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Background: Controlling escalating costs of hip (THA) and knee arthroplasty (TKA) without compromising quality of care has created the need for innovative system reorganization to inform sustainable solutions.Questions/purposes: The purpose of this study was to inform estimates of the value of THA and TKA by determining: (1) the data sources data required to obtain costs across the care continuum; (2) the data required for different analytical perspectives; and (3) the relative costs across the continuum of care.Methods: Within the context of a pragmatic randomized controlled trial comparing alternative care pathways, we captured healthcare resource use: (1) 12 months before surgery; (2) inpatient; (3) acute recovery; and (4) long-term recovery 3 and 12 months postsurgery. We established a standardized costing model to reflect both the healthcare payer and patient perspectives.Results: Multiple data sources from regional health authorities, administrative databases, and patient questionnaire were required to estimate costs across the care continuum. Inpatient and acute care costs were approximately 60% of the total with the remaining 40% incurred 12 months presurgery and 12 months postsurgery. Regional health authorities bear close to 60%, and patient costs are approximately 30% of the mean total costs, most of which were incurred after the acute inpatient stay.Conclusions: To fully understand the value of an orthopaedic intervention such as THA and TKA, a broader perspective than one limited to the payer should be considered using a standardized measurement framework over a relevant time horizon and from multiple viewpoints to reflect the substantial patient burden and support sustainable improvement over the care continuum.Level Of Evidence: Level III, economic and decision analyses study. See Guidelines for Authors for a complete description of levels of evidence. [ABSTRACT FROM AUTHOR]

Context: Adjusted survival curves are often presented in medical research articles. The most commonly used method for calculating such curves is the mean of covariates method, in which average values of covariates are entered into a proportional hazards regression equation. Use of this method is widespread despite published concerns regarding the validity of resulting curves.Objective: To compare the mean of covariates method to the less widely used corrected group prognosis method in an analysis evaluating survival in patients with and without diabetes. In the latter method, a survival curve is calculated for each level of covariates, after which an average survival curve is calculated as a weighted average of the survival curves for each level of covariates.Design, Setting, and Patients: Analysis of cohort study data from 11 468 Alberta residents undergoing cardiac catheterization between January 1, 1995, and December 31, 1996.Main Outcome Measures: Crude and risk-adjusted survival for up to 3 years after cardiac catheterization in patients with vs without diabetes, analyzed by the mean of covariates method vs the corrected group prognosis method.Results: According to the mean of covariates method, adjusted survival at 1044 days was 94.1% and 94.9% for patients with and without diabetes, respectively, with misleading adjusted survival curves that fell above the unadjusted curves. With the corrected group prognosis method, the corresponding survival values were 91.3% and 92.4%, with curves that fell more appropriately between the unadjusted curves.Conclusions: Misleading adjusted survival curves resulted from using the mean of covariates method of analysis for our data. We recommend using the corrected group prognosis method for calculating risk-adjusted curves. [ABSTRACT FROM AUTHOR]

Purpose: The ABCDEF bundle may improve delirium outcomes among intensive care unit (ICU) patients, however population-based studies are lacking. In this study we evaluated effects of a quality improvement initiative based on the ABCDEF bundle in adult ICUs in Alberta, Canada., Material and Methods: We conducted a pre-post, registry-based clinical trial, analysed using interrupted time series methodology. Outcomes were examined via segmented linear regression using mixed effects models. The main data source was a population-based electronic health record., Results: 44,405 consecutive admissions (38,400 unique patients) admitted to 15 general medical/surgical and/or neurologic adult ICUs between 2014 and 2019 were included. The proportion of delirium days per ICU increased from 30.24% to 35.31% during the pre-intervention period. After intervention implementation it decreased significantly (bimonthly decrease of 0.34%, 95%CI 0.18-0.50%, p < 0.01) from 33.48% (95%CI 29.64-37.31%) in 2017 to 28.74% (95%CI 25.22-32.26%) in 2019. The proportion of sedation days using midazolam demonstrated an immediate decrease of 7.58% (95%CI 4.00-11.16%). There were no significant changes in duration of invasive ventilation, proportion of partial coma days, ICU mortality, or potential adverse events., Conclusions: An ABCDEF delirium initiative was implemented on a population-basis within adult ICUs and was successful at reducing the prevalence of delirium., Competing Interests: Declaration of competing interest The authors are unaware of any conflicts of interest., (Copyright © 2024 The Authors. Published by Elsevier Inc. All rights reserved.)

Objective: To examine the association between lifetime lactation and risk and duration of frequent vasomotor symptoms (VMS)., Design: Prospective cohort., Setting: USA, 1995-2008., Sample: 2356 parous midlife women in the Study of Women's Health Across the Nation., Methods: Lifetime lactation was defined as the duration of breastfeeding across all births in months. We used generalised estimating equations to analyse risk of frequent VMS and Cox regression to analyse duration of frequent VMS in years., Main Outcome Measures: Frequent VMS (hot flashes and night sweats) were measured annually for 10 years, defined as occurring ≥6 days in the past 2 weeks., Results: Overall, 57.1% of women reported hot flashes and 43.0% reported night sweats during follow-up. Lifetime lactation was inversely associated with hot flashes plateauing at 12 months of breastfeeding (6 months: adjusted odds ratio [AOR] 0.85, 95% confidence interval (CI) 0.75-0.96; 12 months: AOR 0.78, 95% CI 0.65-0.93) and was inversely associated with night sweats in a downward linear fashion (6 months: AOR 0.93, 95% CI 0.81-1.08; 18 months: AOR 0.82, 95% CI 0.67-1.02; 30 months: AOR 0.73, 95% CI 0.56-0.97). Lifetime lactation was associated with shorter duration of hot flashes and night sweats in a quadratic (bell-shaped) fashion. The association was strongest at 12-18 months of breastfeeding and significant for hot flashes (6 months: adjusted hazard ratio [AHR] 1.35, 95% CI 1.11-1.65; 18 months: AHR 1.54, 95% CI 1.16-2.03; 30 months: AHR 1.18, 95% CI 0.83-1.68)., Conclusions: Longer lifetime lactation is associated with decreased risk and duration of frequent VMS., (© 2022 John Wiley & Sons Ltd.)

Objective: The aim of this study was to examine the association between duration of lifetime lactation and age at natural menopause., Methods: In this prospective cohort study, we analyzed parous premenopausal women in the multiethnic Study of Women's Health Across the Nation who were followed approximately annually for 10 years (1995-2008). Lifetime lactation was defined as the duration of breastfeeding across all births in months. Age at natural menopause was defined as age in years after 12 consecutive months of amenorrhea after the final menstrual period for no other reported cause. We used Cox proportional hazard models to analyze time to natural menopause with age as the underlying time scale. Multivariable models controlled for education, race/ethnicity, parity, smoking, body mass index, and oral contraceptive use., Results: Among 2,377 women, 52.6% experienced natural menopause during follow-up and reported a valid final menstrual period date. The small, crude association between lifetime lactation up to 24 months and later age at natural menopause attenuated to nonsignificance in adjusted models (6 months: adjusted hazard ratio [AHR], 0.96; 95% confidence interval (CI), 0.87-1.06; 12 months: AHR, 0.95; 95% CI, 0.82-1.11; 18 months: AHR, 0.96; 95% CI, 0.82-1.13; 24 months: AHR, 0.99; 95% CI, 0.84-1.16)., Conclusions: Duration of lifetime lactation was not associated with age at natural menopause after controlling for sociodemographic characteristics., Competing Interests: Financial disclosure/conflicts of interest: A.K.S. has received honoraria from Pfizer and Bio-Syent and has received grant funding from Pfizer. P.D.F. is a shareholder and consultant and receives payment in convertible notes from ViTAA medical devices. N.V.S. and E.A.B. have no disclosures to report., (Copyright © 2022 by The North American Menopause Society.)

