Process Control Charts in Falls Prevention: The Experience of the Local Healthcare Authority of Romagna, Italy.

Patient safety is a great concern of healthcare institutions and the correct reporting and management of adverse events is a key element for supporting safety improvement efforts. Patient falls are the most frequent adverse event in hospitals and often cause serious patient outcomes. In this work, we describe the experience of the Local Healthcare Authority of Romagna, Italy that, within the framework of a quality and safety improvement programme, designed, developed and implemented a desktop application for monitoring inpatient falls. A multidisciplinary team created a software tool based on R, an open source software for statistical computing that, appropriately combined with the existing hospital information system, is used to obtain Shewhart u-control charts for monitoring the monthly fall rates. The tool had been implemented in twenty nine hospital units. The results indicate that the proposed application gave a valuable contribution in the safety improvement activities. Its usefulness extended beyond the "safety problem" as it also enabled hospital managers to identify a number of critical issues in data collection. As a result, where necessary, improvement actions had been implemented. Furthermore, the use of open source software led to a considerable cost reduction and facilitated customization of the software tool.

How to identify patients who are less likely to have metachronous neoplasms after a colon cancer: a predictive model.

BACKGROUND: Patients with prior colon cancer have increased risk of metachronous colorectal neoplasms; therefore, endoscopic surveillance is indicated. Current recommendations are not risk-stratified. We investigated predictive factors for colorectal neoplasms to build a model to spare colonoscopies for low-risk patients. METHODS: This was a multicenter, retrospective study including patients who underwent surgery for colon cancer in 2001 - 2008 (derivation cohort) and 2009 - 2013 (validation cohort). A predictive model for neoplasm occurrence at second surveillance colonoscopy was developed and validated. RESULTS: 421 and 203 patients were included in derivation and validation cohort, respectively. At second surveillance colonoscopy, 112 (26.6 %) and 55 (27.1 %) patients had metachronous neoplasms in derivation and validation groups; three cancers were detected in the latter. History of left-sided colon cancer (OR 1.64, 95 %CI 1.02 - 2.64), ≥ 1 advanced adenoma at index colonoscopy (OR 1.90, 95 %CI 1.05 - 3.43), and ≥ 1 adenoma at first surveillance colonoscopy (OR 2.06, 95 %CI 1.29 - 3.27) were independently predictive of metachronous colorectal neoplasms at second surveillance colonoscopy. For patients without such risk factors, diagnostic accuracy parameters were: 89.3 % (95 %CI 82.0 %-94.3 %) and 78.2 % (95 %CI 65.0 %-88.2 %) sensitivity, and 28.5 % (95 %CI 23.5 %-33.9 %) and 33.8 % (95 %CI 26.2 %-42.0 %) specificity in derivation and validation group, respectively. No cancer would be missed. CONCLUSIONS: Patients with prior left-sided colon cancer or ≥ 1 advanced adenoma at index colonoscopy or ≥ 1 adenoma at first surveillance colonoscopy had a significantly higher risk of neoplasms at second surveillance colonoscopy; patients without such factors had much lower risk and could safely skip the second surveillance colonoscopy. A prospective, multicenter validation study is needed.

Do I Need to Operate on That in the Middle of the Night? Development of a Nomogram for the Diagnosis of Severe Acute Cholecystitis.

BACKGROUND: Some authors have proposed different predictive factors of severe acute cholecystitis, but generally, the results of risk analyses are expressed as odds ratios, which makes it difficult to apply in the clinical practice of the acute care surgeon. The severe form of acute cholecystitis should include both gangrenous and phlegmonous cholecystitis, due to their severe clinical course, and cholecystectomy should not be delayed. The aim of this study was to create a nomogram to obtain a graphical tool to compute the probability of having a severe acute cholecystitis. METHODS: This is a retrospective study on 393 patients who underwent emergency cholecystectomy between January 2010 and December 2015 at the Acute Care Surgery Service of the S. Anna University Hospital of Ferrara, Italy. Patients were classified as having a non-severe acute cholecystitis or a severe acute cholecystitis (i.e., gangrenous and phlegmonous) based on the final pathology report. The baseline characteristics, pre-operative signs, and abdominal ultrasound (US) findings were assessed with a stepwise multivariate logistic regression analysis to predict the risk of severe acute cholecystitis, and a nomogram was created. RESULTS: Age as a continuous variable, WBC count ≥ 12.4 × 103/µl, CRP ≥9.9 mg/dl, and presence of US thickening of the gallbladder wall were significantly associated with severe acute cholecystitis at final pathology report. A significant interaction between the effect of age and CRP was found. Four risk classes were identified based on the nomogram total points. CONCLUSIONS: Patients with a nomogram total point ≥ 74 should be considered at high risk of severe acute cholecystitis (at 74 total point, sensitivity = 78.5%; specificity = 78.2%; accuracy = 78.3%) and this finding could be useful for surgical planning once confirmed in a prospective study comparing the risk score stratification and clinical outcomes.

