Web-based Data Collection Tool Research Articles

First-Year Outcomes of Critical Congenital Heart Disease Screening in Maryland.

Objectives. Newborn screening for critical congenital heart disease (CCHD) was added to the Recommended Uniform Screening Panel in 2011, and states have been gradually adding pulse oximetry as point-of-care screening to panels. Few data are available on the effectiveness of pulse oximetry as a mandated screening. This study describes outcomes of the first year of screening in Maryland. Methods. A web-based data collection tool for screening results and outcomes, eScreener Plus, was utilized. Data collected from the start of screening from September 1, 2012, to December 31, 2013, were analyzed. Well-baby nursery data were evaluated separately from neonatal intensive care unit (NICU) data to determine whether setting influenced effectiveness. Results. In the first 15 months of newborn screening for CCHD in Maryland, 4 asymptomatic infants were diagnosed with a critical cardiac condition by newborn screening. Eleven infants passed but were later identified with a primary or secondary target condition. Seventy-one percent of infants with CCHD were identified prenatally or by clinical signs and symptoms. Pulse oximetry screening for CCHD had a specificity of more than 99% in both the well-baby nursery and the NICU. Sensitivity in the well-baby nursery was 10% and 60% in the NICU. Conclusion. Further investigation and interpretation of specific protocols that were used and outcomes of screening is needed for continued refinement of the well-baby algorithm and NICU protocol development. Pulse oximetry screening in newborns provides valuable clinical information, but many infants with CCHD are still not identified with current protocols.

EpiNet study of incidence of status epilepticus in Auckland, New Zealand: Methods and preliminary results.

The EpiNet project has been commenced to facilitate investigator-led collaborative research in epilepsy. A new Web-based data collection tool has been developed within EpiNet to record comprehensive data regarding status epilepticus and has been used for a study of status epilepticus in Auckland, New Zealand. All patients aged >4weeks who presented to any of the five public hospitals and the major private hospital within Auckland city (population = 1.61 million) with an episode of status epilepticus between April 6, 2015 and April 5, 2016 were identified using multiple overlapping sources of information. For this study, status epilepticus was defined as any seizure exceeding 10minutes in duration, or repeated seizures lasting >10minutes without recovery between seizures. Patients who had either convulsive or nonconvulsive status epilepticus were included. Episodes of status epilepticus were classified according to the 2015 International League Against Epilepsy ILAE status epilepticus classification. A total of 477 episodes in 367 patients were considered as definite or probable status epilepticus; 285 episodes (62%) lasted >30minutes, which is the duration that has previously been used for epidemiological studies of status epilepticus.

Remote Collection of Patient-Reported Outcomes Following Outpatient Hand Surgery: A Randomized Trial of Telephone, Mail, and E-Mail

Obtaining remote patient-reported outcomes (PRO) is limited by low patient response rates and resource-intensive collection methods. We hypothesized that an e-mail-delivered Web-based data collection tool would outperform the traditional methods of telephone and standard mail for collecting long-term Boston Carpal Tunnel Questionnaire (BCTQ) scores at a minimum of 1 year following carpal tunnel release (CTR). We conducted a randomized trial of 969 patients who underwent CTR at a tertiary medical center within the past 5 years. Participants were randomized to the PRO collection methods of mail, telephone, and e-mail. The primary outcome was survey response rate at 1year after surgery. Secondary analyses included data completeness and the effect of time from surgery, mode effects, and patient modality preference. At 1 year from surgery, the response rates were 64% for telephone and 42% for both mail and e-mail. Ninety-nine percent of telephone surveys were complete compared with 88% and 83% for mail and e-mail, respectively. There was no significant difference in the overall response rate at 1 or 5 years after surgery, nor in the BCTQ score between the modalities. A higher response rate and increased survey completeness was achieved by telephone contact methods compared with standard mailings or Web-based methods for PRO collection after CTR 1 to 5 years after surgery. A Web-based method demonstrated response rates equivalent to those of standard mail, was the most preferred modality, and offered logistical advantages such as automation and immediate integration with outcome databases. Obtaining PRO routinely after treatment may increase in importance. AWeb-based interface may assist clinicians in decreasing the resource utilization typically associated with more traditional methods used to obtain outcome data.

Need assessment of enhancing the weightage of applied biochemistry in the undergraduate curriculum at MGIMS, sevagram.

