J V Selby

Patient-Centered Outcomes Research Institute, Washington, Washington, D.C., United States

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Publications (206)2055.38 Total impact

  • Joe Selby, Jean Slutsky
    Journal of comparative effectiveness research. 11/2014; 3(6):565-6.
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    Joe V Selby, Jean R Slutsky
    Journal of General Internal Medicine 10/2014; · 3.42 Impact Factor
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    Lori Frank, Ethan Basch, Joe V Selby
    JAMA The Journal of the American Medical Association 08/2014; · 30.39 Impact Factor
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    Journal of General Internal Medicine 07/2014; · 3.42 Impact Factor
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    ABSTRACT: The era of big data, loosely defined as the development and analysis of large or complex data sets, brings new opportunities to empower patients and their families to generate, collect, and use their health information for both clinical and research purposes. In 2013 the Patient-Centered Outcomes Research Institute launched a large national research network, PCORnet, that includes both clinical and patient-powered research networks. This article describes these networks, their potential uses, and the challenges they face. The networks are engaging patients, family members, and caregivers in four key ways: contributing data securely, with privacy protected; including diverse and representative groups of patients in research; prioritizing research questions, participating in research, and disseminating results; and participating in the leadership and governance of patient-powered research networks. If technical, regulatory, and organizational challenges can be overcome, PCORnet will allow research to be conducted more efficiently and cost-effectively and results to be disseminated quickly back to patients, clinicians, and delivery systems to improve patient health.
    Health Affairs 07/2014; 33(7):1212-9. · 4.32 Impact Factor
  • Joe V Selby
    Nature 05/2014; 509(7502):563. · 42.35 Impact Factor
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    ABSTRACT: The Patient-Centered Outcomes Research Institute (PCORI) has launched PCORnet, a major initiative to support an effective, sustainable national research infrastructure that will advance the use of electronic health data in comparative effectiveness research (CER) and other types of research. In December 2013, PCORI's board of governors funded 11 clinical data research networks (CDRNs) and 18 patient-powered research networks (PPRNs) for a period of 18 months. CDRNs are based on the electronic health records and other electronic sources of very large populations receiving healthcare within integrated or networked delivery systems. PPRNs are built primarily by communities of motivated patients, forming partnerships with researchers. These patients intend to participate in clinical research, by generating questions, sharing data, volunteering for interventional trials, and interpreting and disseminating results. Rapidly building a new national resource to facilitate a large-scale, patient-centered CER is associated with a number of technical, regulatory, and organizational challenges, which are described here.
    Journal of the American Medical Informatics Association 05/2014; · 3.57 Impact Factor
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    ABSTRACT: Although all weight-loss approaches may improve insulin sensitivity in type 2 diabetes, bariatric surgery is believed to be the only reliable means of achieving diabetes remission. We conducted a retrospective cohort study to compare rates of diabetes remission, relapse and all-cause mortality among severely obese individuals with diabetes who underwent bariatric surgery vs. nonsurgically treated individuals. Severely obese adults with uncontrolled or medication-controlled diabetes who underwent bariatric surgery or received usual medical care from 2005 to 2008 in three health care delivery systems in the United States were eligible. Diabetes status was identified using pharmacy, laboratory, and diagnosis information from electronic medical records. A propensity approach and exclusion criteria identified 1395 adults with diabetes who had bariatric surgery and 62,322 who did not. Most procedures were Roux-en-Y gastric bypass (72.0% laparoscopic; 8.2% open); 4.4% were gastric banding, 2.4% sleeve gastrectomy, and 13.2% were other procedures. At two years, bariatric subjects experienced significantly higher diabetes remission rates [73.7% (95% CI: 70.6, 76.5)] compared to nonsurgical subjects [6.9% (95%CI: 6.9, 7.1)]. Age, site, duration of diabetes, hemoglobin A1c level, and intensity of diabetes medication treatment were significantly associated with remission. Bariatric subjects also experienced lower relapse rates than nonsurgical subjects (adjusted HR: 0.19; 95% CI: 0.15–0.23) with no higher risk of death (adjusted HR: 0.54; 95% CI: 0.22–1.30). We conclude that bariatric surgery can effectively induce remission of diabetes among most severely obese adults, and this treatment approach appears to be superior to nonsurgical treatment in inducing diabetes remission.:
    Obesity Research & Clinical Practice 07/2013; 7(4):e235-320. · 0.70 Impact Factor
  • Joe V Selby
    Population Health Management 04/2013; 16(2):69-70. · 1.18 Impact Factor
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    ABSTRACT: Clinical research has been driven traditionally by investigators, from generating research questions and outcomes through analysis and release of study results. Building on the work of others, the Patient-Centered Outcomes Research Institute (PCORI) is tapping into its broad-based stakeholder community-especially patients, caregivers, and their clinicians-to generate topics for research, help the institute prioritize those topics, select topics for funding, and ensure patients' involvement in the design of research projects. This article describes PCORI's approach, which is emblematic of the organization's mandate under the Affordable Care Act to seek meaningful ways to integrate the patient's voice into the research process, and describes how it is being used in selection of research that PCORI will fund. We also describe challenges facing our approach, including a lack of common language and training on the part of patients and resistance on the part of researchers to questions that are not researcher generated. Faced with the reality that PCORI will not be able to fund all research questions posed to it, there will also be difficult decisions to make when selecting those that have the highest priority for funding.
