National Clinical Registry Research Articles

SUN-055 REAL WORLD DATA ON THE TRANSITION FROM CKD TO RENAL REPLACEMENT THERAPY: CHARACTERISTICS AND TRENDS IN A METROPOLITAN AREA IN BRAZIL

In Brazil, the number of patients with chronic kidney disease (CKD) is rapidly increasing. In spite of that, we still have few population-based studies on CKD especially regarding patients initiating renal replacement therapy (RRT). Offering the best care for patients initiating of RRT is still a challenge and can result in increased risks for complications and health care related costs. This study consists of a historical cohort of patients in RRT provided by the Sistema Unico de Saude (SUS). All patients initiating RRT from 2012 to 2018, at the city of Contagem, Minas Gerais, Brazil, were included. Data were extracted from an administrative database, the Authorization System for High Complexity/Cost Procedures (APAC). Patients were assessed for their baseline characteristics at the time of initiation of RRT: creatinine clearance, definitive vascular access, primary modality of RRT. Mortality rate and transplantation were also evaluated. This study resulted in no interventions. Privacy of subjects and the confidentiality of their personal information were handled in accordance with the ethical principles of the Declaration of Helsinki. During the study period, 2.436 patients (mean age 53.6 SD 14.8 years; male 55.1%) initiated RRT. 87.7% initiated RRT while hospitalized in an acute care or intensive care unit. 95.1% had a double-lumen dialysis catheter as first vascular access. DM was the most prevalent isolated cause for CKD (35.1%). Peritoneal dialysis was the initial treatment modality for only 4.4%. Median creatinine clearance (CKD-EPI) at the initiation of RRT was 8.4 SD 6.1 ml/min/m2. There was no difference in the Cr Cl when patients were stratified in groups concerning age or diagnosis. After a mean follow-up time of 2.1 SD 1.9 years, the observed mortality was 14.1%. 32 patients were transplanted. Despite the well-known recommendations on how to best transition patients with advanced chronic kidney disease (CKD) to renal replacement therapy, the care of these patients remains a challenge. Our results suggest that pre-dialysis interventions regarding issues as dialysis modality planning, definitive vascular access, and elective RRT initiation are still important challenges to be addressed in our location. In the absence of a national clinical registry, administrative data can be a source of “real-world” evidence to provide reliable information on opportunities to improve care and outcomes.

Quality of MBSAQIP data: bad luck, or lack of QA plan?

National clinical registries are commonly used in clinical research, quality improvement, and health policy. However, little is known about methodological challenges associated with these registry analyses that could limit their impact and compromise patient safety. This study examined the quality of Metabolic and Bariatric Surgery Accreditation and Quality Improvement Program (MSBASQIP) data to assess its usability potential and improve data collection methodologies. We developed a single flat file (n = 168,093) using five subsets (Main, BMI, Readmission, Reoperation, and Intervention) of the 2015 MBSAQIP Participant User Data File (PUF). Logic and validity tests included (1) individual profiles of patient's body mass index (BMI) changes over time, (2) individual patient care pathways, and (3) correlation analysis between variable pairs associated with the same clinical encounters. 8888 (5.3%) patients did not have postoperative weight/BMI data; 20% of patients had different units for preoperative and postoperative weights. Postoperative weight measurements ranged between - 71 and 132% of preoperative weight. There were 325 (3.7%) hospital readmissions reported on the day of or day after MBS. The self-reporting of "emergency" vs. "planned" interventions did not correlate with the type of procedure and its indication. Up to 20% of data could potentially be unused for analysis due to data quality issues. Our analysis revealed various data quality issues in the 2015 MBSAQIP PUF related to completeness, accuracy, and consistency. Since information on where the surgery was performed is lacking, it is not possible to conclude whether these issues represent data errors, patient outliers, or inappropriate care. Including automated data checks and biomedical informatics oversight, standardized coding for complications, additional de-identified facility and provider information, and training/mentorship opportunities in data informatics for all researchers who get access to the data have been shown to be effective in improving data quality and minimizing patient safety concerns.

Preoperative risk evaluation for pancreatic fistula after pancreaticoduodenectomy.

