Automated Portal Placement for Arthroscopic Hip Surgery

Placing portal incisions during arthroscopic hip surgery presents challenges for surgeons in terms of anatomic accessibility and patient safety. Based on key anatomic landmarks and portal placement information from recent literature, suggested portal incisions were determined. Guidance in the placement of the three most common portal incision locations (anterior, anterolateral, and posterolateral) for arthroscopic surgery; in addition to visual feedback on tool trajectory to the hip joint is provided in real time by a computer aided system for hip arthroscopy. By simplifying the portal placement process, one of the most challenging aspects of arthroscopic hip surgery, an increased use of this minimally invasive technique could be possible. In addition to portal information, improvements to an existing computer aided system for arthroscopic hip surgery, including a new hip model and redesigned mechanical tracking linkage, were completed.

Morbidity in surgery: impact of the 50-hour work-week limitation in Switzerland

Work-hour regulations for residency programmes in Switzerland, including a 50-hour weekly limit, were set in on 1 January 2005. Patient safety was one of the major arguments for the implementation. As the effect of the restriction of residency work hours on patient care in Switzerland has not yet been evaluated on objective data, the aim of the present study was to assess its impact by comparing the patients' morbidity and mortality before (2001-2004) and after (2005-2008) the implementation.

LEARNING FROM NEAR MISSES IN MEDICATION ERRORS: A BAYESIAN APPROACH

Medical errors originating in health care facilities are a significant source of preventable morbidity, mortality, and healthcare costs. Voluntary error report systems that collect information on the causes and contributing factors of medi- cal errors regardless of the resulting harm may be useful for developing effective harm prevention strategies. Some patient safety experts question the utility of data from errors that did not lead to harm to the patient, also called near misses. A near miss (a.k.a. close call) is an unplanned event that did not result in injury to the patient. Only a fortunate break in the chain of events prevented injury. We use data from a large voluntary reporting system of 836,174 medication errors from 1999 to 2005 to provide evidence that the causes and contributing factors of errors that result in harm are similar to the causes and contributing factors of near misses. We develop Bayesian hierarchical models for estimating the log odds of selecting a given cause (or contributing factor) of error given harm has occurred and the log odds of selecting the same cause given that harm did not occur. The posterior distribution of the correlation between these two vectors of log-odds is used as a measure of the evidence supporting the use of data from near misses and their causes and contributing factors to prevent medical errors. In addition, we identify the causes and contributing factors that have the highest or lowest log-odds ratio of harm versus no harm. These causes and contributing factors should also be a focus in the design of prevention strategies. This paper provides important evidence on the utility of data from near misses, which constitute the vast majority of errors in our data.

Critical appraisal of meta-analyses: an introductory guide for the practicing surgeon

ABSTRACT: Meta-analyses are an essential tool of clinical research. Meta-analyses of individual randomized controlled trials frequently constitute the highest possible level of scientific evidence for a given research question and allow surgeons to rapidly gain a comprehensive understanding of an important clinical issue. Moreover, meta-analyses often serve as cornerstones for evidence-based surgery, treatment guidelines, and knowledge transfer. Given the importance of meta-analyses to the medical (and surgical) knowledge base, it is of cardinal importance that surgeons have a basic grasp of the principles that guide a high-quality meta-analysis, and be able to weigh objectively the advantages and potential pitfalls of this clinical research tool. Unfortunately, surgeons are often ill-prepared to successfully conduct, critically appraise, and correctly interpret meta-analyses. The objective of this educational review is to provide surgeons with a brief introductory overview of the knowledge and skills required for understanding and critically appraising surgical meta-analyses as well as assessing their implications for their own surgical practice.

