Reperfusion by endovascular thrombectomy and early cerebral edema in anterior circulation stroke: Results from the SITS-International Stroke Thrombectomy Registry.

BACKGROUND: A large infarct and expanding cerebral edema (CED) due to a middle cerebral artery occlusion confers a 70% mortality unless treated surgically. There is still conflicting evidence whether reperfusion is associated with a lower risk for CED in acute ischemic stroke. AIM: To investigate the association of reperfusion with development of early CED after stroke thrombectomy. METHODS: From the SITS-International Stroke Thrombectomy Registry, we selected patients with occlusion of the intracranial internal carotid or middle cerebral artery (M1 or M2). Successful reperfusion was defined as mTICI ⩾ 2b. Primary outcome was moderate or severe CED, defined as focal brain swelling ⩾1/3 of the hemisphere on imaging scans at 24 h. We used regression methods while adjusting for baseline variables. Effect modification by severe early neurological deficits, as indicators of large infarct at baseline and at 24 h, were explored. RESULTS: In total, 4640 patients, median age 70 years and median National Institutes of Health Stroke Score (NIHSS) 16, were included. Of these, 86% had successful reperfusion. Moderate or severe CED was less frequent among patients who had reperfusion compared to patients without reperfusion: 12.5% versus 29.6%, p < 0.05, crude risk ratio (RR) 0.42 (95% confidence interval (CI): 0.37-0.49), and adjusted RR 0.50 (95% CI: 0.44-0.57). Analysis of effect modification indicated that severe neurological deficits weakened the association between reperfusion and lower risk of CED. The RR reduction was less favorable in patients with severe neurological deficits, defined as NIHSS score 15 or more at baseline and at 24 h, used as an indicator for larger infarction. CONCLUSION: In patients with large artery anterior circulation occlusion stroke who underwent thrombectomy, successful reperfusion was associated with approximately 50% lower risk for early CED. Severe neurological deficit at baseline seems to be a predictor for moderate or severe CED also in patients with successful reperfusion by thrombectomy.

Cerebral Edema in Patients with severe Hemispheric Syndrome: Incidence, Risk Factors, and Outcomes-Data from SITS-ISTR.

BACKGROUND AND PURPOSE: Cerebral edema (CED) in ischemic stroke can worsen prognosis and about 70% of patients who develop severe CED die if treated conservatively. We aimed to describe incidence, risk factors and outcomes of CED in patients with extensive ischemia. METHODS: Oservational study based on Safe Implementation of Treatments in Stroke-International Stroke Treatment Registry (2003-2019). Severe hemispheric syndrome (SHS) at baseline and persistent SHS (pSHS) at 24 hours were defined as National Institutes of Health Stroke Score (NIHSS) >15. Outcomes were moderate/severe CED detected by neuroimaging, functional independence (modified Rankin Scale 0-2) and death at 90 days. RESULTS: Patients (n=8,560) presented with SHS and developed pSHS at 24 hours; 82.2% received intravenous thrombolysis (IVT), 10.5% IVT+thrombectomy, and 7.3% thrombectomy alone. Median age was 77 and NIHSS 21. Of 7,949 patients with CED data, 3,780 (47.6%) had any CED and 2,297 (28.9%) moderate/severe CED. In the multivariable analysis, age <50 years (relative risk [RR], 1.56), signs of acute infarct (RR, 1.29), hyperdense artery sign (RR, 1.39), blood glucose >128.5 mg/dL (RR, 1.21), and decreased level of consciousness (RR, 1.14) were associated with moderate/severe CED (for all P<0.05). Patients with moderate/severe CED had lower odds to achieve functional Independence (adjusted odds ratio [aOR], 0.35; 95% confidence interval [CI], 0.23 to 0.55) and higher odds of death at 90 days (aOR, 2.54; 95% CI, 2.14 to 3.02). CONCLUSIONS: In patients with extensive ischemia, the most important predictors for moderate/ severe CED were age <50, high blood glucose, signs of acute infarct, hyperdense artery on baseline scans, and decreased level of consciousness. CED was associated with worse functional outcome and a higher risk of death at 3 months.

Bilateral visual acuity decline in males with choroideremia: a pooled, cross-sectional meta-analysis.

