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1. Full Text Pragmatic Trials
by Ford, Ian and Norrie, John
The New England Journal of Medicine, ISSN 0028-4793, 08/2016, Volume 375, Issue 5, pp. 454 - 463
In pragmatic trials, participants are broadly representative of people who will receive a treatment or diagnostic strategy, and the outcomes affect day-to-day... 
RANDOMIZED CONTROLLED-TRIALS | MEDICINE, GENERAL & INTERNAL | NEED | DESIGN | MYOCARDIAL-INFARCTION | CLINICAL-TRIALS | PREVENTION | ADULTS | RECORD LINKAGE | SIMPLE METHODOLOGIC FIXES | HEALTH-CARE | Follow-Up Studies | Randomized Controlled Trials as Topic - methods | Humans | Treatment Outcome | Pragmatic Clinical Trials as Topic - methods | Patient Selection | Pragmatic Clinical Trials as Topic - standards | Social aspects | Pragmatism | Intervention | Clinical trials | Participation | Research methodology
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2. Full Text A pragmatic–explanatory continuum indicator summary (PRECIS): a tool to help trial designers
by Thorpe, Kevin E and Zwarenstein, Merrick and Oxman, Andrew D and Treweek, Shaun and Furberg, Curt D and Altman, Douglas G and Tunis, Sean and Bergel, Eduardo and Harvey, Ian and Magid, David J and Chalkidou, Kalipso
Journal of Clinical Epidemiology, ISSN 0895-4356, 2009, Volume 62, Issue 5, pp. 464 - 475
Abstract Objective To propose a tool to assist trialists in making design decisions that are consistent with their trial's stated purpose. Study Design and... 
Internal Medicine | Pragmatic trial | Clinical trial | Explanatory trial | Trial design | Randomized controlled trials | Clinical trial methodology | CLINICAL-RESEARCH | PUBLIC, ENVIRONMENTAL & OCCUPATIONAL HEALTH | HEALTH CARE SCIENCES & SERVICES | Decision Making | Randomized Controlled Trials as Topic - methods | Humans | Clinical Trials as Topic - methods | Research Design | Consensus | Practice Guidelines as Topic | Medical colleges | Medicine, Preventive | Public health | Preventive health services
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3. Full Text Good Clinical Practice Guidance and Pragmatic Clinical Trials: Balancing the Best of Both Worlds
by Mentz, Robert J and Hernandez, Adrian F and Berdan, Lisa G and Rorick, Tyrus and O’Brien, Emily C and Ibarra, Jenny C and Curtis, Lesley H and Peterson, Eric D
Circulation, ISSN 0009-7322, 03/2016, Volume 133, Issue 9, pp. 872 - 880
Randomized, clinical trials are commonly regarded as the highest level of evidence to support clinical decisions. Good Clinical Practice guidelines have been... 
clinical trial | Clinical protocols | ethics | pragmatic clinical trial | DESIGN | CARDIAC & CARDIOVASCULAR SYSTEMS | HEART-FAILURE | OPPORTUNITIES | CARE | CHALLENGES | ENROLLMENT | PERIPHERAL VASCULAR DISEASE | clinical protocols | TECHNOLOGY | VALIDITY | PARTICIPATION | TOOL | Research Design - standards | Clinical Trials as Topic - methods | Clinical Trials as Topic - standards | Practice Guidelines as Topic - standards | Humans | Clinical trials | Practice guidelines (Medicine) | Medical protocols | Usage | Analysis | good clinical practice
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4. Full Text Real-World Evidence — What Is It and What Can It Tell Us?
by Sherman, Rachel E and Anderson, Steven A and Dal Pan, Gerald J and Gray, Gerry W and Gross, Thomas and Hunter, Nina L and LaVange, Lisa and Marinac-Dabic, Danica and Marks, Peter W and Robb, Melissa A and Shuren, Jeffrey and Temple, Robert and Woodcock, Janet and Yue, Lilly Q and Califf, Robert M
The New England Journal of Medicine, ISSN 0028-4793, 12/2016, Volume 375, Issue 23, pp. 2293 - 2297
The FDA is developing guidance on the use of “real-world evidence” — health care information from atypical sources, including electronic health records,... 