In order to review the need assessment of enhancing the weightage of Applied Biochemistry in the undergraduate curriculum at Mahatma Gandhi Institute of Medical Sciences (MGIMS), Sevagram, a validated questionnaire was sent to 453 participants which include 387 undergraduate students, 11 interns, 23 postgraduate students, and 32 faculty members. A web-based data collection and analysis tool was designed for online questionnaire distribution, data collection, and analysis. Response rate was 100%. Most of the respondents agreed that the subject Biochemistry has relevance in clinical practice (81.24%) and applied based learning of Biochemistry by medical undergraduates would help in overall improvement in the health standards/patients care (83.44%). According to 65.12% respondents, most of the medical undergraduates read Biochemistry just for examination purpose only. Nearly half of the respondents agreed that minute details of biochemical reactions were not much useful in clinical practice (53.86%) and the vast majority of diagrammatic cycles memorized by the medical undergraduates had no relevance in clinical practice (51.21%), the decreased interest in learning the Applied Biochemistry was due to more amount of clinically irrelevant information taught to medical undergraduates (73.51%), there was a need to rethink for removing the diagrammatic biochemical cycles from curriculum for medical undergraduates (48.12%), the less learning of Applied Biochemistry or competencies would affect the clinical skills and knowledge of medical undergraduates (70.42%). The result of this study suggests that there is need for restructuring the Biochemistry curriculum with more clinical relevance. © 2016 by The International Union of Biochemistry and Molecular Biology, 44:230-240, 2016.

Evaluation of spiritual needs assessments in oncology palliative care: Results of an improvement project.

161 Background: Addressing all facets of serious illness requires attention to patients’ spiritual concerns. At our Cancer Center, we sought to ensure that palliative care (PC) inpatients received evidence-based spiritual care. Methods: Chaplaincy Care, Supportive Care Medicine, and Quality and Safety Departments partnered to improve spiritual care using an iterative Plan-Do-Check-Act Cycle approach. Evidence-based spiritual practices were defined in accordance with the Association of Professional Chaplains and Clinical Practice Guidelines for Quality PC of the National Consensus Project. As a member of the Global Palliative Care Quality Alliance, we also used the web-based Quality Data Collection Tool (QDACT) to guide spiritual assessment. Electronic health record templates were revised to support complete and timely documentation. We monitored performance based on National Quality Forum Measure #1647 for discussion of spiritual/religious concerns. Performance was reviewed monthly by Leadership and with the Chaplaincy Staff. Opportunities to improve performance were discussed and adjustments in practice were made. Results: A total of 1609 oncology patients (average of 89/month) were seen by the inpatient PC team from November 2013–April 2015. With transparent performance reporting and resolution of barriers to spiritual assessment, an increase from 36 to 96% was noted for the percentage of patients with documented spiritual or religious concerns. Spiritual assessment using QDACT indicated that most patients report high spiritual well-being, spiritual peace, and a religious affiliation. Conclusions: As the result of our efforts, the majority of PC oncology patients at our center now have assessment and documentation of spiritual and religious concerns. A team-based approach to quality improvement successfully fostered the integration of spiritual care into oncology palliative care. [Table: see text]

Development of processes allowing near real-time refinement and validation of triage tools during the early stage of an outbreak in readiness for surge: the FLU-CATs Study.

During pandemics of novel influenza and outbreaks of emerging infections, surge in health-care demand can exceed capacity to provide normal standards of care. In such exceptional circumstances, triage tools may aid decisions in identifying people who are most likely to benefit from higher levels of care. Rapid research during the early phase of an outbreak should allow refinement and validation of triage tools so that in the event of surge a valid tool is available. The overarching study aim is to conduct a prospective near real-time analysis of structured clinical assessments of influenza-like illness (ILI) using primary care electronic health records (EHRs) during a pandemic. This abstract summarises the preparatory work, infrastructure development, user testing and proof-of-concept study. (1) In preparation for conducting rapid research in the early phase of a future outbreak, to develop processes that allow near real-time analysis of general practitioner (GP) assessments of people presenting with ILI, management decisions and patient outcomes. (2) As proof of concept: conduct a pilot study evaluating the performance of the triage tools 'Community Assessment Tools' and 'Pandemic Medical Early Warning Score' to predict hospital admission and death in patients presenting with ILI to GPs during inter-pandemic winter seasons. Prospective near real-time analysis of structured clinical assessments and anonymised linkage to data from EHRs. User experience was evaluated by semistructured interviews with participating GPs. Thirty GPs in England, Wales and Scotland, participating in the Clinical Practice Research Datalink. All people presenting with ILI. None. Study outcome is proof of concept through demonstration of data capture and near real-time analysis. Primary patient outcomes were hospital admission within 24 hours and death (all causes) within 30 days of GP assessment. Secondary patient outcomes included GP decision to prescribe antibiotics and/or influenza-specific antiviral drugs and/or refer to hospital - if admitted, the need for higher levels of care and length of hospital stay. Linked anonymised data from a web-based structured clinical assessment and primary care EHRs. In the 24 months to April 2015, data from 704 adult and 159 child consultations by 30 GPs were captured. GPs referred 11 (1.6%) adults and six (3.8%) children to hospital. There were 13 (1.8%) deaths of adults and two (1.3%) of children. There were too few outcome events to draw any conclusions regarding the performance of the triage tools. GP interviews showed that although there were some difficulties with installation, the web-based data collection tool was quick and easy to use. Some GPs felt that a minimal monetary incentive would promote participation. We have developed processes that allow capture and near real-time automated analysis of GP's clinical assessments and management decisions of people presenting with ILI. We will develop processes to include other EHR systems, attempt linkage to data on influenza surveillance and maintain processes in readiness for a future outbreak. This study is registered as ISRCTN87130712 and UK Clinical Research Network 12827. The National Institute for Health Research Health Technology Assessment programme. MGS is supported by the UK NIHR Health Protection Research Unit in Emerging and Zoonotic Infections.