BACKGROUND: Choroideremia is a rare inherited retinal disease that leads to blindness. Visual acuity (VA) is a key outcome measure in choroideremia treatment studies, but VA decline rates change with age. An accurate understanding of the natural deterioration of VA in choroideremia is important to assess the treatment effect of new therapies in which VA is the primary outcome measure. We conducted a meta-analysis of data on individuals with choroideremia to determine the rate of VA deterioration between the better- and worse-seeing eye (BSE and WSE, respectively). METHODS: Data were collected from the prospective Natural History of the Progression of Choroideremia (NIGHT) study (613 eyes, baseline data only), studies included in a recent meta-analysis, and studies identified in a targeted literature search performed on March 25, 2020, including individual best-corrected VA (BCVA) and age data in male individuals with choroideremia. Best-corrected VA decline rates (measured by logMAR units) by age and trends in BCVA decline rates in the BSE and WSE were evaluated.  RESULTS: Data from 1037 males (1602 eyes; mean age, 41.8 years) were included. Before and after an age cutoff of 33.8 years, BCVA decline rates for the WSE were 0.0086 and 0.0219 logMAR per year, respectively. Before and after an age cutoff of 39.1 years, BCVA decline rates for the BSE were 0.00001 and 0.0203 logMAR per year, respectively. Differences in absolute BCVA and decline rates increased between the 2 eyes until age ~ 40; thereafter, differences in absolute BCVA and decline rates were similar between eyes. CONCLUSIONS: Using the largest choroideremia data set to date, this analysis demonstrates accelerated BCVA decline beginning between 30 and 40 years of age. Disparate interocular progression rates were observed before the transition age, with similar interocular progression rates after the transition age.

A Real-World Assessment of Outcomes, Health Resource Utilization, and Costs Associated with Cerebral Edema in US Patients with Large Hemispheric Infarction.

BACKGROUND: Patients with large hemispheric infarction (LHI) are at risk of cerebral edema (CED). This study analyzed health resource use, costs, and outcomes during and after acute hospitalization for LHI in US patients with and without CED. METHODS: Using IBM® MarketScan® Commercial, Medicaid, and Medicare databases, patients with incident hospitalization for LHI (International Classification of Diseases, Tenth Revision, Clinical Modification diagnosis codes of I63.03x, I63.13x, I63.23x, I63.31x, I63.41x, I63.51x) from 31 March 2016 through 31 December 2018 were identified and further categorized by the presence or absence of CED based on related diagnosis codes or a procedure code of craniectomy. Health resource use, costs, and outcomes were compared in patients with and without CED during hospitalization and after discharge. RESULTS: Of 7336 Commercial, 1946 Medicaid, and 5015 Medicare patients with LHI, 7.8%, 6.9%, and 4.3% had CED, respectively. After adjusting for age, sex, and baseline comorbidities, differences (95% confidence intervals) in mean total costs of the index hospitalization in patients with CED versus without CED were $65,572 ($56,506-$76,335), $44,395 ($26,442-$63,495), and $31,417 ($18,982-$48,543) in the Commercial, Medicaid, and Medicare groups, respectively. Similarly, the adjusted differences (95% confidence intervals) in mean lengths of stay between patients with CED and without CED were 11.75 (10.17-13.48), 10.84 (7.59-14.17), and 3.69 (2.40-5.19) days, respectively. Mortality during index hospitalization was 10-20 times greater in patients with CED versus without CED (p < 0.0001). In those patients who survived and had at least 30-days of follow-up after discharge, CED was also associated with higher post-discharge resource utilization and costs in the commercially insured population who were younger than Medicare patients, and had fewer comorbidities than Medicare and Medicaid patients. This indicates the effect of CED after discharge was particularly burdensome for younger individuals. CONCLUSIONS: In this large cohort study, inpatient mortality, health resource utilization and costs were consistently higher in patients with LHI who developed CED than in those without CED. These findings underscore the need for greater awareness of CED among policymakers and healthcare practitioners.

US Health Resource Utilization and Cost Burden Associated with Choroideremia.

