Device-less patent foramen ovale closure by radiofrequency thermal energy

The goal of this study was to assess the feasibility, safety and success of a system which uses radiofrequency energy (RFE) rather than a device for percutaneous closure of patent foramen ovale (PFO). METHODS: Sixteen patients (10 men, 6 women, mean age 50 years) were included in the study. All of them had a proven PFO with documented right-to-left shunt (RLS) after Valsalva manoeuvre (VM) during transoesophageal echocardiography (TEE). The patients had an average PFO diameter of 6 +/- 2 mm at TEE and an average of 23 +/- 4 microembolic signals (MES) in power M-mode transcranial Doppler sonography (pm-TCD), measured over the middle cerebral artery. An atrial septal aneurysm (ASA) was present in 7 patients (44%). Balloon measurement, performed in all patients, revealed a stretched PFO diameter of 8 +/- 3 mm. In 2 patients (stretched diameter 11 and 14 mm respectively, both with ASA >10 mm), radiofrequency was not applied (PFO too large) and the PFO was closed with an Amplatzer PFO occluder instead. A 6-month follow-up TEE was performed in all patients. RESULTS: There were no serious adverse events during the procedure or at follow-up (12 months average). TEE 6 months after the first RFE procedure showed complete closure of the PFO in 50% of the patients (7/14). Closure appeared to be influenced by PFO diameter, complete closure being achieved in 89% (7/8) with a balloon-stretched diameter < or =7 mm but in none of the patients >7 mm. Only one of the complete closure patients had an ASA. Of the remainder, 4 (29%) had an ASA. Although the PFO was not completely closed in this group, some reduction in the diameter of the PFO and in MES was documented by TEE and pm-TCD with VM. Five of the 7 residual shunt patients received an Amplatzer PFO occluder. Except for one patient with a minimal residual shunt, all showed complete closure of PFO at 6-month follow-up TEE and pm-TCD with VM. The other two refused a closure device. CONCLUSIONS: The results confirm that radiofrequency closure of the PFO is safe albeit less efficacious and more complex than device closure. The technique in its current state should not be attempted in patients with a balloon-stretched PFO diameter >7 mm and an ASA.

The Cardica C-Port System: clinical and angiographic evaluation of a new device for automated, compliant distal anastomoses in coronary artery bypass grafting surgery--a multicenter prospective clinical trial

OBJECTIVES: The C-Port System (Cardica, Inc, Redwood City, Calif) integrates in one tool all functions necessary to enable rapid automated distal coronary anastomoses. The goal of this prospective, nonrandomized, and multicenter study is to determine the safety and efficacy of this novel anastomotic system. METHODS: Five centers enrolled 133 patients awaiting elective coronary artery bypass grafting surgery. Outcome variables were intraoperative device performance, incidence of device-related adverse events, predischarge and 6-month angiographic graft patency, and 12-month clinical outcome. Independent core laboratories performed qualitative and quantitative angiographic and computed tomographic assessments. RESULTS: The C-Port was used to perform a vein-to-coronary anastomosis in 130 patients. Intraoperative conversion to a hand-sewn anastomosis was necessary in 11 patients because of inadequate target site preparation, inappropriate target vessel selection, or both. Inadequate blood flow related to poor runoff required conversion in 3 additional patients. Three patients died before discharge of causes unrelated to the device. At discharge, 113 patients had a C-Port implant in place, and 104 C-Port anastomoses were studied by means of angiography, resulting in 100 FitzGibbon A, 3 FitzGibbon B, and 1 FitzGibbon 0 classifications. At 6 months, one additional patient died of a device-unrelated cause, and 98 patients were evaluated by means of angiography (n = 89). Overall patency (FitzGibbon A) was 92.1%. Three C-Port anastomoses were rated FitzGibbon B, and 4 were rated FitzGibbon 0. At 12 months, 107 (98.2%) of 109 alive patients were followed up, without any reports of device-related major adverse cardiac events. CONCLUSIONS: The C-Port System allows for a rapid, reliable, and compliant distal anastomosis and yields favorable 6-month angiographic and 12-month clinical results when compared with published studies.