    Health Affairs 02/2013; 32(2):393-400. · 4.64 Impact Factor
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    ABSTRACT: BACKGROUND: Gastric bypass has profound effects on glycemic control in adults with type 2 diabetes mellitus. The goal of this study was to examine the long-term rates and clinical predictors of diabetes remission and relapse among patients undergoing gastric bypass. METHODS: We conducted a retrospective cohort study of adults with uncontrolled or medication-controlled type 2 diabetes who underwent gastric bypass from 1995 to 2008 in three integrated health care delivery systems in the USA. Remission and relapse events were defined by diabetes medication use and clinical laboratory measures of glycemic control. We identified 4,434 adults with uncontrolled or medication-controlled type 2 diabetes who had gastric bypass. RESULTS: Overall, 68.2 % (95 % confidence interval [CI], 66 and 70 %) experienced an initial complete diabetes remission within 5 years after surgery. Among these, 35.1 % (95 % CI, 32 and 38 %) redeveloped diabetes within 5 years. The median duration of remission was 8.3 years. Significant predictors of complete remission and relapse were poor preoperative glycemic control, insulin use, and longer diabetes duration. Weight trajectories after surgery were significantly different for never remitters, relapsers, and durable remitters (p = 0.03). CONCLUSIONS: Gastric bypass surgery is associated with durable remission of type 2 diabetes in many but not all severely obese diabetic adults, and about one third experience a relapse within 5 years of initial remission. More research is needed to understand the mechanisms of diabetes relapse, the optimal timing of surgery in effecting a durable remission, and the relationship between remission duration and incident microvascular and macrovascular events.
    Obesity Surgery 11/2012; · 3.74 Impact Factor
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    ABSTRACT: What role can rigorous observational comparative effectiveness studies play in guiding clinical decision making? What criteria should be used in determining whether the results of such studies should be communicated to clinicians and to patients? We address these questions by considering two hypothetical observational studies in patients with migraine against the backdrop of the review criteria drawn up by the Patient-Centered Outcomes Research Institute (PCORI). These criteria emphasize that patient-centered comparative effectiveness research should exhibit relevance to patients, have great potential to affect practice and improve outcomes, and be conducted using rigorous analytic methods. We conclude that these hypothetical studies would be unlikely to have been funded or communicated by PCORI, and we offer suggestions for improving their relevance and analytic approaches. We also conclude that high-quality observational studies can effectively complement findings from randomized trials, and that communicating their results to patients and clinicians is warranted.
    Health Affairs 10/2012; 31(10):2193-9. · 4.64 Impact Factor
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    ABSTRACT: Blood pressure, lipid, and glycemic control are essential for reducing cardiovascular disease (CVD) risk. Many health care systems have successfully shifted aspects of chronic disease management, including population-based outreach programs designed to address CVD risk factor control, to non-physicians. The purpose of this study is to evaluate provision of new information to non-physician outreach teams on need for treatment intensification in patients with increased CVD risk. Cluster randomized trial (July 1-December 31, 2008) in Kaiser Permanente Northern California registry of members with diabetes mellitus, prior CVD diagnoses and/or chronic kidney disease who were high-priority for treatment intensification: blood pressure ≥ 140 mmHg systolic, LDL-cholesterol ≥ 130 mg/dl, or hemoglobin A1c ≥ 9%; adherent to current medications; no recent treatment intensification). Randomization units were medical center-based outreach teams (4 intervention; 4 control). For intervention teams, priority flags for intensification were added monthly to the registry database with recommended next pharmacotherapeutic steps for each eligible patient. Control teams used the same database without this information. Outcomes included 3-month rates of treatment intensification and risk factor levels during follow-up. Baseline risk factor control rates were high (82-90%). In eligible patients, the intervention was associated with significantly greater 3-month intensification rates for blood pressure (34.1 vs. 30.6%) and LDL-cholesterol (28.0 vs 22.7%), but not A1c. No effects on risk factors were observed at 3 months or 12 months follow-up. Intervention teams initiated outreach for only 45-47% of high-priority patients, but also for 27-30% of lower-priority patients. Teams reported difficulties adapting prior outreach strategies to incorporate the new information. Information enhancement did not improve risk factor control compared to existing outreach strategies at control centers. Familiarity with prior, relatively successful strategies likely reduced uptake of the innovation and its potential for success at intervention centers. ClinicalTrials.gov Identifier NCT00517686.