Pancreatic fistula remains common, with limited ability to risk stratify patients preoperatively. The objective of this study was to identify risk factors for clinically-relevant postoperative pancreatic fistula (CR-POPF) that are routinely available in the preoperative setting. Preoperatively available variables for all pancreaticoduodenectomies from 2014-2017 were examined using a national clinical registry. The cohort was separated into risk factor identification and internal validation subgroups. Among 15 033 pancreaticoduodenectomies, the CR-POPF rate was 16.7%. CR-POPF was more likely in patients that were male (odds ratio [OR], 1.51), obese (body mass index [BMI] > 30, OR, 1.97), had minimal preoperative weight loss (OR, 1.25), had a nondilated pancreatic duct (OR, 1.81), did not have diabetes, (OR, 1.80), did not receive neoadjuvant therapy (OR, 1.78), had no evidence of biliary obstruction (OR, 1.18), or had nonadenocarcinoma pathology (OR, 1.96; all P < 0.01). Patients with three or fewer risk factors had a CR-POPF rate of 7.1%, while those with six or more risk factors had a CR-POPF rate of 26.3% (P < 0.001). Preoperative CR-POPF risk evaluation could be a useful tool in patient counseling and surgical planning, and risk may allow for more well-informed decisions regarding perioperative management, including enhanced recovery protocols and use of somatostatin analogs.

Acute endovascular reperfusion treatment in patients with ischaemic stroke and large-vessel occlusion (Denmark 2011-2017).

Acute endovascular reperfusion treatment (aERT) of stroke patients with large-vessel occlusions is efficacious and safe according to several clinical trials. Data on outcome and safety of aERT in daily clinical routine are warranted and, in this study, we present national data from Denmark during 2011-2017. National data for Denmark from 2011 to 2017 on all aERT procedures in patients with acute ischaemic stroke and computed tomography angiography/magnetic resonance angiography-verified large-vessel occlusion were derived from the Danish Stroke Registry, a national clinical quality registry to which reporting is mandatory for all hospitals treating stroke patients. Outcome (modified Rankin Scale score) after 3months, including time of death, was assessed prospectively based on clinical examination or the Danish Civil Registration System. During the 7years of observation, a total of 1720 patients were treated with aERT. The annual number of procedures increased from 128 in 2011 to 409 in 2017. The median age was 70years, 58% were males and median National Institutes of Health Stroke Scale score at baseline was 16. Median time from symptom onset to groin puncture was 238min with a decreasing trend during the years. Successful recanalization was reported in 1306 (76%) patients. At 3-month follow-up, an modified Rankin Scale score of 0-2 was reported in 46% of patients, whereas 14% of patients had died. Routine data on aERT in acute ischaemic stroke in Denmark from 2011 to 2017 suggest that the procedure is safe and efficacious.

How Returning Aggregate Research Results Impacts Interest in Research Engagement and Planned Actions Relevant to Health Care Decision Making: Cohort Study.

BackgroundCollection of patient-reported outcomes measures (PROs) may augment clinical data and inform health research, improving care, yet approaches to sustaining interest among patient cohorts in research participation are needed. One approach may involve returning aggregate research results (ARRs), which may help patients contextualize personal experiences, prompt conversations with providers or family, and encourage information seeking. This model has been demonstrated for Web-based patient-centered registries. Studies with clinical cohorts may further elucidate the model, its impacts on interest in research participation and planned actions, and potential for participants to experience this as helpful or harmful—gap areas.ObjectiveWe sought to investigate the impacts of returning ARRs comprising summaries of PROs and clinical metrics to parents of children with rheumatic disease, assessing interest in future research participation among parents who viewed ARRs and plans for acting on returned information. Further, we sought to investigate reactions to viewing ARRs and how these reactions impacted planned actions.MethodsClinical and PRO data were obtained about children in a national clinical disease registry, summarized, and processed into annotated infographics, comprising ARRs for children’s parents. Parents who viewed ARRs (n=111) were surveyed about the information’s perceived value and their reactions. Reaction patterns were summarized using principal components analysis (PCA), and associations among reaction patterns and interest in research participation and planned actions were estimated using multivariate logistic regression.ResultsParental endorsement of the value of ARRs for understanding their child’s condition and making care decisions was high (across 10 topics for which ARRs were shared, 42.2%-77.3% of the parents reported information was “very valuable”). Most (58/111, 52.3%) parents reported being more interested in participating in research after viewing ARRs, with the remainder reporting that their interest levels were unchanged. Reactions to viewing ARRs reflected experiencing validation/affirmation and information burden based on PCA. Reactions were not associated with child demographic or clinical characteristics and PROs, except that parents from households with less education reported greater information burden than those from more educated households (P=.007). In adjusted models, parents with higher validation/affirmation scores had increased odds of reporting heightened interest in research participation (adjusted odds ratio [AOR] 1.97, 95% CI 1.18-3.30), while higher information burden scores were associated with decreased odds of planned discussions with their child (AOR 0.59, 95% CI 0.36-0.95) and increased odds of planned discussions with providers (AOR 1.75, 95% CI 1.02-3.00).ConclusionsReturning ARRs may foster a “virtuous cycle” of research engagement, especially where ARRs are experienced favorably and affect plans to share and discuss ARRs in support of a child’s chronic disease care and treatment. Reactions to ARRs vary with education level, underscoring the need for attention to equity for this model.

