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Fleurence R.,Patient-Centered Outcomes Research Institute | Selby J.V.,PCORI | Odom-Walker K.,PCORI | Hunt G.,National Alliance for Caregiving | And 3 more authors.
Health Affairs | Year: 2013

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 broadbased 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. © 2013 Project HOPE- The People-to-People Health Foundation, Inc. Source

Fleurence R.L.,Patient-Centered Outcomes Research Institute | Sheridan S.E.,PCORI | Johnson L.B.,LymeDisease.org | Selby J.V.,PCORI
Health Affairs | Year: 2014

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 patientpowered 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 costeffectively and results to be disseminated quickly back to patients, clinicians, and delivery systems to improve patient health. © 2014 by Project HOPE - The People-to-People Health Foundation. Source

Chubak J.,Group Health Research Institute | Whitlock E.P.,Patient-Centered Outcomes Research Institute | Williams S.B.,Kaiser Permanente | Kamineni A.,Group Health Research Institute | And 3 more authors.
Annals of Internal Medicine | Year: 2016

Background: Cancer is the second leading cause of death in the United States. Purpose: To conduct systematic reviews of aspirin and 1) total cancer mortality and incidence in persons eligible for primary prevention of cardiovascular disease (CVD) and 2) colorectal cancer (CRC) mortality and incidence in persons at average CRC risk. Data Sources: MEDLINE, PubMed, and the Cochrane Central Register of Controlled Trials through January 2015 and relevant references from other reviews. Study Selection: Trials comparing oral aspirin versus placebo or no treatment in adults aged 40 years or older were included. Two investigators independently reviewed abstracts and articles against inclusion and quality criteria. Data Extraction: Data from 20 good- or fair-quality trials were abstracted by one reviewer and checked by another. Data Synthesis: In CVD primary prevention trials, cancer mortality (relative risk [RR], 0.96 [95% CI, 0.87 to 1.06]) (10 trials; n = 103 787) and incidence (RR, 0.98 [CI, 0.93 to 1.04]) (6 trials; n = 72 926) were similar in aspirin and control groups over 3.6 to 10.1 years. In CVD primary and secondary prevention trials, 20- year CRC mortality was reduced among persons assigned to aspirin therapy (RR, 0.67 [CI, 0.52 to 0.86]) (4 trials; n = 14 033). Aspirin appeared to reduce CRC incidence beginning 10 to 19 years after initiation (RR, 0.60 [CI, 0.47 to 0.76]) (3 trials; n = 47 464). Limitations: Most data were from clinically and methodologically heterogeneous CVD prevention trials. Outcome assessment and follow-up length varied across studies. Data on non- CRC cancer types and subgroups were limited. Conclusion: In CVD primary prevention populations, aspirin's effect on total cancer mortality and incidence was not clearly established. Evidence from CVD primary and secondary prevention studies suggested that aspirin therapy reduces CRC incidence and perhaps mortality approximately 10 years after initiation. © 2016 American College of Physicians. Source

Guirguis-Blake J.M.,University of Washington | Evans C.V.,Kaiser Permanente | Senger C.A.,Kaiser Permanente | O'Connor E.A.,Kaiser Permanente | Whitlock E.P.,Patient-Centered Outcomes Research Institute
Annals of Internal Medicine | Year: 2016