PURPOSE: Choroideremia is a progressive, inherited retinal dystrophy that leads to blindness. This study of choroideremia addresses health resource utilization (HRU) and costs from a US payor perspective using insurance claims data. The retrospective analysis used data between January 2013 and December 2018 from the IBM MarketScan Commercial, Medicare Supplemental, and Multi-State Medicaid Databases. PATIENTS AND METHODS: Patients having ≥1 claim with an International Classification of Diseases, Ninth or Tenth Edition, diagnostic code for choroideremia (363.55/H31.21) were included; a control group was matched 3:1 to the choroideremia group. Patients were followed for ≥6 months. All-cause HRU and costs were compared between cohorts using generalized linear models adjusted for Charlson Comorbidity Index. RESULTS: There were 199 and 597 patients in the choroideremia and control groups, respectively; the choroideremia group had a higher mean baseline Charlson Comorbidity Index (0.47 vs 0.26). The choroideremia group had a significantly greater mean number of hospital admissions (0.09 vs 0.06), outpatient visits (22.33 vs 11.22), and emergency department visits (0.41 vs 0.26) per patient per year than the control group. The choroideremia cohort had higher all-cause total annualized costs than the control cohort ($15,372 vs $9285), primarily driven by outpatient visits ($8306 vs $4702). This trend was observed across age categories, particularly among patients aged 20 to 44 years (choroideremia, $14,544 vs control, $5953). CONCLUSION: The choroideremia group had higher all-cause HRU and total costs versus the control group. These findings provide economic context around HRU associated with choroideremia and help assess the potential impact of novel treatments.

Pharmacists' perceptions of their working conditions and the factors influencing this: Results from 5 Canadian provinces.

INTRODUCTION: Our previous study in British Columbia (BC) indicated that pharmacists have a poor perception of their working conditions. The objective of this study is to assess pharmacists' perceptions of their working conditions in 4 other Canadian provinces. METHODS: This was a cross-sectional study across Alberta, New Brunswick, Prince Edward Island and Newfoundland and Labrador, using a survey adapted from the Oregon Board of Pharmacy. Data collected previously from BC were also included in the analyses. The survey was emailed to all pharmacist registrants. Respondents were provided with 6 statements and asked to rate their agreement with them, using a 5-point Likert scale. Statements were framed such that agreement with them indicated good perception of working conditions. Logistic regression analyses were used to study the relationship between workplace factors on perception of working conditions. RESULTS: Pharmacists perceived their working conditions to be poor. Pharmacists indicated that they do not have time for break/lunch (48.3% of respondents), work in environments that are not conducive to safe and effective primary care (26.5%), are not satisfied with the amount of time they have to do their job (44.0%) and face shortage of staff (shortage of pharmacists: 33.7%, technicians: 36.4%, clerk staff: 30.3%). Significant factors associated with poor perception were workplace-imposed quotas, high prescription volume, working in chain pharmacies and long prescription wait times. CONCLUSION: A high percentage of Canadian pharmacists perceived their working conditions to be poor. Considering the patient-related consequences of pharmacists' poor working conditions and the system-related reasons identified behind it, we call for collaborative efforts to tackle this issue.

Perinatal exposure to conventional synthetic disease-modifying anti-rheumatic drugs in women with rheumatic disease and neonatal outcomes: a population-based study.

OBJECTIVES: Epidemiologic studies evaluating associations between specific arthritis medications and perinatal outcomes are limited. We evaluated the association between conventional synthetic DMARD (csDMARD) use among women with rheumatic disease (RD) and neonatal outcomes. METHODS: We linked population-based data in British Columbia, Canada from 01/01/2002 to 12/31/2012 on all inpatient/outpatient visits and medications with a perinatal registry. For small-for-gestational-age (SGA) births, we assessed csDMARD exposure 90 days preconception or during pregnancy until date of delivery. For congenital anomalies, we determined csDMARD exposure 90 days preconception or during the first trimester. We used multivariable logistic regression models fitted with generalised estimating equations and calculated post-hoc power. RESULTS: There were 185 pregnancies in 175 women (31.3±5.4 years) and 6,064 pregnancies in 4,387 women (31.1±5.4 years) in the csDMARD exposed and unexposed groups, respectively. Hydroxychloroquine, azathioprine, sulfasalazine, and methotrexate exposure before or during pregnancy were not associated with SGA births. The most sufficiently powered analyses were those for hydroxychloroquine, where exposure during pregnancy resulted in an adjusted odds ratio (aOR) of 1.12 (95% confidence interval [CI], 0.65-1.94) for SGA births. Although post-hoc power calculations indicate less power to detect associations between csDMARDs and congenital anomalies, results indicate methotrexate exposure during the first trimester is associated with elevated odds for congenital anomalies (aOR 6.58, 95% CI 1.15-37.75). CONCLUSIONS: Findings are consistent with current guidelines regarding specific csDMARD use during the perinatal period for women with RD. It is important to report well-designed epidemiologic studies to facilitate future RD/csDMARD-specific meta-analyses.

