Background The study was conducted to demonstrate improved survival (30-day mortality) after the introduction of an emergency endovascular therapy protocol for ruptured abdominal aortic aneurysms ...(rAAA). Numerous authors have successfully demonstrated reduced mortality in patients with rAAA using endovascular techniques. Comparison of endovascular aneurysm repair (EVAR) with open repair for rAAA may be misleading, however, because EVAR cannot be performed on all patients, and selection bias may explain the superior performance of any given surgical or endovascular strategy. We developed a model to predict mortality in patients before the introduction of EVAR (preprotocol population), applied this model to predict 30-day mortality among prospective patients (postprotocol population), and compared observed vs expected results. Methods We assessed 126 patients with rAAA. Primary outcome was 30-day mortality. Potential confounding variables were age, sex, presurgical lowest recorded systolic blood pressure (SBP), and glomerular filtration rate (GFR). A logistic regression model incorporating significant confounders was used to evaluate changes in 30-day mortality for all patients with rAAA after introduction of the EVAR protocol. Separate logistic regressions were done to compare 30-day mortality for preprotocol vs patients receiving EVAR and preprotocol vs patients receiving postprotocol open repair. Cumulative sum (CUSUM) analysis was used to assess shifts in the performance of the rAAA program over time. Results Significant confounders were SBP, absence of SBP, and GFR. Logistic regression found evidence of lower mortality after the protocol was introduced, 17.9% vs 30.0% (odds ratio OR, 0.385; 95% confidence interval CI, 0.141 to 0.981; P = .046). Comparison of all open repairs (preprotocol and postprotocol) and EVAR demonstrated decreased risk for EVAR of 5.0% vs 28.3% (OR, 0.109; 95% CI, 0.013 to 0.906; P = .0084). Unstable patients (SBP ≤80) showed a trend towards improved survival with EVAR relative to open repair (14.3% vs 56.0%, P = .061). Comparison of preprotocol surgery with open repair after the introduction of the protocol found no evidence of a difference between mortality rates for the open procedures—30.0% (preprotocol) vs 25.0% (postprotocol; OR, 0.688; 95% CI, 0.335 to 1.415, P = .3031)—demonstrating that the improved performance observed with CUSUM analysis was related to the introduction of the EVAR protocol. Conclusion Our predictive model using “weighted” CUSUM analysis (a measure of performance over time) demonstrated that a predefined strategy of management of rAAA that includes EVAR is associated with improved ( P < .05) mortality. Unstable patients with rAAA may be particularly benefited by EVAR and should not be excluded from repair. Appropriate patients with rAAA who are undergoing treatment in experienced vascular centers should be offered EVAR as the treatment of choice.
To derive a clinical decision guide (CDG) to identify patients best suited for cervical diagnostic facet joint blocks.
Prospective cohort study.
Pain management center.
Consecutive patients with neck ...pain (N=125) referred to an interventional pain management center were approached to participate.
Subjects underwent a standardized testing protocol, performed by a physiotherapist, prior to receiving diagnostic facet joint blocks. All subjects received the reference standard diagnostic facet joint block protocol, namely controlled medial branch blocks (MBBs). The physicians performing the MBBs were blinded to the local anesthetic used and findings of the clinical tests.
Multivariate regression analyses were performed in the derivation of the CDGs. Sensitivity, specificity, positive and negative likelihood ratios, and 95% confidence intervals (CIs) were calculated for the index tests and CDGs.
A CDG involving the findings of the manual spinal examination (MSE), palpation for segmental tenderness (PST), and extension-rotation (ER) test demonstrated a specificity of 84% (95% CI, 77-90) and a positive likelihood ratio of 4.94 (95% CI, 2.8-8.2). Sensitivity of the PST and MSE were 94% (95% CI, 90-98) and 92% (95% CI, 88-97), respectively. Negative findings on the PST were associated with a negative likelihood ratio of .08 (95% CI, .03-.24).
MSE, PST, and ER may be useful tests in identifying patients suitable for diagnostic facet joint blocks. Further research is needed to validate the CDGs prior to their routine use in clinical practice.
