An administrative data validation study of the accuracy of algorithms for identifying rheumatoid arthritis: the influence of the reference standard on algorithm performance

BACKGROUND: We have previously validated administrative data algorithms to identify patients with rheumatoid arthritis (RA) using rheumatology clinic records as the reference standard. Here we reassessed the accuracy of the algorithms using primary care records as the reference standard. METHODS: We performed a retrospective chart abstraction study using a random sample of 7500 adult patients under the care of 83 family physicians contributing to the Electronic Medical Record Administrative data Linked Database (EMRALD) in Ontario, Canada. Using physician-reported diagnoses as the reference standard, we computed and compared the sensitivity, specificity, and predictive values for over 100 administrative data algorithms for RA case ascertainment. RESULTS: We identified 69 patients with RA for a lifetime RA prevalence of 0.9%. All algorithms had excellent specificity (>97%). However, sensitivity varied (75-90%) among physician billing algorithms. Despite the low prevalence of RA, most algorithms had adequate positive predictive value (PPV; 51-83%). The algorithm of “[1 hospitalization RA diagnosis code] or [3 physician RA diagnosis codes with ≥1 by a specialist over 2 years]” had a sensitivity of 78% (95% CI 69–88), specificity of 100% (95% CI 100–100), PPV of 78% (95% CI 69–88) and NPV of 100% (95% CI 100–100). CONCLUSIONS: Administrative data algorithms for detecting RA patients achieved a high degree of accuracy amongst the general population. However, results varied slightly from our previous report, which can be attributed to differences in the reference standards with respect to disease prevalence, spectrum of disease, and type of comparator group

Phase 3 trials of ixekizumab in moderate-to-severe plaque psoriasis

BACKGROUND Two phase 3 trials (UNCOVER-2 and UNCOVER-3) showed that at 12 weeks of treatment, ixekizumab, a monoclonal antibody against interleukin-17A, was superior to placebo and etanercept in the treatment of moderate-to-severe psoriasis. We report the 60-week data from the UNCOVER-2 and UNCOVER-3 trials, as well as 12-week and 60-week data from a third phase 3 trial, UNCOVER-1. METHODS We randomly assigned 1296 patients in the UNCOVER-1 trial, 1224 patients in the UNCOVER-2 trial, and 1346 patients in the UNCOVER-3 trial to receive subcutaneous injections of placebo (placebo group), 80 mg of ixekizumab every 2 weeks after a starting dose of 160 mg (2-wk dosing group), or 80 mg of ixekizumab every 4 weeks after a starting dose of 160 mg (4-wk dosing group). Additional cohorts in the UNCOVER-2 and UNCOVER-3 trials were randomly assigned to receive 50 mg of etanercept twice weekly. At week 12 in the UNCOVER-3 trial, the patients entered a long-term extension period during which they received 80 mg of ixekizumab every 4 weeks through week 60; at week 12 in the UNCOVER-1 and UNCOVER-2 trials, the patients who had a response to ixekizumab (defined as a static Physicians Global Assessment [sPGA] score of 0 [clear] or 1 [minimal psoriasis]) were randomly reassigned to receive placebo, 80 mg of ixekizumab every 4 weeks, or 80 mg of ixekizumab every 12 weeks through week 60. Coprimary end points were the percentage of patients who had a score on the sPGA of 0 or 1 and a 75% or greater reduction from baseline in Psoriasis Area and Severity Index (PASI 75) at week 12. RESULTS In the UNCOVER-1 trial, at week 12, the patients had better responses to ixekizumab than to placebo; in the 2-wk dosing group, 81.8% had an sPGA score of 0 or 1 and 89.1% had a PASI 75 response; in the 4-wk dosing group, the respective rates were 76.4% and 82.6%; and in the placebo group, the rates were 3.2% and 3.9% (P<0.001 for all comparisons of ixekizumab with placebo). In the UNCOVER-1 and UNCOVER-2 trials, among the patients who were randomly reassigned at week 12 to receive 80 mg of ixekizumab every 4 weeks, 80 mg of ixekizumab every 12 weeks, or placebo, an sPGA score of 0 or 1 was maintained by 73.8%, 39.0%, and 7.0% of the patients, respectively. Patients in the UNCOVER-3 trial received continuous treatment of ixekizumab from weeks 0 through 60, and at week 60, at least 73% had an sPGA score of 0 or 1 and at least 80% had a PASI 75 response. Adverse events reported during ixekizumab use included neutropenia, candidal infections, and inflammatory bowel disease. CONCLUSIONS In three phase 3 trials involving patients with psoriasis, ixekizumab was effective through 60 weeks of treatment. As with any treatment, the benefits need to be weighed against the risks of adverse events. The efficacy and safety of ixekizumab beyond 60 weeks of treatment are not yet known

