Occurrence and preventability of adverse drug events in surgical patients: a systematic review of literature.

BACKGROUND: Adverse drug events (ADEs) are a considerable cause of inhospital morbidity and mortality. Patient flow differs substantially for surgical and nonsurgical patients: surgical patients are subjected to multiple medication changes related to surgical intervention or postoperative care. The objective of this study is to systematically review the occurrence and nature of ADEs in surgical patients. Also, a comparison with nonsurgical patients was made. METHODS: A search was conducted in Embase and Medline identifying studies that reported observational data on the occurrence and nature of ADEs in surgical hospitalised adult patients. If sufficient data were available, the occurrence of (preventable) ADEs was compared between surgical and nonsurgical patients. RESULTS: Six studies fulfilled the inclusion criteria. The occurrence of ADEs in surgical patients ranged from 2.0 to 27.7 per 100 admissions, from 4.7 to 8.9 per 1,000 patient days, or involved 8.9% of the patients. Proportions of preventable ADEs in surgical patients were 18% and 54%, described in two studies. A head-to-head comparison of surgical patients and nonsurgical patients was possible for five of six studies. The occurrence of ADEs in nonsurgical patients was significantly higher than in surgical patients in three studies. CONCLUSIONS: ADEs are a relevant problem in surgical patients and nonsurgical patients, with a high proportion of preventable ADEs. The occurrence of ADEs appears to be higher in nonsurgical patients than in surgical patients. However, studies lack details on the differences in nature of ADEs between hospital populations. To improve medication safety this knowledge is essential.

A decision rule to aid selection of patients with abdominal sepsis requiring a relaparotomy.

BACKGROUND: Accurate and timely identification of patients in need of a relaparotomy is challenging since there are no readily available strongholds. The aim of this study is to develop a prediction model to aid the decision-making process in whom to perform a relaparotomy. METHODS: Data from a randomized trial comparing surgical strategies for relaparotomy were used. Variables were selected based on previous reports and common clinical sense and screened in a univariable regression analysis to identify those associated with the need for relaparotomy. Variables with the strongest association were considered for the prediction model which was constructed after backward elimination in a multivariable regression analysis. The discriminatory capacity of the model was expressed with the area under the curve (AUC). A cut-off analysis was performed to illustrate the consequences in clinical practice. RESULTS: One hundred and eighty-two patients were included; 46 were considered cases requiring a relaparotomy. A prediction model was build containing 6 variables. This final model had an AUC of 0.80 indicating good discriminatory capacity. However, acceptable sensitivity would require a low threshold for relaparotomy leading to an unacceptable rate of negative relaparotomies (63%). Therefore, the prediction model was incorporated in a decision rule were the interval until re-assessment and the use of Computed Tomography are related to the outcome of the model. CONCLUSIONS: To construct a prediction model that will provide a definite answer whether or not to perform a relaparotomy seems a utopia. However, our prediction model can be used to stratify patients on their underlying risk and could guide further monitoring of patients with abdominal sepsis in order to identify patients with suspected ongoing peritonitis in a timely fashion.

A systematic review and meta-analysis of diagnostic performance of imaging in acute cholecystitis.