Despite evidence that epilepsy surgery is more effective than medical therapy, significant delays between seizure intractability and surgery exist. We aimed to develop a new Web-based methodology to ...assist physicians in identifying patients who might benefit from an epilepsy surgery evaluation.
The RAND/UCLA appropriateness method was used. Clinical scenarios were developed based on eligibility criteria from previously published surgical series. Thirteen national experts rated the scenarios for their appropriateness for an epilepsy surgery evaluation based on published evidence. All scenarios were rerated after a face-to-face meeting following a modified Delphi process. Appropriate scenarios were rerated for necessity to determine referral priority.
Of the final 2646 scenarios, 20.6% (n = 544) were appropriate, 17.2% (n = 456) uncertain, and 61.5% (n = 1626) inappropriate for a surgical evaluation. Of the appropriate cases, 55.9% (n = 306) were rated as very high priority. Not attempting AED treatment was always rated as inappropriate for a referral. Trial of 2 AEDs was usually rated as appropriate unless seizure-free or not fully investigated Based on these data, a Web-based decision tool (www.epilepsycases.com) was created.
Using the available evidence through 2008 and expert consensus, we developed a Web-based decision tool that provides a guide for determining candidacy for epilepsy surgery evaluations. The tool needs clinical validation, and will be updated and revised regularly. This rendition of the tool is most appropriate for those over age 12 years with focal epilepsy. The Rand/UCLA appropriate methodology might be considered in the development of guidelines in other areas of epilepsy care.
Allocation of donor livers for transplantation in most regions is based on the Model for End-Stage Liver Disease (MELD) or MELD-sodium (MELDNa). Our objective was to assess revisions to MELD and ...MELDNa that include serum albumin for predicting waiting list mortality.
Adults registered for liver transplantation in the United States (2002-2007) were identified from the United Network for Organ Sharing (UNOS) database. Cox regression was used to determine the association between serum albumin and 3-month mortality, and to derive revised MELD and MELDNa scores incorporating albumin ('MELD-albumin' and '5-variable MELD 5vMELD').
Among 40,393 patients, 9% died and 24% underwent transplantation within 3 months of listing. For serum albumin concentrations between 1.0 and 4.0 g/dL, a linear, inverse relationship was observed between albumin and 3-month mortality (adjusted hazard ratio per 1 g/dL reduction in albumin: 1.44; 95% CI 1.35-1.54). The c-statistics for 3-month mortality of MELD-albumin and MELD were 0.913 and 0.896, respectively (P<0.001); 5vMELD was superior to MELDNa (c-statistics 0.922 vs. 0.912, P<0.001). The potential benefit of 5vMELD was greatest in patients with low MELD (<15). Among low MELD patients who died, 27% would have gained ≥10 points with 5vMELD over MELD versus only 4-7% among low MELD survivors and high MELD (≥15) candidates (P<0.0005).
Modification of MELD and MELDNa to include serum albumin is associated with improved prediction of waiting list mortality. If validated and shown to be associated with reduced mortality, adoption of 5vMELD as the basis for liver allograft allocation may improve outcomes on the liver transplant waiting list.
To measure the intra- and interrater reliability of select standardized clinical tests used for the assessment of patients with axial neck pain referred for diagnostic facet joint blocks.
...Single-group, repeated-measures study.
Tertiary interventional pain management center.
Consecutive patients with persistent neck pain, referred to a tertiary interventional pain management center, were approached to participate. Fifty-six patients consented to participate in the study.
Subjects underwent a standardized clinical testing protocol, performed by 2 physiotherapists, before receiving diagnostic facet joint blocks. Subjects were examined twice by 1 assessor for the determination of the intrarater reliability of the testing protocol, and again by a second assessor for determination of interrater reliability.
Intraclass correlation coefficients (ICCs), kappa coefficients, and 95% confidence intervals were calculated to determine the intra- and interrater reliability for cervical range of motion (ROM; 6 directions), extension-rotation (ER) test, manual spinal examination (MSE), and palpation for paraspinal tenderness (PST) from C2 through C7.