Importance: Contrast-associated acute kidney injury (AKI) is a common complication of coronary angiography and percutaneous coronary intervention (PCI) that has been associated with high costs and adverse long-term outcomes., Objective: To determine whether a multifaceted intervention is effective for the prevention of AKI after coronary angiography or PCI., Design, Setting, and Participants: A stepped-wedge, cluster randomized clinical trial was conducted in Alberta, Canada, that included all invasive cardiologists at 3 cardiac catheterization laboratories who were randomized to various start dates for the intervention between January 2018 and September 2019. Eligible patients were aged 18 years or older who underwent nonemergency coronary angiography, PCI, or both; who were not undergoing dialysis; and who had a predicted AKI risk of greater than 5%. Thirty-four physicians performed 7820 procedures among 7106 patients who met the inclusion criteria. Participant follow-up ended in November 2020., Interventions: During the intervention period, cardiologists received educational outreach, computerized clinical decision support on contrast volume and hemodynamic-guided intravenous fluid targets, and audit and feedback. During the control (preintervention) period, cardiologists provided usual care and did not receive the intervention., Main Outcomes and Measures: The primary outcome was AKI. There were 12 secondary outcomes, including contrast volume, intravenous fluid administration, and major adverse cardiovascular and kidney events. The analyses were conducted using time-adjusted models., Results: Of the 34 participating cardiologists who were divided into 8 clusters by practice group and center, the intervention group included 31 who performed 4327 procedures among 4032 patients (mean age, 70.3 [SD, 10.7] years; 1384 were women [32.0%]) and the control group included 34 who performed 3493 procedures among 3251 patients (mean age, 70.2 [SD, 10.8] years; 1151 were women [33.0%]). The incidence of AKI was 7.2% (310 events after 4327 procedures) during the intervention period and 8.6% (299 events after 3493 procedures) during the control period (between-group difference, -2.3% [95% CI, -0.6% to -4.1%]; odds ratio [OR], 0.72 [95% CI, 0.56 to 0.93]; P = .01). Of 12 prespecified secondary outcomes, 8 showed no significant difference. The proportion of procedures in which excessive contrast volumes were used was reduced to 38.1% during the intervention period from 51.7% during the control period (between-group difference, -12.0% [95% CI, -14.4% to -9.4%]; OR, 0.77 [95% CI, 0.65 to 0.90]; P = .002). The proportion of procedures in eligible patients in whom insufficient intravenous fluid was given was reduced to 60.8% during the intervention period from 75.1% during the control period (between-group difference, -15.8% [95% CI, -19.7% to -12.0%]; OR, 0.68 [95% CI, 0.53 to 0.87]; P = .002). There were no significant between-group differences in major adverse cardiovascular events or major adverse kidney events., Conclusions and Relevance: Among cardiologists randomized to an intervention including clinical decision support with audit and feedback, patients undergoing coronary procedures during the intervention period were less likely to develop AKI compared with those treated during the control period, with a time-adjusted absolute risk reduction of 2.3%. Whether this intervention would show efficacy outside this study setting requires further investigation., Trial Registration: ClinicalTrials.gov Identifier: NCT03453996.

Background: It is unknown how frequently damage control (DC) laparotomy is used across trauma centers in different countries. We conducted a cross-sectional survey of trauma centers in the United States, Canada, and Australasia to study variations in use of the procedure and predictors of more frequent use of DC laparotomy., Methods: A self-administered, electronic, cross-sectional survey of trauma centers in the United States, Canada, and Australasia was conducted. The survey collected information about trauma center and program characteristics. It also asked how often the trauma program director estimated DC laparotomy was performed on injured patients at that center on average over the last year. Multivariable logistic regression was used to identify predictors of a higher reported frequency of use of DC laparotomy., Results: Of the 366 potentially eligible trauma centers sent the survey, 199 (51.8%) trauma program directors or leaders responded [United States = 156 (78.4%), Canada = 26 (13.1%), and Australasia = 17 (8.5%)]. The reported frequency of use of DC laparotomy was highly variable across trauma centers. DC laparotomy was used more frequently in level-1 than level-2 or -3 trauma centers. Further, high-volume level-1 centers used DC laparotomy significantly more often than lower volume level-1 centers (p = 0.02). Nearly half (48.4%) of high-volume volume level-1 trauma centers reported using the procedure at least once weekly. Significant adjusted predictors of more frequent use of DC laparotomy included country of origin [odds ratio (OR) for the United States vs. Canada = 7.49; 95% confidence interval (CI) 1.39-40.27], level-1 verification status (OR = 6.02; 95% CI 2.01-18.06), and the assessment of a higher number of severely injured (Injury Severity Scale score > 15) patients (OR per-100 patients = 1.62; 95% CI 1.20-2.18) and patients with penetrating injuries (OR per-5% increase = 1.27; 95% CI 1.01-1.58) in the last year., Conclusions: The reported frequency of use of DC laparotomy was highly variable across trauma centers. Those centers that most need to evaluate the benefit-to-risk ratio of using DC laparotomy in different scenarios may include high-volume, level-1 trauma centers, particularly those that often manage penetrating injuries., (© 2021. The Author(s).)

Background: Although damage control (DC) surgery is widely assumed to reduce mortality in critically injured patients, survivors often suffer substantial morbidity, suggesting that it should only be used when indicated. The purpose of this systematic review was to determine which indications for DC have evidence that they are reliable and/or valid (and therefore in which clinical situations evidence supports use of DC or that DC improves outcomes)., Methods: We searched 11 databases (1950-April 1, 2019) for studies that enrolled exclusively civilian trauma patients and reported data on the reliability (consistency of surgical decisions in a given clinical scenario) or content (surgeons would perform DC in that clinical scenario or the indication predicted use of DC in practice), construct (were associated with poor outcomes), or criterion (were associated with improved outcomes when DC was conducted instead of definitive surgery) validity for suggested indications for DC surgery or DC interventions., Results: Among 34,979 citations identified, we included 36 cohort studies and three cross-sectional surveys in the systematic review. Of the 59 unique indications for DC identified, 10 had evidence of content validity [e.g., a major abdominal vascular injury or a packed red blood cell (PRBC) volume exceeding the critical administration threshold], nine had evidence of construct validity (e.g., unstable patients with combined abdominal vascular and pancreas gunshot injuries or an iliac vessel injury and intraoperative acidosis), and six had evidence of criterion validity (e.g., penetrating trauma patients requiring > 10 U PRBCs with an abdominal vascular and multiple abdominal visceral injuries or intraoperative hypothermia, acidosis, or coagulopathy). No studies evaluated the reliability of indications., Conclusions: Few indications for DC surgery or DC interventions have evidence supporting that they are reliable and/or valid. DC should be used with respect for the uncertainty regarding its effectiveness, and only in circumstances where definitive surgery cannot be entertained.

Background: Although opioid analgesics are not generally recommended for treatment of knee osteoarthritis (OA), they are frequently used. We sought to determine the association between medical comorbidities and self-reported opioid analgesic use in these patients., Methods: This cross-sectional study recruited patients referred to two provincial hip and knee clinics in Alberta, Canada for consideration of total knee arthroplasty. Standardized questionnaires assessed demographic (age, gender, income, education, social support, smoking status) and clinical (pain, function, total number of troublesome joints) characteristics, comorbid medical conditions, and non-surgical OA management participants had ever used or were currently using. Multivariable Poisson regression with robust estimate of the standard errors assessed the association between comorbid medical conditions and current opioid use, controlling for potential confounders., Results: 2,127 patients were included: mean age 65.4 (SD 9.1) years and 59.2% female. Currently used treatments for knee OA were: 57.6% exercise and/or physiotherapy, 61.1% NSAIDs, and 29.8% opioid analgesics. In multivariable regression, controlling for potential confounders, comorbid hypertension (RR 1.18, 95% CI 1.02-1.37), gastrointestinal disease (RR 1.31, 95% CI 1.07-1.60), depressed mood (RR 1.25, 95% CI 1.05-1.48) and a higher number of troublesome joints (RR 1.04 per joint, 95% CI 1.00-1.09) were associated with opioid use, with no association found with having ever used recommended non-opioid pharmacological or non-pharmacological treatments., Conclusions: In a large cohort of patients with knee OA, of 12 comorbidities assessed, comorbid hypertension, gastrointestinal disease, and depressed mood were associated with current use of opioid analgesics, in addition to total burden of troublesome joints. Improved guidance on the management of painful OA in the setting of common comorbidities is warranted., (Copyright © 2020 The Author(s). Published by Elsevier Ltd.. All rights reserved.)