Functional Heartburn Overlaps With Irritable Bowel Syndrome More Often than GERD.

OBJECTIVES: We aimed to evaluate the prevalence of irritable bowel syndrome (IBS) in patients with typical reflux symptoms as distinguished into gastroesophageal reflux disease (GERD), hypersensitive esophagus (HE), and functional heartburn (FH) by means of endoscopy and multichannel intraluminal impedance (MII)-pH monitoring. The secondary aim was to detect pathophysiological and clinical differences between different sub-groups of patients with heartburn. METHODS: Patients underwent a structured interview based on questionnaires for GERD, IBS, anxiety, and depression. Off-therapy upper-gastrointestinal (GI) endoscopy and 24 h MII-pH monitoring were performed in all cases. In patients with IBS, fecal calprotectin was measured and colonoscopy was scheduled for values >100 mg/kg to exclude organic disease. Multivariate logistic regression analysis was performed to identify independent risk factors for FH. RESULTS: Of the 697 consecutive heartburn patients who entered the study, 454 (65%) had reflux-related heartburn (GERD+HE), whereas 243 (35%) had FH. IBS was found in 147/454 (33%) GERD/HE but in 187/243 (77%) FH patients (P<0.001). At multivariate analysis, IBS and anxiety were independent risk factors for FH in comparison with reflux-related heartburn (GERD+HE). CONCLUSIONS: IBS overlaps more frequently with FH than with GERD and HE, suggesting common pathways and treatment. HE showed intermediate characteristic between GERD and FH.

Monitoring operating room turnaround time: a retrospective analysis.

Purpose - Operating room (OR) turnaround time is a key process indicator for hospital business management: delays lead to a reduced surgical interventions per day with a consequent increase in costs and decrease in efficiency. The purpose of this paper is to increase understanding by assessing the process' steady-state behaviour and identifying changes that indicate either improvement or deterioration in quality. Design/methodology/approach - With this purpose, the authors retrospectively applied Shewhart control charts and exponentially weighted moving average control charts to data extracted from an hospital information system. Findings - The results showed that statistical process control is able to identify steady-state behaviour process and to detect positive or negative changes in process performance. In particular the authors detected a deterioration in the process performance coinciding with the change in the operating room patient transfer staff. Practical implications - This study showed that statistical quality control is a valuable tool for monitoring performance indicators. Currently, hospital managers are designing an OR dashboard which also includes the control charts. Originality/value - The paper highlights the control chart application to organizational indicators allowing an objective OR system performance assessment.

Development of a prediction model of adverse events after stent placement for esophageal cancer.

BACKGROUND AND AIMS: Self-expandable metal stent (SEMS) positioning is the recommended method for palliation of dysphagia from esophageal cancer, although it is not adverse event-free. The present study was aimed at identifying predictors for adverse events and at proposing a statistical model to predict them. METHODS: We performed a retrospective analysis of a prospectively collected database. All patients who underwent SEMS placement for stricture due to esophageal cancer between 2002 and 2011 in a tertiary-care center were identified. Multivariable regression analysis in the presence of competing risk events was used to identify factors associated with SEMS-related adverse events and to build a prediction model. RESULTS: A total of 267 patients were included. According to the competing risk regression analysis, only 2 variables were significantly associated with the risk of SEMS-related adverse events: prior chemoradiotherapy (CRT), yielding a hazard ratio (HR) of 1.687 (95% confidence interval [CI], 1.076-2.644), and the SEMS length (HR 0.884; 95% CI, 0.798-0.980) for every 10-mm length increase. Based on the estimated probability curves, after 4 months from SEMS placement, the probability of an adverse event in patients who did receive prior CRT was 50.9% compared with 34.4% in those who did not receive prior therapy, which was reduced to 9.2% and 15.1%, respectively, if a 180 mm-length stent was used. The ability of the predictive model to differentiate between patients who did and did not experience the adverse event was moderate (c-index: 0.617). CONCLUSION: The rate of SEMS-related adverse events was higher in patients with previous CRT and lower in patients receiving longer stents. Both factors were used to build an accurate predictive model.