Frequency of use and knowledge of the WHO-surgical checklist in Swiss hospitals: a cross-sectional online survey

BACKGROUND The WHO-surgical checklist is strongly recommended as a highly effective yet economically simple intervention to improve patient safety. Its use and potentially influential factors were investigated as little data exist on the current situation in Switzerland. METHODS A cross-sectional online survey with members (N = 1378) of three Swiss professional associations of invasive health care professionals was conducted in German, French, and Italian. The survey assessed use of, knowledge of and satisfaction with the WHO-surgical checklist. T-Tests and ANOVA were conducted to test for differences between professional groups. Bivariate correlations were computed to test for associations between measures of knowledge and satisfaction. RESULTS 1090 (79.1%) reported the use of a surgical checklist. 346 (25.1%) use the WHO-checklist, 532 (38.6%) use the Swiss Patient Safety Foundation recommendations to avoid Wrong Site Surgery, and 212 (15.7%) reported the use of other checklists. Satisfaction with checklist use was generally high (doctors: 71.9% satisfied, nurses: 60.8% satisfied) and knowledge was moderate depending on the use of the WHO-checklist. No association between measures of subjective and objective knowledge was found. CONCLUSIONS Implementation of a surgical checklist remains an important task for health care institutions in Switzerland. Although checklist use is present in Switzerland on a regular basis, a substantial group of health care personnel still do not use a checklist as a routine. Influential factors and the associations among themselves need to be addressed in future studies in more detail.

Patientensicherheit in der Hausarztpraxis

Einleitung Aus der Schweizer Grundversorgung lagen bisher noch keine systematischen Daten zu kritischen Ereignissen und zum Sicherheitsklima vor. Aus diesem Grund wurde eine Befragung von Ärzten und Medizinischen Praxisassistentinnen (MPA) in Deutschschweizer Hausarztpraxen sowie ein Folgeprojekt spezifisch zur Telefon-Triage durchgeführt. Methoden Mit Hilfe eines standardisierten Fragebogens wurden Fachpersonen in Hausarztpraxen zu Sicherheitsrisiken und zum Sicherheitsklima in ihren Praxen befragt. Der Fragebogen enthielt neben Fragen zum Sicherheitsklima Beschreibungen von 23 kritischen Ereignissen in Hausarztpraxen, die bezüglich Häufigkeit des Auftretens in der Praxis in den vergangenen zwölf Monaten sowie der Schadensfolge beurteilt wurden, als das Ereignis zum letzten Mal in der Praxis aufgetreten ist. Zudem beantworteten Ärzte und MPA eine offene Frage, nach den für sie besonders relevanten Risiken für die Patientensicherheit in ihren Praxen. Im Folgeprojekt wurden Interviews und Gruppendiskussionen mit MPA und Ärzten geführt, um eine Prozessanalyse der Telefon-Triage durchzuführen und ein Hilfsmittel für Hausarztpraxen zur Stärkung einer sicheren Telefon-Triage zu entwickeln. Ergebnisse 630 Ärzte und MPA (50,2% Ärzte, 49,8% MPA) haben an der Studie teilgenommen. 30% der Ärzte und 17% der MPA gaben an, mindestens einen der untersuchten Ereignisse täglich oder wöchentlich in ihrer Praxis zu beobachten. Fehler bei der Dokumentation wurden am häufigsten beobachtet. Ereignisse, die sich aufgrund der Schadensfolge als besonders relevant erwiesen, waren Fehleinschätzungen bei Kontaktaufnahmen der Patienten mit der Praxis, Diagnosefehler, mangelnde Überwachung von Patienten nach therapeutischen Massnahmen und Fehler in Zusammenhang mit der Medikation. Die Medikation (28% der Nennungen), medizinische Verrichtungen in der Praxis (11%) und die Telefon-Triage (7%) wurden am häufigsten als die Risiken genannt, die die Studienteilnehmer in ihren Praxen gerne eliminieren würden. In Bezug auf das Sicherheitsklima erwiesen sich insbesondere Teamsitzungen und regelmässige Qualitätszirkel-Teilnahme als relevante Prädiktoren für die Dimension „Teambasierte Aktivitäten und Strategien zur Fehlerprävention“. Berufsgruppenunterschiede zwischen Ärzten und MPA konnten sowohl hinsichtlich der berichteten Sicherheitsrisiken, als auch beim Sicherheitsklima beobachtet werden. Fazit Die Ergebnisse der Studie legen die Telefon-Triage als bislang wenig beachteten jedoch sehr relevanten Sicherheitsbereich in der Grundversorgung dar. Um die Sicherheit der Telefon-Triage zu stärken, wurde ein Anschlussprojekt durchgeführt, aus dem heraus ein Leitfaden für Hausarztpraxen entwickelt wurde. Dieser Leitfaden soll Ärzte und MPA in einer gemeinsamen und kritischen Auseinandersetzung von Strukturen und Prozessen rund um die Telefon-Triage sowie der Entwicklung von Verbesserungsschritten unterstützen. Die systematisch beobachteten Berufsgruppenunterschiede sind ein wichtiger Hinweis dafür, dass das gesamte Praxisteam in die Analyse von Sicherheitsrisiken und die Entwicklung von Massnahmen einbezogen werden sollte. Nur so können Risiken umfassend erfasst und für alle Fachpersonen relevante und getragene Verbesserungen initiiert werden. Dieser Ansatz der Team-Involvierung bildet die Basis für den Praxisleitfaden zur Telefon-Triage.