Introduction: Pregnancy-related medical complications are associated with a 2- to 5-fold increased risk of preterm birth (PTB), but the nature of this etiologic relation in context with maternal factors remains poorly understood. Previous studies have generally treated maternal age as a confounder but overlooked its potential as an effect modifier, whereby the magnitude of the effect of complications on PTB could differ significantly across age groups. We investigated whether advanced maternal age (≥35 years) modified the association between pregnancy complications and PTB, and compared population-attributable fractions of PTB from complications in women older vs younger than 35 years., Material and Methods: We analyzed population-based, cross-sectional data from the Alberta Discharge Abstract Database for women aged 18-50 years with singleton live births in hospital between 2014 and 2017 (n = 152 246). Complications were preeclampsia, gestational diabetes, and placental disorders identified using diagnostic codes. Outcomes were spontaneous (sPTB) or iatrogenic (iPTB) PTB before 37 weeks of gestation. We estimated risk ratios and risk differences using modified Poisson and log binomial regression, respectively, adjusting for confounders (pregnancy history, comorbidities). Population-attributable fractions estimates were calculated from risk ratios. Age modification was tested using interaction terms and Z-tests., Results: Prevalence of advanced maternal age was 19.2%. Pregnancy complications and s/iPTB were more common among women aged ≥35 years. Age modified the risk of PTB from preeclampsia only, with risk differences of 9.9% (95% CI 7.2%-12.6%) in older women vs 6.1% (95% CI 4.8%-7.4%) in younger women (P-interaction = 0.012) for sPTB, and 29.5% (95% CI 26.0%-33.1%) vs 20.8% (95% CI 18.9%-22.6%, P-interaction <0.001) for iPTB. Population-attributable fractions of s/iPTB types for all complications were consistently 2%-5% larger in women aged ≥35 years, and significantly larger for preeclampsia (sPTB: 5.1% vs 2.7%, P = 0.002; iPTB: 18.8% vs 14.0%, P < 0.001) and placental disorders (sPTB: 12.5% vs 8.7%, P < 0.001; iPTB: 13.2% vs 8.9%, P < 0.001)., Conclusions: Of the pregnancy complications studied, advanced maternal age only modified the association between PTB and preeclampsia, such that older women with preeclampsia have a higher risk for s/iPTB than younger counterparts. Pregnancy complications contribute to a sizable proportion of PTBs in Alberta, especially among women aged ≥35 years. Findings may inform clinical risk assessment and population-level policy targeting PTB., (© 2019 Nordic Federation of Societies of Obstetrics and Gynecology.)

Objectives: The purpose of this study is to estimate the prevalence of comorbidities among people with osteoarthritis (OA) using administrative health data., Design: Retrospective cohort analysis., Setting: All residents in the province of Alberta, Canada registered with the Alberta Health Care Insurance Plan population registry., Participants: 497 362 people with OA as defined by 'having at least one OA-related hospitalization, or at least two OA-related physician visits or two ambulatory care visits within two years'., Primary Outcome Measures: We selected eight comorbidities based on literature review, clinical consultation and the availability of validated case definitions to estimate their frequencies at the time of diagnosis of OA. Sex-stratified age-standardised prevalence rates per 1000 population of eight clinically relevant comorbidities were calculated using direct standardisation with 95% CIs. We applied χ 2 tests of independence with a Bonferroni correction to compare the percentage of comorbid conditions in each age group., Results: 54.6% (n=2 71 794) of people meeting the OA case definition had at least one of the eight selected comorbidities. Females had a significantly higher rate of comorbidities compared with males (standardised rates ratio=1.26, 95% CI 1.25 to 1.28). Depression, chronic obstructive pulmonary disease (COPD) and hypertension were the most prevalent in both females and males after age-standardisation, with 40% of all cases having any combination of these comorbidities. We observed a significant difference in the percentage of comorbidities among age groups, illustrated by the youngest age group (<45 years) having the highest percentage of cases with depression (24.6%), compared with a frequency of 16.1% in those >65 years., Conclusions: Our findings highlight the high frequency of comorbidity in people with OA, with depression having the highest age-standardised prevalence rate. Comorbidities differentially affect females, and vary by age. These factors should inform healthcare programme and delivery., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Background: The life-course model of modifiable risk factors for dementia now recognizes managing hearing loss and addressing social isolation., Objective: To investigate the contribution and inter-relationship of hearing ability and behaviour change on cognitive ability., Methods: We present the preliminary findings from a prospective longitudinal study of 35 non-demented participants ages 60-93, recruited from community rehabilitation and acute-care programs of Geriatric Medicine, who underwent baseline hearing, behavioural, and cognitive testing., Results: After controlling for age and hearing impairment, the left ear Dichotic Digit Test (DDT) score accounted uniquely for 20% of the variance in MoCA Memory Index ( p = .016 with β = .598). Mild Behavioural Impairment (MBI) was highly prevalent, with 80% of older adults reporting at least one MBI symptom. People with hearing impairment had greater global MBI burden than people with normal hearing, especially in the domains of apathy and impulse dyscontrol; however, greater severity of hearing impairment was not associated with a higher number of neuropsychiatric symptoms (NPS)., Conclusions: Low left DDT contributed to lower memory index and greater MBI burden is associated with hearing impairment. Our findings demonstrate the value of early non-invasive hearing and behavioural assessments as part of dementia risk assessment in older adults., Competing Interests: CONFLICT OF INTEREST DISCLOSURES Zahinoor Ismail has received consultation/advisory board funding from Eli Lilly., (© 2019 Author(s). Published by the Canadian Geriatrics Society.)

Background: As it may be argued that many surgical interventions provide obvious patient benefits, formal, staged assessment of the efficacy and safety of surgical procedures has historically been and remains uncommon. The majority of innovative surgical procedures have therefore often been developed based on anatomical and pathophysiological principles in an attempt to better manage clinical problems., Main Body: In this manuscript, we sought to review and contrast the models for pharmaceutical and surgical innovation in North America, including their stages of development and methods of evaluation, monitoring, and regulation. We also aimed to review the present structure of academic surgery, the role of methodological experts and funding in conducting surgical research, and the current system of regulation of innovative surgical procedures. Finally, we highlight the influence that evidence and surgical history, education, training, and culture have on elective and emergency surgical decision-making. The above discussion is used to support the argument that the model used for assessment of innovative pharmaceuticals cannot be applied to that for evaluating surgical innovations. It is also used to support our position that although the evaluation and monitoring of innovative surgical procedures requires a rigorous, fit-for-purpose, and formal system of assessment to protect patient safety and prevent unexpected adverse health outcomes, it will only succeed if it is supported and championed by surgical practice leaders and respects surgical history, education, training, and culture., Conclusion: We conclude the above debate by providing a recommended approach to the evaluation, monitoring, and regulation of surgical innovations, which we hope may be used as a guide for all stakeholders involved in interpreting and/or conducting future surgical research.

Background: Severe complicated intra-abdominal sepsis (SCIAS) has high mortality, thought due in part to progressive bio-mediator generation, systemic inflammation, and multiple organ failure. Treatment includes early antibiotics and operative source control. At surgery, open abdomen management with negative-peritoneal-pressure therapy (NPPT) has been hypothesized to mitigate MOF and death, although clinical equipoise for this operative approach exists. The Closed or Open after Laparotomy (COOL) study (https://clinicaltrials.gov/ct2/show/NCT03163095) will prospectively randomize eligible patients intra-operatively to formal abdominal closure or OA with NPTT. We review the ethical basis for conducting research in SCIAS., Main Body: Research in critically ill incapacitated patients is important to advance care. Conducting research among SCIAS is complicated due to the severity of illness including delirium, need for emergent interventions, diagnostic criteria confirmed only at laparotomy, and obtundation from anaesthesia. In other circumstances involving critically ill patients, clinical experts have worked closely with ethicists to apply principles that balance the rights of patients whilst simultaneously permitting inclusion in research. In Canada, the Tri-Council Policy Statement-2 (TCPS-2) describes six criteria that permit study enrollment and randomization in such situations: (a) serious threat to the prospective participant requires immediate intervention; (b) either no standard efficacious care exists or the research offers realistic possibility of direct benefit; (c) risks are not greater than that involved in standard care or are clearly justified by prospect for direct benefits; (d) prospective participant is unconscious or lacks capacity to understand the complexities of the research; (e) third-party authorization cannot be secured in sufficient time; and (f) no relevant prior directives are known to exist that preclude participation. TCPS-2 criteria are in principle not dissimilar to other (inter)national criteria. The COOL study will use waiver of consent to initiate enrollment and randomization, followed by surrogate or proxy consent, and finally delayed informed consent in subjects that survive and regain capacity., Conclusions: A delayed consent mechanism is a practical and ethical solution to challenges in research in SCIAS. The ultimate goal of consent is to balance respect for patient participants and to permit participation in new trials with a reasonable opportunity for improved outcome and minimal risk of harm., Competing Interests: Competing interestsJLM is the Clinical Research Director for Innovative Trauma Care, San Antonio, Texas, and has consulted for the Canadian Forces, Acesco Company, Acelity Corporation, and SAM Medical Corporation. EEM reported consulting for Haemonetics, Instrumentation Laboratory, Stago, Humacyte, and Prytime, with all proceeds paid to the University of Colorado. AWK serves in the Canadian Forces Medical Services and has consulted for the Innovative Trauma Care and Acelity Corporations. The other authors declare that they have no competing interests.

