Objective This study aimed to develop and validate a patient-reported outcome measure (PROM) in acute pancreatitis (AP) as an endpoint centred on the patient. Design A PROM instrument (PAtieNt-rePoRted OutcoMe scale in acute pancreatItis, an international proSpEctive cohort study, PAN-PROMISE scale) was designed based on the opinion of patients, professionals and an expert panel. The scale was validated in an international multicentre prospective cohort study, describing the severity of AP and quality of life at 15 days after discharge as the main variables for validation. The COSMIN (COnsensus-based Standards for the selection of health status Measurement INstruments) methodology was applied. Both the design and validation stages considered the content and face validity of this new instrument; the metric properties of the different items, reliability (reproducibility and internal consistence), the construct, structural and criterion validity, responsiveness and interpretability of this scale. Results PAN-PROMISE consists of a seven-item scale based on the symptoms that cause the most discomfort and concern to patients with AP. The validation cohort involved 15 countries, 524 patients. The intensity of symptoms changed from higher values during the first 24 hours to lower values at discharge and 15 days thereafter. Items converged into a unidimensional ordinal scale with good fit indices. Internal consistency and split-half reliability at discharge were adequate. Reproducibility was confirmed using test–retest reliability and comparing the PAN-PROMISE score at discharge and 15 days after discharge. Evidence is also provided for the convergent-discriminant and empirical validity of the scale. Conclusion The PAN-PROMISE scale is a useful tool to be used as an endpoint in clinical trials, and to quantify patient well-being during the hospital admission and follow-up. Trial registration number NCT03650062
Objective: The aim of the study is to propose a visual classification for encrusted stents (ESs) to help choose the appropriate endourologic treatment. Materials and Methods: A multicenter, retrospective, and descriptive study was performed. A total of 140 patients with encrusted Double-J stents were enrolled from 5 different institutions. The novel visual grading for ureteral encrusted stent (V-GUES) classification system ranges from A to D, increasing with severity of encrustation. Results: ESs could be removed with a single intervention in 112 patients (86.8%). Type A and B ESs could be removed in all patients (100% success). Type D stents had minor retrieval and stone-free rates ( p = 0.006 and p < 0.0001, respectively). Flexible ureteroscopy had a low success rate (77.7%) for type C stents (odds ratio [OR]: 0.21). Combined access had a 100% success rate for retrieval of type C ESs and a 92.9% success rate for type D ESs (OR: 9.18). Type D stents were associated with patients requiring more than one session to retrieve the stent (OR: 0.11) and stones (OR: 0.21). Conclusions: The V-GUES system is associated with treatment success rates of ES retrieval and stone-free status. It is also associated with the complication rate and the number of sessions needed for patients to be stent and stone free. The V-GUES classification could help counsel patients about the best treatment options and their outcomes. Further prospective studies will be needed to provide external validation.
Objectives: To evaluate the safety and effectiveness of flexible ureterorenoscopy (fURS) with holmium laser lithotripsy for treating kidney stones without fluoroscopy as method of best practice for patients and endourologists. Patients and Methods: All patients treated for kidney stones by fURS with holmium laser lithotripsy from February 2016 to February 2017 were retrospectively evaluated. The patients’ demographic characteristics, stone features (size, number, and location), surgical variables (use of fluoroscopy, operative and fluoroscopy time), complications, and success rate (employing stone-free rate [SFR]), were included in the analysis. Results: In all, 100 patients met the inclusion criteria: 33 fURS were performed under fluoroscopy (Group 1) and 67 without it (Group 2). The mean operating time was 94.33 vs 98.29 min (P = 0.888), respectively. The mean stone volume was 78.5 vs 82.4 mL (P = 0.885), respectively. The SFR was 63.6% and 64.2% (P = 0.771), the perioperative complications rate was 18.2% vs 11.9% (P = 0.285), and the postoperative complications rate was 24.2% and 10.4%, in groups 1 and 2 respectively (P = 0.174). Conclusions: fURS with holmium laser lithotripsy without fluoroscopy was a feasible and safe treatment for kidney stones. There was no difference between the use of fluoroscopy or not regarding complications or SFR. Thus, we can reduce the risks of radiation exposure to patients and medical staff whilst maintaining surgical success. However, multicentre randomised controlled studies are necessary to evaluate fluoroless URS further and to confirm our present results. Abbreviations: PTFE: polytetrafluoroethylene; SFR: stone-free rate; (f)URS: (flexible) ureterorenoscopy/ureterorenoscopies; US: ultrasonography