Maternal and neonatal outcomes associated with biologic exposure before and during pregnancy in women with inflammatory systemic diseases: a systematic review and meta-analysis of observational studies.

OBJECTIVE: To determine the association between exposure to biologics in pregnant women with inflammatory systemic diseases and maternal and neonatal outcomes through a meta-analysis of findings from studies identified in a systematic review. METHODS: We conducted a systematic review of Medline, Embase, and Cochrane Database of Systematic Reviews to identify observational studies assessing the perinatal impacts of biologic in women with inflammatory systemic disease. Findings were meta-analysed across included studies with random-effects models. Crude risk estimates and, where possible, adjusted risk estimates were pooled to determine the impact on results when confounding is addressed. RESULTS: Overall, 24 studies were included in the meta-analysis. Meta-analyses of crude risk estimates resulted in pooled odds ratios (OR) for the association of biologic use during pregnancy and the following respective outcomes: congenital anomalies (1.30, 95% CI: 1.02, 1.67), preterm birth (OR 1.61, 95% CI: 1.37, 1.89), and low birth weight (OR 1.68, 95% CI: 1.21, 2.31). However, in pooled analyses of adjusted risk estimates we observed that the association between biologics use during pregnancy in disease-matched exposed and unexposed pregnant women was no longer statistically significant for congenital anomalies (adjusted OR 1.18, 95% CI: 0.88, 1.57). CONCLUSION: Pooled results from studies reporting adjusted risk estimates showed no increased risk of congenital anomalies associated with biologics use, suggesting that increased rates of adverse outcomes may be due to disease activity itself or other confounders.

Characterization of pharmacist-based medication management services in a community pharmacy.

BACKGROUND: Medication management (MM) refers to all clinical activities that a pharmacist performs to ensure safe and effective medication therapy for patients. OBJECTIVE: To characterize pharmacist-driven MM services via retrospective analysis of real-world data collected in a community pharmacy in British Columbia (BC), Canada. METHODS: This was a retrospective longitudinal study from January 2014-December 2015. Patient demographics, clinical problems, identified drug-related problems (DTPs), and pharmacists' interventions were summarized using descriptive statistics. The relationship between DTPs and the clinical conditions, as well as DTPs and the interventions, were analyzed. Other outcomes included: the relationship between patients' age and visit time with the number of DTPs; the number of clinical conditions; and the number of interventions. RESULTS: 1,572 patients received MM (mean visit time = 29.1 min). 2,133 DTPs were identified, which resulted in 7176 recommended interventions. The clinical problems most frequently encountered were cardiovascular (20%), and mental (15.7%). The most frequently identified DTP was "needs additional therapy" (61.8%), while the most frequently initiated or recommended interventions were education (43.4%), and changing therapy (21.6%). Elderly patients with multiple comorbidities had more DTPs and required more interventions and even when no DTPs were identified, some patients still received counselling and education in these visits. CONCLUSION: Using real-world data, this research demonstrated that patients benefit from identification and resolution of DTPs through pharmacists-driven MM programs.

eHealth-supported decentralized multi-disciplinary care for gout involving rheumatology, pharmacy, and dietetics: proof-of-concept study.

