Short Stature Screening by Accurate Length Measurement in Infants with a Birth Weight <9th Centile.

BACKGROUND/AIMS: Intrauterine growth restriction is an indication for growth hormone treatment. Birth length (BL) is needed to evaluate the influence of birth size on childhood short stature. However, BL is commonly measured only approximately, if at all. A single-centre study was undertaken to determine the value of measuring accurate and targeted BL and parental height (PH) for neonates with a birth weight (BW) ≤9th centile, identifying short [BL ≤-2 standard deviation scores (SDS)] and light newborns (BW ≤-2 SDS), and remeasuring short neonates at 2 years in order to detect those not showing catch-up growth. METHODS: Information was collected on all live births (n = 3,798) in a single maternity unit during a 1-year period. RESULTS: BW was ≤9th centile in 481 neonates (12.7%) of whom 47 were light but not short, 46 were short, and 60 were both light and short. Of 107 eligible infants, 57 (53%) attended the 2-year follow-up; failure of catch-up growth was identified in 6 infants (11%) of whom only 1 was already known to medical services. PH was measured in both parents of 52/153 (34%) light and/or short infants. CONCLUSION: Targeted and accurate BL measurement in newborns with a BW ≤9th centile is a promising alternative to the current practices. The feasibility of PH measurement after birth still requires further evaluation. © 2015 S. Karger AG, Basel.

The data extraction and longitudinal trend analysis network study of distributed automated postmarket cardiovascular device safety surveillance.

BACKGROUND: Current approaches for postmarket medical device safety surveillance are limited in their ability to produce timely and accurate assessments of adverse event rates. METHODS AND RESULTS: The Data Extraction and Longitudinal Trend Analysis (DELTA) network study was a multicenter prospective observational study designed to evaluate the safety of devices used during percutaneous coronary interventions. All adult patients undergoing percutaneous coronary intervention from January 2008 to December 2012 at 5 participating Massachusetts sites were included. A safety alert was triggered if the cumulative observed adverse event rates for the study device exceeded the upper 95% confidence interval of the event rates of propensity-matched control cohort. Prespecified sensitivity analyses were developed to validate any identified safety signal. A total of 23,805 consecutive percutaneous coronary intervention procedures were evaluated. Two of 24 safety analyses triggered safety alerts. Patients receiving Perclose vascular closure device experienced an increased risk of minor vascular complications (relative risk, 4.14; P<0.01) and any vascular complication (relative risk, 2.06; P=0.01) when compared with propensity-matched patients receiving alternative vascular closure device, a result primarily driven by relatively high event rates at 1 participating center. Sensitivity analyses based on alternative risk adjustment methods confirmed a pattern of increased rate of complications at 1 of the 5 participating sites in their use of Perclose vascular closure device. CONCLUSIONS: The DELTA network study demonstrates that distributed automated prospective safety surveillance has the potential of providing near real-time assessment of safety risks of newly approved medical devices.

Evaluation of an automated safety surveillance system using risk adjusted sequential probability ratio testing.

BACKGROUND: Automated adverse outcome surveillance tools and methods have potential utility in quality improvement and medical product surveillance activities. Their use for assessing hospital performance on the basis of patient outcomes has received little attention. We compared risk-adjusted sequential probability ratio testing (RA-SPRT) implemented in an automated tool to Massachusetts public reports of 30-day mortality after isolated coronary artery bypass graft surgery. METHODS: A total of 23,020 isolated adult coronary artery bypass surgery admissions performed in Massachusetts hospitals between January 1, 2002 and September 30, 2007 were retrospectively re-evaluated. The RA-SPRT method was implemented within an automated surveillance tool to identify hospital outliers in yearly increments. We used an overall type I error rate of 0.05, an overall type II error rate of 0.10, and a threshold that signaled if the odds of dying 30-days after surgery was at least twice than expected. Annual hospital outlier status, based on the state-reported classification, was considered the gold standard. An event was defined as at least one occurrence of a higher-than-expected hospital mortality rate during a given year. RESULTS: We examined a total of 83 hospital-year observations. The RA-SPRT method alerted 6 events among three hospitals for 30-day mortality compared with 5 events among two hospitals using the state public reports, yielding a sensitivity of 100% (5/5) and specificity of 98.8% (79/80). CONCLUSIONS: The automated RA-SPRT method performed well, detecting all of the true institutional outliers with a small false positive alerting rate. Such a system could provide confidential automated notification to local institutions in advance of public reporting providing opportunities for earlier quality improvement interventions.

An evaluation of a distributed medical device safety surveillance system: the DELTA network study.

BACKGROUND: Post-market medical product safety surveillance is a complex task requiring standardized data collection, prompt adverse event reporting mechanisms and appropriate methodologies 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 prospective observational study designed 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 prospective study of a computerized safety surveillance system to monitor and evaluate the safety of new cardiovascular devices.

Automated surveillance to detect postprocedure safety signals of approved cardiovascular devices.