Clinical application of faecal calprotectin in ulcerative colitis patients.

OBJECTIVE: Faecal calprotectin (FC) is the most relevant noninvasive biomarker for monitoring inflammatory status, response to treatment and for predicting clinical relapse in ulcerative colitis (UC). The aim of this study was to evaluate the role of FC in predicting both clinical/endoscopic activity and clinical relapse in a large UC patient cohort. PATIENTS AND METHODS: A two-phase prospective study was carried out. In the first phase, the relationship between FC and clinical/endoscopic activity was evaluated. In the second phase, a cohort of asymptomatic patients with endoscopic mucosal healing was followed up using clinical and FC level determinations. RESULTS: One hundred and twenty-one UC patients were enrolled. The FC concentrations were directly correlated with both clinical and endoscopic activity (r=0.76 and 0.87, respectively, P<0.05) and were capable of differentiating between different degrees of endoscopic severity (P<0.01). An FC cut-off value of 110 µg/g was highly predictive (95%) of endoscopic activity. Seventy-four patients in clinical remission with mucosal healing were followed up for a year or until relapse and 27% developed a clinical relapse. The FC concentration of nonrelapsed patients (48 µg/g) versus relapsed patients (218 µg/g) was significantly different (P<0.01). An FC cut-off value of 193 µg/g had an accuracy of 89% in predicting clinical relapse. High FC levels were associated with clinical relapse using survival analysis and multivariate analysis. CONCLUSION: Our data strongly support the use of FC for staging the activity of disease, predicting relapse and leading decision-making in a UC setting.

Can fecal calprotectin better stratify Crohn's disease activity index?

BACKGROUND: Crohn's disease (CD) activity index (CDAI) is still widely used for monitoring clinical activity in CD patients, but is of little value as indicator of persistent inflammation in symptomless patients. Fecal calprotectin levels ≥150 µg/g are strongly indicative of endoscopically and/or histologically active disease. Our aim was to study, in a large cohort of CD patients, the relationship between CDAI and fecal calprotectin levels. METHODS: CDAI and fecal calprotectin levels were evaluated in consecutive patients from a CD outpatient clinic. RESULTS: We enrolled 193 CD patients, of whom 38% with CDAI <150 had a calprotectin value ≥150 µg/g, suggestive of active disease. A logistic regression model showed that for CDAI levels between 100 and 150, the estimated logistic probability of calprotectin ≥150 µg/g increased progressively to 76%, reaching 94% where disease activity was localized in the colon. With a CDAI cut-off >120, we found a high diagnostic accuracy of 72%, with 88% specificity and 50% sensitivity (positive predictive value: 76%, negative predictive value: 71%) to identify a calprotectin value ≥150 µg/g. CONCLUSION: CDAI scores between 100 and 150 display an acceptable ability to quantify the risk of persistent inflammation as expressed by the high calprotectin level.

Fecal detection of Mycobacterium avium paratuberculosis using the IS900 DNA sequence in Crohn's disease and ulcerative colitis patients and healthy subjects.

BACKGROUND AND AIM: Despite the increasing evidence of MAP/DNA isolation in Crohn's disease (CD), its potential pathogenetic role remains unclear. To further clarify the possible relationship between MAP and CD, we investigated the presence of IS900 DNA fragment in feces from Crohn's disease and ulcerative colitis (UC) patients and from healthy controls (HC). METHODS: Stool samples were collected from 31 CD, 20 UC, and 23 HC and stored at -20°C in 200-mg aliquots. DNA was extracted. MAP presence was detected with a specific PCR amplifying a 409-bp fragment from IS900. The specificity of PCR for IS900 was confirmed sequencing three positive products. Statistical analysis was performed using the Chi-square test. RESULTS: Twenty-one of 31 CD (68%), 13 of 20 UC (65%) and 11 of 23 HC (48%) were MAP-positive (CD vs. HC: p = ns; UC vs. HC: p = ns). With the limits of a small sample size, the IS900-positive percentage in CD and UC was higher than HC, although the difference was not statistically significant. CONCLUSIONS: The possibility to track the MAP presence in human feces represents a new approach to the "MAP hypothesis". Detection of MAP DNA in feces is very common, reaching very high prevalence both in CD and in UC and even in HC. Our findings seem consistent with a high prevalence of MAP asymptomatic infection among the general population and so the possible involvement of MAP in CD pathogenesis could be linked to a specific immune defective response.