Towards a Hybrid Method to Categorize Interruptions and Activities in Healthcare

Objective Interruptions are known to have a negative impact on activity performance. Understanding how an interruption contributes to human error is limited because there is not a standard method for analyzing and classifying interruptions. Qualitative data are typically analyzed by either a deductive or an inductive method. Both methods have limitations. In this paper a hybrid method was developed that integrates deductive and inductive methods for the categorization of activities and interruptions recorded during an ethnographic study of physicians and registered nurses in a Level One Trauma Center. Understanding the effects of interruptions is important for designing and evaluating informatics tools in particular and for improving healthcare quality and patient safety in general. Method The hybrid method was developed using a deductive a priori classification framework with the provision of adding new categories discovered inductively in the data. The inductive process utilized line-by-line coding and constant comparison as stated in Grounded Theory. Results The categories of activities and interruptions were organized into a three-tiered hierarchy of activity. Validity and reliability of the categories were tested by categorizing a medical error case external to the study. No new categories of interruptions were identified during analysis of the medical error case. Conclusions Findings from this study provide evidence that the hybrid model of categorization is more complete than either a deductive or an inductive method alone. The hybrid method developed in this study provides the methodical support for understanding, analyzing, and managing interruptions and workflow.

Interruptions in Workflow for RNs in a Level One Trauma Center

An understanding of interruptions in healthcare is important for the design, implementation, and evaluation of health information systems and for the management of clinical workflow and medical errors. The purpose of this study is to identify and classify the types of interruptions experienced by Emergency Department(ED) nurses working in a Level One Trauma Center. This was an observational field study of Registered Nurses (RNs) employed in a Level One Trauma Center using the shadowing method. Results of the study indicate that nurses were both recipients and initiators of interruptions. Telephones, pagers, and face-to-face conversations were the most common sources of interruptions. Unlike other industries, the healthcare community has not systematically studied interruptions in clinical settings to determine and weigh the necessity of the interruption against their sometimes negative results such as medical errors, decreased efficiency, and increased costs. Our study presented here is an initial step to understand the nature, causes, and effects of interruptions, thereby improving both the quality of healthcare and patient safety. We developed an ethnographic data collection technique and a data coding method for the capturing and analysis of interruptions. The interruption data we collected are systematic, comprehensive, and close to exhaustive. They confirmed the findings from earlier studies by other researchers that interruptions are frequent events in critical care and other healthcare settings. We are currently using these data to analyze the workflow dynamics of ED clinicians, to identify the bottlenecks of information flow, and to develop interventions to improve the efficiency of emergency care through the management of interruptions.