Maximising data value and avoiding data waste: a validation study in stroke research.

To determine the feasibility of linking data from the Australian Stroke Clinical Registry (AuSCR), the National Death Index (NDI), and state-managed databases for hospital admissions and emergency presentations; to evaluate data completeness and concordance between datasets for common variables. Cohort design; probabilistic/deterministic data linkage of merged records for patients treated in hospital for stroke or transient ischaemic attack from New South Wales, Queensland, Victoria, and Western Australia. Descriptive statistics for data matching success; concordance of demographic variables common to linked databases; sensitivity and specificity of AuSCR in-hospital death data for predicting NDI registrations. Data for 16214 patients registered in the AuSCR during 2009-2013 were linked with one or more state datasets: 15482 matches (95%) with hospital admissions data, and 12902 matches (80%) with emergency department presentations data were made. Concordance of AuSCR and hospital admissions data exceeded 99% for sex, age, in-hospital death (each κ=0.99), and Indigenous status (κ=0.83). Of 1498 registrants identified in the AuSCR as dying in hospital, 1440 (96%) were also recorded by the NDI as dying in hospital. In-hospital death in AuSCR data had 98.7% sensitivity and 99.6% specificity for predicting in-hospital death in the NDI. We report the first linkage of data from an Australian national clinical quality disease registry with routinely collected data from several national and state government health datasets. Data linkage enriches the clinical registry dataset and provides additional information beyond that for the acute care setting and quality of life at follow-up, allowing clinical outcomes for people with stroke (mortality and hospital contacts) to be more comprehensively assessed.

Comparability of the Cancer Supportive Care Clinical Studies Collaborative (CSCCSC) study population to national referrals to other specialist palliative care services.

63 Background: There are no agreed national nor international criteria for referral to palliative care. Key population characteristics have been defined to aid the generalizability of research findings in palliative care clinical studies. To codify differences in key demographic factors between patients with cancer participating in the Australian national Cancer Supportive Care Clinical Studies Collaborative (CSCCSC) phase III symptom control studies and the population referred to other Australian palliative care services. Methods: This study compares two contemporaneous consecutive cohorts generated through clinical trial participation and the national palliative care clinical quality improvement registry in Australia. Age, sex, cancer diagnosis, language, and socio-economic status were compared. Results: Cohorts were people with cancer: enrolled in CSCCSC phase III clinical studies (n=902; 17 sites); and registered by the Australian national Palliative Care Outcomes Collaboration (PCOC; n=75,240; 117 sites). Participants in CSCCSC studies were younger than those of PCOC (median 71 (IQR 62, 79) versus median 73 (IQR 63, 81); p=0.003 respectively). There was no significant difference in sex (p=0.483). Patients who spoke English accounted 95.0% of enrollees in the CSCCSC group and 92.2% in the PCOC group (p = 0.004). Clinical study participants had higher socioeconomic status that the PCOC group (p=0.022). Conclusions: Overall, the slightly different demographic patterns are reflective of the differences often seen between phase III trials and the populations to whom the results will be applied. Age differences particularly need to be taken into account when considering the best way to apply each study’s findings.

Learning, Life, and Lactation: Knowledge of Breastfeeding's Impact on Breast Cancer Risk Reduction and Its Influence on Breastfeeding Practices.

Introduction: The protective effects of breastfeeding against developing breast cancer are well known; however, it is unknown whether women are aware of this breastfeeding benefit. Research Aim/Questions: The aim of this investigation was to determine whether mothers received information about breast cancer risk reduction during breastfeeding counseling and whether this knowledge affected their decision to initiate and sustain breastfeeding. Materials and Methods: The survey was conducted at The Ohio State University Comprehensive Cancer Center with women aged 18-50 who had at least one live birth. Participants were recruited through primary care practice and a national clinical research registry. Results: Six hundred sixty-seven (92%) of the 724 respondents breastfed. Over half of them (56%), that is, 407 women (60.4% Caucasian, 46.9% African American), were aware before their most recent childbirth that breastfeeding reduced the risk of breast cancer. Of the 407 women, 36.4% said this knowledge affected their decision to breastfeed. Of the 39 who did not breastfeed, 23 women (59.0%) responded that awareness of risk reduction would have influenced their decision to breastfeed. Only 120 of 724 respondents (16.6%) received this information from healthcare providers. Women with this knowledge breastfed longer than those without this knowledge (13.2 versus 9.3 months; p < 0.001). More Caucasian women (76.4%) breastfed any one child for more than 6 months compared with African American women (63.2%; p = 0.011; chi-squared test). Conclusion: While several factors affect the initiation and duration of breastfeeding, this study demonstrates that knowledge of association between breastfeeding and breast cancer risk reduction may influence breastfeeding practices. Our study illustrates the need for improved counseling for mothers by healthcare providers regarding this benefit.