Late results after percutaneous closure of patent foramen ovale for secondary prevention of paradoxical embolism using the amplatzer PFO occluder without intraprocedural echocardiography: effect of device size

OBJECTIVES: We sought to assess the safety and clinical efficacy of patent foramen ovale (PFO) closure under fluoroscopic guidance only, without intraprocedural echocardiography. BACKGROUND: Percutaneous PFO closure has been shown to be safe and feasible using several devices. It is generally performed using simultaneously fluoroscopic and transesophageal or intracardiac echocardiographic guidance. Transesophageal echocardiography requires sedation or general anesthesia and intubation to avoid aspiration. Intracardiac echocardiography is costly and has inherent risks. Both lengthen the procedure. The Amplatzer PFO Occluder (AGA Medical Corporation, Golden Valley, Minnesota) can be safely implanted without echocardiographic guidance. METHODS: A total of 620 patients (51 +/- 12 years; 66% male) underwent PFO closure using the Amplatzer PFO Occluder for secondary prevention of presumed paradoxical embolism. Based on size and mobility of the PFO and the interatrial septum, an 18-mm device was used in 50 patients, a 25-mm device in 492, and a 35-mm device in 78. RESULTS: All procedures were successful, with 5 procedural complications (0.8%): 4 arteriovenous fistulae requiring elective surgical correction, and 1 transient ischemic attack. Contrast transesophageal echocardiography at 6 months showed complete closure in 91% of patients, whereas a minimal, moderate, or large residual shunt persisted in 6%, 2%, and 1%, respectively. During a mean follow-up period of 3.0 +/- 1.9 years (median: 2.6 years; total patient-years: 1,871), 5 ischemic strokes, 8 transient ischemic attacks, and no peripheral emboli were reported. Freedom from recurrent ischemic stroke, transient ischemic attack, or peripheral embolism was 99% at 1 year, 99% at 2 years, and 97% at 5 years. CONCLUSIONS: The Amplatzer PFO Occluder affords excellent safety and long-term clinical efficacy of percutaneous PFO closure without intraprocedural echocardiography.

Percutaneous left-ventricular support with the Impella-2.5-assist device in acute cardiogenic shock: results of the Impella-EUROSHOCK-registry

BACKGROUND Acute cardiogenic shock after myocardial infarction is associated with high in-hospital mortality attributable to persisting low-cardiac output. The Impella-EUROSHOCK-registry evaluates the safety and efficacy of the Impella-2.5-percutaneous left-ventricular assist device in patients with cardiogenic shock after acute myocardial infarction. METHODS AND RESULTS This multicenter registry retrospectively included 120 patients (63.6±12.2 years; 81.7% male) with cardiogenic shock from acute myocardial infarction receiving temporary circulatory support with the Impella-2.5-percutaneous left-ventricular assist device. The primary end point evaluated mortality at 30 days. The secondary end point analyzed the change of plasma lactate after the institution of hemodynamic support, and the rate of early major adverse cardiac and cerebrovascular events as well as long-term survival. Thirty-day mortality was 64.2% in the study population. After Impella-2.5-percutaneous left-ventricular assist device implantation, lactate levels decreased from 5.8±5.0 mmol/L to 4.7±5.4 mmol/L (P=0.28) and 2.5±2.6 mmol/L (P=0.023) at 24 and 48 hours, respectively. Early major adverse cardiac and cerebrovascular events were reported in 18 (15%) patients. Major bleeding at the vascular access site, hemolysis, and pericardial tamponade occurred in 34 (28.6%), 9 (7.5%), and 2 (1.7%) patients, respectively. The parameters of age >65 and lactate level >3.8 mmol/L at admission were identified as predictors of 30-day mortality. After 317±526 days of follow-up, survival was 28.3%. CONCLUSIONS In patients with acute cardiogenic shock from acute myocardial infarction, Impella 2.5-treatment is feasible and results in a reduction of lactate levels, suggesting improved organ perfusion. However, 30-day mortality remains high in these patients. This likely reflects the last-resort character of Impella-2.5-application in selected patients with a poor hemodynamic profile and a greater imminent risk of death. Carefully conducted randomized controlled trials are necessary to evaluate the efficacy of Impella-2.5-support in this high-risk patient group.