    BMC Health Services Research 07/2012; 12:183. · 1.66 Impact Factor
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    ABSTRACT: Even in high-performing health systems, some patients with diabetes mellitus have poor blood pressure (BP) control because of poor medication adherence and lack of medication intensification. We examined whether the Adherence and Intensification of Medications intervention, a pharmacist-led intervention combining elements found in efficacy studies to lower BP, improved BP among patients with diabetes mellitus with persistent hypertension and poor refill adherence or insufficient medication intensification in 2 high-performing health systems. We conducted a prospective, multisite cluster randomized pragmatic trial with randomization of 16 primary care teams at 5 medical centers (3 Veterans Affairs and 2 Kaiser Permanente) to the Adherence and Intensification of Medications intervention or usual care. The primary outcome was relative change in systolic BP (SBP), comparing 1797 intervention with 2303 control team patients, from 6 months preceding to 6 months after the 14-month intervention period. We examined shorter-term changes in SBP as a secondary outcome. The mean SBP decrease from 6 months before to 6 months after the intervention period was ≈9 mm Hg in both arms. Mean SBPs of eligible intervention patients were 2.4 mm Hg lower (95% CI: -3.4 to -1.5; P<0.001) immediately after the intervention than those achieved by control patients. The Adherence and Intensification of Medications program more rapidly lowered SBPs among intervention patients, but usual-care patients achieved equally low SBP levels by 6 months after the intervention period. These findings show the importance of evaluating in different real-life clinical settings programs found in efficacy trials to be effective before urging their widespread adoption in all settings. URL: http://clinicaltrials.gov. Unique identifier: NCT00495794.
    Circulation 05/2012; 125(23):2863-72. · 14.95 Impact Factor
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    ABSTRACT: Chronic disease care typically involves treatment decisions that are frequently adjusted to the patient's evolving clinical course (e.g., hemoglobin A1c monitoring and treatment intensification in diabetes patients). Thus, in comparative effectiveness and safety research (CER), it often is less clinically relevant to contrast the health effects of static treatment decisions than to compare the effectiveness of competing medical guidelines, that is, adaptive treatment strategies that map the patient's unfolding clinical course to subsequent treatment decisions. With longitudinal observational studies, treatment decisions at any point in time may be influenced by clinical factors that also are risk factors for the outcome of interest. Such time-dependent confounders cannot be properly handled with standard statistical approaches, because such confounders may be influenced by previous treatment decisions and may thus lie on causal pathways between the very outcomes and early treatment decisions whose effects are under study. Under explicit assumptions, we motivate the application of inverse probability weighting estimation to fit dynamic marginal structural models (MSMs) in observational studies to address pragmatic CER questions and properly adjust for time-dependent confounding and informative loss to follow-up. We review the principles behind this modeling approach and describe its application in an observational study of type 2 diabetes patients to investigate the comparative effectiveness of four adaptive treatment intensification strategies for glucose control on subsequent development or progression of urinary albumin excretion. Results indicate a protective effect of more aggressive treatment intensification strategies in patients already on two or more oral agents or basal insulin. These conclusions are concordant with recent randomized trials. Inverse probability weighting estimation to fit dynamic MSM is a viable and appealing alternative to inadequate standard modeling approaches in many CER problems where time-dependent confounding and informative loss to follow-up are expected.