Abstract C57: Knowledge of breastfeeding to reduce breast cancer risk

Abstract Background: Increasing evidence suggests that higher parity and lack of breastfeeding associates strongly with the risk of developing the aggressive triple-negative breast cancer (TNBC). There is a 25-50% reduction in risk of developing TNBC in women who have breastfed &amp;gt;4-6 months when compared to parous women who have never breastfed. Higher rates of breastfeeding and lower incidence of BC observed in native African women support this postulate. Observational studies and recent national statistics indicate that the prevalence of breastfeeding is markedly low among African-American women (AAW) (58.9%) compared to Caucasian women (CW) (75.2%). Due to the remarkable health and economic benefit of breastfeeding, we investigated whether patients received information about breast cancer risk reduction as part of breastfeeding counseling and whether this knowledge affected participants' decision to initiate and sustain breastfeeding. Methods: A cross-sectional survey study was conducted from September 2016 to June 2017 at The Ohio State University Comprehensive Cancer Center (OSUCCC) on women aged 18-50 who had at least one live-born child. Participants completed an electronic survey that included demographic information and details of breastfeeding history. Recruitment occurred via primary care secure patient portal electronic messaging (MyChart) and an online national clinical research registry (Research Match). Summary statistics were used to describe responses. Wilcoxon Rank Sum test was used to compare length of breastfeeding. Results: A total of 724 women (496 CW and 152 AAW and 76 unknown) completed the online survey; 503 responses through Research Match, 197 through MyChart, and 24 unknown. 92% of those who responded had breastfed. 56% (60.7% Caucasians and 46.1% AA) of women said they were aware breastfeeding reduced the risk of cancer. Of those who were aware of the risk, 36.4% said that this knowledge affected their decision to breastfeed. Of the 39 who did not breastfeed, 23 (59.0%) said being aware of this risk would have influenced their decision. Only 16.6% of women reported they received this information from health care providers; others were informed through magazines and Internet. The mean length of breastfeeding among women who were aware of this benefit was significantly longer than the women who were not aware (13.2 months vs 9.3 months, respectively, p&amp;lt;0.001). 39.5% of AAW breastfed any one child for less than 6 months compared to 28% of CW. A greater percentage of women with a high school degree or below breastfed any one child for less than 6 months (59.0%) compared to women with some college or higher (30.1%). Most women (66.3%) went back to the workforce within the first year of their most recent birth, and 39.2% of women marked returning to work as a barrier to breastfeeding. Conclusions: Our study showed that there are disparities between AAW and CW in the knowledge that breastfeeding reduces the risk of breast cancer and in the duration of breast feeding. In addition, we showed that increased knowledge impacts decision-making regarding breastfeeding. Hence, development of culturally relevant communication strategies, especially in AAW, can impact initiation and maintenance of breastfeeding, and ultimately result in aggressive breast cancer reduction. Citation Format: Akaansha Ganju, Anupama Suresh, Julie Stephens, Marilly Palettas, Diana Burke, Laura Miles, Maryam Lustberg, Seuli Brill, Bhuvaneswari Ramaswamy. Knowledge of breastfeeding to reduce breast cancer risk [abstract]. In: Proceedings of the Tenth AACR Conference on the Science of Cancer Health Disparities in Racial/Ethnic Minorities and the Medically Underserved; 2017 Sep 25-28; Atlanta, GA. Philadelphia (PA): AACR; Cancer Epidemiol Biomarkers Prev 2018;27(7 Suppl):Abstract nr C57.

Collective quality improvement in the paediatric cardiology acute care unit: establishment of the Pediatric Acute Care Cardiology Collaborative (PAC3).

