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Purpose: A series of iterative population pharmacokinetic (PK) modeling and probability of target attainment (PTA) analyses based on emerging data supported dose selection for aztreonam-avibactam, an investigational combination antibiotic for serious Gram-negative bacterial infections. Methods: Two iterations of PK models built from avibactam data in infected patients and aztreonam data in healthy subjects with "patient-like" assumptions were used in joint PTA analyses (primary target: aztreonam 60% fT > 8 mg/L, avibactam 50% fT > 2.5 mg/L) exploring patient variability, infusion durations, and adjustments for moderate (estimated creatinine clearance [CrCL] > 30 to ≤ 50 mL/min) and severe renal impairment (> 15 to ≤ 30 mL/min). Achievement of > 90% joint PTA and the impact of differential renal clearance were considerations in dose selection. Results: Iteration 1 simulations for Phase I/IIa dose selection/modification demonstrated that 3-h and continuous infusions provide comparable PTA; avibactam dose drives joint PTA within clinically relevant exposure targets; and loading doses support more rapid joint target attainment. An aztreonam/avibactam 500/137 mg 30-min loading dose and 1500/410 mg 3-h maintenance infusions q6h were selected for further evaluation. Iteration 2 simulations using expanded PK models supported an alteration to the regimen (500/167 mg loading; 1500/500 mg q6h maintenance 3-h infusions for CrCL > 50 mL/min) and selection of doses for renal impairment for Phase IIa/III clinical studies. Conclusion: A loading dose plus 3-h maintenance infusions of aztreonam-avibactam in a 3:1 fixed ratio q6h optimizes joint PTA. These analyses supported dose selection for the aztreonam-avibactam Phase III clinical program. Clinical trial registration: NCT01689207; NCT02655419; NCT03329092; NCT03580044. [ABSTRACT FROM AUTHOR]

Background: Uptake of virtual care increased substantially during the first year of the COVID-19 pandemic. The aim of this study was to evaluate whether a shift from in-person to virtual visits by primary care physicians was associated with increased use of emergency departments among their enrolled patients. Methods: We conducted an observational study of monthly virtual visits and emergency department visits from Apr. 1, 2020, to Mar. 31, 2021, using administrative data from Ontario, Canada. We used multivariable regression analysis to estimate the association between the proportion of a physician's visits that were delivered virtually and the number of emergency department visits among their enrolled patients. Results: The proportion of virtual visits was higher among female, younger and urban physicians, and the number of emergency department visits was lower among patients of female and urban physicians. In an unadjusted analysis, a 1% increase in a physician's proportion of virtual visits was found to be associated with 11.0 (95% confidence interval [CI] 10.1–11.8) fewer emergency department visits per 1000 rostered patients. After controlling for covariates, we observed no statistically significant change in emergency department visits per 1% increase in the proportion of virtual visits (0.2, 95% CI −0.5 to 0.9). Interpretation: We did not find evidence that patients substituted emergency department visits in the context of decreased availability of in-person care with their family physician during the first year of the COVID-19 pandemic. Future research should focus on the long-term impact of virtual care on access and quality of patient care. [ABSTRACT FROM AUTHOR]

Background: Electronic medical record (EMR) systems have the potential to facilitate appropriate laboratory testing. We examined three common medical tests in primary care-hemoglobin A1c (HbA1c), lipid, and thyroid stimulating hormone (TSH)- to assess whether adoption of a laboratory EMR system in Ontario had an impact on the rate of inappropriate testing among primary care physicians.Methods: We used FY2016-17 population-level laboratory data to estimate the association between adoption of a laboratory EMR system and the rate of inappropriate testing. Inappropriate testing was assessed based on recommendations for screening, monitoring, and follow-up that take into account risk factors related to patient age and certain clinical conditions. To overcome the problem of potential endogeneity of physician choice to use the EMR, the EMR penetration rate in the physician's geographical area of practice was used as an instrumental variable in an ordinary least squares (OLS) regression. We then simulated the change in the rate of inappropriate testing, by physician payment model, as the EMR penetration rate increased from the baseline percentage.Results: The simulation models showed that an increase in the rate of EMR penetration from a baseline average was associated with a statistically significant decrease in inappropriate hbA1c and lipid testing, but a statistically insignificant increase in inappropriate TSH testing. The impact of EMR penetration also varied by payment model.Conclusions: This study demonstrated a positive association between availability of an EMR system and appropriate service utilization. Varying impacts of the EMR system availability by primary care payment model may be reflective of different incentives or attributes inherent in payment models. Policies to encourage physicians to increase their use of laboratory EMR systems could improve the quality and continuity of patient care. [ABSTRACT FROM AUTHOR]