OBJECTIVE: To conduct quantitative and qualitative evaluation of an electronic health (eHealth)-supported decentralized multi-disciplinary care model for gout involving rheumatologists, pharmacist, and dietitian. METHODS: We conducted a 12-month proof-of-concept study. Gout patients with ≥ 1 flare in the past year and serum urate (SUA) ≥ 360 µmol/L within the previous 2 months were followed by participating community rheumatologists on an as-needed basis, received monthly telephone consults with a pharmacist, and one telephone consult with a dietitian. Healthcare professionals were not co-located but had shared access to the rheumatologists' electronic medical records (EMR) for remote communication and collaboration. In quantitative evaluation, the primary outcome was the proportion of patients with SUA < 360 µmol/L at 12 months. In qualitative evaluation, we conducted semi-structured interviews with a subset of patients and applied constructivist grounded theory to gather patients' perspectives. RESULTS: Overall, 35 gout patients (86% males, mean age 60.9 ± 14.9 years) participated. At 12 months, 72% of patients achieved target SUA < 360 µmol/L. Qualitative analysis of interviews with a subset of 12 patients resulted in two themes: (1) experiences with receiving care, including categories of improved knowledge about gout, receiving personalized support, and knowing someone cares, and (2) practical considerations, including categories of optimizing timing of care and coordination and accessibility. CONCLUSION: Our multi-method study shows that a decentralized, multi-disciplinary care for gout involving rheumatology, pharmacy, and dietetics with shared EMR access led to gout patients achieving target SUA. It was well-received by patients who perceived better education about gout and personalized care.Key Points• We demonstrated the feasibility and impact of an eHealth-supported, decentralized collaborative care model for gout involving rheumatology, pharmacy, and dietetics• Although prior multi-disciplinary models of care for gout have been reported, the novelty of our model is that healthcare providers are not co-located, lending to potential efficiencies and outreach to patients in rural areas.

Management of Inflammatory Arthritis in pregnancy: a National Cross-Sectional Survey of Canadian rheumatologists.

BACKGROUND: With improved therapies and management, more women with inflammatory arthritides (IA) are considering pregnancy. Our objective was to survey rheumatologists across Canada about their IA management in pregnancy to identify practice patterns and knowledge gaps. METHODS: We administered an online survey with questions regarding medications for IA treatment including conventional synthetic disease modifying antirheumatic drugs (csDMARDs) and biologics/small molecules in planned and unplanned pregnancies. Email invitations were sent to members of the Canadian Rheumatology Association. We calculated responses frequencies and a priori set a cut-off of ≥75% to define consensus. RESULTS: Ninety rheumatologists participated in the survey (20% participation rate); 57% have been practicing for > 10 years, 32% for ≤10 years, and 11% in training. There was consensus on discontinuation of 4 csDMARDs - cyclophosphamide (100%), leflunomide (98%), methotrexate (96%), and mycophenolate mofetil (89%) - in planned pregnancies but varied responses on when to discontinue them or what to do in unplanned pregnancies. Respondents agreed that 3 csDMARDs - azathioprine (84%), hydroxychloroquine (95%), and sulfasalazine (77%) - were safe to continue in planned and unplanned pregnancies. There was consensus with use of 4 biologics - adalimumab (81%), certolizumab (80%), etanercept (83%), and infliximab (76%) - in planned pregnancies but uncertainty on when they should be discontinued and their use in unplanned pregnancies. CONCLUSIONS: This national survey shows consensus among rheumatologists on the use of some csDMARDs and biologics/small molecules in IA patients planning pregnancy but varied knowledge on when to discontinue and what to do in unplanned pregnancies.

Risk of congenital anomalies in infants born to women with autoimmune disease using biologics before or during pregnancy: a population-based cohort study.