Towards a hybrid method to categorize interruptions and activities in healthcare.

OBJECTIVE: Interruptions are known to have a negative impact on activity performance. Understanding how an interruption contributes to human error is limited because there is not a standard method for analyzing and classifying interruptions. Qualitative data are typically analyzed by either a deductive or an inductive method. Both methods have limitations. In this paper, a hybrid method was developed that integrates deductive and inductive methods for the categorization of activities and interruptions recorded during an ethnographic study of physicians and registered nurses in a Level One Trauma Center. Understanding the effects of interruptions is important for designing and evaluating informatics tools in particular as well as improving healthcare quality and patient safety in general. METHOD: The hybrid method was developed using a deductive a priori classification framework with the provision of adding new categories discovered inductively in the data. The inductive process utilized line-by-line coding and constant comparison as stated in Grounded Theory. RESULTS: The categories of activities and interruptions were organized into a three-tiered hierarchy of activity. Validity and reliability of the categories were tested by categorizing a medical error case external to the study. No new categories of interruptions were identified during analysis of the medical error case. CONCLUSIONS: Findings from this study provide evidence that the hybrid model of categorization is more complete than either a deductive or an inductive method alone. The hybrid method developed in this study provides the methodical support for understanding, analyzing, and managing interruptions and workflow.

Interruptions in workflow for RNs in a Level One Trauma Center.

An understanding of interruptions in healthcare is important for the design, implementation, and evaluation of health information systems and for the management of clinical workflow and medical errors. The purpose of this study is to identify and classify the types of interruptions experienced by ED nurses working in a Level One Trauma Center. This was an observational field study of Registered Nurses employed in a Level One Trauma Center using the shadowing method. Results of the study indicate that nurses were both recipients and initiators of interruptions. Telephone, pagers, and face-to-face conversations were the most common sources of interruptions. Unlike other industries, the outcomes caused by interruptions resulting in medical errors, decreased efficiency and increased cost have not been systematically studied in healthcare. Our study presented here is an initial step to understand the nature, causes, and effects of interruptions, and to develop interventions to manage interruptions to improve healthcare quality and patient safety. We developed an ethnographic data collection technique and a data coding method for the capturing and analysis of interruptions. The interruption data we collected are systematic, comprehensive, and close to exhaustive. They confirmed the findings from early studies by other researchers that interruptions are frequent events in critical care and other healthcare settings. We are currently using these data to analyze the workflow dynamics of ED clinicians, identify the bottlenecks of information flow, and develop interventions to improve the efficiency of emergency care through the management of interruptions.

Timely follow-up of abnormal diagnostic imaging test results in an outpatient setting: are electronic medical records achieving their potential?

BACKGROUND: Given the fragmentation of outpatient care, timely follow-up of abnormal diagnostic imaging results remains a challenge. We hypothesized that an electronic medical record (EMR) that facilitates the transmission and availability of critical imaging results through either automated notification (alerting) or direct access to the primary report would eliminate this problem. METHODS: We studied critical imaging alert notifications in the outpatient setting of a tertiary care Department of Veterans Affairs facility from November 2007 to June 2008. Tracking software determined whether the alert was acknowledged (ie, health care practitioner/provider [HCP] opened the message for viewing) within 2 weeks of transmission; acknowledged alerts were considered read. We reviewed medical records and contacted HCPs to determine timely follow-up actions (eg, ordering a follow-up test or consultation) within 4 weeks of transmission. Multivariable logistic regression models accounting for clustering effect by HCPs analyzed predictors for 2 outcomes: lack of acknowledgment and lack of timely follow-up. RESULTS: Of 123 638 studies (including radiographs, computed tomographic scans, ultrasonograms, magnetic resonance images, and mammograms), 1196 images (0.97%) generated alerts; 217 (18.1%) of these were unacknowledged. Alerts had a higher risk of being unacknowledged when the ordering HCPs were trainees (odds ratio [OR], 5.58; 95% confidence interval [CI], 2.86-10.89) and when dual-alert (>1 HCP alerted) as opposed to single-alert communication was used (OR, 2.02; 95% CI, 1.22-3.36). Timely follow-up was lacking in 92 (7.7% of all alerts) and was similar for acknowledged and unacknowledged alerts (7.3% vs 9.7%; P = .22). Risk for lack of timely follow-up was higher with dual-alert communication (OR, 1.99; 95% CI, 1.06-3.48) but lower when additional verbal communication was used by the radiologist (OR, 0.12; 95% CI, 0.04-0.38). Nearly all abnormal results lacking timely follow-up at 4 weeks were eventually found to have measurable clinical impact in terms of further diagnostic testing or treatment. CONCLUSIONS: Critical imaging results may not receive timely follow-up actions even when HCPs receive and read results in an advanced, integrated electronic medical record system. A multidisciplinary approach is needed to improve patient safety in this area.