PWE-221 Improving the practice of nutrition therapy in the critically ill patient: Abstract PWE-221 Table 1

Introduction In 2013, the University Hospital of Wales (UHW) participated in the fourth International Critical Care Nutrition Survey, a period prevalence survey led by Daren Heyland of the Clinical Nutrition Unit, Canada. This Quality Improvement Project aims to compare nutritional practices within and across countries and to highlight strengths and weaknesses leading to practice improvement. Method Critical Care units were eligible to participate in the survey if they had a minimum of 8 beds, and enrolled a minimum of 20 patients within a set time period. Over 100 patients were screened for enrollment criteria - aged ≥ 18 years of age, mechanically ventilated with 48 h of admission and remained for ≥ 72 h in the unit. For each patient a questionnaire was completed. This included patient demographics, diagnosis, co-morbidities, clinical parameters and severity of illness scores, nutritional status, nutritional requirements, feeding route and when nutrition was commenced. Data was subsequently collected for up to 12 days for actual nutrition received from enteral and parenteral sources in addition to insulin and glycaemic control. Patient outcomes included duration of mechanical ventilation, critical care and hospital outcomes. Data was collected by 2 Dietitians and submitted using the web based data collection tool. UHW data was validated for 3 randomly selected patients, and a comprehensive report comparing our patients and practice with Critical Care units in Europe and overall worldwide was provided by the Clinical Nutrition Unit. Results 190 Critical Care Units participated in the 2013 International Survey. UHW enrolled 23 of the total 3997 patients and 243 of the 37460 days analysed. The results of UHW–s practice compared with the other units are shown in the Table 1. Conclusion UHW was ranked joint 4th in the 2013 International Critical Care Survey and is the highest achievement of any UK hospital to date. The UHW feeding protocol has been further revised as a result of this improvement project and is both evidence based and practical. UHW participated in the 2014 survey and is currently awaiting the results. Disclosure of interest None Declared.

PWE-143 Provision of care for patients with autoimmune hepatitis (aih) in 27 hospitals across the united kingdom

Introduction The National Liver Disease Strategy for England aims to provide high-quality care for all patients with all liver disease. There have been moves towards subspecialist management of patients with chronic viral hepatitis. It is unclear if this is also the case for Autoimmune Hepatitis (AIH). We are conducting a (BSG and HQIP funded) Management and Outcome Audit of AIH in 28 UK centres of varying size. Method To report on current infrastructure in hospitals participating in the Multi-centre Audit. Hospitals used a web-based data collection tool to answer questions about their staff, facilities and service provision. Results We received i nformation from 27 hospitals: 13 classified themselves as District General Hospitals (DGHs) (9 with >500 beds) and 14 as University Hospitals (all with >500 beds). Fifteen hospitals accepted Hepatology referrals from other hospitals. Total number of Consultant Gastroenterologists per hospital was (median (range)) 9(3–21). Of these, 2 (0–10) were Hepatologists (>70% of workload liver disease) and a further 0 (0–4) had an interest in liver disease (40–70% of workload). Eight hospitals (35%), all of them DGHs, did not have a Hepatologist and 3 (12%) had no Consultant with an interest in liver disease. Number of Consultant Gastroenterologists managing AIH per hospital was 3.5(1–10) and number of Hepatologists managing AIH was 2(0–10). The percentage of all the Consultants who managed AIH was 43(20–100)%. This was higher in DGHs than in University Hospitals: 100(20–100%) vs 37(20–100%). In 8 hospitals (7 DGHs), all of the 6(3–10) Gastroenterologists managed AIH. In University Hospitals, all Hepatologists managed AIH and in 5 hospitals (with Hepatologists), so did other Gastroenterologists. Eighteen hospitals (67%) had 1(0–6) specialist nurses mainly managing liver disease and 18 (67% provided telephone advice for patients with liver disease. However, in only three hospitals (12%) did these nurses manage outpatients with AIH. 16 hospitals (59%) had at >1 Histopathologist with an interest in liver disease and 70% had a joint clinical-pathological meeting. Eleven hospitals (42%) provided hospital information sheets for patients with AIH. Only three (12%) had departmental hospital guidelines for the management of AIH. Nine (33%) had database of patients with AIH. Conclusion In contrast to chronic viral hepatitis, there has been little development of subspecialisation amongst Gastroenterology and Hepatology physicians and nurses in regard to management of AIH. There is variability in service provision but it is unclear if this influences outcome. All centres in the Audit now have a database to monitor their patients with AIH: this should help improve resource provision and aid management. Disclosure of interest None Declared.

