***TASK*** the task is to summarize an input biomedical literature in six sentences 
    ***INPUT*** the input is a biomedical literature 
    ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences 
    ***DOCUMENTATION*** 
    ***EXAMPLES*** 
    Input: BACKGROUND Post-market medical product safety surveillance is a complex task requiring st and ardized data collection , prompt adverse event reporting mechanisms and appropriate method ologies to identify low frequency safety threats and risk communication . PURPOSE To review the design of the DELTA ( Data Extraction and Longitudinal Trend Analysis ) network study of the medical device safety surveillance . METHODS This is a multicenter prospect i ve observational study design ed to evaluate the  safety  of new cardiovascular devices used during percutaneous coronary intervention ( PCI ) performed through continuous analysis of the routinely collected American College of Cardiology-National Cardiovascular Data Registry ( ACC-NCDR ) data elements . The primary endpoint of the study is detection of adverse event rates specific to several classes of new medical devices , including drug eluting coronary stents , embolic protection devices , and vascular closure devices in patients undergoing PCI . Secondary endpoints include the time-savings between the DELTA network detection of a true device safety alert and the time taken to detect the same outcome using conventional retrospective data analysis , overall sensitivity , specificity , positive predictive value and negative predictive value of the DELTA network surveillance system . RESULTS The details of the study are described including system design , eligibility criteria , methods and components of data collection , data security and statistical methods . In addition , the methods of adjudication and verification following an adverse event alert , overall study outcomes , end points , limitations and potential advantages are discussed . CONCLUSION This report describes the first multicenter prospect i ve study of a computerized safety surveillance system to monitor and evaluate the safety of new cardiovascular devices OBJECTIVE To investigate physicians ' knowledge about evidence -based patient safety practice s , their attitudes on preventing and managing medical errors and to explore physicians ' behavior when facing medical errors . DESIGN A nationwide cross-sectional survey . SETTING We first stratified our population by the 20 Italian regions . Then , within each stratum , we selected by simple r and om sampling , for each region , one regional general hospital and one district general hospital to yield a sample of 40 hospitals overall . PARTICIPANTS Twelve hundred physicians involved in direct patient care ( 30 per hospital ) were sent a survey by mail and 696 responded . MAIN OUTCOME MEASURES Knowledge on patient safety practice s , attitudes and practice s toward the prevention of medical errors . RESULTS Physicians ' knowledge of evidence -based safety practice s was inconsistent . More than 90 % of physicians reported that counting surgical items during an invasive surgical procedure represented a patient safety practice . Positive attitudes about patient safety were revealed by responses , but 44.5 and 44.1 % , respectively , agreed or were uncertain about the disclosure of errors to the patients . The pattern of behavior showed that 7.6 % of physicians reported to have never been involved in medical errors , and among system failures , ' overwork , stress or fatigue of health professionals ' was the most highly rated item . CONCLUSIONS The results from our study highlight that greater efforts are needed to facilitate the translation of positive attitudes towards patient safety into appropriate practice s that have proven to be effective in the reduction of medical errors Background : A limited framework of incident reporting exists in most of the health care system in Pakistan . This poses a risk to the patient population and therefore there is a need to find the causes behind the lack of such a system in healthcare setting s in Pakistan . Aims : To determine the attitudes and perceived barriers towards incident reporting among tertiary care health professionals in Pakistan Material s and Methods : The study was done in Shifa International Hospitals and consisted of a question naire given to 217 r and omly selected doctors and nurses . Mean ± SD of continuous variables and frequency ( percentage % ) of categorical variables are presented . Chi square statistical analysis was used to test the significance of association among doctors and nurses with various outcome variables ( motivators to report , perceived barriers , preferred person to report and patient 's outcome that influence reporting behaviors ) . P value of < 0.05 was considered significant . Student doctors and student nurses were not included in the study . Results : Unlike consultant , registrars , medical officers and nurses ( more than 95 % are willing to report ) , only 20 % of house officers will report the incident happened through them . Sixty nine percent of doctors and 67 % of nurses perceive ‘ administration sanction ’ as a common barrier to incident reporting . Sixty percent of doctors and 80 % of nurses would prefer reporting to the head of the department . Conclusions : By giving immunity from administrative sanction , providing prompt feedback and