Novel prototype sewing device, EndoSew ® , for minimally invasive surgery: an extracorporeal ileal conduit construction pilot study in 10 patients

What's known on the subject? and What does the study add? The EndoSew® prototype was first tested in a porcine model several years ago. The investigators found it both simple to master and reliable, its greatest advantage being a 2.4-fold time saving compared with straight laparoscopic suturing. In addition to that publication, there is a single case report describing the performance of an open EndoSew® suture to close parts (16 cm) of an ileal neobladder. The time for suturing the 16 cm ileum was 25 min, which is in line with our experience. The knowledge on this subject is limited to these two publications. We report on the first consecutive series of ileal conduits performed in humans using the novel prototype sewing device EndoSew®. The study shows that the beginning and the end of the suture process represent the critical procedural steps. It also shows that, overall, the prototype sewing machine has the potential to facilitate the intracorporeal suturing required in reconstructive urology for construction of urinary diversions. Objective To evaluate the feasibility and safety of the novel prototype sewing device EndoSew® in placing an extracorporeal resorbable running suture for ileal conduits. Patients and Methods We conducted a prospective single-centre pilot study of 10 consecutive patients undergoing ileal conduit, in whom the proximal end of the ileal conduit was closed extracorporeally using an EndoSew® running suture. The primary endpoint was the safety of the device and the feasibility of the sewing procedure which was defined as a complete watertight running suture line accomplished by EndoSew® only. Watertightness was assessed using methylene blue intraoperatively and by loopography on postoperative days 7 and 14. Secondary endpoints were the time requirements and complications ≤30 days after surgery. Results A complete EndoSew® running suture was feasible in nine patients; the suture had to be abandoned in one patient because of mechanical failure. In three patients, two additional single freehand stitches were needed to anchor the thread and to seal tiny leaks. Consequently, all suture lines in 6/10 patients were watertight with EndoSew® suturing alone and in 10/10 patients after additional freehand stitches. The median (range) sewing time was 5.5 (3–10) min and the median (range) suture length was 4.5 (2–5.5) cm. There were no suture-related complications. Conclusions The EndoSew® procedure is both feasible and safe. After additional freehand stitches in four patients all sutures were watertight. With further technical refinements, EndoSew® has the potential to facilitate the intracorporeal construction of urinary diversions.

First Clinical Experience With Celt ACD(®) : A Femoral Arterial Puncture Closure Device

Introduction This prospective nonrandomized study compared the safety and efficacy of a novel arterial closure device (ACD) in common femoral artery procedures to that of the FDA submitted historical manual pressure control group, who underwent either a diagnostic angiogram (DA) or a percutaneous coronary intervention (PCI) procedure. Methods and Results A total of 55 patients were enrolled in this study of the novel ACD. Of the 55 patients, 39 were enrolled in the DA group and 16 were enrolled in the PCI group. Six patients were excluded. A device was deployed in 49 patients. Time to hemostasis (TTH), time to ambulation (TTA), device function, and device-related vascular complications were measured. In the device group, the TTH for the combined DA and PCI patients was 32 seconds (0.54 ± 0.93 minutes), significantly lower when compared with 16.0 ± 12.2 minutes (P < 0.0001) for the control group. Overall major vascular complication rate did not differ significantly, device group (1/49) and the historical control group (1/217). TTA in the combined PCI and DA device group was 226.4 ± 231.9 at the German site (site ambulation policy). In the Irish site, the average TTA in the PCI group was 187 minutes (n = 8) and 85 minutes (n = 14) in the DA group. Conclusion The Celt ACD® device is safe, effective, and significantly decreases the TTH compared to manual pressure and has a low vascular complications rate. The device may be effective in early ambulation and discharge of patients postcoronary intervention procedures.