Collaborative quality improvement and learning networks have amended healthcare quality and value across specialities. Motivated by these successes, the Pediatric Acute Care Cardiology Collaborative (PAC3) was founded in late 2014 with an emphasis on improving outcomes of paediatric cardiology patients within cardiac acute care units; acute care encompasses all hospital-based inpatient non-intensive care. PAC3 aims to deliver higher quality and greater value care by facilitating the sharing of ideas and building alignment among its member institutions. These aims are intentionally aligned with the work of other national clinical collaborations, registries, and parent advocacy organisations. The mission and early work of PAC3 is exemplified by the formal partnership with the Pediatric Cardiac Critical Care Consortium (PC4), as well as the creation of a clinical registry, which links with the PC4 registry to track practices and outcomes across the entire inpatient encounter from admission to discharge. Capturing the full inpatient experience allows detection of outcome differences related to variation in care delivered outside the cardiac ICU and development of benchmarks for cardiac acute care. We aspire to improve patient outcomes such as morbidity, hospital length of stay, and re-admission rates, while working to advance patient and family satisfaction. We will use quality improvement methodologies consistent with the Model for Improvement to achieve these aims. Membership currently includes 36 centres across North America, out of which 26 are also members of PC4. In this report, we describe the development of PAC3, including the philosophical, organisational, and infrastructural elements that will enable a paediatric acute care cardiology learning network.

Identification of potential organ donors after aneurysmal subarachnoid hemorrhage in a population-based neurointensive care in Eastern Finland

BackgroundTo analyze the organ donation action in population-based neurointensive care of acute aneurysmal subarachnoid hemorrhage (aSAH) and to seek factors that would improve the identification of potential organ donors (PODs) and increase the donor conversion rate (DCR) after aSAH.MethodsThe Kuopio Intracranial Aneurysm Database, prospective since 1995, includes all aSAH patients admitted to the Kuopio University Hospital (KUH) from its defined Eastern Finnish catchment population. We analyzed 769 consecutive acute aSAH patients from 2005 to 2015, including their data from the Finnish Transplantation Unit and the national clinical registries. We analyzed PODs vs. actual donors among the 145 (19%) aSAH patients who died within 14 days of admission. Finland had implemented the national presumed consent (opt-out) within the study period in the end of 2010.ResultsWe retrospectively identified 83 (57%) PODs while only 49 (34%) had become actual donors (total DCR 59%); the causes for non-donorship were 15/34 (44%) refusals of consent, 18/34 (53%) medical contraindications for donation, and 1/34 (3%) failure of recognition. In 2005–2010, there were 11 refusals by near relatives with DCR 52% (29/56) and only three in 2011–2015 with DCR 74% (20/27). Severe condition on admission (Hunt and Hess grade IV or V) independently associated with the eventual POD status.ConclusionsNearly 20% of all aSAH patients acutely admitted to neurointensive care from a defined catchment population died within 14 days, almost half from cardiopulmonary causes at a median age of 69 years. Of all aSAH patients, 11% were considered as potential organ donors (PODs). Donor conversion rate (DCR) was increased from 52 to 74% after the national presumed consent (opt-out). Implicitly, DCR among aSAH patients could be increased by admitting them to the intensive care regardless of dismal prognosis for the survival, along a dedicated organ donation program for the catchment population.

Tu1140 REGIONAL VARIATIONS AND TRENDS IN QUALITY INDICATOR (QI) PERFORMANCE IN BARRETT’S ESOPHAGUS (BE): RESULTS FROM A POPULATION-BASED STUDY USING A NATIONAL BENCHMARKING REGISTRY