CONTEXT: Ensuring the safety of medical devices challenges current surveillance approaches, which rely heavily on voluntary reporting of adverse events. Automated surveillance of clinical registries may provide early warnings in the postmarket evaluation of medical device safety. OBJECTIVE: To determine whether automated safety surveillance of clinical registries using a computerized tool can provide early warnings regarding the safety of new cardiovascular devices. DESIGN, SETTING, AND PATIENTS: Prospective propensity-matched cohort analysis of 7 newly introduced cardiovascular devices, using clinical data captured in the Massachusetts implementation of the National Cardiovascular Data Repository CathPCI Registry for all adult patients undergoing percutaneous coronary intervention from April 2003 through September 2007 in Massachusetts. MAIN OUTCOME MEASURE: Presence of any safety alert, triggered if the cumulative observed risk for a given device exceeded the upper 95% confidence interval (CI) of comparator control device. Predefined sensitivity analyses assessed robustness of alerts when triggered. RESULTS: We evaluated 74,427 consecutive interventional coronary procedures. Three of 21 safety analyses triggered sustained alerts in 2 implantable devices. Patients receiving Taxus Express2 drug-eluting stents experienced a 1.28-fold increased risk of postprocedural myocardial infarction (2.87% vs 2.25%; absolute risk increase, 0.62% [95% CI, 0.25%-0.99%]) and a 1.21-fold increased risk of major adverse cardiac events (4.24% vs 3.50%; absolute increase, 0.74% [95% CI, 0.29%-1.19%]) compared with those receiving alternative drug-eluting stents. Patients receiving Angio-Seal STS vascular closure devices experienced a 1.51-fold increased risk of major vascular complications (1.09% vs 0.72%; absolute increased risk, 0.37% [95% CI, 0.03%-0.71%]) compared with those receiving alternative vascular closure devices. Sensitivity analyses confirmed increased risk following use of the Taxus Express2 stent but not the Angio-Seal STS device. CONCLUSION: Automated prospective surveillance of clinical registries is feasible and can identify low-frequency safety signals for new cardiovascular devices.

Validation of long-term benefits of bivalirudin versus unfractionated heparin in routine clinical practice after percutaneous coronary intervention.

Randomized controlled trials have shown improved short-term bleeding outcomes for bivalirudin compared to unfractionated heparin (UFH) in patients undergoing percutaneous coronary intervention (PCI) for stable angina and acute coronary syndrome. This study analyzed the impact of bivalirudin-based anticoagulation strategy versus UFH-based anticoagulation strategy on long-term bleeding complications and major adverse cardiac events in patients undergoing PCI in routine clinical practice. From September 2005 to April 2009, 3,367 consecutive patients who underwent PCI for stable angina or non-ST-segment elevation acute coronary syndrome at Brigham and Women's Hospital were studied. Of these patients, 2,228 patients (66%) received UFH and 1,139 (34%) received bivalirudin. Bleeding complication and major adverse cardiac event rates were compared at discharge, 30 days, and 1 year. In a propensity-score matched analysis, bivalirudin-based anticoagulation strategy was associated with lower bleeding complications at 30 days (7.0% vs 13.7%, p = 0.001) and 1 year (12.7% vs 18.9%, p = 0.013). Major adverse cardiac event rates were not significantly different between groups at discharge, 30 days, and 1 year (6.4% vs 8.3%, p = 0.103; 9.4% vs 10.9%, p = 0.449; 12.1% vs 14.8%, p = 0.235, respectively). There was no difference in all-cause mortality rates between the 2 groups (0.9% vs 0.8%, p = 0.808, at discharge; 1.9% vs 3.6%, p = 0.112, at 30 days; 3.6% vs 5.5%, p = 0.195, at 1 year). In conclusion, in a real-world cohort of patients undergoing PCI, bivalirudin-based anticoagulation strategy is associated with a significant decrease in risk of bleeding complications after 30 days and 1 year compared to a UFH-based anticoagulation strategy with no increase in risk for major adverse cardiac events.

Setting up a training course to improve care for burn and plastic surgery patients.

The National Burn Care Review recommended that the care of all inpatient burn injuries should be provided by specialists trained in burn care. This article outlines an initiative by The Newcastle Upon Tyne Hospitals Foundation Trust to deliver a university accredited course for practitioners in its burn service.

Use of a personal digital assistant for managing antibiotic prescribing for outpatient respiratory tract infections in rural communities.