OBJECTIVES: To determine the association between perinatal biologic use and congenital anomalies in women with autoimmune disease. METHODS: We linked population-based administrative health data including information on all medications with a perinatal registry in British Columbia, Canada. Women with one or more autoimmune diseases who had pregnancies between January 1st, 2002 and December 31st, 2012 were included. Exposure to biologics was defined as having at least one biologic prescription 3 months before conception or during the first trimester of pregnancy. Each exposed pregnancy was matched with five unexposed pregnancies using high dimensional propensity scores (HDPS). Logistic regression modelling was used to evaluate the association between biologics use and congenital anomalies. RESULTS: The HDPS-matched cohort included 117 pregnancies (107 women) exposed to biologics, and 585 pregnancies (562 women) that were not exposed to biologics during the period of interest; 6% of newborns had ≥1 congenital anomalies at birth, in the exposed and unexposed groups. There were no obvious patterns with regards to the congenital anomalies observed in the biologics exposed group. In primary analysis, the OR for the association between biologic exposure and congenital anomalies was 1.06 (95%CI 0.46-2.47). Secondary and sensitivity analyses did not change the results appreciably. CONCLUSIONS: These population-based data suggest that the use of biologics before and during pregnancy is not associated with an increased risk of congenital anomalies.

Use of biologics during pregnancy and risk of serious infections in the mother and baby: a Canadian population-based cohort study.

OBJECTIVES: To investigate the association between exposure to biologics during pregnancy and serious infections in mothers and infants. DESIGN: Retrospective cohort study. SETTING: Population-based. PARTICIPANTS: Women with one or more autoimmune diseases identified by International Classification of Diseases 9th/10th revision codes in healthcare administrative databases in British Columbia, Canada, who had pregnancies ending in a live or stillbirth between 1 January 2002 and 31 December 2012. Women were defined as exposed if they had at least one biologic prescription during pregnancy, and infants born to these women were considered exposed in utero. Disease-matched women with no biologics prescriptions during pregnancy, and their infants, comprised the unexposed groups. PRIMARY OUTCOME MEASURES: Serious infections requiring hospitalisation. RESULTS: Over the 10-year study period, there were 6218 women (8607 pregnancies) who had an autoimmune disease diagnosis, of which 90 women were exposed to biologics during pregnancy, with 100 babies born to these women. Among women exposed to biologics during pregnancy, occurrence of serious postpartum infections were low, ranging from 0% to 5%, depending on concomitant exposures to immunosuppressants. In multivariable models using logistic regression, the OR for the association of biologics exposure with serious maternal postpartum infections was 0.79 (95% CI 0.24 to 2.54). In infants exposed to biologics in utero, occurrence of serious infections during the first year of life ranged from 0% to 7%, depending on concomitant exposures to immunosuppressants in utero. Multivariable models showed no association between biologics exposure in utero and serious infant infections (OR 0.56, 95% CI 0.17 to 1.81). CONCLUSIONS: These population-based data suggest that the use of biologics by women with autoimmune diseases during pregnancy is not associated with an increased risk of serious infections in mothers, during post partum or in infants during the first year of life.

Mobile Phone Apps Targeting Medication Adherence: Quality Assessment and Content Analysis of User Reviews.

BACKGROUND: With the accessibility and widespread use of mobile phones, mobile phone apps targeting medication adherence may be useful tools to help patients take medications as prescribed. OBJECTIVE: Our objectives were to (1) characterize and assess mobile phone medication adherence apps guided by a conceptual framework on the focus of adherence interventions and (2) conduct a content analysis of Web-based reviews to explore users' perspectives and experiences with mobile phone medication adherence apps. METHODS: We searched for mobile phone medication adherence apps using keyword searches in Apple and Android operating systems. We characterized all apps in terms of number of downloads, ratings, languages, cost, and disease target. We categorized apps according to 4 key features of (1) alerting to take medication, (2) tracking medication taking, (3) reminding to refill or indicating amount of medication left, and (4) storing medication information. We then selected representative apps from each operating system for detailed quality assessment and user testing. We also downloaded Web-based reviews for these selected apps and conducted a qualitative content analysis using an inductive approach involving steps of initial open coding, construction of categories, and abstraction into themes. RESULTS: We identified 704 apps (443 from Apple and 261 from Android). The majority of apps across both operating systems had 1 or 2 features-specifically, 37.2% (165/443) and 38.1% (169/443) of Apple apps, respectively, and 41.4% (108/261) and 31.4% (108/261) of Android apps, respectively. Quality assessment and user testing of 20 selected apps revealed apps varied in quality and commonly focused on behavioral strategies to enhance medication adherence through alerts, reminders, and logs. A total of 1323 eligible Web-based reviews from these 20 selected apps were analyzed, and the following themes emerged: (1) features and functions appreciated by users, which included the ability to set up customized medication regimen details and reminders, monitor other health information (eg, vitals, supplements, and manage multiple people or pets), support health care visits (eg, having a list of medications and necessary health information in 1 app); (2) negative user experiences that captured technical difficulties (glitches, confusing app navigation, and poor interoperability), dosage schedule, and reminder setup inflexibility; and (3) desired functions and features related to optimization of information input, improvement of reminders, and upgrading app performance (better synchronization or backup of data and interoperability). CONCLUSIONS: A large number of mobile phone medication adherence apps are currently available. The majority of apps have features representing a behavioral approach to intervention. Findings of the content analysis offer mostly positive feedback as well as insights into current limitations and improvements that could be addressed in current and future medication adherence apps.

