Pragmatic Trial of Hospitalization Rate in Chronic Kidney Disease.

BACKGROUND: Despite the availability of effective therapies for patients with chronic kidney disease, type 2 diabetes, and hypertension (the kidney-dysfunction triad), the results of large-scale trials examining the implementation of guideline-directed therapy to reduce the risk of death and complications in this population are lacking. METHODS: In this open-label, cluster-randomized trial, we assigned 11,182 patients with the kidney-dysfunction triad who were being treated at 141 primary care clinics either to receive an intervention that used a personalized algorithm (based on the patient's electronic health record [EHR]) to identify patients and practice facilitators to assist providers in delivering guideline-based interventions or to receive usual care. The primary outcome was hospitalization for any cause at 1 year. Secondary outcomes included emergency department visits, readmissions, cardiovascular events, dialysis, and death. RESULTS: We assigned 71 practices (enrolling 5690 patients) to the intervention group and 70 practices (enrolling 5492 patients) to the usual-care group. The hospitalization rate at 1 year was 20.7% (95% confidence interval [CI], 19.7 to 21.8) in the intervention group and 21.1% (95% CI, 20.1 to 22.2) in the usual-care group (between-group difference, 0.4 percentage points; P = 0.58). The risks of emergency department visits, readmissions, cardiovascular events, dialysis, or death from any cause were similar in the two groups. The risk of adverse events was also similar in the trial groups, except for acute kidney injury, which was observed in more patients in the intervention group (12.7% vs. 11.3%). CONCLUSIONS: In this pragmatic trial involving patients with the triad of chronic kidney disease, type 2 diabetes, and hypertension, the use of an EHR-based algorithm and practice facilitators embedded in primary care clinics did not translate into reduced hospitalization at 1 year. (Funded by the National Institutes of Health and others; ICD-Pieces ClinicalTrials.gov number, NCT02587936.).

A Cluster Randomized Trial of Primary Care Practice Redesign to Integrate Behavioral Health for Those Who Need It Most: Patients With Multiple Chronic Conditions.

PURPOSE: Patient outcomes can improve when primary care and behavioral health providers use a collaborative system of care, but integrating these services is difficult. We tested the effectiveness of a practice intervention for improving patient outcomes by enhancing integrated behavioral health (IBH) activities. METHODS: We conducted a pragmatic, cluster randomized controlled trial. The intervention combined practice redesign, quality improvement coaching, provider and staff education, and collaborative learning. At baseline and 2 years, staff at 42 primary care practices completed the Practice Integration Profile (PIP) as a measure of IBH. Adult patients with multiple chronic medical and behavioral conditions completed the Patient-Reported Outcomes Measurement Information System (PROMIS-29) survey. Primary outcomes were the change in 8 PROMIS-29 domain scores. Secondary outcomes included change in level of integration. RESULTS: Intervention assignment had no effect on change in outcomes reported by 2,426 patients who completed both baseline and 2-year surveys. Practices assigned to the intervention improved PIP workflow scores but not PIP total scores. Baseline PIP total score was significantly associated with patient-reported function, independent of intervention. Active practices that completed intervention workbooks (n = 13) improved patient-reported outcomes and practice integration (P ≤ .05) compared with other active practices (n = 7). CONCLUSION: Intervention assignment had no effect on change in patient outcomes; however, we did observe improved patient outcomes among practices that entered the study with greater IBH. We also observed more improvement of integration and patient outcomes among active practices that completed the intervention compared to active practices that did not. Additional research is needed to understand how implementation efforts to enhance IBH can best reach patients.

COPD Population in US Primary Care: Data From the Optimum Patient Care DARTNet Research Database and the Advancing the Patient Experience in COPD Registry.