PURPOSE: To update previously summarized estimates of diagnostic accuracy for acute cholecystitis and to obtain summary estimates for more recently introduced modalities. MATERIALS AND METHODS: A systematic search was performed in MEDLINE, EMBASE, Cochrane Library, and CINAHL databases up to March 2011 to identify studies about evaluation of imaging modalities in patients who were suspected of having acute cholecystitis. Inclusion criteria were explicit criteria for a positive test result, surgery and/or follow-up as the reference standard, and sufficient data to construct a 2 × 2 table. Studies about evaluation of predominantly acalculous cholecystitis in intensive care unit patients were excluded. Bivariate random-effects modeling was used to obtain summary estimates of sensitivity and specificity. RESULTS: Fifty-seven studies were included, with evaluation of 5859 patients. Sensitivity of cholescintigraphy (96%; 95% confidence interval [CI]: 94%, 97%) was significantly higher than sensitivity of ultrasonography (US) (81%; 95% CI: 75%, 87%) and magnetic resonance (MR) imaging (85%; 95% CI: 66%, 95%). There were no significant differences in specificity among cholescintigraphy (90%; 95% CI: 86%, 93%), US (83%; 95% CI: 74%, 89%) and MR imaging (81%; 95% CI: 69%, 90%). Only one study about evaluation of computed tomography (CT) met the inclusion criteria; the reported sensitivity was 94% (95% CI: 73%, 99%) at a specificity of 59% (95% CI: 42%, 74%). CONCLUSION: Cholescintigraphy has the highest diagnostic accuracy of all imaging modalities in detection of acute cholecystitis. The diagnostic accuracy of US has a substantial margin of error, comparable to that of MR imaging, while CT is still underevaluated.

Cost-effectiveness of ward-based pharmacy care in surgical patients: protocol of the SUREPILL (Surgery & Pharmacy In Liaison) study.

BACKGROUND: Preventable adverse drug events (pADEs) are widely known to be a health care issue for hospitalized patients. Surgical patients are especially at risk, but prevention of pADEs in this population is not demonstrated before. Ward-based pharmacy interventions seem effective in reducing pADEs in medical patients. The cost-effectiveness of these preventive efforts still needs to be assessed in a comparative study of high methodological standard and also in the surgical population. For these aims the SUREPILL (Surgery & Pharmacy in Liaison) study is initiated. METHODS/DESIGN: A multi-centre controlled trial, with randomisation at ward-level and preceding baseline assessments is designed. Patients admitted to the surgical study wards for elective surgery with an expected length of stay of more than 48 hours will be included. Patients admitted to the intervention ward, will receive ward-based pharmacy care from the clinical pharmacy team, i.e. pharmacy practitioners and hospital pharmacists. This ward-based pharmacy intervention includes medication reconciliation in consultation with the patient at admission, daily medication review with face-to-face contact with the ward doctor, and patient counselling at discharge. Patients admitted in the control ward, will receive standard pharmaceutical care.The primary clinical outcome measure is the number of pADEs per 100 elective admissions. These pADEs will be measured by systematic patient record evaluation using a trigger tool. Patient records positive for a trigger will be evaluated on causality, severity and preventability by an independent expert panel. In addition, an economic evaluation will be performed from a societal perspective with the costs per preventable ADE as the primary economic outcome. Other outcomes of this study are: severity of pADEs, number of patients with pADEs per total number of admissions, direct (non-)medical costs and indirect non-medical costs, extra costs per prevented ADE, number and type of pharmacy interventions, length of hospital stay, complications registered in a national complication registration system for surgery, number of readmissions within three months after initial admission (follow-up), quality of life and number of non-institutionalized days during follow-up. DISCUSSION: This study will assess the cost-effectiveness of ward-based pharmacy care on preventable adverse drug events in surgical patients from a societal perspective, using a comparative study design. TRIAL REGISTRATION: Netherlands Trial Register (NTR): NTR2258.

Failure of available scoring systems to predict ongoing infection in patients with abdominal sepsis after their initial emergency laparotomy.