Background: Information on an individual's risk for death following dialysis therapy initiation may inform the decision to initiate maintenance dialysis for older adults. We derived and validated a clinical risk prediction tool for all-cause mortality among older adults during the first 6 months of maintenance dialysis treatment., Study Design: Prediction model using retrospective administrative and clinical data., Setting & Participants: We linked administrative and clinical data to define a cohort of 2,199 older adults (age ≥ 65 years) in Alberta, Canada, who initiated maintenance dialysis therapy (excluding acute kidney injury) in May 2003 to March 2012., Candidate Predictors: Demographics, laboratory data, comorbid conditions, and measures of health system use., Outcomes: All-cause mortality within 6 months of dialysis therapy initiation., Analytical Approach: Predicted mortality by logistic regression with 10-fold cross-validation., Results: 375 (17.1%) older adults died within 6 months. We developed a 19-point risk score for 6-month mortality that included age 80 years or older (2 points), glomerular filtration rate of 10 to 14.9mL/min/1.73m 2 (1 point) or ≥15mL/min/1.73m 2 (3 points), atrial fibrillation (2 points), lymphoma (5 points), congestive heart failure (2 points), hospitalization in the prior 6 months (2 points), and metastatic cancer (3 points). Model discrimination (C statistic = 0.72) and calibration (Hosmer-Lemeshow χ 2 =10.36; P=0.2) were reasonable. As examples, a score < 5 equated to <25% of individuals dying in 6 months, whereas a score > 12 predicted that more than half the individuals would die in the first 6 months., Limitations: The tool has not been externally validated; thus, generalizability cannot be assessed., Conclusions: We used readily available clinical information to derive and internally validate a 7-variable tool to predict early mortality among older adults after dialysis therapy initiation. Following successful external validation, the tool may be useful as a clinical decision tool to aid decision making for older adults with kidney failure., (Copyright © 2016 National Kidney Foundation, Inc. Published by Elsevier Inc. All rights reserved.)

Background: Variation in use of damage control (DC) surgery across trauma centers may be partially driven by surgeon uncertainty as to when it is appropriately indicated. We sought to determine opinions of practicing surgeons on the appropriateness of published indications for trauma DC surgery., Study Design: We asked 384 trauma centers in the United States, Canada, and Australasia to nominate 1 to 3 surgeons at their center to participate in a survey about DC surgery. We then asked nominated surgeons their opinions on the appropriateness (benefit-to-harm ratio) of 43 literature-derived indications for use of DC surgery in adult civilian trauma patients., Results: In total, 232 (64.8%) trauma centers nominated 366 surgeons, of whom 201 (56.0%) responded. Respondents rated 15 (78.9%) preoperative and 23 (95.8%) intraoperative indications to be appropriate. Indications respondents agreed had the greatest expected benefit included a temperature <34°C, arterial pH <7.2, and laboratory-confirmed (international normalized ratio/prothrombin time and/or partial thromboplastin time >1.5 times normal) or clinically observed coagulopathy in the pre- or intraoperative setting; administration of >10 units of packed red blood cells; requirement for a resuscitative thoracotomy in the emergency department; and identification of a juxtahepatic venous injury or devascularized or destroyed pancreas, duodenum, or pancreaticoduodenal complex during operation. Ratings were consistent across subgroups of surgeons with different training, experience, and practice settings., Conclusions: We identified 38 indications that practicing surgeons agreed appropriately justified the use of DC surgery. Until further studies become available, these indications constitute a consensus opinion that can be used to guide practice in the current era of changing trauma resuscitation practices., (Copyright © 2016 American College of Surgeons. Published by Elsevier Inc. All rights reserved.)

Objectives: To characterize and evaluate indications for use of damage control (DC) surgery in civilian trauma patients., Background: Although DC surgery may improve survival in select, severely injured patients, the procedure is associated with significant morbidity, suggesting that it should be used only when appropriately indicated., Methods: Two investigators used an abbreviated grounded theory method to synthesize indications for DC surgery reported in peer-reviewed articles between 1983 and 2014 into a reduced number of named, content-characteristic codes representing unique indications. An international panel of trauma surgery experts (n = 9) then rated the appropriateness (expected benefit-to-harm ratio) of the coded indications for use in surgical practice., Results: The 1107 indications identified in the literature were synthesized into 123 unique pre- (n = 36) and intraoperative (n = 87) indications. The panel assessed 101 (82.1%) of these indications to be appropriate. The indications most commonly reported and assessed to be appropriate included pre- and intraoperative hypothermia (median temperature <34°C), acidosis (median pH <7.2), and/or coagulopathy. Others included 5 different injury patterns, inability to control bleeding by conventional methods, administration of a large volume of packed red blood cells (median >10 units), inability to close the abdominal wall without tension, development of abdominal compartment syndrome during attempted abdominal wall closure, and need to reassess extent of bowel viability., Conclusions: This study identified a comprehensive list of candidate indications for use of DC surgery. These indications provide a practical foundation to guide surgical practice while studies are conducted to evaluate their impact on patient care and outcomes.

Background: Vasovagal syncope (VVS) is a common problem associated with a poor quality of life, which improves when syncope frequency is reduced. Effective pharmacological therapies for VVS are lacking. Metoprolol is a β-adrenergic receptor antagonist that is ineffective in younger patients, but may benefit older (≥40 years) VVS patients. Given the limited therapeutic options, a placebo-controlled clinical trial of metoprolol for the prevention of VVS in older patients is needed., Structure of Study: The POST5 is a multicenter, international, randomized, placebo-controlled study of metoprolol in the prevention of VVS in patients ≥40 years old. The primary endpoint is the time to first recurrence of syncope. Patients will be randomized 1:1 to receive metoprolol 25 to 100 mg BID or matching placebo, and followed up for 1 year. Secondary end points include syncope frequency, presyncope, quality of life, and cost analysis. Primary analysis will be intention to treat, with a secondary on-treatment analysis., Power Calculations: A sample size of 222, split equally between the groups achieves 85% power to detect a hazard rate of 0.3561 when the event rates are 50% and 30% in the placebo and metoprolol arms. Allowing for 10% dropout, we propose to enroll 248 patients., Implications: This study will be the first adequately powered trial to determine whether metoprolol is effective in preventing VVS in patients ≥40 years. If effective, metoprolol may become the first line pharmacological therapy for these patients., (Copyright © 2016 Elsevier Inc. All rights reserved.)

Background: Although Kaplan-Meier survival analysis is commonly used to estimate the cumulative incidence of revision after joint arthroplasty, it theoretically overestimates the risk of revision in the presence of competing risks (such as death). Because the magnitude of overestimation is not well documented, the potential associated impact on clinical and policy decision-making remains unknown., Questions/purposes: We performed a meta-analysis to answer the following questions: (1) To what extent does the Kaplan-Meier method overestimate the cumulative incidence of revision after joint replacement compared with alternative competing-risks methods? (2) Is the extent of overestimation influenced by followup time or rate of competing risks?, Methods: We searched Ovid MEDLINE, EMBASE, BIOSIS Previews, and Web of Science (1946, 1980, 1980, and 1899, respectively, to October 26, 2013) and included article bibliographies for studies comparing estimated cumulative incidence of revision after hip or knee arthroplasty obtained using both Kaplan-Meier and competing-risks methods. We excluded conference abstracts, unpublished studies, or studies using simulated data sets. Two reviewers independently extracted data and evaluated the quality of reporting of the included studies. Among 1160 abstracts identified, six studies were included in our meta-analysis. The principal reason for the steep attrition (1160 to six) was that the initial search was for studies in any clinical area that compared the cumulative incidence estimated using the Kaplan-Meier versus competing-risks methods for any event (not just the cumulative incidence of hip or knee revision); we did this to minimize the likelihood of missing any relevant studies. We calculated risk ratios (RRs) comparing the cumulative incidence estimated using the Kaplan-Meier method with the competing-risks method for each study and used DerSimonian and Laird random effects models to pool these RRs. Heterogeneity was explored using stratified meta-analyses and metaregression., Results: The pooled cumulative incidence of revision after hip or knee arthroplasty obtained using the Kaplan-Meier method was 1.55 times higher (95% confidence interval, 1.43-1.68; p < 0.001) than that obtained using the competing-risks method. Longer followup times and higher proportions of competing risks were not associated with increases in the amount of overestimation of revision risk by the Kaplan-Meier method (all p > 0.10). This may be due to the small number of studies that met the inclusion criteria and conservative variance approximation., Conclusions: The Kaplan-Meier method overestimates risk of revision after hip or knee arthroplasty in populations where competing risks (such as death) might preclude the occurrence of the event of interest (revision). Competing-risks methods should be used to more accurately estimate the cumulative incidence of revision when the goal is to plan healthcare services and resource allocation for revisions.