Middle managers' attitudes toward employee assistance programs in the corporate setting

Several studies have shown that successful Employee Assistance Programs (EAPs) have strong management endorsement. Strong management endorsement is defined as positive support in utilizing EAP services for themselves and their employees. This study focuses solely on middle management as opposed to upper or general management support. The study further examines success or lack of success of an EAP by the utilization rate defined as the number of employees over a year period who access EAP services.^ A analytical cross-sectional design was used to compare and observe differences between two groups of middle managers (utilizers and nonutilizers). Middle manager data was collected through a mail questionnaire. The study focused on identifying predictors that influence middle managers' utilization rate specifically: attitude toward EAPs, EAP knowledge level, attitude toward mental health professionals, age, gender, years worked as a middle manager, education level, training, and other possible predictors of utilization. The overall hypothesis states middle manager utilizers of EAP services have more positive attitudes and a better understanding of their EAP than middle management nonutilizers.^ As predicted, nonparametric bivariate results showed significant differences between the two groups. Middle managers in the utilization group (n = 473) tended to show more positive attitudes toward their EAP and mental health professionals and demonstrated greater EAP knowledge compared to the nonutilization group (n = 154). These findings support past studies on variables that influence EAP utilization rates.^ Further variables found to influence middle management utilization were identified by multivariate logistic regression results. These variable were gender (female supervisors), educational levels of employees supervised (employees with lower levels of education), number of employees supervised (greater the number supervised, more likely to utilize), managerial EAP training (trained supervisors) and awareness that problems do influence an employee's productivity.^ These findings strengthen the assertion that middle management's attitudes, as well as other variables may influence utilization. Study findings add new information about important variables specifically influencing middle management who utilize EAPs. An understanding of these variables is essential in developing competent EAP program training and orientation programs for middle managers. ^

Managing the risks of medical technology: Do hazard surveillance systems provide an early warning of medical device problems?

The Food and Drug Administration (FDA) is responsible for risk assessment and risk management in the post-market surveillance of the U.S. medical device industry. One of the FDA regulatory mechanisms, the Medical Device Reporting System (MDR) is an adverse event reporting system intended to provide the FDA with advance warning of device problems. It includes voluntary reporting for individuals, and mandatory reporting for device manufacturers. ^ In a study of alleged breast implant safety problems, this research examines the organizational processes by which the FDA gathers data on adverse events and uses adverse event reporting systems to assess and manage risk. The research reviews the literature on problem recognition, risk perception, and organizational learning to understand the influence highly publicized events may have on adverse event reporting. Understanding the influence of an environmental factor, such as publicity, on adverse event reporting can provide insight into the question of whether the FDA's adverse event reporting system operates as an early warning system for medical device problems. ^ The research focuses on two main questions. The first question addresses the relationship between publicity and the voluntary and mandatory reporting of adverse events. The second question examines whether government agencies make use of these adverse event reports. ^ Using quantitative and qualitative methods, a longitudinal study was conducted of the number and content of adverse event reports regarding breast implants filed with the FDA's medical device reporting system during 1985–1991. To assess variation in publicity over time, the print media were analyzed to identify articles related to breast implant failures. ^ The exploratory findings suggest that an increase in media activity is related to an increase in voluntary reporting, especially following periods of intense media coverage of the FDA. However, a similar relationship was not found between media activity and manufacturers' mandatory adverse event reporting. A review of government committee and agency reports on the FDA published during 1976–1996 produced little evidence to suggest that publicity or MDR information contributed to problem recognition, agenda setting, or the formulation of policy recommendations. ^ The research findings suggest that the reporting of breast implant problems to FDA may reflect the perceptions and concerns of the reporting groups, a barometer of the volume and content of media attention. ^

Team training to establish a safety culture in dialysis access surgery.

Operating room (OR) team safety training and learning in the field of dialysis access is well suited for the use of simulators, simulated case learning and root cause analysis of adverse outcomes. The objectives of OR team training are to improve communication and leadership skills, to use checklists and to prevent errors. Other objectives are to promote a change in the attitudes towards vascular access from learning through mistakes in a nonpunitive environment, to positively impact the employee performance and to increase staff retention by making the workplace safer, more efficient and user friendly.