OBJECTIVE: To assess the acceptability and usage of a standalone personal digital assistant (PDA)-based clinical decision-support system (CDSS) for the diagnosis and management of acute respiratory tract infections (RTIs) in the outpatient setting. DESIGN: Observational study performed as part of a larger randomized trial in six rural communities in Utah and Idaho from January 2002 to March 2004. Ninety-nine primary care providers received a PDA-based CDSS for use at the point-of-care, and were asked to use the tool with at least 200 patients with suspected RTIs. MEASUREMENTS: Clinical data were collected electronically from the devices at periodic intervals. Providers also completed an exit questionnaire at the end of the study period. RESULTS: Providers logged 14,393 cases using the CDSS, the majority of which (n=7624; 53%) were from family practitioners. Overall adherence with CDSS recommendations for the five most common diagnoses (pharyngitis, otitis media, sinusitis, bronchitis, and upper respiratory tract infection) was 82%. When antibiotics were prescribed (53% of cases), adherence with the CDSS-recommended antibiotic was high (76%). By logistic regression analysis, the odds of adherence with CDSS recommendations increased significantly with each ten cases completed (P=0.001). Questionnaire respondents believed the CDSS was easy to use, and most (44/65; 68%) did not believe it increased their encounter time with patients, regardless of prior experience with PDAs. CONCLUSION: A standalone PDA-based CDSS for acute RTIs used at the point-of-care can encourage better outpatient antimicrobial prescribing practices and easily gather a rich set of clinical data.

Clinical decision support and appropriateness of antimicrobial prescribing: a randomized trial.

CONTEXT: The impact of clinical decision support systems (CDSS) on antimicrobial prescribing in ambulatory settings has not previously been evaluated. OBJECTIVE: To measure the added value of CDSS when coupled with a community intervention to reduce inappropriate prescribing of antimicrobial drugs for acute respiratory tract infections. DESIGN, PARTICIPANTS AND SETTING: Cluster randomized trial that included 407,460 inhabitants and 334 primary care clinicians in 12 rural communities in Utah and Idaho (6 with 1 shared characteristic and 6 with another), and a third group of 6 communities that served as nonstudy controls. The preintervention period was January to December 2001 and the postintervention period was January 2002 to September 2003. Acute respiratory tract infection diagnoses were classified into groups based on indication for antimicrobial use. Multilevel regression methods were applied to account for the clustered design. INTERVENTION: Six communities received a community intervention alone and 6 communities received community intervention plus CDSS that were targeted toward primary care clinicians. The CDSS comprised decision support tools on paper and a handheld computer to guide diagnosis and management of acute respiratory tract infection. MAIN OUTCOME MEASURE: Community-wide antimicrobial usage was assessed using retail pharmacy data. Diagnosis-specific antimicrobial use was compared by chart review. RESULTS: Within CDSS communities, 71% of primary care clinicians participated in the use of CDSS. The prescribing rate decreased from 84.1 to 75.3 per 100 person-years in the CDSS arm vs 84.3 to 85.2 in community intervention alone, and remained stable in the other communities (P = .03). A total of 13,081 acute respiratory tract infection visits were abstracted. The relative decrease in antimicrobial prescribing for visits in the antibiotics "never-indicated" category during the post-intervention period was 32% in CDSS communities and 5% in community intervention-alone communities (P = .03). Use of macrolides decreased significantly in CDSS communities but not in community intervention-alone communities. CONCLUSION: CDSS implemented in rural primary care settings reduced overall antimicrobial use and improved appropriateness of antimicrobial selection for acute respiratory tract infections. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT00235703.

A multifaceted intervention to improve antimicrobial prescribing for upper respiratory tract infections in a small rural community.

BACKGROUND: Antibiotic prescribing for upper respiratory tract infections (URTIs) is widespread, is often inappropriate, and may contribute to antibiotic resistance among community-acquired pathogens, such as Streptococcus pneumoniae. METHODS: A multifaceted intervention involving health care professionals and patients was introduced to a small rural Utah community and included the repetitive use of printed diagnostic and treatment algorithms by professionals. Data on the quantity and class of antibiotic prescribing, which were collected from multiple sources, were measured for the intervention period (from January through June) in 2001 and compared with data for the baseline period during the same months in 2000. RESULTS: Medicaid claims data revealed that the percentage of patients in the community who received antibiotics for URTIs during the intervention period was 15.6% less than that for the baseline period, whereas the percentage in the rest of rural Utah was relatively stable, with a 1.5% decrease (P=.006). The greatest impact of the intervention was on prescribing for acute bronchitis (decreases of 56.1% and 1.7% in the community and rural Utah, respectively; P=.024) and on prescribing of macrolides (decreases of 13.4% and 0.2% in the community and rural Utah, respectively; P<.001). Community pharmacy data likewise revealed a 17.5% decrease in the rate of antibiotic prescribing during the intervention period (P<.001), with the largest decrease observed for macrolide prescribing (50.9%; P<.001). Chart review data, in contrast, revealed no significant decrease in the percentage of patients with URTI who were prescribed an antibiotic (3.8%; P=.49), although there was a significant decrease of 11.2% in macrolide use (P=.045). CONCLUSIONS: A multifaceted intervention involving the repetitive use of printed algorithms resulted in modest improvements in antibiotic prescribing for outpatient URTIs, although one data source did not corroborate this. However, macrolide prescribing decreased sharply, irrespective of the source of data.