Background: Sepsis has a high prevalence, mortality-rate and cost. Sepsis patients usually enter the hospital through the Emergency Department (ED). Process or structural issues related to care may affect outcome., Methods: Multi-centered retrospective observational cohort study using administrative databases to identify adult patients (> = 18 years) with sepsis and severe sepsis admitted to Alberta Health Services Calgary zone adult multisystem intensive care units (ICU) through the ED between January 1, 2006 and September 30, 2009. We examined the association between ICU occupancy and hospital outcome. We explored other associations of hospital outcome including the effect of ED wait time, admission from ED during weekdays versus weekends and ED admission during the day versus at night., Results: One thousand and seven hundred seventy patients were admitted to hospital via ED, 1036 (58.5 %) with sepsis and 734 (41.5 %) with severe sepsis. In patients with sepsis, ICU occupancy > 90 % was associated with an increase in hospital mortality even after adjusting for age, sex, triage level, Charlson index, time of first ED physician assessment and ICU admission. No differences in hospital mortality were found for patients who waited more than 7 h, were admitted during the day versus night or weekdays versus weekends., Conclusions: In patients with sepsis admitted via the ED, increased ICU occupancy was associated with higher in-hospital mortality.

Background: The use of abbreviated or damage control (DC) interventions may improve outcomes in severely injured patients when appropriately indicated. We sought to determine which indications for DC interventions have been most commonly reported in the peer-reviewed literature to date and evaluate the opinions of experts regarding the appropriateness (expected benefit-to-harm ratio) of the reported indications for use in practice., Methods: Two investigators used an abbreviated grounded theory method to synthesize indications for 16 different DC interventions reported in peer-reviewed articles between 1983 and 2014 into a reduced number of named, content-characteristic codes representing unique indications. For each indication code, an international panel of trauma surgery experts (n = 9) then rated the appropriateness of conducting the DC intervention of interest in an adult civilian trauma patient., Results: The 424 indications identified in the literature were synthesized into 101 unique indications. The panel assessed 12 (70.6%) of the coded indications for the 7 different thoracic, 47 (78.3%) for the 7 different abdominal/pelvic, and 18 (75.0%) for the 2 different vascular interventions to be appropriate for use in practice. These included indications for rapid lung-sparing surgery (pneumonorrhaphy, pulmonary tractotomy, and pulmonary wedge resection) (n = 1); pulmonary tractotomy (n = 3); rapid, simultaneously stapled pneumonectomy (n = 1); therapeutic mediastinal and/or pleural space packing (n = 4); temporary thoracic closure (n = 3); therapeutic perihepatic packing (n = 28); staged pancreaticoduodenectomy (n = 2); temporary abdominal closure (n = 12); extraperitoneal pelvic packing (n = 5); balloon catheter tamponade (n = 6); and temporary intravascular shunting (n = 11)., Conclusion: This study identified a list of candidate appropriate indications for use of 12 different DC interventions that were suggested by authors of peer-reviewed articles and assessed by a panel of independent experts to be appropriate. These indications may be used to focus future research and (in the interim) guide surgical practice while studies are conducted to evaluate their impact on patient outcomes.

Objective: To determine whether active negative pressure peritoneal therapy with the ABThera temporary abdominal closure device reduces systemic inflammation after abbreviated laparotomy., Background: Excessive systemic inflammation after abdominal injury or intra-abdominal sepsis is associated with poor outcomes., Methods: We conducted a single-center, randomized controlled trial. Forty-five adults with abdominal injury (46.7%) or intra-abdominal sepsis (52.3%) were randomly allocated to the ABThera (n = 23) or Barker's vacuum pack (n = 22). On study days 1, 2, 3, 7, and 28, blood and peritoneal fluid were collected. The primary endpoint was the difference in the plasma concentration of interleukin-6 (IL-6) 24 and 48 hours after temporary abdominal closure application., Results: There was a significantly lower peritoneal fluid drainage from the ABThera at 48 hours after randomization. Despite this, there was no difference in plasma concentration of IL-6 at baseline versus 24 (P = 0.52) or 48 hours (P = 0.82) between the groups. There was also no significant intergroup difference in the plasma concentrations of IL-1β, -8, -10, or -12 p70 or tumor necrosis factor α between these time points. The cumulative incidence of primary fascial closure at 90 days was similar between groups (hazard ratio, 1.6; 95% confidence interval, 0.82-3.0; P = 0.17). However, 90-day mortality was improved in the ABThera group (hazard ratio, 0.32; 95% confidence interval, 0.11-0.93; P = 0.04)., Conclusions: This trial observed a survival difference between patients randomized to the ABThera versus Barker's vacuum pack that did not seem to be mediated by an improvement in peritoneal fluid drainage, fascial closure rates, or markers of systemic inflammation., Trial Registration: ClinicalTrials.gov identifier NCT01355094.

Background: Variation in the use of damage control (DC) surgery across trauma centers may partially be driven by uncertainty as to when the procedure is indicated. We sought to scope the literature on DC surgery and DC interventions, identify their reported indications, and examine the content and evidence upon which they are based., Methods: We searched MEDLINE, EMBASE, PubMed, Scopus, Web of Science, and the Cochrane Library (1950-February 14, 2014) and the grey literature for original and nonoriginal citations reporting indications for DC surgery or DC interventions in civilian trauma patients., Results: Among 27,732 citations identified, we included 270 peer-reviewed articles in the scoping review. Of these, 156 (57.8%) represented original research, primarily (75.0%) cohort studies. The articles reported 1,099 indications for DC surgery and 418 indications for 15 different DC interventions. The majority of indications for DC interventions were for abdominal (56.5%) procedures, including therapeutic perihepatic packing (56.5%), temporary abdominal closure/open abdominal management (40.7%), and staged pancreaticoduodenectomy (2.8%). Most DC surgery indications were based on intraoperative findings (71.7%) and represented characteristics of the injured patient (94.5%), including their physiology (57.6%), injuries (38.9%), and/or the amount or type of resuscitation provided (14.3%). Others were dependent on characteristics of the treating surgeon (12.1%), the patient's physiologic response to trauma care (9.6%), and/or the trauma care environment (1.5%). Approximately half (49.5%) included a decision threshold (e.g., pH < X) and, while most (74.7%) were based on a single clinical finding/injury, 25.3% required the presence of multiple findings concurrently. Only 87 indications were evaluated in original research studies and only 9 by more than one study., Conclusion: The vast number, varying underlying content, and lack of original research relating to indications for DC suggests that substantial uncertainty exists around when the procedure is indicated and highlights the need to establish evidence-informed consensus indications.

Objective: To determine whether the reported clinical presentation of tension pneumothorax differs between patients who are breathing unassisted versus receiving assisted ventilation., Background: Animal studies suggest that the pathophysiology and physical signs of tension pneumothorax differ by subject ventilatory status., Methods: We searched electronic databases through to October 15, 2013 for observational studies and case reports/series reporting clinical manifestations of tension pneumothorax. Two physicians independently extracted clinical manifestations reported at diagnosis., Results: We identified 5 cohort studies (n = 310 patients) and 156 case series/reports of 183 cases of tension pneumothorax (n = 86 breathing unassisted, n = 97 receiving assisted ventilation). Hypoxia was reported among 43 (50.0%) cases of tension pneumothorax who were breathing unassisted versus 89 (91.8%) receiving assisted ventilation (P < 0.001). Pulmonary dysfunction progressed to respiratory arrest in 9.3% of cases breathing unassisted. As compared to cases who were breathing unassisted, the adjusted odds of hypotension and cardiac arrest were 12.6 (95% confidence interval, 5.8-27.5) and 17.7 (95% confidence interval, 4.0-78.4) times higher among cases receiving assisted ventilation. One cohort study reported that none of the patients with tension pneumothorax who were breathing unassisted versus 39.6% of those receiving assisted ventilation presented without an arterial pulse. In contrast to cases breathing unassisted, the majority (70.4%) of those receiving assisted ventilation who experienced hypotension or cardiac arrest developed these signs within minutes of clinical presentation., Discussion: The reported clinical presentation of tension pneumothorax depends on the ventilatory status of the patient. This may have implications for improving the diagnosis and treatment of this life-threatening disorder.

Background: Although health care providers utilize classically described signs and symptoms to diagnose tension pneumothorax, available literature sources differ in their descriptions of its clinical manifestations. Moreover, while the clinical manifestations of tension pneumothorax have been suggested to differ among subjects of varying respiratory status, it remains unknown if these differences are supported by clinical evidence. Thus, the primary objective of this study is to systematically describe and contrast the clinical manifestations of tension pneumothorax among patients receiving positive pressure ventilation versus those who are breathing unassisted., Methods/design: We will search electronic bibliographic databases (MEDLINE, PubMed, EMBASE, and the Cochrane Database of Systematic Reviews) and clinical trial registries from their first available date as well as personal files, identified review articles, and included article bibliographies. Two investigators will independently screen identified article titles and abstracts and select observational (cohort, case-control, and cross-sectional) studies and case reports and series that report original data on clinical manifestations of tension pneumothorax. These investigators will also independently assess risk of bias and extract data. Identified data on the clinical manifestations of tension pneumothorax will be stratified according to whether adult or pediatric study patients were receiving positive pressure ventilation or were breathing unassisted, as well as whether the two investigators independently agreed that the clinical condition of the study patient(s) aligned with a previously published tension pneumothorax working definition. These data will then be summarized using a formal narrative synthesis alongside a meta-analysis of observational studies and then case reports and series where possible. Pooled or combined estimates of the occurrence rate of clinical manifestations will be calculated using random effects models (for observational studies) and generalized estimating equations adjusted for reported potential confounding factors (for case reports and series)., Discussion: This study will compile the world literature on tension pneumothorax and provide the first systematic description of the clinical manifestations of the disorder according to presenting patient respiratory status. It will also demonstrate a series of methods that may be used to address difficulties likely to be encountered during the conduct of a meta-analysis of data contained in published case reports and series. PROSPERO registration number: CRD42013005826.