Comparative Effectiveness and Safety of New-Generation Versus Early-Generation Drug-Eluting Stents According to Complexity of Coronary Artery Disease: A Patient-Level Pooled Analysis of 6,081 Patients.

OBJECTIVES The purpose of this study was to compare the 2-year safety and effectiveness of new- versus early-generation drug-eluting stents (DES) according to the severity of coronary artery disease (CAD) as assessed by the SYNTAX (Synergy between Percutaneous Coronary Intervention with Taxus and Cardiac Surgery) score. BACKGROUND New-generation DES are considered the standard-of-care in patients with CAD undergoing percutaneous coronary intervention. However, there are few data investigating the effects of new- over early-generation DES according to the anatomic complexity of CAD. METHODS Patient-level data from 4 contemporary, all-comers trials were pooled. The primary device-oriented clinical endpoint was the composite of cardiac death, myocardial infarction, or ischemia-driven target-lesion revascularization (TLR). The principal effectiveness and safety endpoints were TLR and definite stent thrombosis (ST), respectively. Adjusted hazard ratios (HRs) with 95% confidence intervals (CIs) were calculated at 2 years for overall comparisons, as well as stratified for patients with lower (SYNTAX score ≤11) and higher complexity (SYNTAX score >11). RESULTS A total of 6,081 patients were included in the study. New-generation DES (n = 4,554) compared with early-generation DES (n = 1,527) reduced the primary endpoint (HR: 0.75 [95% CI: 0.63 to 0.89]; p = 0.001) without interaction (p = 0.219) between patients with lower (HR: 0.86 [95% CI: 0.64 to 1.16]; p = 0.322) versus higher CAD complexity (HR: 0.68 [95% CI: 0.54 to 0.85]; p = 0.001). In patients with SYNTAX score >11, new-generation DES significantly reduced TLR (HR: 0.36 [95% CI: 0.26 to 0.51]; p < 0.001) and definite ST (HR: 0.28 [95% CI: 0.15 to 0.55]; p < 0.001) to a greater extent than in the low-complexity group (TLR pint = 0.059; ST pint = 0.013). New-generation DES decreased the risk of cardiac mortality in patients with SYNTAX score >11 (HR: 0.45 [95% CI: 0.27 to 0.76]; p = 0.003) but not in patients with SYNTAX score ≤11 (pint = 0.042). CONCLUSIONS New-generation DES improve clinical outcomes compared with early-generation DES, with a greater safety and effectiveness in patients with SYNTAX score >11.

Taking up national safety alerts to improve patient safety in hospitals: The perspective of healthcare quality and risk managers.

BACKGROUND National safety alert systems publish relevant information to improve patient safety in hospitals. However, the information has to be transformed into local action to have an effect on patient safety. We studied three research questions: How do Swiss healthcare quality and risk managers (qm/rm(1)) see their own role in learning from safety alerts issued by the Swiss national voluntary reporting and analysis system? What are their attitudes towards and evaluations of the alerts, and which types of improvement actions were fostered by the safety alerts? METHODS A survey was developed and applied to Swiss healthcare risk and quality managers, with a response rate of 39 % (n=116). Descriptive statistics are presented. RESULTS The qm/rm disseminate and communicate with a broad variety of professional groups about the alerts. While most respondents felt that they should know the alerts and their contents, only a part of them felt responsible for driving organizational change based on the recommendations. However, most respondents used safety alerts to back up their own patient safety goals. The alerts were evaluated positively on various dimensions such as usefulness and were considered as standards of good practice by the majority of the respondents. A range of organizational responses was applied, with disseminating information being the most common. An active role is related to using safety alerts for backing up own patient safety goals. CONCLUSIONS To support an active role of qm/rm in their hospital's learning from safety alerts, appropriate organizational structures should be developed. Furthermore, they could be given special information or training to act as an information hub on the issues discussed in the alerts.