REGULATORY ISSUES | APP | MEDICINE, GENERAL & INTERNAL | PRAGMATIC CLINICAL-TRIALS | Prescription Fees - legislation & jurisprudence | Evidence-Based Practice | Observational Studies as Topic - methods | United States | Humans | Government Regulation | Clinical Trials as Topic - methods | Research Design | United States Food and Drug Administration | Medical records | Usage | Health care | Effectiveness | Patient safety | Information | Evidence-based medicine | Electronic health records | Electronic medical records
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5. Full Text Ethics and Regulatory Complexities for Pragmatic Clinical Trials
by Sugarman, Jeremy and Califf, Robert M
JAMA, ISSN 0098-7484, 06/2014, Volume 311, Issue 23, pp. 2381 - 2382
The article discusses some of the ethics and regulatory issues associated with pragmatic clinical trials (PCTs). 10 complexities with regards to PCTs that have... 
MEDICINE, GENERAL & INTERNAL | Off-Label Use | Risk Assessment | Pragmatic Clinical Trials as Topic - legislation & jurisprudence | United States | Ethics Committees, Research | Humans | Informed Consent - ethics | Evidence-Based Medicine | Pragmatic Clinical Trials as Topic - ethics | Comparative Effectiveness Research - ethics | Comparative Effectiveness Research - legislation & jurisprudence | Government Regulation | Research Subjects | United States Food and Drug Administration | Clinical trials | Analysis | Medical ethics | Federal regulation
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6. Full Text A pragmatic view on pragmatic trials
by Patsopoulos, Nikolaos A
Dialogues in Clinical Neuroscience, ISSN 1294-8322, 2011, Volume 13, Issue 2, pp. 217 - 224
Clinical trials have been the main tool used by the health sciences community to test and evaluate interventions, Trials can fall into two broad categories:... 
Trial | Pragmatic | Evidencebased medicine | Randomized controlled trial | Comparative | Treatment Outcome | Clinical Trials as Topic - methods | Evidence-Based Medicine | Research Design | Humans | Clinical Research | evidencebased medicine | pragmatic | trial | comparative | randomized controlled trial
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7. Full Text Informed Consent for Pragmatic Trials — The Integrated Consent Model
by Kim, Scott Y.H and Miller, Franklin G
The New England Journal of Medicine, ISSN 0028-4793, 02/2014, Volume 370, Issue 8, pp. 769 - 772
The authors argue that informed consent is ethically necessary in pragmatic trials that randomly assign individual patients to treatments, even when treatment... 
MEDICINE, GENERAL & INTERNAL | Informed Consent | Ethics Committees, Research | Humans | Patient Participation | Pragmatic Clinical Trials as Topic - ethics | Ethics, Research | Delivery of Health Care - ethics | Clinical trials | Informed consent | Patients rights | Models | Recruitment
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8. Full Text Per-Protocol Analyses of Pragmatic Trials
by Hernán, Miguel A and Robins, James M
The New England Journal of Medicine, ISSN 0028-4793, 10/2017, Volume 377, Issue 14, pp. 1391 - 1398
Pragmatic trials are designed to address real-world questions about care options. This article addresses issues that may arise from per-protocol and... 
MORTALITY | MEDICINE, GENERAL & INTERNAL | MODELS | INTENTION-TO-TREAT | CAUSAL INFERENCE | NONADHERENCE | MISSING DATA | NONCOMPLIANCE | ADHERENCE | Data Interpretation, Statistical | Humans | Clinical Protocols | Intention to Treat Analysis | Patient Compliance | Pragmatic Clinical Trials as Topic - methods | Research Design | Medicine, Experimental | Medical research | Usage | Statistics | Quality management | Clinical trials | Protocol | Epidemiology | Research methodology | Public health
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9. Full Text Real-world Data for Clinical Evidence Generation in Oncology
by Khozin, Sean and Blumenthal, Gideon M and Pazdur, Richard
Journal of the National Cancer Institute, ISSN 0027-8874, 11/2017, Volume 109, Issue 11
Conventional cancer clinical trials can be slow and costly, often produce results with limited external validity, and are difficult for patients to participate... 