The Royal College of Radiologists' Audit of Prostate Brachytherapy in the Year 2012

AimsThis audit provides a comprehensive overview of UK prostate brachytherapy practice in the year 2012, measured against existing standards, immediately before the introduction of new Royal College of Radiologists (RCR) guidelines. This audit allows comparison with European and North American brachytherapy practice and for the impact of the RCR 2012 guidelines to be assessed in the future. Materials and methodsA web-based data collection tool was developed by the RCR Clinical Audit Committee and sent to audit leads at all cancer centres in the UK. Standards were developed based on available guidelines in use at the start of 2012 covering case mix and dosimetry. Further questions were included to reflect areas of anticipated change with the implementation of the 2012 guidelines. Audit findings were compared with similar audits of practice in Europe, the USA and Latin America. ResultsForty-nine of 59 cancer centres submitted data. Twenty-nine centres reported carrying out prostate brachytherapy; of these, 25 (86%) provided data regarding the number of implants, staffing, dosimetry, medication and anaesthesia and follow-up. Audit standards achieved excellent compliance in most areas, although were low in post-implant dosimetry and in post-implant scanning at 30 days. ConclusionThis audit provides a comprehensive picture of prostate brachytherapy in the UK in 2012. Patterns of care of prostate brachytherapy are similar to practice in the USA and Europe. The number of prostate brachytherapy implants carried out in the UK has grown significantly since a previous RCR audit in 2005 and it is important that centres maintain minimum numbers of cases to ensure that experience can be maintained and compliance to guidelines achieved.

Techniques, Success, and Adverse Events of Emergency Department Adult Intubations

We describe the operators, techniques, success, and adverse event rates of adult emergency department (ED) intubation through multicenter prospective surveillance. Eighteen EDs in the United States, Canada, and Australia recorded intubation data onto a Web-based data collection tool, with a greater than or equal to 90% reporting compliance requirement. We report proportions with binomial 95% confidence intervals (CIs) and regression, with year as the dependent variable, to model change over time. Of 18 participating centers, 5 were excluded for failing to meet compliance standards. From the remaining 13centers, we report data on 17,583 emergency intubations of patients aged 15 years or older from 2002 to 2012. Indications were medical in 65% of patients and trauma in 31%. Rapid sequence intubation was the first method attempted in 85% of encounters. Emergency physicians managed 95% of intubations and most (79%) were physician trainees. Direct laryngoscopy was used in 84% of first attempts. Video laryngoscopy use increased from less than 1% in the first 3 years to 27% in the last 3 years (risk difference 27%; 95% CI 25% to 28%; mean odds ratio increase per year [ie,slope] 1.7; 95% CI 1.6 to 1.8). Etomidate was used in 91% and succinylcholine in 75% of rapid sequence intubations. Among rapid sequence intubations, rocuronium use increased from 8.2% in the first 3 years to 42% in the last 3 years (mean odds ratio increase per year 1.3; 95% CI 1.3 to 1.3). The first-attempt intubation success rate was 83% (95% CI 83% to 84%) and was higher in the last 3 years than in the first 3 (86% versus 80%; risk difference 6.2%; 95% CI 4.2% to 7.8%). The airway was successfully secured in 99.4% of encounters (95% CI 99.3% to 99.6%). In the EDs we studied, emergency intubation has a high and increasing success rate. Both drug and device selection evolved significantly during the study period.

EFFICIENT CAPTURE OF HIGH-QUALITY DATA ON OUTCOMES OF TREATMENT FOR MACULAR DISEASES

To describe the development of a web-based high-quality data collection tool to track the outcomes of treatment of macular disease in routine practice. Testing of a larger data collection tool established which fields a clinician would reliably fill out. The program, which was developed using freely available software, consists of modules interacting with a core system. The module for neovascular age-related macular degeneration is described here. Data for initial visits can be entered within 30 seconds, 15 seconds for follow-up visits. Fifteen centers from Australia, New Zealand, and Switzerland are currently contributing data. Finalized data from 2,052 eyes of 1,693 participants dating from January 2006 were analyzed. Median (25th and 75th percentiles) visual acuity at the index visit was 55 (41, 68) logarithm of the minimum angle of resolution letters with the following lesion types: minimally classic 17.2%, predominantly classic 24.6%, occult 52.0%, idiopathic polypoidal choroidal vasculopathy 1.2%, and retinal angiomatous proliferation 3.2%. This software tool will facilitate the collection of large amounts of data on the routine use of treatments of neovascular age-related macular degeneration. This will allow us to analyze important potentially modifiable variables, such as the effect of different treatment patterns on visual outcomes, and to evaluate new treatments as they are introduced into practice.