Atrasentan and renal events in patients with type 2 diabetes and chronic kidney disease (SONAR): a double-blind, randomised, placebo-controlled trial

Background: Short-term treatment for people with type 2 diabetes using a low dose of the selective endothelin A receptor antagonist atrasentan reduces albuminuria without causing significant sodium retention. We report the long-term effects of treatment with atrasentan on major renal outcomes. Methods: We did this double-blind, randomised, placebo-controlled trial at 689 sites in 41 countries. We enrolled adults aged 18–85 years with type 2 diabetes, estimated glomerular filtration rate (eGFR)25–75 mL/min per 1·73 m 2 of body surface area, and a urine albumin-to-creatinine ratio (UACR)of 300–5000 mg/g who had received maximum labelled or tolerated renin–angiotensin system inhibition for at least 4 weeks. Participants were given atrasentan 0·75 mg orally daily during an enrichment period before random group assignment. Those with a UACR decrease of at least 30% with no substantial fluid retention during the enrichment period (responders)were included in the double-blind treatment period. Responders were randomly assigned to receive either atrasentan 0·75 mg orally daily or placebo. All patients and investigators were masked to treatment assignment. The primary endpoint was a composite of doubling of serum creatinine (sustained for ≥30 days)or end-stage kidney disease (eGFR <15 mL/min per 1·73 m 2 sustained for ≥90 days, chronic dialysis for ≥90 days, kidney transplantation, or death from kidney failure)in the intention-to-treat population of all responders. Safety was assessed in all patients who received at least one dose of their assigned study treatment. The study is registered with ClinicalTrials.gov, number NCT01858532. Findings: Between May 17, 2013, and July 13, 2017, 11 087 patients were screened; 5117 entered the enrichment period, and 4711 completed the enrichment period. Of these, 2648 patients were responders and were randomly assigned to the atrasentan group (n=1325)or placebo group (n=1323). Median follow-up was 2·2 years (IQR 1·4–2·9). 79 (6·0%)of 1325 patients in the atrasentan group and 105 (7·9%)of 1323 in the placebo group had a primary composite renal endpoint event (hazard ratio [HR]0·65 [95% CI 0·49–0·88]; p=0·0047). Fluid retention and anaemia adverse events, which have been previously attributed to endothelin receptor antagonists, were more frequent in the atrasentan group than in the placebo group. Hospital admission for heart failure occurred in 47 (3·5%)of 1325 patients in the atrasentan group and 34 (2·6%)of 1323 patients in the placebo group (HR 1·33 [95% CI 0·85–2·07]; p=0·208). 58 (4·4%)patients in the atrasentan group and 52 (3·9%)in the placebo group died (HR 1·09 [95% CI 0·75–1·59]; p=0·65). Interpretation: Atrasentan reduced the risk of renal events in patients with diabetes and chronic kidney disease who were selected to optimise efficacy and safety. These data support a potential role for selective endothelin receptor antagonists in protecting renal function in patients with type 2 diabetes at high risk of developing end-stage kidney disease. Funding: AbbVie

Patient visits and prescriptions for attention-deficit/hyperactivity disorder from 2017-2021: Impacts of COVID-19 pandemic in primary care.

ObjectiveTo determine whether more patients presented with Attention-deficit/hyperactivity disorder (ADHD)-related visits and/or sought care from family physicians more frequently during the COVID-19 pandemic.MethodsElectronic medical records from the University of Toronto Practice-Based Research Network were used to characterize changes in family physician visits and prescriptions for ADHD medications. Annual patient prevalence and visit rates pre-pandemic (2017-2019) were used to calculate the expected rates in 2020 and 2021. The expected and observed rates were compared to identify any pandemic-related changes.ResultsThe number of patients presenting for ADHD-related visits during the pandemic was consistent with pre-pandemic trends. However, observed ADHD-related visits in 2021 were 1.32 times higher than expected (95% CI: 1.05-1.75), suggesting that patients visited family physicians more frequently than before the pandemic.ConclusionDemand for primary care services related to ADHD has continued to increase during the pandemic, with increased health service use among those accessing care

Are family physicians comprehensively using electronic medical records such that the data can be used for secondary purposes? A Canadian perspective