    Pharmacoepidemiology and Drug Safety 05/2012; 21 Suppl 2:99-113. · 2.90 Impact Factor
  • Joe V Selby, Anne C Beal, Lori Frank
    JAMA The Journal of the American Medical Association 04/2012; 307(15):1583-4. · 29.98 Impact Factor
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    ABSTRACT: Despite a recent American Heart Association (AHA) consensus statement emphasizing the importance of resistant hypertension, the incidence and prognosis of this condition are largely unknown. This retrospective cohort study in 2 integrated health plans included patients with incident hypertension in whom treatment was begun between 2002 and 2006. Patients were followed up for the development of resistant hypertension based on AHA criteria of uncontrolled blood pressure despite use of ≥3 antihypertensive medications, with data collected on prescription filling information and blood pressure measurement. We determined incident cardiovascular events (death or incident myocardial infarction, heart failure, stroke, or chronic kidney disease) in patients with and without resistant hypertension with adjustment for patient and clinical characteristics. Among 205 750 patients with incident hypertension, 1.9% developed resistant hypertension within a median of 1.5 years from initial treatment (0.7 cases per 100 person-years of follow-up). These patients were more often men, were older, and had higher rates of diabetes mellitus than nonresistant patients. Over 3.8 years of median follow-up, cardiovascular event rates were significantly higher in those with resistant hypertension (unadjusted 18.0% versus 13.5%, P<0.001). After adjustment for patient and clinical characteristics, resistant hypertension was associated with a higher risk of cardiovascular events (hazard ratio, 1.47; 95% confidence interval, 1.33-1.62). Among patients with incident hypertension in whom treatment was begun, 1 in 50 patients developed resistant hypertension. Patients with resistant hypertension had an increased risk of cardiovascular events, which supports the need for greater efforts toward improving hypertension outcomes in this population.
    Circulation 02/2012; 125(13):1635-42. · 14.95 Impact Factor
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    ABSTRACT: To describe a protocol for active surveillance of acute myocardial infarction (AMI) in users of a recently approved oral antidiabetic medication, saxagliptin, and to provide the rationale for decisions made in drafting the protocol. A new-user cohort design is planned for evaluating data from at least four Mini-Sentinel data partners from 1 August 2009 (following US Food and Drug Administration's approval of saxagliptin) through mid-2013. New users of saxagliptin will be compared in separate analyses with new users of sitagliptin, pioglitazone, long-acting insulins, and second-generation sulfonylureas. Two approaches to controlling for confounding will be evaluated: matching by exposure propensity score and stratification by AMI risk score. The primary analyses will use Cox regression models specified in a way that does not require pooling of patient-level data from the data partners. The Cox models are fit to summarized data on risk sets composed of saxagliptin users and similar comparator users at the time of an AMI. Secondary analyses will use alternative methods including Poisson regression and will explore whether further adjustment for covariates available only at some data partners (e.g., blood pressure) modifies results. The results of this study are pending. The proposed protocol describes a design for surveillance to evaluate the safety of a newly marketed agent as postmarket experience accrues. It uses data from multiple partner organizations without requiring sharing of patient-level data and compares alternative approaches to controlling for confounding. It is hoped that this initial active surveillance project of the Mini-Sentinel will provide insights that inform future population-based surveillance of medical product safety.
    Pharmacoepidemiology and Drug Safety 01/2012; 21 Suppl 1:282-90. · 2.90 Impact Factor
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    ABSTRACT: More than 1.5 million US adults use stimulants and other medications labeled for treatment of attention-deficit/hyperactivity disorder (ADHD). These agents can increase heart rate and blood pressure, raising concerns about their cardiovascular safety. To examine whether current use of medications prescribed primarily to treat ADHD is associated with increased risk of serious cardiovascular events in young and middle-aged adults. Retrospective, population-based cohort study using electronic health care records from 4 study sites (OptumInsight Epidemiology, Tennessee Medicaid, Kaiser Permanente California, and the HMO Research Network), starting in 1986 at 1 site and ending in 2005 at all sites, with additional covariate assessment using 2007 survey data. Participants were adults aged 25 through 64 years with dispensed prescriptions for methylphenidate, amphetamine, or atomoxetine at baseline. Each medication user (n = 150,359) was matched to 2 nonusers on study site, birth year, sex, and calendar year (443,198 total users and nonusers). Serious cardiovascular events, including myocardial infarction (MI), sudden cardiac death (SCD), or stroke, with comparison between current or new users and remote users to account for potential healthy-user bias. During 806,182 person-years of follow-up (median, 1.3 years per person), 1357 cases of MI, 296 cases of SCD, and 575 cases of stroke occurred. There were 107,322 person-years of current use (median, 0.33 years), with a crude incidence per 1000 person-years of 1.34 (95% CI, 1.14-1.57) for MI, 0.30 (95% CI, 0.20-0.42) for SCD, and 0.56 (95% CI, 0.43-0.72) for stroke. The multivariable-adjusted rate ratio (RR) of serious cardiovascular events for current use vs nonuse of ADHD medications was 0.83 (95% CI, 0.72-0.96). Among new users of ADHD medications, the adjusted RR was 0.77 (95% CI, 0.63-0.94). The adjusted RR for current use vs remote use was 1.03 (95% CI, 0.86-1.24); for new use vs remote use, the adjusted RR was 1.02 (95% CI, 0.82-1.28); the upper limit of 1.28 corresponds to an additional 0.19 events per 1000 person-years at ages 25-44 years and 0.77 events per 1000 person-years at ages 45-64 years. Among young and middle-aged adults, current or new use of ADHD medications, compared with nonuse or remote use, was not associated with an increased risk of serious cardiovascular events. Apparent protective associations likely represent healthy-user bias.