Treatment Response and Predictors of Response Among Patients with Chronic Myeloid Leukemia: A Retrospective Medical Record Review

AbstractAbstract 4450 Objective:To assess treatment responses and predictors of response among patients with chronic myeloid leukemia (CML) in Australia, Canada, and South Korea. Methods:Oncologists and hematologists abstracted data from medical records of patients diagnosed with CML between 1/1/2005 and 9/30/2010 via a web-based data collection tool. Patients included were at least 18 years old; had chronic phase, Philadelphia chromosome and/or BCR-ABL positive CML at the time of diagnosis; received imatinib as first-line therapy; and were not enrolled in a clinical trial between the date of CML diagnosis and the end of available chart data. A subset of patients received second- and/or third-line therapy with dasatinib or nilotinib. We assessed rates of complete hematological response (CHR), complete cytogenetic response (CCyR), and complete or major molecular response (MMR) at 3, 6, 12, and 18 months. Multivariable logistic regression models were fitted to assess predictors of response (CHR, CCyR, and MMR) to 1stline therapy with imatinib. The independent and control variables incorporated into the models were age, gender, employment status, Charlson comorbidity index (CCI) score, time to initiation of therapy, imatinib dose at treatment initiation, and presence of treatment-related side effects. Follow-up was truncated if the patient had a change in dose. Only those still in chronic phase at the time of imatinib initiation who had non-missing data on the variables of interest (n=387) were included in the regression analyses. Results:Ninety-three physicians (31 in Australia, 28 in Canada, and 34 in S. Korea) provided data on 609 patients (203 in Australia, 199 in Canada, and 207 in S. Korea). The average patient age was 57 years, and 59% of the patients were male. At 3 months after imatinib initiation, CHR was attained by 67%, 83%, and 86% of patients in Australia, S. Korea, and Canada respectively. Over 85% of all patients maintained CHR at 6, 12, and 18 months. Cytogenetics were not commonly evaluated at 3 and 6 months in the three countries studied. At month 12, 48% of patients achieved CCyR (42% in Australia and Canada, 60% in S. Korea), and a similar proportion of patients had CCyR at 18 months. Overall, MMR was achieved by 59% of patients at month 12, increasing to 70% at month 18. Multivariable regressions showed that receipt of previous treatment (odds ratio [OR]=1.88, 95% CI=1.08–3.25; reference [ref]: no previous treatment), and low Sokal score (OR=2.04, 95% CI=1.13–3.69; ref: intermediate) were associated with a greater likelihood of CHR at 3 months while initial dose > 400mg (OR=0.37 95% CI=0.13–1.03; ref: initial dose <= 400 mg), CCI score of 2 or higher (OR=0.23, 95% CI=0.11–0.51; ref: CCI score 0), and presence of treatment-related side effects (OR=0.41, 95% CI=0.18–0.95; ref: no side effects) predicted a lower likelihood of CHR at 3 months. High Sokal score (OR=0.39, 95% CI=0.18–0.87; ref: intermediate) was found to be associated with a lower likelihood of achieving CCyR at 12 months while the presence of treatment-related side effects (OR=1.86, 95% CI=1.04 – 3.33; ref: no side effects) was found to be associated with a higher probability of achieving CCyR at 12 months. Low Sokal score (OR=1.85, 95% CI=1.10–3.10; ref: intermediate) was the only significant prognostic indicator that was associated with a greater likelihood of MMR at 18 months while age >65 years was the only significant adverse prognostic indicator of MMR by 18 months (OR=0.42, 95% CI=0.20–0.86; ref: age 45–65). Conclusions:The favorable prognostic indicators of response among patients with chronic phase CML included previous treatment, low Sokal score, lower initial imatinib dose (< 400 mg), and no comorbidities. Better understanding of predictors of response may enable physicians to better tailor therapy to optimize patient outcomes. Disclosures:Whiteley:Pfizer Inc: Employment, Equity Ownership. Mitra:Pfizer Inc: Research Funding. Iyer:Pfizer Inc: Employment. Candrilli:Pfizer Inc: Research Funding. Kaye:Pfizer Inc: Research Funding.

Abstract 2: Outcomes Of Carotid Endarterctomy In The Elderly: A Report From The Care Registry ®