Unintended pregnancy: Attitudes toward contraception of women obtaining abortions

Forty-nine percent of pregnancies in the United States are unintended and significant numbers of pregnancies are unintended for women of all ages. One possible reason for the high rate is that while 85% of women at risk for an unintended pregnancy use contraception, negative attitudes about the method used make them poor contraceptors. Negative attitudes may prevent the remaining 15% of women from using any method of birth control. This study examined adult women's attitudes toward contraception and its use to see if attitudes correlate with unintended pregnancy. ^ To obtain a sample of women experiencing unintended pregnancies, women obtaining therapeutic abortions were surveyed since almost all women obtaining therapeutic abortions are experiencing an unintended pregnancy. The study used a cross-sectional survey design and included 312 women obtaining abortions at the Planned Parenthood Surgical Services Clinic in Houston in the latter half of 1999. ^ The responses revealed a lack of knowledge about the safety and effectiveness of contraception, particularly for methods other than oral contraceptives and condoms. Thirty-four percent of the participants were uncomfortable buying contraception. While 71% of the participants said their physician recommended their use of contraception, 17% were unsure and 35% did not talk to their physician about contraception on a regular basis. ^ The attitudes of women using contraception were compared with those not using contraception and many differences were seen. Women not using contraception responded with more ‘unsure’ answers and believed contraception was more difficult to use. They felt planning ahead for the use of contraception interfered with the enjoyment of sex (p-value = 0.06). They were less likely to use contraception if their partner disapproved (p-value = 0.01) and more of them believed their church disapproved of contraception (p-value = 0.02). In comparison, women using contraception had negative attitudes about the safety of the pill (p-values = 0.01–0.08) and the effectiveness of the condom (p-value = 0.04). Therefore, the negative attitudes women using contraception had about contraception may interfere with their effective use of birth control. Those not using contraception were found to hold attitudes that may contribute to their non-use of contraception. ^

Effects of congressional modernization laws on public access to innovative medical device technologies

The Federal Food and Drug Administration (FDA) and the Centers for Medicare and Medicaid (CMS) play key roles in making Class III, medical devices available to the public, and they are required by law to meet statutory deadlines for applications under review. Historically, both agencies have failed to meet their respective statutory requirements. Since these failures affect patient access and may adversely impact public health, Congress has enacted several “modernization” laws. However, the effectiveness of these modernization laws has not been adequately studied or established for Class III medical devices. ^ The aim of this research study was, therefore, to analyze how these modernization laws may have affected public access to medical devices. Two questions were addressed: (1) How have the FDA modernization laws affected the time to approval for medical device premarket approval applications (PMAs)? (2) How has the CMS modernization law affected the time to approval for national coverage decisions (NCDs)? The data for this research study were collected from publicly available databases for the period January 1, 1995, through December 31, 2008. These dates were selected to ensure that a sufficient period of time was captured to measure pre- and post-modernization effects on time to approval. All records containing original PMAs were obtained from the FDA database, and all records containing NCDs were obtained from the CMS database. Source documents, including FDA premarket approval letters and CMS national coverage decision memoranda, were reviewed to obtain additional data not found in the search results. Analyses were conducted to determine the effects of the pre- and post-modernization laws on time to approval. Secondary analyses of FDA subcategories were conducted to uncover any causal factors that might explain differences in time to approval and to compare with the primary trends. The primary analysis showed that the FDA modernization laws of 1997 and 2002 initially reduced PMA time to approval; after the 2002 modernization law, the time to approval began increasing and continued to increase through December 2008. The non-combined, subcategory approval trends were similar to the primary analysis trends. The combined, subcategory analysis showed no clear trends with the exception of non-implantable devices, for which time to approval trended down after 1997. The CMS modernization law of 2003 reduced NCD time to approval, a trend that continued through December 2008. This study also showed that approximately 86% of PMA devices do not receive NCDs. ^ As a result of this research study, recommendations are offered to help resolve statutory non-compliance and access issues, as follows: (1) Authorities should examine underlying causal factors for the observed trends; (2) Process improvements should be made to better coordinate FDA and CMS activities to include sharing data, reducing duplication, and establishing clear criteria for “safe and effective” and “reasonable and necessary”; (3) A common identifier should be established to allow tracking and trending of applications between FDA and CMS databases; (4) Statutory requirements may need to be revised; and (5) An investigation should be undertaken to determine why NCDs are not issued for the majority of PMAs. Any process improvements should be made without creating additional safety risks and adversely impacting public health. Finally, additional studies are needed to fully characterize and better understand the trends identified in this research study.^