Background: Damage control laparotomy, or abbreviated initial laparotomy followed by temporary abdominal closure (TAC), intensive care unit resuscitation, and planned re-laparotomy, is frequently used to manage intra-abdominal bleeding and contamination among critically ill or injured adults. Animal data suggest that TAC techniques that employ negative pressure to the peritoneal cavity may reduce the systemic inflammatory response and associated organ injury. The primary objective of this study is to determine if use of a TAC dressing that affords active negative pressure peritoneal therapy, the ABThera Open Abdomen Negative Pressure Therapy System, reduces the extent of the systemic inflammatory response after damage control laparotomy for intra-abdominal sepsis or injury as compared to a commonly used TAC method that provides potentially less efficient peritoneal negative pressure, the Barker's vacuum pack., Methods/design: The Intra-peritoneal Vacuum Trial will be a single-center, randomized controlled trial. Adults will be intraoperatively allocated to TAC with either the ABThera or Barker's vacuum pack after the decision has been made by the attending surgeon to perform a damage control laparotomy. The study will use variable block size randomization. On study days 1, 2, 3, 7, and 28, blood will be collected. Whenever possible, peritoneal fluid will also be collected at these time points from the patient's abdomen or TAC device. Luminex technology will be used to quantify the concentrations of 65 mediators relevant to the inflammatory response in peritoneal fluid and plasma. The primary endpoint is the difference in the plasma concentration of the pro-inflammatory cytokine IL-6 at 24 and 48 h after TAC dressing application. Secondary endpoints include the differential effects of these dressings on the systemic concentration of other pro-inflammatory cytokines, collective peritoneal and systemic inflammatory mediator profiles, postoperative fluid balance, intra-abdominal pressure, and several patient-important outcomes, including organ dysfunction measures and mortality., Discussion: Results from this study will improve understanding of the effect of active negative pressure peritoneal therapy after damage control laparotomy on the inflammatory response. It will also gather necessary pilot information needed to inform design of a multicenter trial comparing clinical outcomes among patients randomized to TAC with the ABThera versus Barker's vacuum pack., Trial Registration: ClinicalTrials.gov identifier http://www.clicaltrials.gov/ct2/show/NCT01355094.

Objective: To compare the diagnostic accuracy of computed tomographic angiography (CTA) with digital subtraction angiography (DSA) for blunt cerebrovascular injury (BCVI) detection in trauma patients., Background: Controversy exists as to whether the diagnostic performance of CTA compares favorably with the reference-standard, DSA., Methods: We searched electronic databases (1950 to May 22, 2012), article bibliographies, conference proceedings (2008-2011), and clinical trial registries for studies comparing the accuracy of CTA with DSA for BCVI detection in trauma patients. Pooled estimates of sensitivity, specificity, and positive and negative likelihood ratios were calculated using bivariate random effects models., Results: Eight studies that examined 5704 carotid or vertebral arteries in 1426 trauma patients met inclusion criteria. The pooled sensitivity and specificity for BCVI detection with CTA versus DSA was 66% (95% CI, 49%-79%; I = 80.4%) and 97% (95% CI, 91%-99%; I = 94.6%), respectively. Corresponding pooled positive and negative likelihood ratios were 20.0 (95% CI, 6.9-58.4; I = 87.7%) and 0.35 (95% CI, 0.22-0.56; I = 74.9%), respectively. Although pooled sensitivity varied with the number of available CT slices, the training of interpreting radiologists, and in a pattern suggestive of differences in diagnostic threshold for judging CTA positivity, it remained 80% or less among studies that used scanners with 16 or more slices per rotation and where the CTA was read by neuroradiologists., Conclusions: Existing evidence suggests that the diagnostic performance of CTA varies considerably across studies, likely due to an implicit variation in diagnostic threshold across trauma centers. Moreover, although CTA appears to lack sensitivity to adequately rule out BCVI, it may be useful to rule in BCVI among trauma patients with a high pretest probability of injury.

Background: Vasovagal syncope is a common problem associated with a poor quality of life, which improves when the frequency of syncope is reduced. Effective pharmacological therapies for vasovagal syncope have been elusive. Midodrine is a pro-drug whose primary metabolite is an alpha-1 adrenoreceptor agonist. A few studies have suggested that it may be beneficial in syncope, but all have had significant methodological limitations. A placebo-controlled clinical trial of midodrine for the prevention of vasovagal syncope is needed., Structure of Study: The prevention of syncope trial IV (POST 4) is a multicenter, international, randomized, placebo-controlled study of midodrine in the prevention of vasovagal syncope. The primary end point is the time to first recurrence of syncope. Patients will be randomized 1:1 to receive midodrine 10-30 mg/day or matching placebo, and followed for 1 year. Secondary end points include syncope frequency, presyncope, and quality of life. Primary analysis will be performed with an intention-to-treat approach, with a secondary on-treatment analysis., Power Calculations: A total sample size of 112, split equally between the two groups, achieves 85 % power to detect a 50 % relative risk reduction when the event rates are 55 and 27.5 % in the placebo and midodrine arms. Allowing for 20 % dropout, we propose to enroll 140 patients., Registration: POST 4 is registered with http://www.clinicaltrials.gov (NCT01456481)., Implications: This study will be the first adequately powered trial to determine whether midodrine is effective in preventing vasovagal syncope. If it is effective, then midodrine may become the first-line pharmacological therapy for this condition.

Objective: Total hip replacement (THR) and total knee replacement (TKR) (arthroplasty) surgery for end-stage osteoarthritis (OA) are ideal candidates for optimization through an algorithmic care pathway. Using a comparative effectiveness study design, we compared the effectiveness of a new clinical pathway (NCP) featuring central intake clinics, dedicated inpatient resources, care guidelines and efficiency benchmarks vs. the standard of care (SOC) for THR or TKR., Methods: We compared patients undergoing primary THR and TKR who received surgery in NCP vs. SOC in a randomised controlled trial within the trial timeframe. 1,570 patients (1,066 SOC and 504 NCP patients) that underwent surgery within the study timeframe from urban and rural practice settings were included. The primary endpoint was improvement in Western Ontario and McMaster University osteoarthritis index (WOMAC) overall score over 12 months post-surgery. Secondary endpoints were improvements in the physical function (PF) and bodily pain (BP) domains of the Short Form 36 (SF-36)., Results: NCP patients had significantly greater improvements from baseline WOMAC scores compared to SOC patients after adjusting for covariates (treatment effect=2.56; 95% confidence interval (CI) [1.10-4.01]). SF-36 BP scores were significantly improved for both hip and knee patients in the NCP (treatment effect=3.01, 95% CI [0.70-5.32]), but SF-36 PF scores were not. Effects of the NCP were more pronounced in knee patients., Conclusion: While effect sizes were small compared with major effects of the surgery itself, an evidence-informed clinical pathway can improve health related quality of life (HRQoL) of hip and knee arthroplasty patients with degenerative joint disorder in routine clinical practice for up to 12 months post-operatively. CLINICALTRIALS.GOV IDENTIFIER: NCT00277186., (Copyright © 2012 Osteoarthritis Research Society International. Published by Elsevier Ltd. All rights reserved.)

Objectives: 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., Methods: 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., Results: 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., Conclusions: 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.

Background: There is variation in cardiac catheterization utilization across jurisdictions. Previous work from Alberta, Canada, showed no evidence of a plateau in the yield of high-risk disease at cardiac catheterization rates as high as 600 per 100,000 population suggesting that the optimal rate is higher. This work aims 1) To determine if a previously demonstrated linear relationship between the yield of high-risk coronary disease and cardiac catheterization rates persists with contemporary data and 2) to explore whether the linear relationship exists in other jurisdictions., Methods: Detailed clinical information on all patients undergoing cardiac catheterization in 3 Canadian provinces was available through the Alberta Provincial Project for Outcomes Assessment in Coronary Heart (APPROACH) disease and partner initiatives in British Columbia and Nova Scotia. Population rates of catheterization and high-risk coronary disease detection for each health region in these three provinces, and age-adjusted rates produced using direct standardization. A mixed effects regression analysis was performed to assess the relationship between catheterization rate and high-risk coronary disease detection., Results: In the contemporary Alberta data, we found a linear relationship between the population catheterization rate and the high-risk yield. Although the yield was slightly less in time period 2 (2002-2006) than in time period 1(1995-2001), there was no statistical evidence of a plateau. The linear relationship between catheterization rate and high-risk yield was similarly demonstrated in British Columbia and Nova Scotia and appears to extend, without a plateau in yield, to rates over 800 procedures per 100,000 population., Conclusions: Our study demonstrates a consistent finding, over time and across jurisdictions, of linearly increasing detection of high-risk CAD as population rates of cardiac catheterization increase. This internationally-relevant finding can inform country-level planning of invasive cardiac care services.