Risk of preterm delivery and small-for-gestational-age births in women with autoimmune disease using biologics before or during pregnancy: a population-based cohort study.

OBJECTIVES: To assess the risk of preterm delivery and small-for-gestational-age (SGA) births in women with autoimmune diseases using biologics before or during pregnancy. METHODS: Using population-based administrative data in British Columbia, Canada, women with one or more autoimmune diseases who had pregnancies between 1 January 2002 and 31 December 2012 were included. Exposure to biologics was defined as having at least one biologic prescription 3 months before or during pregnancy. Each exposed pregnancy was matched with five unexposed pregnancies using high-dimensional propensity scores (HDPS). Logistic regression modelling was used to evaluate the association between biologics use and preterm delivery and SGA. RESULTS: There were 6218 women with 8607 pregnancies who had an autoimmune disease diagnosis; of which 109 women with 120 pregnancies were exposed to biologics 3 months before or during pregnancy. In unadjusted analyses, the ORs for the association of biologics exposure with preterm deliveries were 1.64 (95% CI 1.02 to 2.63) and 1.34 (95% CI 0.72 to 2.51) for SGA. After HDPS matching with 600 unexposed pregnancies, the ORs for the association of biologics exposure and preterm deliveries were 1.13 (95% CI 0.67 to 1.90) and 0.91 (95% CI 0.46 to 1.78) for SGA. Sensitivity analyses using HDPS deciles, continuous HDPS covariate or longer exposure window did not result in marked changes in point estimates and CIs. CONCLUSIONS: These population-based data suggest that the use of biologics before and during pregnancy is not associated with an increased risk of preterm delivery or SGA births.

Patient Satisfaction and Costs of Multidisciplinary Models of Care in Rheumatology: a Review of the Recent Literature.

PURPOSE OF THE REVIEW: A number of novel models of care utilizing allied healthcare professionals, including nurses and pharmacists, have emerged as an alternate to rheumatologist specialist care to achieve disease outcomes in patients with inflammatory arthritis. We conducted a review of the literature for studies from the past 5 years that reported on measures of patient satisfaction and/or any health economic outcome in a model of care where the care providers had substantial, but not completely independent, responsibility. RECENT FINDINGS: Previous reviews have summarized the available evidence for collaborative models of care led by nurses (only), which demonstrate that patients with inflammatory arthritis achieve similar disease outcomes and feel well supported with their person-centered care. Patients are generally highly satisfied with the care provided in collaborative care models, in line with if not greater than that provided by rheumatologists. However, we identified substantial variability in direct costs and/or overall intervention costs and measures of health-related quality of life across the various countries and healthcare systems. Overall, nursing-led interventions likely cost more than do physician-led models of care in the short-term but may lead to greater quality of life, as demonstrated with a disease-specific measure.

Utility of Electronic Medical Records in Community Rheumatology Practice for Assessing Quality of Care Indicators for Gout: A Feasibility Study.