Background: New case-mix tools from the Canadian Institute for Health Information offer a novel way of exploring the prevalence of chronic disease and multimorbidity using diagnostic data. We took a comprehensive approach to determine whether the prevalence of chronic disease and multimorbidity has been rising in Ontario, Canada.Methods: In this observational study, we applied case-mix methodology to a population-based cohort. We used 10 years of patient-level data (fiscal years 2008/09 to 2017/18) from multiple care settings to compute the rolling 5-year prevalence of 85 chronic diseases and multimorbidity (i.e., the co-occurrence of 2 or more diagnoses). Diseases were further classified based on type and severity. We report both crude and age- and sex-standardized trends.Results: The number of patients with chronic disease increased by 11.0% over the 10-year study period to 9.8 million in 2017/18, and the number with multimorbidity increased 12.2% to 6.5 million. Overall increases from 2008/09 to 2017/18 in the crude prevalence of chronic conditions and multimorbidity were driven by population aging. After adjustments for age and sex, the prevalence of patients with ≥ 1 chronic conditions decreased from 70.2% to 69.1%, and the prevalence of multimorbidity decreased from 47.1% to 45.6%. This downward trend was concentrated in minor and moderate diseases, whereas the prevalence of many major chronic diseases rose, along with instances of extreme multimorbidity (≥ 8 conditions). Age- and sex-standardized resource intensity weights, which reflect relative expected costs associated with patient diagnostic profiles, increased 4.6%.Interpretation: Evidence of an upward trend in the prevalence of chronic disease was mixed. However, the change in case mix toward more serious conditions, along with increasing patient resource intensity weights overall, may portend a future need for population health management and increased health system spending above that predicted by population aging. [ABSTRACT FROM AUTHOR]

Background: Prior research has consistently shown that the heaviest users account for a disproportionate share of health care costs. As such, predicting high-cost users may be a precondition for cost containment. We evaluated the ability of a new health risk predictive modelling tool, which was developed by the Canadian Institute for Health Information (CIHI), to identify future high-cost cases.Methods: We ran the CIHI model using administrative health care data for Ontario (fiscal years 2014/15 and 2015/16) to predict the risk, for each individual in the study population, of being a high-cost user 1 year in the future. We also estimated actual costs for the prediction period. We evaluated model performance for selected percentiles of cost based on the discrimination and calibration of the model.Results: A total of 11 684 427 individuals were included in the analysis. Overall, 10% of this population had annual costs exceeding $3050 per person in fiscal year 2016/17, accounting for 71.6% of total expenditures; 5% had costs above $6374 (58.2% of total expenditures); and 1% exceeded $22 995 (30.5% of total expenditures). Model performance increased with higher cost thresholds. The c-statistic was 0.78 (reasonable), 0.81 (strong) and 0.86 (very strong) at the 10%, 5% and 1% cost thresholds, respectively.Interpretation: The CIHI Population Grouping Methodology was designed to predict the average user of health care services, yet performed adequately for predicting high-cost users. Although we recommend the development of a purpose-designed tool to improve model performance, the existing CIHI Population Grouping Methodology may be used - as is or in concert with additional information - for many applications requiring prediction of future high-cost users. [ABSTRACT FROM AUTHOR]

Background: Chronic postsurgical pain (CPSP) is a surgical complication associated with increased functional disability, psychological distress, and economic costs. The aims of this paper were to prospectively: (1) examine the incidence of CPSP 6 and 12 months after pediatric major surgery; (2) identify pain intensity and pain unpleasantness trajectories before, and up to 12 months after, surgery; (3) identify pre-operative factors that predict pain trajectory group membership; and (4) identify predictors of 12-month functional disability. Methods: This study followed 265 children aged 8–17 years at four time points (pre-surgical [T0], in-hospital [T1], 6 [T2] and 12 [T3] months after surgery). Children and parents completed pain and psychological questionnaires. In-hospital physical activity was monitored using actigraphy. Results and discussion: The incidence of moderate-to-severe CPSP at 6 and 12 months was 35% (95% CI 29.1% to 41.9%) and 38% (95% CI 32.4% to 45.1%), respectively. Three percent (95% CI 1.17% to 6.23%) and 4% (95% CI 1.45% to 6.55%) of children reported using opioids to manage pain at 6 and 12 months, respectively. Growth mixture modeling revealed a two-class trajectory model with a quadratic slope best fit the data for both pain intensity (Bayesian information criterion [BIC] = 3977.03) and pain unpleasantness (BIC = 3644.45) over the 12 months. Preoperative functional disability and cumulative in-hospital opioid consumption predicted pain intensity trajectories. Preoperative functional disability predicted pain unpleasantness trajectories. Preoperative functional disability (OR: 1.05, 95% CI: 1.01 to 1.09) and pain unpleasantness trajectories (OR: 2.59, 95% CI: 1.05 to 6.37) predicted 12-month moderate-to-severe functional disability. Conclusion: Pre-surgical functional disability is the only factor that predicts both 12-month functional disability and the course of pain intensity and pain unpleasantness ratings over the 12-month period. [ABSTRACT FROM AUTHOR]