Survey analysis on dental infection control & occupational safety from India---1999 & 2010

The objective was to study knowledge, attitudes, practice (KAP) and needs regarding infection control measures using two cross-sectional surveys from 1999 and 2010 conducted in India. Both data collection instruments had only about 35 comparable variables in common. In 1999, there were 456 respondents (dentists) who completed a self-administered survey instrument compared to 272 respondents in 2010. Both the 1999 and 2010 samples were mutually independent with no overlap, had regional differences, and therefore, were not completely comparable for changes in KAP over time. While almost all respondents from both surveys felt that education in dental safety was needed and wanted mandatory dental safety curriculum in dental schools, severe inadequacies in dental safety knowledge, protection against immunizable diseases, and practice of universal precaution were noted. Data from the study demonstrated that there is a substantial opportunity to improve the knowledge, attitude and practice of dental infection control and occupational safety in India. Few respondents (27%) reported that the infectious disease status of a patient is always known and a significant number reported that they had the right to refuse care for patients of known infectious disease status. This indicates that Stigma in treating HIV/AIDS patients remains a concern, which in turn suggests that a stronger focus on educating dentists about dental safety and on stigma and infectious disease is needed. Information obtained from this study could be utilized for developing policies oriented towards increasing dental safety educational efforts, in both dental schools as curriculum, and for practicing dentists through professional updates or continuing dental education.^

Teaching safety at a summer camp: Evaluation of a children's fire safety curriculum in an urban community setting

Objectives: The purpose of this study was to evaluate the effectiveness of the Danger Rangers Fire Safety Curriculum in increasing the fire safety knowledge of low-income, minority children in pre-kindergarten to third grade in Austin, TX during a summer day camp in 2007.^ Methods: Data was collected from child participants via teacher and researcher administered tests at pretest, posttest (immediately after the completion of the fire safety module), and at a 3 week follow-up to asses retention. In addition, a self-administered questionnaire was collected from parents pre- and post-intervention to assess home-related fire/burn risk factors. Paired t-tests were conducted using STATA 12.0 to evaluate pretest, posttest, and retention test mean scores as well as mean fire safety rules listed by grade group. McNemar's test was used to determine if there was a difference in fire-related risk factors as reported by the parents of the participants before and after the intervention. Only those who had paired data for the tests/surveys being compared were included in the analysis.^ Results: The first/second grade group and the third grade group scored significantly higher on fire safety knowledge on the posttest compared to the pretest (p<0.0001 for both groups). However, there was no significant change in knowledge scores for the pre-kindergarten to kindergarten group (p=0.14). Among the first/second grade group, knowledge levels did not significantly decline between the posttest and retention test (p=0.25). However, the third grade group had significantly lower fire safety knowledge scores on the retention test compared to the posttest (p<0.001). A similar increase was seen in the amount of fire safety rules listed after the intervention (p<0.0001 between pre and posttest for both the first/second grade and third grade groups), with no decline from the posttest to the retention test (p=0.50) for the first/second grade group, but a significant decline in the third grade group (p=0.001). McNemar's chi-square test showed a significant increase in the percentage of participants' parents reporting smoke detector testing on a regular basis and having a fire escape plan for their family after the intervention (p=0.01 and p<0.0001, respectively). However, there was no significant change in the frequency of reports of the child playing in the kitchen while the parent cooks or the house/apartment having a working smoke detector.^ Conclusion: We found that general fire safety knowledge improved and the number of specific fire safety rules increased among the first to third grade children who participated in the Danger Rangers fire safety program. However, it did not significantly increase general fire safety knowledge among the pre-k/k group. This study also showed that a program targeted towards children has the potential to influence familial risk factors by proxy. The Danger Rangers Fire Safety Curriculum should be further evaluated by conducting a randomized controlled trial, using valid measures that assess fire safety attitudes, beliefs, behaviors, as well as fire/burn related outcomes.^