For intrarater reliability, kappa coefficients ranged from .51 to .88 for the ER test, MSE, and PST, and ICCs ranged from .91 to .97 for ROM. For interrater reliability, kappa coefficients ranged from .74 to .96 for the ER test, MSE, and PST, and ICCs ranged from .90 to .95 for ROM.
The standardized clinical tests exhibited moderate to substantial reliability in patients with axial neck pain referred for diagnostic facet joint blocks. The data justify the incorporation of these tests into a clinical prediction model to screen patients before referral for diagnostic facet blocks.
Objective. To describe obstetrical and neonatal outcomes in Canadian women with rheumatoid arthritis (RA) or systemic lupus erythematosus (SLE). Methods. An administrative database of ...hospitalizations for neonatal delivery (1998–2009) from Calgary, Alberta was searched to identify women with RA (38 pregnancies) or SLE (95 pregnancies), and women from the general population matched on maternal age and year of delivery (150 and 375 pregnancies, resp.). Conditional logistic regression was used to calculate odds ratios (OR) for maternal and neonatal outcomes, adjusting for parity. Results. Women with SLE had increased odds for preeclampsia or eclampsia (SLE OR 2.16 (95% CI 1.10–4.21; P=0.024); RA OR 2.33 (95% CI 0.76–7.14; P=0.138)). Women with SLE had increased odds for cesarean section after adjustment for dysfunctional labour, instrumentation and previous cesarean section (OR 3.47 (95% CI 1.67–7.22; P<0.001)). Neonates born to women with SLE had increased odds of prematurity (SLE OR 6.17 (95% CI 3.28–11.58; P<0.001); RA OR 2.66 (95% CI 0.90–7.84; P=0.076)) and of SGA (SLE OR 2.54 (95% CI 1.42–4.55; P=0.002); RA OR 2.18 (95% CI 0.84–5.66; P=0.108)) after adjusting for maternal hypertension. There was no excess risk of congenital defects in neonates. Conclusions. There is increased obstetrical and neonatal morbidity in Canadian women with RA or SLE.
Time-to-event curves are routinely presented in the medical literature. The most widely used method is the Kaplan–Meier (K-M) method, but this analysis approach may not be appropriate when an ...analysis focuses on time-to-first event in scenarios where there are competing events. We compared K-M methods applying various censoring approaches with the lesser-known “cumulative incidence competing risks” (CICR) method in an analysis of competing events.
A registry containing data on 21,624 patients undergoing cardiac catheterization was analyzed. Time to coronary artery bypass grafting (CABG) was assessed in an analysis for which percutaneous coronary intervention and death were competing events. Time-to-CABG curves were calculated using the “K-M censor all method,” “K-M censor death only method,” “K-M ignore all method,” and the CICR method.
One-year CABG rates calculated for the K-M “censor all,” “censor death only,” and “ignore all” methods were 28.8%, 22.8%, and 22.4%, respectively compared to the “actual” rate of 20.8%. For the CICR method, the corresponding 1-year rate was identical to the “actual” rate.
In situations with competing risks, and where an analysis focuses on first events, the CICR method is most appropriate, as K-M methods will tend to overestimate event rates.
Risk adjustment and mortality prediction in studies of critical care are usually performed using acuity of illness scores, such as Acute Physiology and Chronic Health Evaluation II (APACHE II), which ...emphasize physiological derangement. Common risk adjustment systems used in administrative datasets, like the Charlson index, are entirely based on the presence of co-morbid illnesses. The purpose of this study was to compare the discriminative ability of the Charlson index to the APACHE II in predicting hospital mortality in adult multisystem ICU patients.
This was a population-based cohort design. The study sample consisted of adult (>17 years of age) residents of the Calgary Health Region admitted to a multisystem ICU between April 2002 and March 2004. Clinical data were collected prospectively and linked to hospital outcome data. Multiple regression analyses were used to compare the performance of APACHE II and the Charlson index.