PURPOSE: To describe demographic and clinical characteristics of chronic obstructive pulmonary disease patients managed in US primary care. METHODS: This was an observational registry study using data from the Chronic Obstructive Pulmonary Disease (COPD) Optimum Patient Care DARTNet Research Database from which the Advancing the Patient Experience COPD registry is derived. Registry patients were aged ≥35 years at diagnosis. Electronic health record data were collected from both registries, supplemented with patient-reported information/outcomes from the Advancing the Patient Experience registry from 5 primary care groups in Texas, Ohio, Colorado, New York, and North Carolina (June 2019 through November 2020). RESULTS: Of 17,192 patients included, 1,354 were also in the Advancing the Patient Experience registry. Patients were predominantly female (56%; 9,689/17,192), White (64%; 9,732/15,225), current/ex-smokers (80%; 13,784/17,192), and overweight/obese (69%; 11,628/16,849). The most commonly prescribed maintenance treatments were inhaled corticosteroid with a long-acting ß2-agonist (30%) and inhaled corticosteroid with a long-acting muscarinic antagonist (27%). Although 3% (565/17,192) of patitents were untreated, 9% (1,587/17,192) were on short-acting bronchodilator monotherapy, and 4% (756/17,192) were on inhaled corticosteroid monotherapy. Despite treatment, 38% (6,579/17,192) of patients experienced 1 or more exacerbations in the last 12 months. These findings were mirrored in the Advancing Patient Experience registry with many patients reporting high or very high impact of disease on their health (43%; 580/1,322), a breathlessness score 2 or more (45%; 588/1,315), and 1 or more exacerbation in the last 12 months (50%; 646/1,294). CONCLUSIONS: Our findings highlight the high exacerbation, symptom, and treatment burdens experienced by COPD patients managed in US primary care, and the need for more real-life effectiveness trials to support decision making at the primary care level.

Leveraging technology to promote smoking cessation in urban and rural primary care medical offices.

We examined the use of automated voice recognition (AVR) messages targeting smokers from primary care practices located in underserved urban and rural communities to promote smoking cessation. We partnered with urban and rural primary care medical offices (n = 7) interested in offering this service to patients. Current smokers, 18 years and older, who had completed an office visit within the previous 12 months, from these sites were used to create a smoker's registry. Smokers were recruited within an eight county region of western New York State between June 2012 and August 2013. Participants were contacted over six month intervals using the AVR system. Among 5812 smokers accrued 1899 (32%) were reached through the AVR system and 55% (n = 1049) continued to receive calls. Smokers with race other than white or African American were less likely to be reached (OR = 0.71, 0.57-0.90), while smokers ages 40 and over were more likely to be reached. Females (OR = 0.78, 0.65-0.95) and persons over age 40 years were less likely to opt out, while rural smokers were more likely to opt out (OR = 3.84, 3.01-4.90). Among those receiving AVR calls, 30% reported smoke free (self-reported abstinence over a 24 h period) at last contact; smokers from rural areas were more likely to report being smoke free (OR = 1.41, 1.01-1.97). An AVR-based smoking cessation intervention provided added value beyond typical tobacco cessation efforts available in these primary care offices. This intervention required no additional clinical staff time and served to satisfy a component of patient center medical home requirements for practices.

Recruiting primary care practices for practice-based research: a case study of a group-randomized study (TRANSLATE CKD) recruitment process.

Background: We assessed the challenging process of recruiting primary care practices in a practice-based research study. Methods: In this descriptive case study of recruitment data collected for a large practice-based study (TRANSLATE CKD), 48 single or multiple-site health care organizations in the USA with a total of 114 practices were invited to participate. We collected quantitative and qualitative measures of recruitment process and outcomes for the first 25 practices recruited. Information about 13 additional practices is not provided due to staff transitions and limited data collection resources. Results: Initial outreach was made to 114 practices (from 48 organizations, 41% small); 52 (45%) practices responded with interest. Practices enrolled in the study (n = 25) represented 22% of the total outreach number, or 48% of those initially interested. Average time to enroll was 71 calendar days (range 11-107). There was no difference in the number of days practices remained under recruitment, based on enrolled versus not enrolled (44.8 ± 30.4 versus 46.8 ± 25.4 days, P = 0.86) or by the organization size, i.e. large versus small (defined by having ≤4 distinct practices; 52 ± 23.6 versus 43.6 ± 27.8 days; P = 0.46). The most common recruitment barriers were administrative, e.g. lack of perceived direct organizational benefit, and were more prominent among large organizations. Conclusions: Despite the general belief that the research topic, invitation method, and interest in research may facilitate practice recruitment, our results suggest that most of the recruitment challenges represent managerial challenges. Future research projects may need to consider relevant methodologies from businesses administration and marketing fields.