Introduction: This retrospective analysis compares the probability of target attainment (PTA) for ceftriaxone, levofloxacin and ceftaroline fosamil against Staphylococcus aureus, Streptococcus pneumoniae and Haemophilus influenzae in a representative patient population with moderate-to-severe community-acquired pneumonia (CAP). Methods: Published pharmacokinetic (PK) models for levofloxacin and ceftriaxone, and an existing model for ceftaroline, were used with standard dosage regimens for simulating individual PK data with covariates representative of patients with CAP (5000 patients/drug regimen). PTA for clinically relevant pharmacokinetic/pharmacodynamic (PK/PD) targets was calculated from steady state PK profiles for a range of minimum inhibitory concentrations (MICs). Cumulative fractions of response (CFRs) were also calculated using MIC distributions from 2012 to 2017 global surveillance data. Results: Ceftaroline fosamil (600 mg q12 h) achieved > 90% PTA at all exposure targets for each pathogen at European Committee on Antimicrobial Susceptibility Testing (EUCAST)/Clinical and Laboratory Standards Institute (CLSI) susceptibility breakpoints, and CFRs were > 99%. Ceftriaxone, but not levofloxacin, achieved 100% PTA and > 90% CFR against S. pneumoniae. Both levofloxacin and ceftriaxone achieved high PTA and CFR against H. influenzae. Levofloxacin achieved PTAs < 90% at EUCAST/CLSI breakpoints and ceftriaxone achieved PTAs < 90% at MICs up to 2 mg/L against S. aureus; both agents produced generally low CFRs against S. aureus (except levofloxacin against methicillin-sensitive S. aureus), reflecting the lack of activity of these agents against methicillin-resistant S. aureus. Conclusion: Ceftaroline fosamil demonstrated higher overall PTA rates than levofloxacin and ceftriaxone, in particular against S. aureus. These results provide insight regarding the potential comparative efficacy of the described antibiotics for moderate-to-severe CAP. Funding: Pfizer. [ABSTRACT FROM AUTHOR]

Ceftazidime‐avibactam is a novel β‐lactam/β‐lactamase inhibitor combination for the treatment of serious infections caused by resistant gram‐negative pathogens. Population pharmacokinetic (PopPK) models were built to incorporate pharmacokinetic (PK) data from five phase III trials in patients with complicated intra‐abdominal infection (cIAI), complicated urinary tract infection (cUTI), or nosocomial (including ventilator‐associated) pneumonia. Ceftazidime and avibactam pharmacokinetics were well‐described by two‐compartment disposition models, with creatinine clearance (CrCL) the key covariate determining clearance variability. Steady‐state ceftazidime and avibactam exposure for most patient subgroups differed by ≤ 20% vs. healthy volunteers. Probability of PK/pharmacodynamic (PD) target attainment (free plasma ceftazidime > 8 mg/L and avibactam > 1 mg/L for ≥ 50% of dosing interval) was ≥ 94.9% in simulations for all patient subgroups, including indication and renal function categories. No exposure‐microbiological response relationship was identified because target exposures were achieved in almost all patients. These modeling results support the approved ceftazidime‐avibactam dosage regimens (2000‐500 mg every 8 hours, adjusted for CrCL ≤ 50 mL/min). [ABSTRACT FROM AUTHOR]

Background: Congenital idiopathic clubfoot is a condition that affects, on average, approximately 1 in 1,000 infants. One broadly adopted method of management, described by Ponseti, is the performance of a percutaneous complete tenotomy when hindfoot stall occurs. The use of onabotulinum toxin A (BTX-A) along with the manipulation and cast protocol described by Ponseti has been previously reported. Our goal was to compare the clinical outcomes between BTX-A and placebo injections into the gastrocnemius-soleus muscle at the time of hindfoot stall in infants with idiopathic clubfoot treated with the Ponseti method of manipulation and cast changes.Methods: This was a double-blind, placebo-controlled, parallel-group study with balanced randomization.Results: At 6 weeks after the study injection (T1), 66% of the 32 feet in the BTX-A arm and 63% of the 30 in the placebo arm responded to the treatment (i.e., obtained ≥15° of dorsiflexion). Seven of the 11 patients in the BTX-A arm and all of the 11 in the placebo arm who had not responded at T1 responded to a rescue BTX-A injection at 12 weeks after the first injection (T2). The combined response rate at T2, which included the first-time responders as well as the patients who did not respond at T1 but did at T2, was 88% in the BTX-A arm and 100% in the placebo arm, culminating in a 94% response rate at T2. At T3 (2 years of age), 89% of the feet continued to respond and there was an 8% surgical rate.Conclusions: There was no difference in outcomes between the BTX-A and placebo groups when the injection was performed at the time of hindfoot stall. Overall, 92% of the clubfeet in this study responded to a manipulation and cast protocol alone, with or without BTX-A injection, by 12 weeks after hindfoot stall, or we can say that 92% of the clubfeet did not require percutaneous Achilles tendon lengthening by 2 years of age. The need for tenotomy is limited to those who have not responded to treatment at this point, and the need for surgery is limited to those for whom all attempts at treatment with sequential casts, BTX-A, and percutaneous Achilles tendon lengthening have failed.Level Of Evidence: Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence. [ABSTRACT FROM AUTHOR]

