [aOR] = 6.62, 95% confidence interval [CI] = 2.40–18.23, P <0.001) and patients with other causes and a history of pancreatitis (aOR = 4.41, 95% CI = 1.07–18.27, P = 0.041) were more likely to develop a recurrence [Supplementary Table 2, https://links.lww.com/CM9/B746]. Supplementary Table 3 [https://links.lww.com/CM9/B746] presents the proportion of patients reporting problems (moderate or severe problems) in the EQ-5D-3L. At 12 months, patients without recurrence had lower proportions of problems than those with recurrence regarding mobility (0 vs. 10.3%, P <0.05), usual activities (0 vs. 17.2%, P <0.05), pain/discomfort (13.7% vs. 41.4%, P <0.05), and anxiety/depression (19.6% vs. 41.4%, P <0.05). There was no significant difference in the self-care domain between patients with and without recurrence. As shown in Supplementary Figure 1, https://links.lww.com/CM9/B746, patients with AP and without recurrence had higher QoL scores than patients with recurrence in each domain of the SF-36, the PCS, and the MCS. Supplementary Figure 2 [https://links.lww.com/CM9/B746] shows the EQ-5D-3L health utility, the EQ-VAS, the PCS scores, and the MCS scores for patients with AP over the 12-month period. Patients without recurrence had higher medians scores than those with recurrence (P <0.001). For patients without recurrence, the IQR ranges of all four scores reduced with time. The median utility reached 1 at one month and remained unchanged until the end of the study. Results of Friedman's tests indicated significant differences in QoL between time points among patients without recurrence (utility: P = 0.003, VAS: P = 0.001, PCS: P <0.001, and MCS: P = 0.033). The QoL scores showed an increasing trend but became stable after six months. The differences between 6 months and 12 months were insignificant in utility, VAS, PCS, and MCS scores (P = 0.860, 0.483, 0.524, and 0.982, respectively). For patients with recurrence, no pattern of the IQR was found, with increasing but lower scores in PCS and MCS scores than patients without recurrence. We removed the history of pancreatitis and hypertriglyceridemia from the models because they were multicollinearity with recurrence. According to the results of the linear mixed models, recurrence had a significantly negative impact on QoL in all four models (P <0.01) [Supplementary Table 4, https://links.lww.com/CM9/B746]. Furthermore, a history of diabetes was associated with reduced health utility and PCS scores (P <0.05). Moreover, patients with other causes of AP showed a higher MCS score of SF-36 than those with biliary disease (P = 0.045). When we excluded the patients with pancreatitis history, we got similar results that recurrence negatively influenced QoL in all four models (P <0.01) and a history of diabetes reduced the PCS scores (P <0.05). Among patients without recurrence, only a history of diabetes was related to reduced PCS scores (P <0.05). We performed a longitudinal observational study on patients with AP to explore the factors related to recurrence and QoL. To our best knowledge, few studies compared the QoL of AP patients with and without recurrence. We found that the risk of developing recurrence was increased in patients with a history of AP and hypertriglyceridemia etiology. Furthermore, patients with AP without recurrence recovered better than patients with recurrence. We also compared our EQ-5D-3L health state results with the results received using the Chinese norms and observed that patients without recurrence were able to recover to normal mobility, self-care, and usual life activities within 3–6 months. However, both patients with and without recurrence in this study had more problems with pain/discomfort and anxiety/depression than were reported with the Chinese norms. Similar results were supported by the findings of the SF-36. Patients without recurrence recovered quickly, and their QoL stabilized approximately six months after discharge. In the linear mixed model, both recurrence and a history of diabetes were associated with worse QoL. This study has several strengths. First, we followed up on the surveys at five time points, which helped us understand the recovery progress of AP patients after discharge. Second, we compared QoL between patients with and without recurrence, as RAP and AP had different characteristics. Third, we found a six-month follow-up is enough for AP patients without recurrence. Some limitations should be stated as well. First, recurrence was self-reported by the patients, but we reviewed the relevant clinical data to confirm this self-report. Second, we did not include a control group for comparison, although we compared our results with the Chinese norms. Third, the sample size is relatively small, mainly when we conducted subgroup analyses. Funding This study was funded by grants from National Natural Science Foundation of China (No. 32170788), National Clinical Key Specialty Construction Project (No. ZK108000), National High Level Hospital Clinical Research Funding (No. 2022-PUMCH-B-023), and Beijing Natural Science Foundation (No. 7232123). Conflicts of interest None.

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