Background: Although bilateral internal thoracic artery (BITA) grafting in coronary artery bypass grafting (CABG) is associated with low morbidity and good long-term results, controversy exists about the age after which BITA grafting is no longer beneficial. We sought to determine if such an age cutoff point exists., Methods: The study cohort consisted of 5,601 consecutive patients from a cardiac surgery registry who underwent isolated CABG (1,038 [19%] BITA grafts, 4,029 [72%] single internal thoracic artery [SITA] grafts, 534 [10%] vein-only grafts) between 1995 and 2008. A Cox model was used to compare survival by use of bilateral, single, or no internal thoracic artery (ITA) grafts, adjusting for baseline clinical and demographic characteristics., Results: Mean follow-up was 7.1 years. Patients undergoing BITA grafting had the lowest 1-year mortality (2.4% versus 4.3% SITA grafting and 8.2% vein-only grafting; p < 0.0001). Relative to SITA grafting, a crude survival benefit of 54% existed for BITA grafting (hazard ratio [HR] 0.46; 95% confidence interval [CI], 0.37 to 0.57; p < 0.0001) with worse survival for vein-only grafts (HR, 1.16; 95% CI, 0.99 to 1.37; p = 0.07). After adjustment, the benefit of BITA grafting was no longer statistically significant (HR, 0.87; 95% CI, 0.69 to 1.08; p = 0.2). However age may be an effect modifier: a spline analysis plotting HR (BITA grafting versus SITA grafting) against age suggested a potential survival advantage associated with BITA grafting in patients younger than 69.9 years., Conclusions: Bilateral internal thoracic artery grafting is a reasonable revascularization strategy in suitable patients up to age 70 years. As benefits of arterial grafting become more obvious over time, a longer period of follow-up will be needed to confirm the advantage of a BITA grafting strategy. In the meantime the BITA grafting advantage for patients older than 70 years is not clear., (Copyright © 2011 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.)

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.

Background: Administrative data are widely used to study health systems and make important health policy decisions. Yet little is known about the influence of coder characteristics on administrative data validity in these studies. Our goal was to describe the relationship between several measures of validity in coded hospital discharge data and 1) coders' volume of coding (> or = 13,000 vs. <13,000 records), 2) coders' employment status (full- vs. part-time), and 3) hospital type., Methods: This descriptive study examined 6 indicators of face validity in ICD-10 coded discharge records from 4 hospitals in Calgary, Canada between April 2002 and March 2007. Specifically, mean number of coded diagnoses, procedures, complications, Z-codes, and codes ending in 8 or 9 were compared by coding volume and employment status, as well as hospital type. The mean number of diagnoses was also compared across coder characteristics for 6 major conditions of varying complexity. Next, kappa statistics were computed to assess agreement between discharge data and linked chart data reabstracted by nursing chart reviewers. Kappas were compared across coder characteristics., Results: 422,618 discharge records were coded by 59 coders during the study period. The mean number of diagnoses per record decreased from 5.2 in 2002/2003 to 3.9 in 2006/2007, while the number of records coded annually increased from 69,613 to 102,842. Coders at the tertiary hospital coded the most diagnoses (5.0 compared with 3.9 and 3.8 at other sites). There was no variation by coder or site characteristics for any other face validity indicator. The mean number of diagnoses increased from 1.5 to 7.9 with increasing complexity of the major diagnosis, but did not vary with coder characteristics. Agreement (kappa) between coded data and chart review did not show any consistent pattern with respect to coder characteristics., Conclusions: This large study suggests that coder characteristics do not influence the validity of hospital discharge data. Other jurisdictions might benefit from implementing similar employment programs to ours, e.g.: a requirement for a 2-year college training program, a single management structure across sites, and rotation of coders between sites. Limitations include few coder characteristics available for study due to privacy concerns.

Background: Although obstructive sleep apnoea (OSA) has been linked to insulin resistance and glucose intolerance, it is unclear whether there is an independent association between OSA and diabetes mellitus (DM) and whether all patients with OSA are at risk. The objective of this study was to determine the association between OSA and DM in a large cohort of patients referred for sleep diagnostic testing., Methods: A cross-sectional analysis of participants in a clinic-based study was conducted between July 2005 and August 2007. DM was defined by self-report and concurrent use of diabetic medications (oral hypoglycaemics and/or insulin). Sensitivity analysis was performed using a validated administrative definition of diabetes. OSA was defined by the respiratory disturbance index (RDI) using polysomnography or ambulatory monitoring. Severe OSA was defined as an RDI > or = 30/h. Subjective sleepiness was defined as an Epworth Sleepiness Scale score > or = 10., Results: Complete data were available for 2149 patients. The prevalence of DM increased with increasing OSA severity (p<0.001). Severe OSA was associated with DM following adjustment for patient demographics, weight and neck circumference (odds ratio (OR) 2.18; 95% CI 1.22 to 3.89; p<0.01). Following a stratified analysis, this relationship was observed exclusively in sleepy patients (OR 2.59 (95% CI 1.35 to 4.97) vs 1.16 (95% CI 0.31 to 4.37) in non-sleepy patients)., Conclusions: Severe OSA is independently associated with DM in patients who report excessive sleepiness. Future studies investigating the impact of OSA treatment on DM may wish to focus on this patient population.

Background: The Alberta Hip and Knee Replacement Project developed a new evidence-based clinical pathway (NCP) for total hip (THR) and knee (TKR) replacement. The aim was to facilitate the delivery of services in a timely and cost-effective manner while achieving the highest quality of care for the patient across the full continuum of care from patient referral to an orthopedic surgeon through surgery, recovery, and rehabilitation. The purpose of this article is to provide an overview of the study design, rationale, and execution of this project as a model for health technology assessment based on comparative effectiveness of alternative clinical pathways., Methods: A pragmatic randomized controlled trial study design was used to evaluate the NCP compared with the standard of care (SOC) for these procedures. The pragmatic study design was selected as a rigorous approach to produce high quality evidence suitable for informing decisions between relevant interventions in real clinical practice. The NCP was evaluated in three of the nine regional health authorities (RHAs) in Alberta with dedicated central intake clinics offering multidisciplinary care teams, constituting 80 percent of THR and TKR surgeries performed annually in Alberta. Patients were identified in the offices of twenty orthopedic surgeons who routinely performed THR or TKR surgeries. Evaluation outcome measures were based on the six dimensions of the Alberta Quality Matrix for Health (AQMH): acceptability, accessibility, appropriateness, effectiveness, efficiency and safety. Data were collected prospectively through patient self-completed questionnaires at baseline and 3 and 12 months after surgery, ambulatory and inpatient chart reviews, and electronic administrative data., Results: The trial design was successful in establishing similar groups for rigorous evaluation. Of the 4,985 patients invited to participate, 69 percent of patients consented. A total of 3,434 patients were randomized: 1,712 to SOC and 1,722 to the NCP. The baseline characteristics of patients in the two study arms, including demographics, comorbidity as measured by CDS and exposure to pain medications, and health-related quality of life, as measured by Western Ontario and McMaster Universities Osteoarthritis Index and Short Form-36, were similar., Conclusions: The Alberta Hip and Knee Replacement Project demonstrates the feasibility and advantages of applying a pragmatic randomized controlled trial to ascertain comparative effectiveness. This is a model for health technology assessment that incorporates how clinical pathways can be effectively evaluated.