Objectives: Our objective was to develop population pharmacokinetic (PK) models for ceftazidime and avibactam in the plasma and epithelial lining fluid (ELF) of healthy volunteers and to compare ELF concentrations to plasma PK/pharmacodynamic (PD) targets.Methods: Plasma and ELF population PK models were developed for ceftazidime and avibactam concentration data from 42 subjects (NCT01395420). Two- and three-compartment plasma PK models were fitted to ceftazidime and avibactam plasma PK data, and different plasma-ELF linked models were evaluated. Using best-fitting models, plasma and ELF concentration-time profiles were simulated for 1000 subjects. ELF concentration-time profiles for ceftazidime/avibactam 2000-500 mg every 8 h were compared with plasma PK/PD targets for ceftazidime (50% of time above [fT >] 8 mg/l) and avibactam (50% fT > 1 mg/l).Results: Three-compartment PK models best fitted the plasma concentration data for ceftazidime and avibactam. ELF data for both drugs were best described by a direct response (instantaneous equilibrium) model. Ceftazidime plasma-ELF relationships were best described by a saturable Michaelis-Menten model. For avibactam, departure from plasma-ELF relationship linearity was more modest than for ceftazidime. ELF:plasma penetration ratios of both ceftazidime (52%) and avibactam (42%) at plasma concentrations relevant for efficacy (~ 8 mg/l for ceftazidime and ~ 1 mg/l for avibactam) were greater than previously calculated using non-compartmental area under the curve (AUC) methods, which average across the entire concentration range. Ceftazidime and avibactam ELF exposures exceeded their respective plasma PK/PD time-above-threshold targets by the dosing interval mid-point in most subjects.Conclusions: This compartmental modelling analysis suggests ELF exposures of both ceftazidime and avibactam exceed levels required for efficacy in plasma. [ABSTRACT FROM AUTHOR]

Background: Up to 40% of patients with idiopathic clubfoot who are treated with the Ponseti method experience recurrence of deformity. Many of these patients receive surgery (e.g., anterior tibial tendon transfer). An alternative approach for recurrent clubfoot is repeat Ponseti casting. The purpose of this study was to evaluate the outcome of repeat Ponseti casting in the treatment of recurrent clubfoot.Methods: Patients with recurrent idiopathic clubfoot who were treated at our hospital, between 2004 and 2012, with repeat serial casting and bracing (the recurrent group) were eligible for inclusion in the study. The recurrent group and a control group of randomly selected patients seen during the same period who had not had recurrence were compared with respect to demographic data, age at the time of treatment, number of casts, subsequent surgical intervention(s), and the Disease-Specific Instrument (DSI) clubfoot scale. Patients were deemed to have a successful outcome if they had a well-corrected foot (defined as dorsiflexion of ≥10°, hindfoot in valgus, and a straight lateral border) at the time of follow-up.Results: Of a total of 71 eligible patients with clubfeet, 35 patients participated. At the time of follow-up, success rates were 74% for the recurrent group and 83% for the control group. Dorsiflexion past neutral was significantly higher in the control group than the patient group (20° versus 12°, respectively; p < 0.001). Ninety-five percent of the control subjects had a straight lateral border in comparison with 78% in the recurrent group (p = 0.004). Likewise, 97% of controls had the hindfoot in valgus in comparison with 80% of the recurrent group (p = 0.02). There was a significant difference in the ability to squat (76% in the control group and 43% in the recurrent group; p = 0.03). There was no difference between groups in the total outcome of the DSI.Conclusions: Recurrence was seen in 19% (71) of 382 children who were eligible for our study who were typically discharged after the age of 5 years from our clinic, indicating the importance of continued follow-up until after that age. Treatment with casting was successful in many patients and may be a reasonable choice for recurrent idiopathic clubfeet.Level Of Evidence: Therapeutic Level III. See Instructions for Authors for a complete description of levels of evidence. [ABSTRACT FROM AUTHOR]

Purpose Healthcare providers have limited time to spend with scoliosis patients who are considering surgery and their families. The purpose of this study was to evaluate an e-health strategy to increase knowledge and coping in patients with scoliosis who are surgical candidates and their families. Methods We enrolled patients with scoliosis who were candidates for surgery and their families. Patients and their families completed the scoliosis knowledge questionnaire, meaning of illness questionnaire, social support and coping questionnaires before and after access to a comprehensive evidence-based scoliosis website (http://www.aboutkidshealth.ca/scoliosis). Results Seventy-four patients and 71 parents completed the evaluation. While both patients and parents improved their knowledge of scoliosis (p = 0.001 and p = 0.003, respectively), the scores of patients were consistently lower than those of the parents both before and after website use (p = 0.0001). Only parents demonstrated a change in the meaning of illness questionnaire, with a small increase in the negative attitude towards illness and a small decrease in the positive attitude towards illness (p = 0002 and p = 0.01, respectively). Of the 12 coping methods examined on the Adolescent Coping Orientation for Problem Experiences (A-COPE) instrument, patients were slightly more likely than parents to use relaxing and solving family problems as tools to cope following website access (p = 0.02 and p = 0.09, respectively). Parents demonstrated no significant changes in the four methods of coping on the Coping Health Inventory for Parents (CHIP) after website exposure. While the majority of patients and parents reported receiving sufficient support, over half of the patients indicated a need for more support in social participation. Conclusion An evidence-based website increased the knowledge of patients and parents but simply providing access to the website had minimal impact on their coping and perceptions of social support. The website, however, provides users with the opportunity to absorb vital information about scoliosis across several media. [ABSTRACT FROM AUTHOR]

The article offers information regarding concept of the small simple trial (SST), a modified approach to randomized clinical trials (RCTs) that is directed toward rare orthopaedic conditions and specifically addresses issues of generalizability and cost. Topics discussed include use of rotationplasty for osteosarcoma of the lower limb; information on Simple Bone Cyst Trial; and benefits of methylprednisolone over bone marrow injection.