    JAMA The Journal of the American Medical Association 12/2011; 306(24):2673-83. · 29.98 Impact Factor
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    ABSTRACT: The Seventh Report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure recommends that clinicians consider the use of multidrug therapy to increase likelihood of achieving blood pressure goal. Little is known about recent patterns of combination antihypertensive therapy use in patients being initiated on hypertension treatment. We investigated combination antihypertensive therapy use in newly diagnosed hypertensive patients from the Cardiovascular Research Network Hypertension Registry. Multivariable logistic regression was used to assess the relationship between combination antihypertensive therapy and 12-month blood pressure control. Between 2002 and 2007, a total of 161,585 patients met criteria for incident hypertension and were initiated on treatment. During the study period, an increasing proportion of patients were treated initially with combination rather than with single-agent therapy (20.7% in 2002 compared with 35.8% in 2007, P < .001). This increase in combination therapy use was more pronounced in patients with stage 2 hypertension, whose combination therapy use increased from 21.6% in 2002 to 44.5% in 2007. Nearly 90% of initial combination therapy was accounted for by 2 combinations, a thiazide and a potassium-sparing diuretic (47.6%) and a thiazide and an angiotensin-converting enzyme inhibitor (41.4%). After controlling for relevant clinical factors, including subsequent intensification of treatment and medication adherence, combination therapy was associated with increased odds of blood pressure control at 12 months (odds ratio compared with single-drug initial therapy 1.20; 95% CI 1.15-1.24, P < .001). Initial treatment of hypertension with combination therapy is increasingly common and is associated with better long-term blood pressure control.
    American heart journal 08/2011; 162(2):340-6. · 4.56 Impact Factor

Publication Stats

13k Citations
2,055.38 Total Impact Points


  • 2012–2014
    • Patient-Centered Outcomes Research Institute
      Washington, Washington, D.C., United States
    • Group Health Cooperative
      • Group Health Research Institute
      Seattle, WA, United States
  • 1987–2013
    • Kaiser Permanente
      • Department of Cardiology
      Oakland, California, United States
  • 2010–2012
    • University of Colorado
      • Division of Cardiology
      Denver, CO, United States
    • Minneapolis Medical Research Foundation
      Minneapolis, Minnesota, United States
  • 1993–2012
    • Permanente Medical Group
      Pasadena, California, United States
  • 2006
    • University of Lausanne
      • Department of Community Health and Medicine
      Lausanne, VD, Switzerland
    • University of California, Los Angeles
      • Department of Medicine
      Los Angeles, CA, United States
  • 2005
    • Harvard University
      • Department of Society, Human Development, and Health
      Boston, MA, United States
  • 1998–2004
    • Harvard Medical School
      • Department of Medicine
      Boston, Massachusetts, United States
    • University of North Carolina at Chapel Hill
      • Department of Epidemiology
      Chapel Hill, NC, United States
  • 1995–2004
    • University of Washington Seattle
      • Department of Epidemiology
      Seattle, WA, United States
  • 2003
    • University of California, Berkeley
      Berkeley, California, United States
    • Brigham and Women's Hospital
      • Department of Medicine
      Boston, MA, United States
  • 1997–2000
    • University of California, San Francisco
      • • Institute for Health Policy Studies
      • • Division of Gastroenterology
      San Francisco, CA, United States
  • 1999
    • CSU Mentor
      Long Beach, California, United States
  • 1998–1999
    • Texas Tech University Health Sciences Center
      • Department of Medicine
      Lubbock, TX, United States