Perspectives on Smoking Cessation in Northern Appalachia.

This study applies qualitative research methods to explore perspectives on cessation among smokers/former smokers recruited from an area of Northern Appalachia. Six focus groups, stratified by age group (18-39 years old and 40 years and older), were conducted among participants (n = 54) recruited from community settings. Participants described varied interest in and challenges with quitting smoking. Smokers 40 years and older more readily endorsed the health risks of smoking and had greater interest in quitting assistance. Participants expressed frustration with the US government for allowing a harmful product (e.g., cigarettes) to be promoted with minimal regulation. Use of social media was robust among both age groups; participants expressed limited interest in various social media/technology platforms for promoting smoking cessation. Findings from this understudied area of northern Appalachia reflect the heterogeneity of this region and contribute novel information about the beliefs, attitudes, and experiences of current and formers smokers with regard to cessation.

Positive Predictive Value of a Single Assessment of Estimated GFR in the Diagnosis of Chronic Kidney Disease.

OBJECTIVES: The positive predictive value (PPV) of a single assessment of estimated glomerular filtration rate (eGFR) in the diagnosis of chronic kidney disease (CKD) is not known. Our objective was to determine the PPV of a single assessment of eGFR among adults with at least one eGFR <60 mL/min in their lifetime, using the Distributed Area Research and Therapeutics Network CKD natural history dataset. METHODS: In all, 47,104 adults who were cared for by 113 practices in the United States were included. Proportions of patients in eGFR categories at baseline were calculated using the following categories: <15 mL/min, 15 to 29.99 mL/min, 30 to 44.99 mL/min, and 45 to 59.99 mL/min. Comparisons were then made between the baseline and the endpoint to identify patients who had a follow-up eGFR that remained at <60 mL/min. The proportions of patients in each eGFR category were compared baseline to endpoint using cross-tabulations. To test the proposed cutpoint, the proportions of patients who had an eGFR that remained at <60 mL/min were measured, using the cutpoints that included the highest cumulative proportion of patients. The sensitivity and specificity of that cutpoint were calculated. RESULTS: A cutpoint of <45 mL/min was identified, yielding a PPV of 93% with a sensitivity of 28% and a specificity of 94%. CONCLUSIONS: A valid cutpoint to screen for CKD was identified. This cutpoint may prove important to early screening for CKD while reducing the burden on the healthcare system and patients suspected of having CKD.

KDOQI US commentary on the 2012 KDIGO clinical practice guideline for the evaluation and management of CKD.

The National Kidney Foundation-Kidney Disease Outcomes Quality Initiative (NKF-KDOQI) guideline for evaluation, classification, and stratification of chronic kidney disease (CKD) was published in 2002. The KDOQI guideline was well accepted by the medical and public health communities, but concerns and criticisms arose as new evidence became available since the publication of the original guidelines. KDIGO (Kidney Disease: Improving Global Outcomes) recently published an updated guideline to clarify the definition and classification of CKD and to update recommendations for the evaluation and management of individuals with CKD based on new evidence published since 2002. The primary recommendations were to retain the current definition of CKD based on decreased glomerular filtration rate or markers of kidney damage for 3 months or more and to include the cause of kidney disease and level of albuminuria, as well as level of glomerular filtration rate, for CKD classification. NKF-KDOQI convened a work group to write a commentary on the KDIGO guideline in order to assist US practitioners in interpreting the KDIGO guideline and determining its applicability within their own practices. Overall, the commentary work group agreed with most of the recommendations contained in the KDIGO guidelines, particularly the recommendations regarding the definition and classification of CKD. However, there were some concerns about incorporating the cause of disease into CKD classification, in addition to certain recommendations for evaluation and management.

Implementing asthma guidelines using practice facilitation and local learning collaboratives: a randomized controlled trial.