Copyright of Canadian Journal of Surgery is the property of CMA Impact Inc. and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

Background: In 2003, The Journal of Bone & Joint Surgery (American Volume) implemented a requirement for submitted clinical research articles to include a level of evidence rating. The aim of this study was to analyze the agreement between authors and JBJS regarding the level of evidence rating of accepted clinical articles. Methods: A random sample of 353 clinical research articles accepted by JBJS from 2010 to 2012 was analyzed; 188 had a level of evidence rating provided by the author. Articles were grouped by study type and subspecialty. An unweighted kappa value was calculated to measure agreement between the authors and the JBJS editor, whose decision was used as the gold standard. In a secondary analysis, the articles in each subspecialty were categorized according to the year of submission to evaluate temporal trends. Results: Of the 353 articles, 69.4% (245) were classified by JBJS as representing a therapeutic study, 17.6% (sixty-two) were classified as representing Level-I evidence, and 25.2% (eighty-nine) dealt with arthroplasty. Agreement between the author and the JBJS editor was 0.79 (95% confidence interval [CI], 0.71 to 0.89; p < 0.001) for the study type, 0.62 (95% CI, 0.53 to 0.70; p < 0.001) for the level of evidence, and 0.65 (95% CI, 0.58 to 0.73; p < 0.001) for the full level of evidence rating (study type and level of evidence). Conclusions: Level of evidence ratings suggested by authors from 2010 to 2012 had moderate to substantial agreement with the ratings assigned by the JBJS editor. This suggests that the level of evidence rating system is being properly understood by authors of articles published in JBJS. However, the low frequency of reporting suggests that JBJS needs to strictly enforce requirements for submission of a level of evidence rating at the time of manuscript submission. [ABSTRACT FROM AUTHOR]

Background: Pelvic osteotomies are frequently used as part of the surgical management of bladder exstrophy. The outcomes are often measured on the basis of the residual symphyseal diastasis. The aims of this study were to evaluate and validate a more reliable radiographic measure of ischiopubic rotation, to utilize this measure in analyzing pelves from patients with exstrophy and controls, and to propose a model for rediastasis in a pelvis with exstrophy. Methods: Pelvic radiographs of 164 normal children two months to eighteen years of age were used to determine the changes in interpubic and interischial distances and in the interischial/interpubic (IS/IP) ratio with age. Twenty-one pelvic CT (computed tomography) studies of normal children, two to sixteen years of age, were also used to study the change in the ischiopubic divergence angle. The same parameters were measured on radiographs or CT or magnetic resonance imaging studies of seventy-three patients with classic bladder exstrophy who were followed for two to nineteen years after exstrophy closure with or without pelvic osteotomies. Results: In normal children, the interpubic distance and the ischiopubic divergence angle had a narrow range and were constant with age, whereas the interischial distance and the IS/IP ratio increased progressively and were strongly correlated with age. In the patients with exstrophy, the interpubic distance was positively correlated with the interischial distance, whereas the IS/IP ratio was lower than that in normal controls and was not correlated with age. Conclusions: The IS/IP ratio is a useful measure of ischiopubic rotation and can be used to characterize pelvic growth, including the phenomenon of rediastasis in patients with exstrophy. Pelvic rediastasis is a progressive increase in interpubic distance resulting from growth without loss of rotational correction, as shown by the constancy of the IS/IP ratio with age in these patients. A better rotational position at the time of osteotomy may lead to a better pelvic shape at maturity. Clinical Relevance: Symphyseal rediastasis following neonatal pelvic osteotomies in patients with exstrophy is not due to loss of correction and progressive derotation of the hemipelves but is a consequence of the normal three-dimensional growth of the pelvis. The best correction of the pelvic deformity should always be the aim even in neonatal pelvic osteotomies because this will permanently change the pelvic shape. [ABSTRACT FROM AUTHOR]

Copyright of Canadian Journal of Surgery is the property of CMA Impact Inc. and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

Background: One aim of publicly-funded health care systems is to provide equitable access to care irrespective of ability to pay. At the same time, differences in socioeconomic status (SES) are associated with health outcomes and access to care, including waiting times for surgery. In public systems where both high- and low-SES patients use the same resources, low-SES patients may be adversely impacted in surgical waiting times. The purpose of this study was to determine whether a publicly-funded health system can provide equitable access to surgical care across socioeconomic status.Methods: Patient-level records were obtained from a comprehensive provincially-administered surgical wait time database, encompassing years 2006-2015 and 98% of Ontario hospitals. Patient SES was determined by linking postal code with the Material and Social Deprivation Index. Surgical waiting times (time in days between decision to treat and surgery) accounted for patient-initiated delays in treatment, and regression analysis considered age, SES, rurality, sex, priority level for surgical urgency (assigned by surgeons), surgical subspecialty, number of visits, and procedure year.Results: For the 4,253,305 surgical episodes, the mean wait time was 62.3 (SD 75.4) days. Repeated measures least squares regression analysis showed the least deprived SES quintile waited 3 days longer than the most deprived quintile. Wait times dropped in the initial study period but then increased. The proportion of procedures exceeding wait time access targets remained low at 11-13%.Conclusions: The least deprived SES quintile waited the longest, although the absolute difference was small. This study demonstrates that publicly-funded healthcare systems can provide equitable access to surgical care across SES. [ABSTRACT FROM AUTHOR]