Background: Although stroke affects the elderly disproportionately, benchmark clinical trials of CEA often did not include this population at all or in insufficient numbers. Because trial patients are chosen rather strictly, the results may not be easily generalized and must be applied cautiously to the general population. The CARE Registry is a hospital wide web based data collection tool designed to assess use quality and outcomes of cardiovascular procedures including CEA. We determined the perioperative outcomes of CEA based upon age. Methods: Details of data collection and management in the CARE Registry has been previously published. Using the dataset we analyzed the outcome of CEA procedures done in elderly symptomatic and asymptomatic patients (age &gt; 70 years). We compared outcomes (discharge status, and risk of stroke or death) stratified by age. Statistical analysis was performed by using Student’s t- test for continuous variables and Chi square or Fisher’s exact test for categorical variables Results: There were a total of 4149 symptomatic and asymptomatic patients &gt; 70 who underwent CEA. Mean age was 78.1 + 5.2 years of which 59% were male. 96% were Caucasian, 89.7% had hypertension, 32.4% had diabetes, and 65% were smokers. The overall mortality rate after the procedure was 0.5%. New stroke or TIA was documented in 2.0%. Risk of combined stroke or death was 2.3%. The risk of death was highest in the 85 years and over group compared to the 70-75, 75-80 and the 80-85 years groups (p=0.002). The combined risk of death or stroke was also highest in the &gt;85 years group (4.9%, p=0.001) compared to the other groups. Among symptomatic elderly patients, the risk of death (0.5% vs. 0.4%, p=1.00) and risk of combined perioperative stroke and death 2.8% vs. 3.2%,p=0.67) was not statistically different between those &lt;75 years compared to those &gt;75 years. Among asymptomatic elderly patients who underwent CEA, the risk of death was significantly higher among those &gt;75 years compared to those &lt; 75 years 0.7% vs 0.0% p=0.006) and the combined risk of death or perioperative stroke was 2.2% vs. 1.6%, p=0.25) Conclusions: In the CARE Registry, elderly patients more than 85 years of age are at increased risk of death or perioperative complications of stroke compared to those relatively younger. Elderly patients undergoing CEA for asymptomatic carotid stenosis also had higher mortality than the younger counterparts.

Impact of Provider Specialty on Pediatric Procedural Sedation Complication Rates

To determine if pediatric procedural sedation-provider medical specialty affects major complication rates when sedation-providers are part of an organized sedation service. The 38 self-selected members of the Pediatric Sedation Research Consortium prospectively collected data under institutional review board approval. Demographic data, primary and coexisting illness, procedure, medications used, outcomes, airway interventions, provider specialty, and adverse events were reported on a self-audited, Web-based data collection tool. Major complications were defined as aspiration, death, cardiac arrest, unplanned hospital admission or level-of-care increase, or emergency anesthesia consultation. Event rates per 10 000 sedations, 95% confidence intervals, and odds ratios were calculated using anesthesiologists as the reference group and were then adjusted for age, emergency status, American Society of Anesthesiologists physical status > 2, nil per os for solids, propofol use, and clustering by site. Between July 1, 2004, and December 31, 2008, 131 751 pediatric procedural sedation cases were recorded; there were 122 major complications and no deaths. Major complication rates and 95% confidence intervals per 10 000 sedations were as follows: anesthesiologists, 7.6 (4.6-12.8); emergency medicine, 7.8 (5.5-11.2); intensivist, 9.6 (7.3-12.6); pediatrician, 12.4 (6.9-20.4); and other, 10.2 (5.1-18.3). There was no statistical difference (P > .05) among provider's complication rates before or after adjustment for potential confounding variables. In our sedation services consortium, pediatric procedural sedation performed outside the operating room is unlikely to yield serious adverse outcomes. Within this framework, no differences were evident in either the adjusted or unadjusted rates of major complications among different pediatric specialists.

Development of a data dictionary for the Strategies for Post Arrest Resuscitation Care (SPARC) network for post cardiac arrest research

Background The widely accepted Utstein style has standardized data collection and analysis in resuscitation and post resuscitation research. However, collection of many of these variables poses significant practical challenges. In addition, several important variables in post resuscitation research are missing. Objective Our aim was to develop a comprehensive data dictionary and web-based data collection tool as part of the Strategies for Post Arrest Resuscitation Care (SPARC) Network project, which implemented a knowledge translation program for post cardiac arrest therapeutic hypothermia in 37 Ontario hospitals. Methods A list of data variables was generated based on the current Utstein style, previous studies and expert opinion within our group of investigators. We developed a data dictionary by creating clear definitions and establishing abstraction instructions for each variable. The data dictionary was integrated into a web-based collection form allowing for interactive data entry. Two blinded investigators piloted the data collection tool, by performing a retrospective chart review. Results A total of 454 variables were included of which 400 were Utstein, 2 were adapted from existing studies and 52 were added to address missing elements. Kappa statistics for two outcome variables, survival to discharge and induction of therapeutic hypothermia were 0.86 and 0.64, respectively. Conclusion This is the first attempt in the literature to develop a data dictionary as part of a standardized, pragmatic data collection tool for post cardiac arrest research patients. In addition, our dataset defined important variables that were previously missing. This data collection tool can serve as a reference for future trials in post cardiac arrest care.

RIFLE-Based Data Collection/Management System Applied to a Prospective Cohort Multicenter Italian Study on the Epidemiology of Acute Kidney Injury in the Intensive Care Unit