Reasons for the persistence of adverse events in the era of safer surgery - a qualitative approach

OBJECTIVE We sought to evaluate potential reasons given by board-certified doctors for the persistence of adverse events despite efforts to improve patient safety in Switzerland. SUMMARY BACKGROUND DATA In recent years, substantial efforts have been made to improve patient safety by introducing surgical safety checklists to standardise surgeries and team procedures. Still, a high number of adverse events remain. METHODS Clinic directors in operative medicine in Switzerland were asked to answer two questions concerning the reasons for persistence of adverse events, and the advantages and disadvantages of introducing and implementing surgical safety checklists. Of 799 clinic directors, the arguments of 237 (29.7%) were content-analysed using Mayring's content analysis method, resulting in 12 different categories. RESULTS Potential reasons for the persistence of adverse events were mainly seen as being related to the "individual" (126/237, 53.2%), but directors of high-volume clinics identified factors related to the "group and interactions" significantly more often as a reason (60.2% vs 40.2%; p = 0.003). Surgical safety checklists were thought to have positive effects on the "organisational level" (47/237, 19.8%), the "team level" (37/237, 15.6%) and the "patient level" (40/237, 16.9%), with a "lack of willingness to implement checklists" as the main disadvantage (34/237, 14.3%). CONCLUSION This qualitative study revealed the individual as the main player in the persistence of adverse events. Working conditions should be optimised to minimise interface problems in the case of cross-covering of patients, to assure support for students, residents and interns, and to reduce strain. Checklists are helpful on an "organisational level" (e.g., financial benefits, quality assurance) and to clarify responsibilities.

IN.PACT Amphirion paclitaxel eluting balloon versus standard percutaneous transluminal angioplasty for infrapopliteal revascularization of critical limb ischemia: rationale and protocol for an ongoing randomized controlled trial

BACKGROUND The effectiveness and durability of endovascular revascularization therapies for chronic critical limb ischemia (CLI) are challenged by the extensive burden of infrapopliteal arterial disease and lesion-related characteristics (e.g., severe calcification, chronic total occlusions), which frequently result in poor clinical outcomes. While infrapopliteal vessel patency directly affects pain relief and wound healing, sustained patency and extravascular care both contribute to the ultimate "patient-centric" outcomes of functional limb preservation, mobility and quality of life (QoL). METHODS/DESIGN IN.PACT DEEP is a 2:1 randomized controlled trial designed to assess the efficacy and safety of infrapopliteal arterial revascularization between the IN.PACT Amphirion™ paclitaxel drug-eluting balloon (IA-DEB) and standard balloon angioplasty (PTA) in patients with Rutherford Class 4-5-6 CLI. DISCUSSION This multicenter trial has enrolled 358 patients at 13 European centers with independent angiographic core lab adjudication of the primary efficacy endpoint of target lesion late luminal loss (LLL) and clinically driven target lesion revascularization (TLR) in major amputation-free surviving patients through 12-months. An independent wound core lab will evaluate all ischemic wounds to assess the extent of healing and time to healing at 1, 6, and 12 months. A QoL questionnaire including a pain scale will assess changes from baseline scores through 12 months. A Clinical Events Committee and Data Safety Monitoring Board will adjudicate the composite primary safety endpoints of all-cause death, major amputation, and clinically driven TLR at 6 months and other trial endpoints and supervise patient safety throughout the study. All patients will be followed for 5 years. A literature review is presented of the current status of endovascular treatment of CLI with drug-eluting balloon and standard PTA. The rationale and design of the IN.PACT DEEP Trial are discussed. IN.PACT DEEP is a milestone, prospective, randomized, robust, independent core lab-adjudicated CLI trial that will evaluate the role of a new infrapopliteal revascularization technology, the IA-DEB, compared to PTA. It will assess the overall impact on infrapopliteal artery patency, limb salvage, wound healing, pain control, QoL, and patient mobility. The 1-year results of the adjudicated co-primary and secondary endpoints will be available in 2014. TRIAL REGISTRATION NCT00941733