Objective To investigate the effect of patient gender on patient-physician communication in the process of recommendation for total knee arthroplasty (TKA). Methods Seventy-one physicians (38 family physicians and 33 orthopedic surgeons) in Ontario performed blinded assessments of 2 standardized patients (1 man and 1 woman) with moderate knee osteoarthritis and otherwise identical scenarios. Four surgeons did not consent to including their data. Standardized patients and accompanying mock family members recorded elements of informed decision making (IDM) as present/absent in the patient-physician discussion and rated the physicians' interpersonal skills. Results Overall, the completeness of IDM was low, but was lower still for the woman. Only 57% (38 of 67) and 15% (10 of 67) of physicians discussed the nature of the decision and elicited the patient's preference while consulting with the man and woman, respectively. Even after adjusting for physicians' recommendations regarding TKA, when interacting with the woman, physicians included fewer IDM elements (adjusted mean difference in IDM score 1.2 [95% confidence interval (95% CI) 0.6, 1.8]; P < 0.001) and had poorer interpersonal skills (adjusted mean difference 14.1 [95% CI 9.0, 19.2]; P < 0.001) compared with their consultation with the man. Conclusion Physicians provided less medical information and less encouragement to participate in the decision to undergo TKA to a woman compared with a man, irrespective of their recommendation regarding TKA. Our findings suggest that in addition to directly influencing physicians' clinical decision making, gender bias may also influence physicians' interpersonal behavior. [ABSTRACT FROM AUTHOR]

Background: Scheduling emergency cases among elective surgeries often results in prolonged waits for emergency surgery and delays or cancellation of elective cases. We evaluated the benefits of a dedicated operating room (OR) for emergency procedures available to all surgical services at a large children's hospital.Methods: We compared a 6-month period (January 2009 to June 2009) preimplementation with a 6-month period (January 2010 to June 2010) postimplementation of a dedicated OR. We evaluated OR use, wait times, percentage of cases done within and outside of access targets, off-hours surgery, cancellations, overruns and length of stay.Results: Preimplementation, 1069 of the 5500 surgeries performed were emergency cases. Postimplementation, 1084 of the 5358 surgeries performed were emergency cases. Overall use of the dedicated OR was 53% (standard deviation 25%) postimplementation. Excluding outliers, the average wait time for priority 3 emergency patients decreased from 11 hours 8 minutes to 10 hours 5 minutes (p = 0.004). An increased proportion of priority 3 patients, from 52% to 58%, received surgery within 12 hours (p = 0.020). There was a 9% decrease in the proportion of priority 3 cases completed during the evening and night (p < 0.001). The elective surgical schedule benefited from the dedicated OR, with a significant decrease in cancellations (1.5% v. 0.7%, p < 0.001) and an accumulated decrease of 5211 minutes in overrun minutes in elective rooms. The average hospital stay after emergency surgery decreased from 16.0 days to 14.7 days (p = 0.12) following implementation of the dedicated OR.Conclusion: A dedicated OR for emergency cases improved quality of care by decreasing cancellations and overruns in elective rooms and increasing the proportion of priority 3 patients who accessed care within the targeted time. [ABSTRACT FROM AUTHOR]

Copyright of Canadian Journal of Surgery is the property of CMA Impact Inc. and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

Background: Assessment of health state and health-related quality of life (HR-QOL) are limited by a child's age and cognitive ability. Parent-proxy reports are known to differ from children's reports. Simultaneous assessment using a parent-child dyad is an alternative approach. Objective: Our objective was to assess the validity, reliability and responsiveness of a parent-child dyad approach to utility and HR-QOL assessment of paediatric asthma health states. Methods: The setting was specialist care in a hospital-based asthma clinic. Participants were 91 girls and boys with asthma aged 8 to 17 years and 91 parents. The intervention employed was parent-child dyad administration of the Health Utilities Index (HUI) 2 and 3, the Pediatric Quality of Life Inventory™ (PedsQL™) Core and Asthma modules, and the Pediatric Asthma Quality of Life Questionnaire (PAQLQ). Questionnaires were administered by interview to children and parents separately and then together as a dyad to assess the child's health state. The dyad interview was repeated at the next clinic visit. Dyad-child agreement was measured by intra-class correlation (ICC) coefficient; Spearman correlations were used to assess convergent validity. Test-retest reliability was assessed in 28 children who remained clinically stable between visits with a two-way ICC coefficient. Responsiveness to change from baseline was assessed with Spearman coefficients in 30 children who demonstrated clinical change between visits. Results: There was no significant agreement between parent and child for the HUI2 or HUI3 whereas agreement between dyad and child was 0.55 (95% confidence interval [CI] 0.36, 0.69) for the HUI2 and 0.74 (95% CI 0.61, 0.82) for the HUI3 overall. With respect to dyad performance characteristics, both HUI2 and HUI3 overall scores demonstrated moderate convergent validity with the generic PedsQL™ Core domains (range r = 0.30-0.52; p < 0.01). Dyad HUI2 attributes demonstrated moderate convergent validity with the generic PedsQL™ Core domains of similar constructs (range r = 0.35-0.43; p < 0.001) and weaker convergent validity with disease-specific domains (range r = 0.13-0.32). Dyad HUI3 attributes demonstrated weaker convergent validity compared with the HUI2. For the assessment of test-retest reliability, significant agreement between baseline and follow-up was observed for dyad HUI2 total (r = 0.53), dyad PedsQL™ Core summary (r = 0.70) and select dyad disease-specific domains. Significant responsiveness (r > 0.4; p < 0.05) was observed for dyad HUI2 total score change over time as correlated with dyad HUI3, dyad PedsQL™ Core summary and select disease-specific domains. Conclusions: The parent-child dyad approach demonstrated moderate to strong performance characteristics in generic and disease-specific questionnaires suggesting it may be a valuable alternative to relying on parent proxies for assessing children's utility and HR-QOL. Future research in additional paediatric populations, younger children and a population-based sample would be useful. [ABSTRACT FROM AUTHOR]