The epidemiology of acute kidney injury (AKI) has been difficult to explore in the past, due to different definitions across various studies. Nevertheless, this is a very important topic today in light of the high morbidity and mortality of critically ill patients presenting renal dysfunction during their stay in the intensive care unit (ICU). The case mix has changed over the years, and AKI is a common problem in critically ill patients often requiring renal replacement therapy (RRT). The RIFLE and AKIN initiatives have provided a unifying definition for AKI, making possible large retrospective studies in different countries. The present study aims at validating a unified web-based data collection and data management tool based on the most recent AKI definition/classification system. The interactive database is designed to elucidate the epidemiology of AKI in a critically ill population. As a test, we performed a prospective observational multicenter study designed to prospectively evaluate all incident admissions in ten ICUs in Italy and the relevant epidemiology of AKI. Thus, a simple user-friendly web-based data collection tool was created with the scope to serve for this study and to facilitate future multicenter collaborative efforts. We enrolled 601 consecutive incident patients into the study; 25 patients with end-stage renal disease were excluded, leaving 576 patients for analysis. The median age was 66 (IQR 53–76) years, 59.4% were male, while median Simplified Acute Physiology Score II and Acute Physiology and Chronic Health Evaluation II scores were 43 (IQR 35–54) and 18 (IQR 13–24), respectively. The most common diagnostic categories for ICU admission were: respiratory (27.4%), followed by neurologic (17%), trauma (14.4%), and cardiovascular (12.1%). Crude ICU and hospital mortality were 21.7% and median ICU length of stay was 5 (IQR 3–14) days. Of 576 patients, 246 patients (42.7%) had AKI within 24 h of ICU admission, while 133 developed new AKI later during their ICU stay. RIFLE-initial class was Risk in 205 patients (54.1%), Injury in 99 (26.1%) and Failure in 75 (19.8%). Progression of AKI to a worse RIFLE class was seen in 114 patients (30.8% of AKI patients). AKI patients were older, with higher frequency of common risk factors. 116 AKI patients (30.6%) fulfilled criteria for sepsis during their ICU stay, compared to 33 (16.7%) of non-AKI patients (p < 0.001). 48 patients (8.3%) were treated with RRT in the ICU. Patients were started on RRT a median of 2 (IQR 0–6) days after ICU admission. AKI patients were started on RRT a median of 1 (IQR 0–4) day after fulfilling criteria for AKI. Median duration of RRT was 5 (IQR 2–10) days. AKI patients had a higher crude ICU mortality (28.8 vs. 8.1%, non-AKI; p < 0.001) and longer ICU length of stay (median 7 vs. 3 days, non-AKI; p < 0.001). Crude ICU mortality and ICU length of stay increased with greater severity of AKI. 225 (59.4% of AKI patients) had complete recovery of renal function, with a serum creatinine at time of ICU discharge which was ≤120% of baseline; an additional 51 AKI patients (13.5%) had partial renal recovery, while 103 (27.2%) had not recovered renal function at the time of death or ICU discharge. The study supports the use of RIFLE as an optimal classification system to stage AKI severity. AKI is indeed a deadly complication for ICU patients, where the level of severity is correlated with mortality and length of stay. The tool developed for data collection was user-friendly and easy to implement. Some of its features, including a RIFLE class alert system, may help the treating physician to systematically collect AKI data in the ICU and possibly may guide specific decisions on the institution of RRT.

Patient reported outcome data following influenza A (H1N1p) vaccination in the 2009&amp;ndash;2010 season: web-based and telephone evaluation

BackgroundThere has been worldwide interest in the safety of the pandemic influenza A (H1N1p) vaccines, although limited data are available from the vaccine recipients’ perspective. This evaluation was designed to collect data from people who had received an influenza vaccination during the 2009–2010 season using a web-based data collection tool supplemented by telephone reporting (PROBE).MethodsPeople scheduled to receive the influenza A (H1N1p) or seasonal influenza vaccines were recruited through media advertising and campaigns throughout the West of Scotland. Vaccine recipients participated in the evaluation by answering demographic and side effect questions using PROBE methodology on the day of the immunization, after 3 days, 8 days, 6 weeks, 12 weeks, and 26 weeks.ResultsA total of 1103 vaccine recipients including 134 young children (0–4 years) participated in the evaluation; 694 (63%) received H1N1p vaccine only, 135 (12%) seasonal vaccine only, 224 (20%) both H1N1p and seasonal vaccines, and 50 (5%) received H1N1p or seasonal vaccine with a non-influenza vaccine (eg, travel or pneumococcal). Overall, 42% of recipients reported experiencing a side effect after their baseline vaccination; the most commonly reported were general and arm side effects (>20%). Injection site discomfort/pain and flu-like symptoms were reported by 57% and 24% of recipients, respectively. A significantly higher proportion of the 960 H1N1p vaccine recipients experienced a side effect (44% vs 27%, P < 0.001) or injection site discomfort/pain (61% vs 26%, P < 0.001) than those receiving seasonal influenza vaccines. Female sex and H1N1p vaccination were associated with a significantly higher risk of injection site discomfort/pain, whereas the 70+ age group was associated with a significantly lower risk. H1N1p vaccine was well tolerated by children under 5 years with side effects reported at a similar frequency to that found in the total population.ConclusionsSafety and tolerability data from influenza vaccine recipients including young children (via parents/carers) can be effectively collected using an online questionnaire with a telephone option (PROBE). The influenza A (H1N1p) vaccine was well tolerated, but was associated with more local short-term reactions than the seasonal influenza vaccine.