Abstract Background With the introduction and implementation of a variety of government programs and policies to encourage adoption of electronic medical records (EMRs), EMRs are being increasingly adopted in North America. We sought to evaluate the completeness of a variety of EMR fields to determine if family physicians were comprehensively using their EMRs and the suitability of use of the data for secondary purposes in Ontario, Canada. Methods We examined EMR data from a convenience sample of family physicians distributed throughout Ontario within the Electronic Medical Record Administrative data Linked Database (EMRALD) as extracted in the summer of 2012. We identified all physicians with at least one year of EMR use. Measures were developed and rates of physician documentation of clinical encounters, electronic prescriptions, laboratory tests, blood pressure and weight, referrals, consultation letters, and all fields in the cumulative patient profile were calculated as a function of physician and patient time since starting on the EMR. Results Of the 167 physicians with at least one year of EMR use, we identified 186,237 patients. Overall, the fields with the highest level of completeness were for visit documentations and prescriptions (>70 %). Improvements were observed with increasing trends of completeness overtime for almost all EMR fields according to increasing physician time on EMR. Assessment of the influence of patient time on EMR demonstrated an increasing likelihood of the population of EMR fields overtime, with the largest improvements occurring between the first and second years. Conclusions All of the data fields examined appear to be reasonably complete within the first year of adoption with the biggest increase occurring the first to second year. Using all of the basic functions of the EMR appears to be occurring in the current environment of EMR adoption in Ontario. Thus the data appears to be suitable for secondary use

Trends in health service use among persons with Parkinson's disease by rurality: A population-based repeated cross-sectional study.

BackgroundThe global burden of Parkinson's disease (PD) has more than doubled over the past three decades, and this trend is expected to continue. Despite generally poorer access to health care services in rural areas, little previous work has examined health system use in persons with PD by rurality. We examined trends in the prevalence of PD and health service use among persons with PD by rurality in Ontario, Canada.MethodsWe conducted a repeated, cross-sectional analysis of persons with prevalent PD aged 40+ years on April 1st of each year from 2000 to 2018 using health administrative databases and calculated the age-sex standardized prevalence of PD. Prevalence of PD was also stratified by rurality and sex. Negative binomial models were used to calculate rate ratios with 95% confidence intervals comparing rates of health service use in rural compared to urban residents in 2018.ResultsThe age-sex standardized prevalence of PD in Ontario increased by 0.34% per year (pInterpretationLower rates of outpatient health service use among persons residing in rural regions, contrasting with higher rates of emergency department visits suggest inequities in access. Efforts to improve access to primary and specialist care for persons with PD in rural regions are needed

Acceptability and Feasibility of an Evidence-Based Requisition for Bone Mineral Density Testing in Clinical Practice

Introduction. The purpose of this study is to understand the experience of primary care providers (PCPs) using an evidence-based requisition for bone mineral density (BMD) testing. Methods. A qualitative descriptive approach was adopted. Participants were given 3 BMD Recommended Use Requisitions (RUR) to use over a 2-month period. Twenty-six PCPs were interviewed before using the RUR. Those who had received at least one BMD report resulting from RUR use were then interviewed again. An inductive thematic analysis was performed. Results. We identified four themes in interview data: (1) positive and negative characteristics of the RUR, (2) facilitators and barriers for implementation, (3) impact of the RUR, and (4) requisition preference. Positive characteristics of the RUR related to both its content and format. Negative characteristics related to the increased amount of time needed to complete the form. Facilitators to implementation included electronic availability and organizational endorsement. Time constraints were identified as a barrier to implementation. Participants perceived that the RUR would promote appropriate referrals and the majority of participants preferred the RUR to their current requisition. Conclusions. Findings from this study provide support for the RUR as an acceptable point-of-care tool for PCPs to promote appropriate BMD testing.Peer Reviewe

Acceptability and Feasibility of an Evidence-Based Requisition for Bone Mineral Density Testing in Clinical Practice

Introduction. The purpose of this study is to understand the experience of primary care providers (PCPs) using an evidence-based requisition for bone mineral density (BMD) testing. Methods. A qualitative descriptive approach was adopted. Participants were given 3 BMD Recommended Use Requisitions (RUR) to use over a 2-month period. Twenty-six PCPs were interviewed before using the RUR. Those who had received at least one BMD report resulting from RUR use were then interviewed again. An inductive thematic analysis was performed. Results. We identified four themes in interview data: (1) positive and negative characteristics of the RUR, (2) facilitators and barriers for implementation, (3) impact of the RUR, and (4) requisition preference. Positive characteristics of the RUR related to both its content and format. Negative characteristics related to the increased amount of time needed to complete the form. Facilitators to implementation included electronic availability and organizational endorsement. Time constraints were identified as a barrier to implementation. Participants perceived that the RUR would promote appropriate referrals and the majority of participants preferred the RUR to their current requisition. Conclusions. Findings from this study provide support for the RUR as an acceptable point-of-care tool for PCPs to promote appropriate BMD testing