Randomized controlled trials continue to be at the pinnacle of the evidence hierarchy. With this unique vantage point, they inform medical practice, clinical guidelines, health policy, and reimbursement. Prior to an emphasis on randomized controlled trials, traditional clinical research consisted primarily of uncontrolled case series and expert opinions. Randomized controlled trials are a true experiment in clinical practice and provide the most valid answers to clinical questions by reducing bias originating from patients, providers, and investigators. Riding on the coattails of other medical subspecialties, orthopaedic surgeons have recognized the importance of evidence-based medicine. From 1975 to 2005, the number of Level-I studies increased over fivefold and comprised >20% of studies published in The Journal of Bone and Joint Surgery (American Volume) (JBJS). With the emergence of comparative effectiveness research, the definition and methods of best evidence may continue to evolve. In conclusion, substantial improvements in both the quantity and the quality of randomized controlled trials in orthopaedic surgery have occurred, although unique considerations still limit their widespread use. [ABSTRACT FROM AUTHOR]

Background: Improving the quality of care is essential and a priority for patients, surgeons, and healthcare providers. Strategies to improve quality have been proposed at the national level either through accreditation standards or through national payment schemes; however, their effectiveness in improving quality is controversial.Questions/purposes: The purpose of this review was to address three questions: (1) does pay-for-performance improve the quality of care; (2) do surgical safety checklists improve the quality of surgical care; and (3) do practice guidelines improve the quality of care? These three strategies were chosen because there has been some research assessing their effectiveness in improving quality, and implementation had been attempted on a large scale such as entire countries.Methods: We performed a literature review from 1950 forward using Medline to identify Level I and II studies. We evaluated the three strategies and their effects on processes and outcomes of care. When possible, we examined strategy implementation, patients, and systems, including provider characteristics, which may affect the relationship between intervention and outcomes with a focus on factors that may have influenced effect size.Results: Pay-for-performance improved the process and to a lesser extent the outcome of care. Surgical checklists reduced morbidity and mortality. Explicit practice guidelines influenced the process and to a lesser extent the outcome of care. Although not definitively showed, clinician involvement during development of intervention and outcomes, with explicit strategies for communication and implementation, appears to increase the likelihood of positive results.Conclusion: Although the cost-effectiveness of these three strategies is unknown, quality of care could be enhanced by implementing pay-for-performance, surgical safety checklists, and explicit practice guidelines. However, this review identified that the effectiveness of these strategies is highly context-specific. [ABSTRACT FROM AUTHOR]

Background: Rates of use of total joint arthroplasty among appropriate and willing candidates are lower in women than in men. A number of factors may explain this gender disparity, including patients' preferences for surgery, gender bias influencing physicians' clinical decision-making, and the patient-physician interaction. Questions/purposes: We propose a framework of how patient gender affects the patient and physician decision-making process of referral and recommendation for total joint arthroplasty and consider potential interventions to close the gender gap in total joint arthroplasty utilization. Methods: The process involved in the referral and recommendation for total joint arthroplasty involves eight discrete steps. A systematic review is used to describe the influence of patient gender and related clinical and nonclinical factors at each step. Where are we now?: Patient gender plays an important role in the process of referral and recommendation for total joint arthroplasty. Female gender primarily affects Steps 3 through 8, suggesting barriers unique to women exist in the patient-physician interaction. Where do we need to go?: Developing and evaluating interventions that improve the quality of the patient-physician interaction should be the focus of future research. How do we get there?: Potential interventions include using decision support tools that facilitate shared decision-making between patients and their physicians and promoting cultural competency and shared decision-making skills programs as a core component of medical education. Increasing physicians' acceptance and awareness of the unconscious biases that may be influencing their clinical decision-making may require additional skills programs. [ABSTRACT FROM AUTHOR]