Dietary patterns among the Metro Atlanta Cohort: Implications for population-based longitudinal dietary pesticide exposure and risk assessment

Characterizing dietary consumption patterns is critical to dietary pesticide exposure assessment. We compared consumption patterns between adults (age 18-60) in the Metro Atlanta Cohort (MAC), a longitudinal study of pesticide exposure among Atlanta residents, and US National Health and Nutrition Examination Survey (NHANES) adults. We focused on foods commonly eaten by US adults and foods likely to contain certain pesticide residues. MAC participants provided consumption data for 6 days per month for 1 year using a web-based data collection tool. We defined "percent eaters" as the percent of participants who reported eating a particular food in 24 h. We computed the NHANES weighted percent eaters and 95% confidence limits (CLs) using the 24-h dietary recall data. We calculated the MAC percent eaters for each sampling day and the percent of days this number fell below, within, or above the NHANES 95% CLs. We also re-sampled the MAC percent eaters across sampling days to find whether the resulting distribution resembled the NHANES estimate, and used the Kruskal-Wallis test to evaluate whether season affected the number of MAC eaters of a particular food on a given sampling day. In general, across all sampling days, a greater proportion of MAC participants reported eating banana, broccoli, cream, grapes, lettuce, onion, peach, pear, peas, strawberries, string beans, and tomatoes than the national estimate, whereas the proportion of apple, spinach, ketchup and white bread/roll eaters was similar, and the proportion of milk drinkers was lower. Season predicted the number of MAC peach and strawberry eaters but not other foods. The data show how a higher proportion of Atlanta adults may eat certain foods (e.g., peaches in summer or strawberries in spring) than the national average depending on season or other factors. An exposure assessment that ignored this difference could underestimate dietary pesticide intakes.

Evolution and Elements of the Quality Oncology Practice Initiative Measure Set

Over the past 5 years, the American Society of Clinical Oncology (ASCO) has supported the development of a Web-based quality-reporting tool in response to a recognized need to provide medical oncologists the opportunity to demonstrate the quality of care that they are providing to patients. The development of quality measures, their basis in the literature, and the descriptions and organizational structure of the measures are discussed. Specific results are the property of practices and are not shared outside of the practices except in aggregate. The system allows collection of information concerning a wide range of quality measures in a short period of time. In the last data collection period in the fall of 2008, information was submitted concerning 81 measures of quality divided into one required and six optional modules from over 250 practices concerning 15,000 patients. The timely collection of information on a wide range of quality measures regarding cancer patients can be efficiently collected using a Web-based data collection tool allowing for practice self-examination and comparison with other practices.

The Incidence and Nature of Adverse Events During Pediatric Sedation/Anesthesia With Propofol for Procedures Outside the Operating Room: A Report From the Pediatric Sedation Research Consortium

We used a large database of prospectively collected data on pediatric sedation/anesthesia outside the operating room provided by a wide range of pediatric specialists to delineate the nature and frequency of adverse events associated with propofol-based sedation/anesthesia care. Data were collected by the Pediatric Sedation Research Consortium, a collaborative group of institutions dedicated to improving sedation/anesthesia care for children internationally. Members prospectively enrolled consecutive patients receiving sedation or sedation/anesthesia for procedures. The primary inclusion criterion was the need for some form of sedation/anesthesia to perform a diagnostic or therapeutic procedure outside the operating room. There were no exclusion criteria. Data on demographics, primary illness, coexisting illness, procedure performed, medications used, procedure and recovery times, medication doses outcomes of anesthesia, airway interventions and adverse events were collected and reported using web-based data collection tool. For this study, we evaluated all instances where propofol was used as the primary drug in the sedation/anesthesia technique. Thirty-seven locations submitted data on 49,836 propofol sedation/anesthesia encounters during the study period from July 1, 2004 until September 1, 2007. There were no deaths. Cardiopulmonary resuscitation was required twice. Aspiration during sedation/anesthesia occurred four times. Less serious events were more common with O(2) desaturation below 90% for more than 30 s, occurring 154 times per 10,000 sedation/anesthesia administrations. Central apnea or airway obstruction occurred 575 times per 10,000 sedation/anesthesia administrations. Stridor, laryngospasm, excessive secretions, and vomiting had frequencies of 50, 96, 341, and 49 per 10,000 encounters, respectively. Unexpected admissions (increases in levels of care required) occurred at a rate of 7.1 per 10,000 encounters. In an unadjusted analysis, the rate of pulmonary adverse events was not different for anesthesiologists versus other providers. We report the largest series of pediatric propofol sedation/anesthesia for procedures outside the operating room. The data indicate that propofol sedation/anesthesia is unlikely to yield serious adverse outcomes in a collection of institutions with highly motivated and organized sedation/anesthesia services. However, the safety of this practice is dependent on a system's ability to manage less serious events. We propose that our data suggest variables for training and credentialing providers of propofol sedation/anesthesia and the system characteristics that promote safe use of this drug.