PURPOSE: Guideline implementation in primary care has proven difficult. Although external assistance through performance feedback, academic detailing, practice facilitation (PF), and learning collaboratives seems to help, the best combination of interventions has not been determined. METHODS: In a cluster randomized trial, we compared the independent and combined effectiveness of PF and local learning collaboratives (LLCs), combined with performance feedback and academic detailing, with performance feedback and academic detailing alone on implementation of the National Heart, Lung and Blood Institute's Asthma Guidelines. The study was conducted in 3 primary care practice-based research networks. Medical records of patients with asthma seen during pre- and postintervention periods were abstracted to determine adherence to 6 guideline recommendations. McNemar's test and multivariate modeling were used to evaluate the impact of the interventions. RESULTS: Across 43 practices, 1,016 patients met inclusion criteria. Overall, adherence to all 6 recommendations increased (P ≤.002). Examination of improvement by study arm in unadjusted analyses showed that practices in the control arm significantly improved adherence to 2 of 6 recommendations, whereas practices in the PF arm improved in 3, practices in the LLCs improved in 4, and practices in the PF + LLC arm improved in 5 of 6 recommendations. In multivariate modeling, PF practices significantly improved assessment of asthma severity (odds ratio [OR] = 2.5, 95% CI, 1.7-3.8) and assessment of asthma level of control (OR = 2.3, 95% CI, 1.5-3.5) compared with control practices. Practices assigned to LLCs did not improve significantly more than control practices for any recommendation. CONCLUSIONS: Addition of PF to performance feedback and academic detailing was helpful to practices attempting to improve adherence to asthma guidelines.

Assessing the delivery of cessation services to smokers in urban, safety-net clinics.

Inequities in smoking behaviors continue to exist with higher rates among persons with limited formal education and for those living below the poverty level. This report describes the scope of tobacco cessation services delivered to low socio-economic status (SES) patients in several primary care medical offices, considered as "safety-net" sources of health care. Using a cross-sectional design, a random sample of records were reviewed for 922 smokers from 4 medical offices. The primary outcome variable was the delivery of smoking cessation services as documented in medical records; information on patient demographics and number of visits during the past 12 months was also abstracted. Smoking status was assessed during the last office visit for 65 % of smokers, 59 % were advised to quit, readiness to quit was assessed for 24 %, 2 % indicated a willingness to quit within the next 30 days and a quit date was established for 1 %. Among smokers not yet ready to quit, few were counseled on the "5 R's" (Relevance, Risks, Rewards, Roadblocks, Repetition). These results expand our understanding of the unfortunately limited scope of cessation services delivered to persons seen in safety-net medical offices and call attention to the need to redouble efforts to more effectively address smoking cessation among diverse, low SES patients served by safety-net primary care clinics.

NSAID-avoidance education in community pharmacies for patients at high risk for acute kidney injury, upstate New York, 2011.

INTRODUCTION: Nonsteroidal anti-inflammatory drugs (NSAIDs) are frequently associated with community-acquired acute kidney injury (AKI), a strong risk factor for development and progression of chronic kidney disease. Using access to prescription medication profiles, pharmacists can identify patients at high risk for NSAID-induced AKI. The primary objective of this analysis was to evaluate the effectiveness of a community pharmacy-based patient education program on patient knowledge of NSAID-associated renal safety concerns. METHODS: Patients receiving prescription medications for hypertension or diabetes mellitus were invited to participate in an educational program on the risks of NSAID use. A patient knowledge questionnaire (PKQ) consisting of 5 questions scored from 1 to 5 was completed before and after the intervention. Information was collected on age, race, sex, and frequency of NSAID use. RESULTS: A total of 152 participants (60% women) completed both the pre- and post-intervention questionnaire; average age was 54.6 (standard deviation [SD], 17.5). Mean pre-intervention PKQ score was 3.3 (SD, 1.4), and post-intervention score was 4.6 (SD, 0.9) (P = .002). Participants rated program usefulness (1 = not useful to 5 = extremely useful) as 4.2 (SD, 1.0). In addition, 48% reported current NSAID use and 67% reported that the program encouraged them to limit their use. CONCLUSION: NSAID use was common among patients at high risk for AKI. A brief educational intervention in a community pharmacy improved patient knowledge on NSAID-associated risks. Pharmacists practicing in the community can partner with primary care providers in the medical home model to educate patients at risk for AKI.