Context: Observational studies have suggested an association between active smoking and the incidence of type 2 diabetes., Objective: To conduct a systematic review with meta-analysis of studies assessing the association between active smoking and incidence of type 2 diabetes., Data Sources: A search of MEDLINE (1966 to May 2007) and EMBASE (1980 to May 2007) databases was supplemented by manual searches of bibliographies of key retrieved articles, reviews of abstracts from scientific meetings, and contact with experts., Study Selection: Studies were included if they reported risk of impaired fasting glucose, impaired glucose tolerance, or type 2 diabetes in relationship to smoking status at baseline; had a cohort design; and excluded persons with diabetes at baseline., Data Extraction and Data Synthesis: Two authors independently extracted the data, including the presence or absence of active smoking at baseline, the risk of diabetes, methods used to detect diabetes, and key criteria of study quality. Relative risks (RRs) were pooled using a random-effects model. Associations were tested in subgroups representing different patient characteristics and study quality criteria., Results: The search yielded 25 prospective cohort studies (N = 1.2 million participants) that reported 45 844 incident cases of diabetes during a study follow-up period ranging from 5 to 30 years. Of the 25 studies, 24 reported adjusted RRs greater than 1 (range for all studies, 0.82-3.74). The pooled adjusted RR was 1.44 (95% confidence interval [CI], 1.31-1.58). Results were consistent and statistically significant in all subgroups. The risk of diabetes was greater for heavy smokers (> or =20 cigarettes/day; RR, 1.61; 95% CI, 1.43-1.80) than for lighter smokers (RR,1.29; 95% CI, 1.13-1.48) and lower for former smokers (RR, 1.23; 95% CI, 1.14-1.33) compared with active smokers, consistent with a dose-response phenomenon., Conclusion: Active smoking is associated with an increased risk of type 2 diabetes. Future research should attempt to establish whether this association is causal and to clarify its mechanisms.

Background and Objective: 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., Methods: 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., Results: 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., Conclusion: 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.

Background: Census-based measures of income derived from median income of a geographic area are often used in health research. Many national census surveys gather information on both the respondent's individual income and the income for the entire household, giving researchers a choice of census income measures. We compared the extent to which individual respondent income and household income (both obtained from census data) are associated with outcomes in a cohort of patients with cardiac disease., Methods: We used data from the Alberta Provincial Project for Outcome Assessment in Coronary Heart Disease (APPROACH), where postal codes were linked to the Postal Code Conversion File (PCCF) to determine each patient's census Dissemination Areas (DA). DA-derived median household income and median individual income were obtained from the 2001 Canadian Census and survival outcomes were then directly determined for income groupings defined by quintile. Two-year survival adjusted for age and sex was described with a proportional hazards analysis., Results: There were 9,397 patients undergoing cardiac catheterization between January 1, 2001 and March 31, 2002, with complete DA-level median income measures. Household income quintiles yielded a wider spread of survival across quintiles (range of 2-year estimated survival, 91.8% to 95.9% for household income versus 92.8% to 95.6% for respondent income), as well as a more progressive decline in survival as income decreased. This progressive decline was not seen for the respondent income measure., Conclusions: The greater spread and progressive decline of survival for household income relative to respondent income leads us to conclude that household income is the better socio-economic determinant of health in our data and for the outcome measure we studied.

Background: The optimal population rate of cardiac catheterization is unknown. One potential way to determine it would be to examine whether there is a population rate beyond which the yield of high-risk coronary artery disease (CAD) does not rise., Methods: Using a detailed clinical registry that captures all patients undergoing cardiac catheterization in Alberta, we determined annual population rates of cardiac catheterization and the corresponding yield of cases of high-risk CAD in each of Alberta's 17 health regions from 1995 to 2002. Least squares linear regression analysis and hierarchical modelling methods were then used to assess the linear relation between catheterization rates and rates of high-risk CAD., Results: The age-adjusted average rate of cardiac catheterization among men ranged from 404.9 to 638.1 per 100,000 population aged over 20 years. Among women, the average rate ranged from 171.8 to 314.0 per 100,000. For both sexes, increased regional rates of catheterization were associated with a linearly increasing yield of high-risk CAD, with no evidence of a plateau in yield when more procedures were performed. One additional case of high-risk CAD was identified for every 2.5 additional cardiac catheterization procedures performed among men, and for every 3.7 additional procedures performed among women., Interpretation: The increasing yield of patients with high-risk CAD associated with increased regional population rates of cardiac catheterization, together with the absence of a plateau in yield, suggests that Alberta's population rates of cardiac catheterization are suboptimal to detect people with high-risk CAD.

Objective: Many consider smoking to be a personal choice for which individuals should be held accountable. We assessed whether there is any evidence of bias against smokers in cardiac care decision-making by determining whether smokers were as likely as non-smokers to undergo revascularization procedures after cardiac catheterization., Design: Prospective cohort study. Subjects and setting. All patients undergoing cardiac catheterization in Alberta, Canada., Main Measure: Patients were categorized as current smokers, former smokers, or never smokers, and then compared for their risk-adjusted likelihood of undergoing revascularization procedures (percutaneous coronary intervention or coronary artery bypass grafting) after cardiac catheterization., Results: Among 20406 patients undergoing catheterization, 25.4% were current smokers at the time of catheterization, 36.6% were former smokers, and 38.0% had never smoked. When compared with never smokers (reference group), the hazard ratio for undergoing any revascularization procedure after catheterization was 0.98 (95% CI 0.93-1.03) for current smokers and 0.98 (0.94-1.03) for former smokers. The hazard ratio for undergoing coronary artery bypass grafting was 1.09 (1.00-1.19) for current smokers and 1.00 (0.93-1.08) for former smokers. For percutaneous coronary intervention, the hazard ratios were 0.93 (0.87-0.99) for current smokers and 1.00 (0.94-1.06) for former smokers., Conclusion: Despite potential for discrimination on the basis of smoking status, current and former smokers undergoing cardiac catheterization in Alberta, Canada were as likely to undergo revascularization procedures as catheterization patients who had never smoked.

Background: The centralization of health care services has numerous potential benefits but April compromise access for individuals living in remote areas., Objectives: To examine the association between a patient's place of residence and the likelihood of undergoing a coronary revascularization procedure within one year after cardiac catheterization., Methods: All Alberta residents undergoing cardiac catheterization between 1995 and 1998 were examined. Geographical distance from patient place of residence to a centralized catheterization facility was calculated. The adjusted odds of undergoing cardiac revascularization within one year of catheterization was determined as a function of distance, controlling for differences in patient age, clinical factors and economic status., Results: Of 21816 residents who underwent cardiac catheterization in the province, 10997 had a revascularization procedure. Graphical examination of distance revealed a change in revascularization rates in patients living more than 450 km from revascularization centres. Further analysis was conducted using this cutpoint. Patients living in these remote areas were more likely to undergo a coronary revascularization procedure within the next year (adjusted odds ratio 1.65, 95% CI 1.05 to 2.59). However, these same residents were also less likely to undergo catheterization in the first place when compared with other Albertans (270 versus 398 procedures per 100000 population)., Conclusion: Only a small proportion of the population living in Alberta's most remote areas were more likely to undergo a revascularization procedure, indicating a remarkable uniformity of access to revascularization after coronary cardiac catheterization has occurred. This study examines the use of an existing database to gain further insights into the relationship between geography and access to cardiac care, and the distance-access relationship for coronary revascularization in Alberta.

BACKGROUND: Health studies sometimes rely on postal code location as a proxy for the location of residence. This study compares the postal code location to that of the street address using a database from the Alberta Provincial Project for Outcome Assessment in Coronary Heart Disease (APPROACHCopyright ). Cardiac catheterization cases in an urban Canadian City were used for calendar year 1999. We determined location in meters for both the address (using the City of Calgary Street Network File in ArcView 3.2) and postal code location (using Statistic Canada's Postal Code Conversion File). RESULTS: The distance between the two estimates of location for each case were measured and it was found that 87.9% of the postal code locations were within 200 meters of the true address location (straight line distances) and 96.5% were within 500 meters of the address location (straight line distances). CONCLUSIONS: We conclude that postal code locations are a reasonably accurate proxy for address location. However, there may be research questions for which a more accurate description of location is required.

Background: Despite evidence of regional variation across North America, there have been no comprehensive studies of cardiac procedure rates for coronary heart disease in Canada., Objectives: To use available administrative data and a survey of catheterization facilities to examine regional and demographic variations in cardiovascular procedure rates., Methods: A survey of all cardiac catheterization facilities in Canada was conducted, and the procedure counts from these facilities were used to determine provincial catheterization rates from 1997/1998 to 2001/2002. Procedure counts for 1997/1998 to 1999/2000 for coronary artery bypass graft (CABG) surgery and percutaneous coronary intervention (PCI) were provided by the Canadian Institute for Health Information and used to calculate revascularization procedure rates. Population projections provided by Statistics Canada were used as denominators for calculating the rates, and direct standardization was used to obtain age- and sex-adjusted rates., Results and Conclusions: The crude rate of cardiac catheterization in Canada increased from 359.9 to 471.5 per 100,000 population across the five years studied. There was considerable variation in revascularization procedure rates across health regions and provinces. Between 1997/1998 and 1999/2000, there was little increase in the rate of CABGs performed in Canada but a marked increase in the rate of PCIs. For both CABG and PCI, rates were higher for men than women, and highest in the 65- to 74-year-old age category. This study provides a valuable 'snapshot' of cardiac procedure use rates but indicates a clear need for more comprehensive collection of cardiac care data in Canada.