The Charlson index was a poor predictor of mortality (C = 0.626). There was minimal difference between a baseline model containing age, sex and acute physiology score (C = 0.74) and models containing either chronic health points (C = 0.76) or Charlson index variations (C = 0.75, 0.76, 0.77). No important improvement in prediction occurred when the Charlson index was added to the full APACHE II model (C = 0.808 to C = 0.813).
The Charlson index does not perform as well as the APACHE II in predicting hospital mortality in ICU patients. However, when acuity of illness scores are unavailable or are not recorded in a standard way, the Charlson index might be considered as an alternative method of risk adjustment and therefore facilitate comparisons between intensive care units.
Catheter ablation is a promising therapy for atrial fibrillation (AF), but its utility in patients with left ventricular systolic dysfunction (LVSD) is uncertain. The objectives of this study were to ...perform a systematic review and meta-analysis of randomized and observational studies comparing the rates of recurrent AF, atrial tachycardia (AT), and complications after AF catheter ablation in those with versus without LVSD and to summarize the impact of catheter ablation on the left ventricular ejection fraction. Seven observational studies and 1 randomized trial were included (total n = 1,851). Follow-up ranged from 6 to 27 months. In those with LVSD, 28% to 55% were free of AF or AT on follow-up after 1 AF catheter ablation, increasing to 64% to 96% after a mean of 1.4 procedures. The relative risk for recurrent AF or AT in those with versus without LVSD was 1.5 (95% confidence interval 1.2 to 1.8, p <0.001) after 1 procedure and 1.2 (95% confidence interval 0.9 to 1.5, p = 0.2) after multiple procedures. No difference in complications was observed in patients with (3.5%) versus without (2.5%) heart failure (p = 0.55). After catheter ablation, those with LVSD experienced a pooled absolute improvement in the left ventricular ejection fraction of 0.11 (95% confidence interval 0.07 to 0.14, p <0.001). In conclusion, patients with and without LVSD had similar risk for recurrent AF or AT after catheter ablation, but repeat procedures were required more often in those with LVSD. Significant improvements in left ventricular ejection fractions after ablation were observed in those with LVSD. Randomized trials are needed given the limitations of present data.
Liver cirrhosis is a leading cause of morbidity, premature mortality and acute care utilization in patients with digestive disease. In the province of Alberta, hospital readmission rates for patients ...with cirrhosis are estimated at 44% at 90 days. For hospitalized patients, multiple care gaps exist, the most notable stemming from i) the lack of a structured approach to best practice care for cirrhosis complications, ii) the lack of a structured approach to broader health needs and iii) suboptimal preparation for transition of care into the community. Cirrhosis Care Alberta (CCAB) is a 4-year multi-component pragmatic trial which aims to address these gaps. The proposed intervention is initiated at the time of hospitalization through implementation of a clinical information system embedded electronic order set for delivering evidence-based best practices under real-world conditions. The overarching objective of the CCAB trial is to demonstrate effectiveness and implementation feasibility for use of the order set in routine patient care within eight hospital sites in Alberta.
A mixed methods hybrid type I effectiveness-implementation design will be used to evaluate the effectiveness of the order set intervention. The primary outcome is a reduction in 90-day cumulative length of stay. Implementation outcomes such as reach, adoption, fidelity and maintenance will also be evaluated alongside other patient and service outcomes such as readmission rates, quality of care and cost-effectiveness. This theory-based trial will be guided by Normalization Process Theory, Consolidated Framework on Implementation Research (CFIR) and the Reach-Effectiveness-Adoption-Implementation-Maintenance (RE-AIM) Framework.
The CCAB project is unique in its breadth, both in the comprehensiveness of the multi-component order set and also for the breadth of its roll-out. Lessons learned will ultimately inform the feasibility and effectiveness of this approach in "real-world" conditions as well as adoption and adaptation of these best practices within the rest of Alberta, other provinces in Canada, and beyond.
ClinicalTrials.gov: NCT04149223, November 4, 2019.
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