Infection Prevention in the Emergency Department.

Infection prevention remains a major challenge in emergency care. Acutely ill and injured patients seeking evaluation and treatment in the emergency department (ED) not only have the potential to spread communicable infectious diseases to health care personnel and other patients, but are vulnerable to acquiring new infections associated with the care they receive. This article will evaluate these risks and review the existing literature for infection prevention practices in the ED, ranging from hand hygiene, standard and transmission-based precautions, health care personnel vaccination, and environmental controls to strategies for preventing health care-associated infections. We will conclude by examining what can be done to optimize infection prevention in the ED and identify gaps in knowledge where further research is needed. Successful implementation of evidence-based practices coupled with innovation of novel approaches and technologies tailored specifically to the complex and dynamic environment of the ED are the keys to raising the standard for infection prevention and patient safety in emergency care.

Evaluating the optimal timing of surgical antimicrobial prophylaxis: study protocol for a randomized controlled trial

BACKGROUND Surgical site infections are the most common hospital-acquired infections among surgical patients. The administration of surgical antimicrobial prophylaxis reduces the risk of surgical site infections . The optimal timing of this procedure is still a matter of debate. While most studies suggest that it should be given as close to the incision time as possible, others conclude that this may be too late for optimal prevention of surgical site infections. A large observational study suggests that surgical antimicrobial prophylaxis should be administered 74 to 30 minutes before surgery. The aim of this article is to report the design and protocol of a randomized controlled trial investigating the optimal timing of surgical antimicrobial prophylaxis.Methods/design: In this bi-center randomized controlled trial conducted at two tertiary referral centers in Switzerland, we plan to include 5,000 patients undergoing general, oncologic, vascular and orthopedic trauma procedures. Patients are randomized in a 1:1 ratio into two groups: one receiving surgical antimicrobial prophylaxis in the anesthesia room (75 to 30 minutes before incision) and the other receiving surgical antimicrobial prophylaxis in the operating room (less than 30 minutes before incision). We expect a significantly lower rate of surgical site infections with surgical antimicrobial prophylaxis administered more than 30 minutes before the scheduled incision. The primary outcome is the occurrence of surgical site infections during a 30-day follow-up period (one year with an implant in place). When assuming a 5 surgical site infection risk with administration of surgical antimicrobial prophylaxis in the operating room, the planned sample size has an 80% power to detect a relative risk reduction for surgical site infections of 33% when administering surgical antimicrobial prophylaxis in the anesthesia room (with a two-sided type I error of 5%). We expect the study to be completed within three years. DISCUSSION The results of this randomized controlled trial will have an important impact on current international guidelines for infection control strategies in the hospital. Moreover, the results of this randomized controlled trial are of significant interest for patient safety and healthcare economics.Trial registration: This trial is registered on ClinicalTrials.gov under the identifier NCT01790529.