Perceptions and use of the national kidney foundation KDOQI guidelines: a survey of U.S. renal healthcare providers.

BACKGROUND: The National Kidney Foundation (NKF) Kidney Disease Outcomes Quality Initiative (KDOQI) developed guidelines to care for patients with chronic kidney disease (CKD). While these are disseminated through the NKF's website and publications, the guidelines' usage remains suboptimal. The KDOQI Educational Committee was formed to identify barriers to guideline implementation, determine provider and patient educational needs and develop tools to improve care of patients with CKD. METHODS: An online survey was conducted from May to September 2010 to evaluate renal providers' familiarity, current use of and attitudes toward the guidelines and tools to implement the guidelines. RESULTS: Most responders reported using the guidelines often and felt that they could be easily implemented into clinical practice; however, approximately one-half identified at least one barrier. Physicians and physician extenders most commonly cited the lack of evidence supporting KDOQI guidelines while allied health professionals most commonly listed patient non-adherence, unrealistic guideline goals and provider time-constraints. Providers thought that the guidelines included too much detail and identified the lack of a quick resource as a barrier to clinical implementation. Most were unaware of the Clinical Action Plans. CONCLUSIONS: Perceived barriers differed between renal clinicians and allied health professionals; educational and implementation tools tailored for different providers are needed.

Fistula first breakthrough initiative: targeting catheter last in fistula first.

An arteriovenous fistula (AVF) is the optimal vascular access for hemodialysis (HD), because it is associated with prolonged survival, fewer infections, lower hospitalization rates, and reduced costs. The AVF First breakthrough initiative (FFBI) has made dramatic progress, effectively promoting the increase in the national AVF prevalence since the program's inception from 32% in May 2003 to nearly 60% in 2011. Central venous catheter (CVC) use has stabilized and recently decreased slightly for prevalent patients (treated more than 90 days), while CVC usage in the first 90 days remains unacceptably high at nearly 80%. This high prevalence of CVC utilization suggests important specific improvement goals for FFBI. In addition to the current 66% AVF goal, the initiative should include specific CVC usage target(s), based on the KDOQI goal of less than 10% in patients undergoing HD for more than 90 days, and a substantially improved initial target from the current CVC proportion. These specific CVC targets would be disseminated through the ESRD networks to individual dialysis facilities, further emphasizing CVC avoidance in the transition from advanced CKD to chronic kidney failure, while continuing to decrease CVC by prompt conversion of CVC-based hemodialysis patients to permanent vascular access, utilizing an AVF whenever feasible.

Practices, perceptions, and concerns of primary care physicians about opioid dependence associated with the treatment of chronic pain.

When prescribing opioids to treat chronic pain, physicians face the dilemma of balancing effective pain management while avoiding iatrogenic opioid addiction. Through mailed surveys, the current study assessed concerns, perceptions, and practices of primary care physicians related to this dilemma. Of the 35 (43%) physicians that replied, 32 (91.4%) reported to prescribe opioids for pain. Twenty-six (81.3%) physicians mentioned that "legitimate pain" was the main reason why most patients who are opioid dependent begin using opioids. Most physicians (71.5%) rated their knowledge/comfort of treatment/management of opioid dependence as being low. Although these physicians believed training is essential to learning about the risks involved with chronic pain and opioid dependence, many of these physicians evaluated their own medical training in these areas as unsatisfactory. Training programs may better equip primary care physicians when addressing the treatment of chronic pain and addiction to opioids.

Variation in Demographic and Clinical Characteristics of Patients with COPD Receiving Care in US Primary Care: Data from the Advancing the Patient EXperience (APEX) in COPD Registry.