Background: Cardiovascular disease (CVD) is the leading cause of death in the United States. Purpose: To update a systematic review about the benefits of aspirin for the primary prevention of cardiovascular events in adults aged 40 years or older and to evaluate effect modification in subpopulations. Data Sources: MEDLINE, PubMed, Cochrane Central Register of Controlled Trials (January 2008 to January 2015), and Cochrane Database of Systematic Reviews. Study Selection: Two investigators independently reviewed 3396 abstracts and 65 articles according to prespecified criteria. All included trials evaluated aspirin for the primary prevention of cardiovascular events. Data Extraction: Two investigators assessed study quality; data were abstracted by 1 reviewer and checked by a second. Data Synthesis: Two good-quality and 9 fair-quality randomized, controlled trials were identified. In analyses of all doses, aspirin reduced the risk for nonfatal myocardial infarction (MI) (relative risk [RR], 0.78 [95% CI, 0.71 to 0.87]) but not nonfatal stroke; aspirin showed little or no benefit for all-cause or cardiovascular mortality. Benefits began within the first 5 years. Older adults achieved greater relative MI reduction, but no other effect modifications were found in analyzed subpopulations. In trials with aspirin doses of 100 mg or less per day, the reduction in nonfatal MI benefit persisted (absolute risk reduction, 0.15 to 1.43 events per 1000 person-years) and a 14% reduction in nonfatal stroke benefit was noted, but no benefit was found for allcause mortality (RR, 0.95 [CI, 0.89 to 1.01]) or cardiovascular mortality (RR, 0.97 [CI, 0.85 to 1.10]). Limitation: Evidence for aspirin in primary prevention is heterogeneous and limited by rare events and few credible subgroup analyses. Conclusion: The beneficial effect of aspirin for the primary prevention of CVD is modest and occurs at doses of 100 mg or less per day. Older adults seem to achieve a greater relative MI benefit. © 2016 American College of Physicians. Source

Naci H.,The London School of Economics and Political Science | Brugts J.J.,Erasmus Medical Center | Fleurence R.,Patient-Centered Outcomes Research Institute | Ades A.E.,University of Bristol
European Journal of Preventive Cardiology | Year: 2013

Aims: The extent to which individual statins vary in terms of their impact on serum lipid levels has been studied mainly on the basis of placebo-controlled trials. Our objective was to review and quantify the dose-comparative effects of different statins on serum lipid levels using both placebo- and active-comparator trials. Methods: We systematically reviewed randomized trials evaluating different statins in participants with, or at risk of developing, cardiovascular disease. We performed random-effects Bayesian network meta-analyses to quantify the the relative potency of individual statins across all possible dose combinations using both direct and indirect evidence. Dosecomparative effects were determined by estimating the mean change from baseline in serum lipids as compared to control treatment. (systematic review registration: PROSPERO 2011:CRD42011001470). Results: We included 181 placebo-controlled and active-comparator trials including 256,827 individuals. There were 83 two-armed placebo-controlled trials and the remaining 98 were two- or multi-armed active-comparator trials. All statins reduced serum LDL and total cholesterol levels: higher doses resulted in higher reductions in pretreatment LDL and total cholesterol concentrations. In absolute terms, all statins significantly reduced LDL cholesterol levels as compared to control treatment from average baseline levels of approximately 150 mg/dl, except for fluvastatin at ≤20 mg/day and lovastatin at ≤10 mg/day. Atorvastatin, rosuvastatin, and simvastatin were broadly equivalent in terms of their LDL cholesterol-lowering effects. Dose-comparative effects of indivudual statins were not different between those with and without coronary heart disease at baseline. According to meta-regression analyses, LDL cholesterol-lowering effects of individual statins were not impacted by differences across trials in terms of baseline mean age and proportion of women as trial participants. Pretreatment LDL cholesterol concentrations had a marginally statistically significant effect on LDL cholesterol change from baseline. Mean differences from baseline in HDL cholesterol as compared to control treatment was not significant for any statin-dose combination. Conclusions: The findings of this comprehensive review provide supporting evidence for the doseresponse relationship of statins in reducing LDL and total cholesterol. The LDL cholesterol-reducing effects of some statins appear less pronounced than the findings of previous meta-analyses, which is particularly the case for the high-dose formulations of atorvastatin and rosuvastatin. The most consistent evidence for a combined reduction in both LDL and total cholesterol was achieved with atorvastatin at >40 mg/day, rosuvastatin at >10 mg/day, and simvastatin at >40 mg/day, which appear equivalent in terms of their LDL and total cholesterol-reducing effects. © 2013 The European Society of Cardiology. Source

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