QIs in BE have been defined with the goal of improving patient outcomes. While adherence to the Seattle biopsy protocol (4-quadrant q2 cm) and surveillance intervals in non-dysplastic BE patients (NDBE) of 3-5 yrs are proposed QIs, population-based data addressing regional variations are not available. Using a national benchmarking clinical registry, to evaluate regional variation in adherence to the Seattle biopsy protocol and adherence to recommended surveillance intervals in NDBE and low-grade dysplasia (LGD). We analyzed data from the GI Quality Improvement Consortium (GIQuIC) Registry, a national data repository of endoscopy quality measures. Upper endoscopy data include procedure indication, demographics, endoscopy findings, and pathology results. EGD records from 1/2012-9/2017 were assessed. Patients (pts) with an indication of BE screening or surveillance, or an endoscopic finding of BE, were included. Adherence to Seattle protocol was defined by dividing the BE length by number of pathology jars, with a ratio of ≤2.0 with rounding down (lenient definition) or rounding up (stringent definition) for odd BE lengths considered adherent. Adherence to surveillance for NDBE was calculated as the proportion recommended to undergo EGD between 3-5 yrs (non-adherent if EGD recommended at 3 months–2 yrs from the index EGD) for NDBE and the proportion recommended an EGD at ≤1 year for LGD. Cochran-Armitage test for trend was applied to detect improvement in adherence. 786,712 EGDs were assessed, and 58,709 (7.5%) EGDs in 53,541 pts met inclusion criteria [mean age 61.3 yrs (SD 12.6), 60.4% male, 90.2% Caucasian]. Majority of cases were performed by GIs (92.3%) with propofol (78.7%), and represented 263 practices nationwide and 1457 unique providers. Distribution of cases based on US census region was: Northeast (n=14735, 27.6%), South (n=16376, 30.7%), Midwest (n=10,068, 18.8%) and West (n=12,152, 22.8%). Mean BE length was 2.3 cm (SD 2.3). No significant regional variations were noted in demographics, proportion of pts undergoing biopsies and confirmed BE and BE pts diagnosed with dysplasia (Table 1). There are marked variations in adherence with Seattle protocol by region (Table 2), with the highest rates of adherence noted in the Northeast and the lowest in the Midwest. In time-trend analysis, there was an improvement in adherence rates in the Midwest and a decline in the South. Among NDBE pts, non-adherence rates with the 3-yr surveillance endoscopy threshold ranged from 24-33% with the highest rates in the Northeast (Table 2). Endoscopists in the Northeast are most likely to be compliant with adherence to the Seattle biopsy protocol, but least likely to be compliant with recommended surveillance intervals. Further research to understand the factors influencing non-adherence to guidelines is warranted.Tabled 1Table 1: Regional variations in patient demographics and endoscopy-based variablesVariableNortheastSouthMidwestWestOverallDemographics (patient-based)Mean age, yrs (SD)61.2 (12.6)61.5 (12.4)60.9 (13.0)61.4 (12.5)61.3 (12.6)Males (n,%)8772 (59.5%)9921 (60.6%)6188 (61.4%)7350 (60.4%)32,346 (60.4%)Caucasians (n,%)89.9%89.2%93.1%89.4%90.2%Endoscopy-based variablesGIs*13,198 (95.1%)15,406 (89.8%)9272 (91.7%)11,671 (93.6%)49,654 (92.3%)Propofol sedation6475 (83%)4775 (79.6%)3283 (65.1%)5686 (83%)20,264 (78.7%)Adverse event rate0.01%0.02%0.02%0.03%0.02%Mean BE length, cm, SD2.05 (1.97)2.4 (2.38)2.5 (2.46)2.3 (2.44)2.3 (2.3)Proportion of patients with biopsies (n, %)15,792 (97.3%)16,594 (92.7%)10,007 (90.3%)12,332 (92.9%)54,943 (93.6%)Confirmed BE (n, %)8413 (55%)8745 (54.9%)5709 (57.5%)7012 (56.8%)29,978 (55.8%)Pathology results (n, %)NDBE7311 (92.2%)7561 (91.7%)4782 (88.5%)6202 (92.7%)25,945 (91.5%)IND/LGD499 (6.3%)565 (6.8%)506 (9.3%)376 (5.6%)1951 (6.8%)HGD113 (1.4%)117 (1.4%)111 (2.1%)107 (1.6%)449 (1.6%) Open table in a new tab

Pilot for the Australian Breast Device Registry (ABDR): a national opt-out clinical quality registry for breast device surgery

PurposeTo establish a pilot clinical quality registry (CQR) to monitor the quality of care and device performance for breast device surgery in Australia.ParticipantsAll patients having breast device surgery from contributing...

Improving quality through clinical registries in urology.

In this review, we highlight the use of clinical registries for quality improvement and research purposes in urology. We focus on national and regional clinical database registries, such as the National Surgical Quality Improvement Programme, the Cancer of the Prostate Strategic Urologic Research Endeavor, the Michigan Urological Surgery Improvement collaborative and the American Urological Association Quality Registry programme. It is widely known that claims-based and institutional databases are limited in their capacity to provide granular, real-time data for quality improvement purposes. As a result, clinical registries have emerged as an attractive alternative given their ability to capture large amounts of data across networks of health records. Another added benefit of Federally Qualified Clinical Data Registries (QCDRs) is the ability to meet emerging Medicare quality reporting standards, such as Physician Quality Reporting System and Meaningful Use. Despite the enthusiasm for QCDRs in the field of urology, however, myriad challenges remain in their implementation and widespread adoption including integration of existing health-information technology infrastructure, the accurate measurement of quality measures and the availability of clinically relevant quality measures in subspecialty practices. Quality measurement and improvement have become important aspects of modern clinical practice. Advances in health information technology have ushered in new tools, such as clinical registries, which simultaneously improve the quality of scientific research and clinical care while assisting eligible professionals in meeting federally mandated reporting requirements.