Introduction: Little is known about the variability in chronic obstructive pulmonary disease (COPD) management and how it may be affected by patient characteristics across different healthcare systems in the US. This study aims to describe demographic and clinical characteristics of people with COPD and compare management across five primary care medical groups in the US. Methods: This is a retrospective observational registry study utilizing electronic health records stored in the Advancing the Patient Experience (APEX) COPD registry. The APEX registry contains data from five US healthcare organizations located in Texas, Ohio, Colorado, New York, and North Carolina. Data on demographic and clinical characteristics of primary care patients with COPD between December 2019 and January 2020 were extracted and compared. Results: A total of 17,192 patients with COPD were included in analysis: Texas (n = 811), Ohio (n = 8722), Colorado (n = 472), New York (n = 1149) and North Carolina (n = 6038). The majority of patients at each location were female (>54%) and overweight/obese (>60%). Inter-location variabilities were noted in terms of age, race/ethnicity, exacerbation frequency, treatment pattern, and prevalence of comorbid conditions. Patients from the Colorado site experienced the lowest number of exacerbations per year while those from the New York site reported the highest number. Hypertension was the most common co-morbidity at 4 of 5 sites with the highest prevalence in New York. Depression was the most common co-morbidity in Ohio. Treatment patterns also varied by site; Colorado had the highest proportion of patients not on any treatment. ICS/LABA was the most commonly prescribed treatment except in Ohio, where ICS/LABA/LAMA was most common. Conclusions and Relevance: Our data show heterogeneity in demographic, clinical, and treatment characteristics of patients diagnosed with COPD who are managed in primary care across different healthcare organizations in the US.

Patient and provider determinants of nephrology referral in older adults with severe chronic kidney disease: a survey of provider decision making.

BACKGROUND: Although chronic kidney disease (CKD) disproportionately affects older adults, they are less likely to be referred to a nephrologist. Factors that influence the referral decisions of primary care providers (PCPs) specifically for older CKD patients have been incompletely described. Patient factors such as dementia, functional disability, and co-morbidity may complicate the decision to refer an older adult. This study evaluated the role of patient and PCP factors in the referral decisions for older adults with stage 4 CKD. METHODS: We administered a two-part survey to study the decisions of practicing PCPs. First, using a blocked factorial design, vignettes systematically varied 6 patient characteristics: age, race, gender, co-morbidity, functional status, and cognitive status. CKD severity, patient preferences, and degree of anemia were held constant. Second, covariates from a standard questionnaire included PCP estimates of life expectancy, demographics, reaction to clinical uncertainty, and risk aversion. The main outcome was the decision to refer to the nephrologist. Random effects logistic regression models tested independent associations of predictor variables with the referral decision. RESULTS: More than half (62.5%) of all PCP decisions (n = 680) were to refer to a nephrologist. Vignette-based factors that independently decreased referral included older patient age (OR = 0.27; 95% CI, 0.15 to 0.48) and having moderate dementia (OR = 0.14; 95%CI, 0.07 to 0.25). There were no associations between co-morbidity or impaired functional activity with the referral decision. Survey-based PCP factors that significantly increased the referral likelihood include female gender (OR = 7.75; 95%CI, 2.07 to 28.93), non-white race (OR = 30.29; 95%CI, 1.30 to 703.73), those who expect nephrologists to discuss goals of care (OR = 53.13; 95%CI, 2.42 to 1168.00), those with higher levels of anxiety about uncertainty (OR = 1.28; 95%CI, 1.04 to 1.57), and those with greater risk aversion (OR = 3.39; 95%CI, 1.02 to 11.24). CONCLUSIONS: In this decision making study using hypothetical clinical vignettes, we found that the PCP decision to refer older patients with severe CKD to a nephrologist reflects a complex interplay between patient and provider factors. Age, dementia, and several provider characteristics weighed more heavily than co-morbidity and functional status in PCP referral decisions. These results suggest that practice guidelines should develop a more nuanced approach to the referral of older adults with CKD.

High prevalence of undetected vitamin D deficiency in an urban minority primary care practice.