BACKGROUND: To examine commonly used scoring systems, designed to predict overall outcome in critically ill patients, for their ability to select patients with an abdominal sepsis that have ongoing infection needing relaparotomy. METHODS: Data from a RCT comparing two surgical strategies was used. The study population consisted of 221 patients at risk for ongoing abdominal infection. The following scoring systems were evaluated with logistic regression analysis for their ability to select patients requiring a relaparotomy: APACHE-II score, SAPS-II, Mannheim Peritonitis Index (MPI), MODS, SOFA score, and the acute part of the APACHE-II score (APS). RESULTS: The proportion of patients requiring a relaparotomy was 32% (71/221). Only 2 scores had a discriminatory ability in identifying patients with ongoing infection needing relaparotomy above chance: the APS on day 1 (AUC 0.61; 95%CI 0.52-0.69) and the SOFA score on day 2 (AUC 0.60; 95%CI 0.52-0.69). However, to correctly identify 90% of all patients needing a relaparotomy would require such a low cut-off value that around 80% of all patients identified by these scoring systems would have negative findings at relaparotomy. CONCLUSIONS: None of the widely-used scoring systems to predict overall outcome in critically ill patients are of clinical value for the identification of patients with ongoing infection needing relaparotomy. There is a need to develop more specific tools to assist physicians in their daily monitoring and selection of these patients after the initial emergency laparotomy.

External validation of two tools for the clinical diagnosis of acute diverticulitis without imaging.

AIM: External validation and comparison of the diagnostic accuracy of two predictive tools, the emergency department triad and the clinical scoring tool in diagnosing acute diverticulitis. METHODS: Two derivation datasets were used crosswise for external validation. In addition, both tools were validated in a third independent cohort. Predictive values were reassessed and the Area Under the Curve expressed discriminatory capacity. Performance was compared by calculating positive predictive values of the emergency department triad in the validation cohorts and with a cut-off analysis for the clinical scoring tool at a positive predictive value of 90%. RESULTS: Predictive value of the emergency department triad was comparable to the clinical scoring tool. The positive predictive value of the emergency department triad (97%) decreased in the clinical scoring tool cohort (81%) and was excellent in the independent cohort (100%), identifying 24%, 20% and 14% of the patients. A smaller proportion of patients with diverticulitis could be identified with the clinical scoring tool (6%, 19% and 9%). CONCLUSION: The emergency department triad as well as the clinical scoring tool have significant predictive value in external cohorts of patients suspected of diverticulitis. These tools can be used to select patients in whom additional imaging to diagnose acute diverticulitis may be omitted.

Adverse drug events in surgical patients: an observational multicentre study.

BACKGROUND: Errors occurring during different steps of the medication process can lead to adverse drug events (ADEs). Surgical patients are expected to have an increased risk for ADEs during hospitalization. However, detailed information about ADEs in the surgical patient is lacking. OBJECTIVE: In this study, we aim to measure the incidence and nature of (preventable) ADEs, potential risk factors for and outcome parameters of (preventable) ADEs in surgical patients. SETTING: Observational multicentre cohort study in which eight surgical wards participated from three Dutch hospitals, all using computerized physician order entry (CPOE) systems with clinical decision support. METHODS: Electively admitted surgical patients of the participating wards were included from March until June 2009. ADEs were measured using a standardized method with expert judgment. Incidence, severity, preventability and accountable medication were assessed. Poisson regression analysis was applied to determine the associations between possible risk factors and the occurrence of ADEs, expressed as incidence rate ratio (IRR). Also outcomes of ADEs in surgical patients were measured. MAIN OUTCOME MEASURE: The incidence and nature of (preventable) ADEs in surgical patients. RESULTS: A total of 567 surgical patients were included. We found an incidence of 27.5 ADEs and 4.2 preventable ADEs (pADEs) per 100 admissions (15.4 %). A quarter of the pADEs were severe or life-threatening. Opioids and anti-coagulation medication play a major role in the occurrence of ADEs and pADEs respectively. Univariate analysis revealed an American Society of Anesthesiologists classification of III or more as a risk factor for ADEs. Patients older than 65 years [IRR 2.77 (1.14-6.72)], with cardiovascular comorbidity [IRR 2.87 (1.13-7.28)], or undergoing vascular surgery [IRR 2.32 (1.01-5.32)] were at risk for pADEs. Patients experiencing an ADE had a significant longer duration of admission than patients without an ADE. CONCLUSIONS: Surgical patients are at considerable risk of experiencing one or more ADEs during their admission, also in CPOE-hospitals. Risk factors for pADEs are age older than 65 years, cardiovascular comorbidity, and vascular surgery. Intensified monitoring may be needed in patients with a higher than average risk for pADEs.