OBJECTIVES: With comprehensive capture of information on patient encounters, electronic medical records (EMRs) may have utility for assessing adherence to quality indicators (QIs) in gout. Our objectives were to translate 10 previously established gout QIs into relevant EMR data and evaluate and describe the feasibility of using EMRs to assess gout QIs. METHODS: Using EMRs from 3 community rheumatology practices in Vancouver, British Columbia, Canada, we identified gout patients seen between January 1, 2012, and December 31, 2013. We translated each gout QI into potential EMR variables that would allow identification of patients the QI pertains to and whether the QI could be assessed. We extracted deidentified EMR data on gout diagnosis, medications, laboratory tests, radiological tests, and clinical notes and calculated the percent availability of data for each QI. RESULTS: We included 125 patients with gout, with mean age of 64 ± 17 years and with males comprising 78%. Overall, there were sufficient EMR data to allow translation of 7 QIs and assessment of 6 QIs including therapy-related gout QIs (69%-83% data availability) and one counseling-related QI (8% data availability). The highest percent data availability was observed in the single QI translated into EMR data and assessed based on diagnostic codes and prescription medications and not laboratory tests. CONCLUSIONS: Electronic medical records are promising tools for assessing QIs for gout. It was feasible to translate seven gout QIs into relevant EMR variables and there was sufficient EMR data to feasibly assess six of these QIs -Our findings lend evidence to support the utility of EMRs for ut QI assessment, with implications for helping improve management of this disease.

Patterns of Biologics Utilization and Discontinuation Before and During Pregnancy in Women With Autoimmune Diseases: A Population-Based Cohort Study.

OBJECTIVE: To characterize patterns of biologics use and discontinuation before and during pregnancy in women with autoimmune diseases in British Columbia, Canada. METHODS: Women with ≥1 autoimmune diseases, as identified by International Classification of Diseases Ninth/Tenth Revision codes, who had pregnancies ending in deliveries between January 1, 2002, and December 31, 2012, and had ≥1 prescription for a biologic drug 1 year before pregnancy or during pregnancy, were included. Secular trends, patterns of biologics use, and risk of biologics discontinuation before and during pregnancy were examined. Associations between drug discontinuations and various factors were investigated using multilevel logistic regression models, fitted with binomial generalized estimating equations. RESULTS: Of 6,218 women (8,431 pregnancies) with autoimmune diseases, 131 women (144 pregnancies) were exposed to a biologic before or during pregnancy. The use of biologics in this cohort increased from 0% in 2002 to 5.7% by 2012 (P < 0.001). Within the first trimester of pregnancy, 31% of women (34/110) discontinued their biologic treatment, and 38% (30/79) discontinued use in the second trimester, while 98% of those receiving treatment in the second trimester (50/51) continued treatment in the third trimester. Women with rheumatoid arthritis had three times higher odds (odds ratio 3.40 [95% confidence interval 1.33-8.71]) of discontinuing biologics during pregnancy, compared to those with inflammatory bowel disease. CONCLUSION: Given the increased use of biologics and high odds of discontinuation during pregnancy in certain populations, more research is needed to improve our understanding of the risks and benefits of biologics for fetal and maternal health.

Opinions and preferences of British Columbia pharmacists and physicians on medication management services.

BACKGROUND: Medication management (MM) services are being provided by pharmacists across Canada in various forms, but pharmacist-physician collaboration is still not a routine practice in most jurisdictions. This survey aimed to gather pharmacists' and physicians' opinions and preferences for MM provision. METHODS: Two parallel, cross-sectional online surveys, including best-worst scaling tasks, were designed for pharmacists and physicians in British Columbia to capture and compare their preferences for a number of attributes of MM. RESULTS: Surveys were completed by 119 pharmacists and 146 physicians. Results indicate that pharmacists and physicians had similar opinions on many aspects of MM. Ninety-five percent of pharmacists and 69% of physicians believed that additional health services are needed to help patients optimize the use of their medications. However, the majority of each group felt that they were the most important health care professional in providing this service. Most pharmacists (79%) and some physicians (25%) thought that optimizing use of medications would result in both decreased costs and utilization to the health care system. Both pharmacists and physicians felt that the best attribute of an MM service would be if the services resulted in improved health and medication use for patients. Both groups were motivated by increased remuneration for MM; however, the relative strength of preference for this was higher among physicians. Interestingly, physicians valued improved medication adherence as a result of MM more highly than pharmacists did. DISCUSSION AND CONCLUSION: Most pharmacists and physicians agreed that improving patients' health and medication use would be the best attribute of MM and that there is a need for such services. However, physicians also had strong preferences for being remunerated for participating in MM provision.