59 Are type 2 myocardial infarctions clouding the minap databases mortality data?

BackgroundThe Myocardial Ischemia National Audit Project (MINAP) is a national clinical registry of the management of Myocardial Infarctions (MIs) and Acute Coronary Syndromes. It was established in 1998 to allow...

Predictors of the effectiveness of accreditation on hospital performance: A nationwide stepped-wedge study.

To identify predictors of the effectiveness of hospital accreditation on process performance measures. A multi-level, longitudinal, stepped-wedge, nationwide study. All patients admitted for acute stroke, heart failure, ulcers, diabetes, breast cancer and lung cancer at Danish hospitals. The Danish Healthcare Quality Programme that was designed to create a framework for continuous quality improvement. Changes in week-by-week trends of hospitals' process performance measures during the study period of 269 weeks prior to, during and post-accreditations. Process performance measures were based on 43 different processes of care obtained from national clinical quality registries. Analyses were stratified according to condition, type of care (i.e. treatment, diagnostics, secondary prevention and patient monitoring) and hospital characteristics (i.e. university affiliation, location, size, experience with accreditation and accreditation compliance). A total of 1 624 518 processes of care were included. The impact of accreditation differed across the conditions. During accreditation, heart failure and breast cancer showed less improvement than other disease areas. Across all conditions, diagnostic processes improved less rapidly than other types of processes. However, after stratifying the data by hospital characteristics, process performance measures improved more uniformly. In respect of the measures that had an unsatisfactory level of quality, the processes related to diabetes, diagnostics and patient monitoring all responded to accreditation and showed an increased improvement during the preparatory work. Hospital characteristics were not found to be predictors for the effects of accreditation, whereas conditions and types of care to some extent predicted the effectiveness.

Contemporary Trends in Oral Anticoagulant Prescription in Atrial Fibrillation Patients at Low to Moderate Risk of Stroke After Guideline-Recommended Change in Use of the CHADS2 to the CHA2DS2-VASc Score for Thromboembolic Risk Assessment: Analysis From the National Cardiovascular Data Registry's Outpatient Practice Innovation and Clinical Excellence Atrial Fibrillation Registry.

Use of the CHA2DS2-VASc score instead of the CHADS2 score for thromboembolic risk stratification and initiation of oral anticoagulation (OAC) was recommended in the 2014 American Heart Association/American College of Cardiology/Heart Rhythm Society atrial fibrillation (AF) guidelines. We sought to define the proportion of patients with AF qualifying for and receiving OAC in contemporary practice by applying the CHA2DS2-VASc score to patients with a low CHADS2 score. Among patients with AF enrolled in the American College of Cardiology National Cardiovascular Data Registry's outpatient Practice Innovation and Clinical Excellence registry (2008-2014) CHADS2 score of 0 or 1, we calculated the impact of adoption of the CHA2DS2-VASc score on the proportion of patients with an indication for OAC. We examined trends in prescription of OAC overall, direct OAC (dabigatran/rivaroxaban/apixaban), and multivariable associations between clinical characteristics and OAC use. Of 346 068 patients with AF aged 65±12 years, 61% were men and 65% were white. In total, 24% of those with CHADS2=0 and 81% of those with a CHADS2=1 were reclassified as having a definite indication for OAC (CHA2DS2-VASc score ≥2). OAC use increased from 37% to 48% during the study period, and direct OAC use increased from 5% to 30%. Increasing CHA2DS2-VASc score (odds ratio, 2.07; 95% confidence interval, 1.97-2.19 for score of 4 versus 0) and rhythm control strategy (odds ratio, 1.34; 95% confidence interval, 1.30-1.39) were associated with increased OAC use. Adoption of the CHA2DS2-VASc score reclassifies 64.5% of patients with AF with low CHADS2 scores into a class I indication for OAC prescription. Overall OAC prescription increased between 2011 and 2014.

The Maternal Quality Improvement Program: A Clinical Data-Driven National Registry for Maternity Care.

Advancing the quality and safety of maternity care should be data-driven. Defining a standard set of clinical data elements, across electronic health record platforms and facilities, could accelerate performance measurement, benchmarking, and identification of better practices. In 2014, the American College of Obstetricians and Gynecologists and the American Society of Anesthesiologists launched the Maternal Quality Improvement Program, a data-driven national clinical registry for maternity care. Having an agreed-on set of discrete data elements related to labor and delivery will set the stage for analysis of this care. Through the use of clinical performance measures and data quality metrics, the Maternal Quality Improvement Program will provide an opportunity for health care providers to better understand the overall quality and safety of the maternity care provided within their institution.