A targeted method for standardized assessment of adverse drug events in surgical patients.

OBJECTIVES: This study demonstrates the development, reliability and outcome of a targeted method for standardized assessment of adverse drug events (ADEs) in surgical patients. METHODS: Initial practice evaluation of this ADE assessment method was carried out in a prospective single centre cohort study. In total, 262 electively admitted surgical patients were included. The surgical trigger tool was applied to patients' medical records by two independent reviewers, and subsequent assessment of causality, severity and preventability of ADEs was carried out by two independent expert panels consisting of a consultant surgeon and a clinical pharmacologist. The surgical trigger tool and causality assessment method were each tested on reliability in a separate group of 50 randomly selected patients using Fleiss and Cohen's kappa statistics and percentages of agreement. Comparison of this method with an existing trigger tool method for ADEs was performed. RESULTS: Our surgical trigger tool contains 51 triggers. The inter- and intra-rater calculations showed substantial to almost perfect levels of agreement (kappa range 0.71-0.83), with a 97.8-98.5% percentage of agreement. Fair to substantial levels of agreement were calculated for causality, severity and preventability (kappa range 0.38-0.79). The percentages of inter- and intra-rater agreement were 68.9 and 70.5% for causality, 67.0 and 82.0% for severity, and both 98.4% for preventability, respectively. Compared with the existing trigger tool method for ADEs, we found an additional 363 triggers, 18 ADEs (an extra 20%) and 3 preventable ADEs in our surgical cohort. CONCLUSIONS: This targeted trigger tool for standardized assessment of ADEs in surgical patients shows excellent agreement between reviewers. The assessment of medication-related harm had acceptable agreement. Compared with an existing ADE trigger tool method, the present method found almost 20% extra ADEs. This method can be a useful alternative to existing trigger tool methods, in particular to assess medication safety in surgical patients.

[Treatment of secondary peritonitis: slow progress]. / Behandeling van secundaire peritonitis: langzame vooruitgang.

Secondary peritonitis is associated with a high mortality and morbidity. Besides adequate antimicrobial therapy and resuscitation, surgical intervention is the cornerstone of the treatment of these often severely ill patients. Antifungal prophylaxis is advised for patients who have a high risk of developing a fungal infection. Extensive lavage of the peritoneal cavity after elimination of the intra-abdominal infectious focus has no demonstrable positive effect and can even be harmful. A randomised clinical trial showed that relaparotomy on demand (ROD) after the first surgery is the preferred treatment strategy in the case of clinical deterioration, irrespective of the severity of disease. The effective and safe use of ROD requires intensive monitoring of the patient in a setting where diagnostic tests and decision making about relaparotomy are guaranteed around the clock. A reduction in the mortality and morbidity associated with secondary peritonitis can be achieved with a multidisciplinary approach involving more extensive diagnostic and decisional support.

Two Patients with Chronic Pancreatitis Complicated by a Pancreaticopleural Fistula.

Two patients presented with dyspnea and signs of chronic pancreatitis. Patient B had pleural effusion on chest X-ray. Patient A developed pleural effusion during the course of disease. On further analysis these pleural effusions showed elevated amylase concentrations. This finding suggested the diagnosis of a pancreaticopleural fistula which was confirmed by magnetic resonance cholangiopancreatography. Because of the distinct localization of the fistulas the patients were treated differently. In patient A an endoprosthesis was successfully placed in the pancreatic duct, and patient B underwent distal pancreatic resection. Considering the rarity of pancreaticopleural fistula, there is no consensus on diverse aspects of treatment, such as length of treatment with octreotide. However, a rationale for the distinction between fistulas suited for treatment with endoprosthesis or surgery seems to provide some grip.