Background: In addition to possibly prolonged suffering and anxiety, extended waits for children's surgery beyond critical developmental periods has potential for lifelong impact. The goal of this study was to determine the duration of waits for surgery for children and youth at Canadian paediatric academic health sciences centres using clinically-derived access targets (i.e., the maximum acceptable waiting periods for completion of specific types of surgery) as used in this Canadian Paediatric Surgical Wait Times project. Methods: We prospectively applied standardized wait-time targets for surgery, created by nominal-group consensus expert panels, to pediatric patients at children's health sciences centres across Canada with decision-to-treat dates of Sept. 1, 2007 or later. From Jan. 1 to Dec. 30, 2009, patients' actual wait times were compared with their target wait times to determine the percentage of patients receiving surgery after the target waiting period. Results: Overall, 27% of pediatric patients from across Canada (17411 of 64012) received their surgery after their standardized target waiting period. Dentistry, ophthalmology, plastic surgery and cancer surgery showed the highest percentages of surgeries completed past target. Interpretation: Many children wait too long for surgery in Canada. Specific attention is required, in particular, in dentistry, ophthalmology, plastic surgery and cancer care, to address children's wait times for surgery. Improved access may be realized with use of national wait-time targets. [ABSTRACT FROM AUTHOR]

Background: Although many children with spina bifida and associated scoliosis or dislocated hips undergo spine or hip surgery, the benefits are uncertain. Questions/purposes: The purpose was to perform an evidence-based review on the benefits and risks of surgery for dislocated hips and scoliosis in spina bifida. Methods: I performed a Medline and Embase search from 1950 to 2009 for Level I to Level III studies investigating the benefits and risks of surgery for scoliosis and hip dislocation in patients with spina bifida. When available, I extracted types of surgery, complication rates, functional outcomes of seating, walking, and overall physical function. All treatment recommendations received a Grade of Recommendation: Grade A (consistent Level I studies); Grade B (consistent Level II and III studies); Grade C (consistent level IV and V studies); or Grade I (insufficient or contradictory studies). Results: Combined anterior and posterior surgery had lower rates of nonunion for scoliosis. Although there may be some benefit in seating, overall physical function measured in a different and nonstandardized fashion was not much changed and major complication rates, including nonunion and infections for scoliosis surgery, exceed 50% in several studies. For dislocated hips, the impact on walking ability appears related to contracture (not dislocation). Surgery for hip dislocation did not improve walking ability. The literature provides no guidance on the best treatment for unilateral dislocation. Conclusions: The benefits of scoliosis surgery are uncertain (Grade I). Spine surgery, if performed, should be anterior and posterior (Grade B). An all-pedicle approach for scoliosis surgery may be effective (Level I). Hip reduction surgery did not improve walking (Grade B) but may be appropriate in low-level unilateral dislocation (Level I). [ABSTRACT FROM AUTHOR]

Copyright of Canadian Journal of Surgery is the property of CMA Impact Inc. and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

Background: The relationship between industry and the orthopaedic community is under increasing scrutiny. Industry traditionally has funded a substantial amount of the orthopaedic research published in this and other journals. The objective of the present study was to investigate associations between the level of evidence and declared source(s) of funding in papers published in the American volume of The Journal of Bone and Joint Surgery. Methods: All articles published in the American volume of The Journal of Bone and Joint Surgery from January 2003 to December 2007 were reviewed by a single individual. Primary research papers with an assigned level of evidence were assessed with regard to source of funding, subject area, and results. The association between source of funding and level of evidence was described with use of contingency tables and chi-square tests. Results: Of 886 studies with an assigned level of evidence, 246 were funded by industry, of which 124 (50%) were graded as Level-IV evidence. Among 274 studies funded by governments, foundations, or universities, only seventy-nine (29%) were graded as Level-IV evidence. Among 366 studies with no funding declared, 209 (57%) were graded as Level-IV evidence. The association between industry funding and a lower level of evidence was significant (p < 0.0001). Conclusions: While industry funded a larger number of studies than any other single source in this journal, the level of evidence of industry-funded studies was lower that that for studies funded by governments, foundations, or universities. Improving the scientific quality of industry-funded research might increase the quality of evidence for making orthopaedic decisions. [ABSTRACT FROM AUTHOR]

Background The relationship between industry and the orthopaedic community is under increasing scrutiny. Industry traditionally has funded a substantial amount of the orthopaedic research published in this and other journals. The objective of the present study was to investigate associations between the level of evidence and declared source(s) of funding in papers published in the American volume of The Journal of Bone and Joint Surgery. Methods All articles published in the American volume of The Journal of Bone and Joint Surgery from January 2003 to December 2007 were reviewed by a single individual. Primary research papers with an assigned level of evidence were assessed with regard to source of funding, subject area, and results. The association between source of funding and level of evidence was described with use of contingency tables and chi-square tests. Results Of 886 studies with an assigned level of evidence, 246 were funded by industry, of which 124 (50%) were graded as Level-IV evidence. Among 274 studies funded by governments, foundations, or universities, only seventy-nine (29%) were graded as Level-IV evidence. Among 366 studies with no funding declared, 209 (57%) were graded as Level-IV evidence. The association between industry funding and a lower level of evidence was significant (p < 0.0001). Conclusions While industry funded a larger number of studies than any other single source in this journal, the level of evidence of industry-funded studies was lower that that for studies funded by governments, foundations, or universities. Improving the scientific quality of industry-funded research might increase the quality of evidence for making orthopaedic decisions. [ABSTRACT FROM AUTHOR]