Registry-Based Prospective, Active Surveillance of Medical-Device Safety

BackgroundThe process of assuring the safety of medical devices is constrained by reliance on voluntary reporting of adverse events. We evaluated a strategy of prospective, active surveillance of a national clinical registry to monitor the safety of an implantable vascular-closure device that had a suspected association with increased adverse events after percutaneous coronary intervention (PCI).MethodsWe used an integrated clinical-data surveillance system to conduct a prospective, propensity-matched analysis of the safety of the Mynx vascular-closure device, as compared with alternative approved vascular-closure devices, with data from the CathPCI Registry of the National Cardiovascular Data Registry. The primary outcome was any vascular complication, which was a composite of access-site bleeding, access-site hematoma, retroperitoneal bleeding, or any vascular complication requiring intervention. Secondary safety end points were access-site bleeding requiring treatment and postprocedural blood transfusion.ResultsWe analyzed data from 73,124 patients who had received Mynx devices after PCI procedures with femoral access from January 1, 2011, to September 30, 2013. The Mynx device was associated with a significantly greater risk of any vascular complication than were alternative vascular-closure devices (absolute risk, 1.2% vs. 0.8%; relative risk, 1.59; 95% confidence interval [CI], 1.42 to 1.78; P<0.001); there was also a significantly greater risk of access-site bleeding (absolute risk, 0.4% vs. 0.3%; relative risk, 1.34; 95% CI, 1.10 to 1.62; P=0.001) and transfusion (absolute risk, 1.8% vs. 1.5%; relative risk, 1.23; 95% CI, 1.13 to 1.34; P<0.001). The initial alerts occurred within the first 12 months of monitoring. Relative risks were greater in three prespecified high-risk subgroups: patients with diabetes, those 70 years of age or older, and women. All safety alerts were confirmed in an independent sample of 48,992 patients from April 1, 2014, to September 30, 2015.ConclusionsA strategy of prospective, active surveillance of a clinical registry rapidly identified potential safety signals among recipients of an implantable vascular-closure device, with initial alerts occurring within the first 12 months of monitoring. (Funded by the Food and Drug Administration and others.)

Sex differences in mortality and morbidity following repair of intact abdominal aortic aneurysms

ObjectiveMedicare studies have shown increased perioperative mortality in women compared with men following endovascular and open abdominal aortic aneurysm (AAA) repair. However, a recent regional study of high-volume centers, adjusting for anatomy but limited in sample size, did not show sex to be predictive of worse outcomes. This study aimed to evaluate sex differences after intact AAA repair in a national clinical registry. MethodsThe targeted vascular module of the National Surgical Quality Improvement Program was queried to identify patients undergoing endovascular aneurysm repair (EVAR) or open repair for intact, infrarenal AAA from 2011 to 2014. Univariate analysis was performed using the Fisher exact test and Mann-Whitney test. Multivariable logistic regression was used to account for differences in comorbidities, aneurysm details, and operative characteristics. ResultsWe identified 6661 patients (19% women) who underwent intact AAA repair (87% EVAR; 83% women vs 88% men; P < .001). Women were older (median age, 76 vs 73 years; P < .001), had smaller aneurysms (median, 5.4 vs 5.5 cm; P < .001), and had more chronic obstructive pulmonary disease (22% vs 17%; P < .001). Among patients undergoing EVAR, women had longer operative times (median, 138 [interquartile range, 103-170] vs 131 [106-181] minutes; P < .01) and more often underwent renal (6.3% vs 4.1%; P < .01) and lower extremity (6.6% vs 3.8%; P < .01) revascularization. After open repair, women had shorter operative time (215 [177-304] vs 226 [165-264] minutes; P = .02), but women less frequently underwent lower extremity revascularization (3.1% vs 8.2%; P = .03). Thirty-day mortality was higher in women after EVAR (3.2% vs 1.2%; P < .001) and open repair (8.0% vs 4.0%; P = .04). After adjusting for repair type, age, aneurysm diameter, and comorbidities, female sex was independently associated with mortality (odds ratio [OR], 1.7; 95% confidence interval [CI], 1.1-2.6; P = .02) and major complications (OR, 1.4; CI, 1.1-1.7; P < .01) after intact AAA repair. However, after adjusting for aortic size index rather than for aortic diameter, the association between female sex and mortality (OR, 1.5; CI, 0.98-2.4; P = .06) and major complications (OR, 1.1; CI, 0.9-1.4; P = .24) was reduced. ConclusionsWomen were at higher risk for 30-day death and major complications after intact AAA repair. Some of this disparity may be explained by differences in aortic size index, which should be further evaluated to determine the ideal threshold for repair.