assurance that the incident reporting will be used to make changes in the system , there is considerable willingness of doctors and nurses to take time out of their busy schedules to su bmi t reports BACKGROUND : Although anesthesiologists are leaders in patient safety , there has been little research on factors affecting their reporting of adverse events and errors . First , we explored the attitudinal/emotional factors influencing reporting of an unspecified adverse event caused by error . Second , we used a between-groups study design to ask whether there are different perceived barriers to reporting a case of anaphylaxis caused by an error compared with anaphylaxis not caused by error . Finally , we examined strategies that anesthesiologists believe would facilitate reporting . Where possible , we contrasted our results with published findings from other physician groups . METHODS : An anonymous , self-administered , mailed survey was conducted of 629 consultant anesthesiologists and 263 anesthesiology residents on the mailing list of the Australian and New Zeal and College of Anaesthetists in Victoria , Australia . Participants were r and omized into  “ Error ” versus “ No Error ” groups for the specified anaphylaxis adverse event section of the survey . Data were analyzed using nonparametric descriptive and inferential tests . RESULTS : There were 433 usable returned surveys , a usable response rate of 49 % . First , there was only 1 of 13 statements on attitudinal/emotional factors that influenced reporting of an unspecified adverse event caused by error with which more anesthesiologists agreed/strongly agreed than disagreed/strongly disagreed : “ Doctors who make errors are blamed by their colleagues . ” Second , when an error rather than no error had caused anaphylaxis , participants were more likely to agree/strongly agree that 6 statements about litigation , getting into trouble , disciplinary action , being blamed , unsupportive colleagues , and not wanting the case discussed in meetings , were perceived as reporting barriers . Finally , the most favored assistive strategies for reporting were generalized deidentified feedback about adverse event and error reports , role models such as senior colleagues who openly encourage reporting , and legislated protection of reports from legal discoverability . CONCLUSION : The majority of anesthesiologists in our study did not agree that the attitudinal/emotional barriers surveyed would influence reporting of an unspecified adverse event caused by error , with the exception of the barrier of being concerned about blame by colleagues . The probable influence of 6 perceived barriers to reporting a specified adverse event of anaphylaxis differed with the presence or absence of error . Anesthesiologists in our study supported assistive reporting strategies . There seem to be some differences between our results and previously published research for other physician groups Objectives : To assess the effectiveness of an intervention package comprising intense education , a range of reporting options , changes in report management and enhanced feedback , in order to improve incident-reporting rates and change the types of incidents reported . Design , setting and participants : Non-equivalent group controlled clinical trial involving medical and nursing staff working in 10 intervention and 10 control units in four major cities and two regional hospitals in South Australia . Main outcome measures : Comparison of reporting rates by type of unit , profession , location of hospital , type of incident reported and reporting mechanism between baseline and study periods in control and intervention units . Results : The intervention result ed in significant improvement in reporting in inpatient areas ( additional 60.3 reports/10 000 occupied bed days ( OBDs ) ; 95 % CI 23.8 to 96.8 , p<0.001 ) and in emergency departments ( EDs ) ( additional 39.5 reports/10 000 ED attendances ; 95 % CI 17.0 to 62.0 , p<0.001 ) . More reports were generated ( a ) by doctors in EDs ( additional 9.5 reports/10 000 ED attendances ; 95 % CI 2.2 to 16.8 , p = 0.001 ) ; ( b ) by nurses in inpatient areas ( additional 59.0 reports/10 000 OBDs ; 95 % CI 23.9 to 94.1 , p<0.001 ) and ( c ) anonymously ( additional 20.2 reports/10 000 OBDs and ED attendances combined ; 95 % CI 12.6 to 27.8 , p<0.001 ) . Compared with control units , the study result ed in more documentation , clinical management and aggression-related incidents in intervention units . In intervention units , more reports were su bmi tted on one-page forms than via the call centre ( 1005 vs 264 reports , respectively ) . Conclusions : A greater variety and number of incidents were reported by the intervention units during the study , with improved reporting by doctors from a low baseline . However , there was considerable heterogeneity between reporting rates in different types of units BACKGROUND Little is known of the factors that underlie surgical errors . Incident reporting has been proposed as a method of obtaining information about medical errors to help identify such factors . METHODS Between November 1 , 2000 , and March 15 , 2001 , we conducted confidential interviews with r and omly selected surgeons from three Massachusetts teaching hospitals to elicit detailed reports on surgical adverse events result ing from errors in management ( " incidents " ) . Data on