OBJECTIVES: To assess the prevalence of vitamin D deficiency among patients in an inner-city practice with a large African American population, and to evaluate the efficacy of vitamin D replacement as part of routine care. METHODS: A chart review was undertaken to identify patients aged 18 years and more with at least one 25-hydroxyvitamin D level. When patients were found to be deficient (vitamin D < 20) they were placed on 50000 units ergocalciferol monthly or over-the-counter calcium supplements with vitamin D. Descriptive statistics were used to calculate the prevalence rate, and paired t tests were used to compare the vitamin D levels pre and post treatment. RESULTS: A total of 369 (65%) out of 570 patients were found to be vitamin D deficient, and 253 were treated with ergocalciferol or vitamin D supplements. For patients deficient at baseline and treated with vitamin D supplementation (n = 253), significant differences were found between baseline and follow-up vitamin D levels (t(1,120) = 11.56, p < .001). Among 253 patients deficient at baseline and treated, 201 were corrected with oral vitamin D (79%), leaving 52 patients (21%) deficient after vitamin D supplementation. CONCLUSIONS: The results of this study show that there is a very high prevalence of vitamin D deficiency in an urban, mostly African American population. This can be readily improved with the addition of oral vitamin D. The study also suggests that routine vitamin D screening may be helpful for the detection and treatment of vitamin D deficiency, especially in urban minority populations.

Advancing the Patient EXperience (APEX) in COPD Registry: Study Design and Strengths.

The Advancing the Patient Experience (APEX) in Chronic Obstructive Pulmonary Disease (COPD) registry (https://www.apexcopd.org/) is the first primary care health system-based COPD registry in the United States. While its ultimate goal is to improve the care of patients diagnosed with COPD, the registry is also designed to describe real-life experiences of people with COPD, track key outcomes longitudinally, and assess the effectiveness of interventions. It will retrospectively and prospectively collect information from 3000 patients enrolled in 5 health care organizations. Information will be obtained from electronic health records, and from extended annual and brief questionnaires completed by patients before clinic visits. Core variables to be collected into the APEX COPD registry were agreed on by Delphi consensus and fall into 3 domains: demographics, COPD monitoring, and treatment. Main strengths of the registry include: 1) its size and scope (in terms of patient numbers, geographic spread and use of multiple information sources including patient-reported information); 2) collection of variables which are clinically relevant and practical to collect within primary care; 3) use of electronic data capture systems to ensure high-quality data and minimization of data-entry requirements; 4) inclusion of clinical, database development, management and communication experts; 5) regular sharing of key findings, both at international/national congresses and in peer-reviewed publications; and 6) a robust organizational structure to ensure continuance of the registry, and that research outputs are ethical, relevant and continue to bring value to both patients and physicians.

Development of the Advancing the Patient Experience in COPD Registry: A Modified Delphi Study.

BACKGROUND: Chronic obstructive pulmonary disease (COPD) is commonly managed by family physicians, but little is known about specifics of management and how this may be improved. The Advancing the Patient Experience in COPD (APEX COPD) registry will be the first U.S. primary care, health system-based registry following patients diagnosed with COPD longitudinally, using a standardized set of variables to investigate how patients are managed in real life and assess outcomes of various management strategies. OBJECTIVE: Gaining expert consensus on a standardized list of variables to capture in the APEX COPD registry. METHODS: A modified, Delphi process was used to reach consensus on which data to collect in the registry from electronic health records (EHRs), patient-reported information (PRI) and patient-reported outcomes (PRO), and by physicians during subsequent office visits. The Delphi panel comprised 14 primary care and specialty COPD experts from the United States and internationally. The process consisted of 3 iterative rounds. Responses were collected electronically. RESULTS: Of the initial 195 variables considered, consensus was reached to include up to 115 EHR variables, 34 PRI/PRO variables and 5 office-visit variables in the APEX COPD registry. These should include information on symptom burden, diagnosis, COPD exacerbations, lung function, quality of life, comorbidities, smoking status/history, treatment specifics (including side effects), inhaler management, and patient education/self-management. CONCLUSION: COPD experts agreed upon the core variables to collect from EHR data and from patients to populate the APEX COPD registry. Data will eventually be integrated, standardized and stored in the APEX COPD database and used for approved COPD-related research.

The importance of patient education in the treatment of chronic kidney disease.

The article by Finkelstein and colleagues is a seminal work in helping us to understand the educational needs of pre-end-stage renal disease (pre-ESRD) patients. There are currently major deficits in patients' perceived knowledge of their options for ESRD care. The Canadian system, with its more integrated and multidisciplinary approach to care, does a better job of communicating these options to patients. African Americans are less likely to be aware of their options.