the characteristics of the incidents and the factors that surgeons reported to have contributed to the errors were recorded and analyzed . RESULTS Among 45 surgeons approached for interviews , 38 ( 84 % ) agreed to participate and provided reports on 146 incidents . Thirty-three percent of incidents result ed in permanent disability and 13 % in patient death . Seventy-seven percent involved injuries related to an operation or other invasive intervention ( visceral injuries , bleeding , and wound infection/dehiscence were the most common subtypes ) , 13 % involved unnecessary or inappropriate procedures , and 10 % involved unnecessary advancement of disease . Two thirds of the incidents involved errors during the intraoperative phase of surgical care , 27 % during preoperative management , and 22 % during postoperative management . Two or more clinicians were cited as substantially contributing to errors in 70 % of the incidents . The most commonly cited systems factors contributing to errors were inexperience/lack of competence in a surgical task ( 53 % of incidents ) , communication breakdowns among personnel ( 43 % ) , and fatigue or excessive workload ( 33 % ) . Surgeons reported significantly more systems failures in incidents involving emergency surgical care than those involving nonemergency care ( P < .001 ) . CONCLUSIONS Subjective incident reports gathered through interviews allow identification of characteristics of surgical errors and their leading contributing factors , which may help target research and interventions to reduce such errors OBJECTIVES We aim ed to investigate experiences of , and responses to , medical error amongst junior doctors and to examine the challenges junior doctors face and the support they receive . METHODS We carried out a qualitative study of 38 r and omly selected pre- registration house officers ( PRHOs ) in 10 hospitals . All 38 had graduated in 2000 or 2001 from a single medical school . RESULTS Errors were common and sometimes serious . In relation to disclosure and learning from error , four main themes emerged : a norm of selective disclosure ; the effects of the team ; individualised blame and responsibility , and the ' learning moment ' . Trainees reported disclosing errors informally , particularly when teams were seen as supportive , but were reluctant to criticize colleagues . Formal reports and disclosure to patients were very rare . Patient care was compromised when juniors did not access senior help , often when working outside their usual team environment . Lack of cooperation between teams and poor continuity of care also contributed to errors . Learning was maximised when errors were formally discussed and constructive feedback offered . However , both blame and the prioritization of reassurance over learning and structured feedback appeared to inhibit reflection on the experience of error . CONCLUSIONS Junior doctors need help to reflect on their experiences and to recognise where they may have made mistakes , particularly in the context s of shift-work and fragmented teams . Formal reporting systems alone will not facilitate learning from error . Juniors require individual clinical supervision from seniors with appropriate training . Such expertise may benefit the whole team and the training environment Background Non-drug technologies offer many benefits , but have been associated with adverse events , prompting calls for improved postmarket surveillance . There is little empirical research to guide the development of such a system . The purpose of this study was to identify optimal postmarket surveillance strategies for medical and surgical devices . Methods Qualitative methods were used for sampling , data collection and analysis . Stakeholders from Canada and the USA representing different roles and perspectives were first interviewed to identify examples and characteristics of different surveillance strategies . These stakeholders and others they recommended were then assembled at a 1-day nominal group meeting to discuss and prioritise the components of a postmarket device surveillance system , and research needed to achieve such a system . Results Consultations were held with 37 participants , and 47 participants attended the 1-day meeting . They recommended a multicomponent system including reporting by facilities , clinicians and patients , supported with some external surveillance for validation and real-time trials for high-risk devices . Many considerations were identified that constitute desirable characteristics of , and means by which to implement such a system . An overarching network was envisioned to broker linkages , establish a shared minimum data set , and support communication and decision making . Numerous research questions were identified , which could be pursued in t and em with phased implementation of the system . Discussion These findings provide unique guidance for establishing a device safety network that is based on existing initi 
    Output:
    
The study findings indicate that fear of punishment , uncertainty of what should be reported and how incident reports will be used and time constraints to incident reporting are common barriers to incident recognition and reporting .
Strategies to improve error reporting include the use of an electronic error reporting system , increased training and feedback to frontline clinicians about the reported error .