EXTERNAL VALIDITY | BIG-DATA | TRIALS | NETWORK | ONCOLOGY | DISEASE | HEALTH RECORD DATA | NATURAL-HISTORY | PHARMACOVIGILANCE | CANCER | PARTICIPATION | Reproducibility of Results | United States | Humans | Insurance Claim Review | Pragmatic Clinical Trials as Topic | Antineoplastic Agents - therapeutic use | Clinical Trials as Topic | Evidence-Based Medicine | Data Collection - methods | Patient Selection | Medical Oncology | Point-of-Care Systems | Observational Studies as Topic | Registries | Electronic Health Records
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10. Full Text Do large pragmatic randomised trials change clinical practice? ASSESSING THE IMPACT OF THE DISTAL RADIUS ACUTE FRACTURE FIXATION TRIAL (DRAFFT)
by Costa, ML and Jameson, SS and Reed, MR
BONE & JOINT JOURNAL, ISSN 2049-4394, 03/2016, Volume 98B, Issue 3, pp. 410 - 413
Aims Our aim, using English Hospital Episode Statistics data before during and after the Distal Radius Acute Fracture Fixation Trial (DRAFFT), was to assess... 
SURGERY | VOLAR LOCKING PLATE | ADULT PATIENTS | COST-EFFECTIVENESS | DORSALLY DISPLACED FRACTURE | ORTHOPEDICS | KIRSCHNER WIRES | Wrist Injuries - surgery | Fracture Fixation, Internal - trends | Humans | Pragmatic Clinical Trials as Topic | England | Fracture Fixation, Internal - methods | Professional Practice - statistics & numerical data | Bone Plates | Randomized Controlled Trials as Topic | Health Services Research - methods | Professional Practice - trends | Fracture Fixation, Internal - instrumentation | Diffusion of Innovation | Bone Wires | Fracture Fixation, Internal - statistics & numerical data | Radius Fractures - surgery
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11. Full Text The Changing Landscape of Randomized Clinical Trials in Cardiovascular Disease
by Jones, W. Schuyler, MD and Roe, Matthew T., MD, MHS and Antman, Elliott M., MD and Pletcher, Mark J., MD, MPH and Harrington, Robert A., MD and Rothman, Russell L., MD, MPP and Oetgen, William J., MD, MBA and Rao, Sunil V., MD and Krucoff, Mitchell W., MD and Curtis, Lesley H., PhD and Hernandez, Adrian F., MD, MHS and Masoudi, Frederick A., MD, MSPH
JACC (Journal of the American College of Cardiology), ISSN 0735-1097, 2016, Volume 68, Issue 17, pp. 1898 - 1907
Abstract Large randomized clinical trials in cardiovascular disease have proliferated over the past 3 decades, with results that have influenced every aspect... 
Cardiovascular | Internal Medicine | coronary artery disease | aspirin | Patient-Centered Outcomes Research Institute | pragmatic clinical trial | CARDIAC & CARDIOVASCULAR SYSTEMS | OPPORTUNITIES | PERCUTANEOUS CORONARY INTERVENTION | HEART-DISEASE | ACCESS SITE | ENHANCEMENT | ACUTE MYOCARDIAL-INFARCTION | ASSOCIATION TASK-FORCE | OUTCOMES | HEALTH | SAFE-PCI | Randomized Controlled Trials as Topic - methods | United States | Humans | Pragmatic Clinical Trials as Topic | Cardiovascular Diseases - therapy | Registries | Randomized Controlled Trials as Topic - standards | Medical colleges | Aspirin | Low density lipoproteins | Clinical trials | Research institutes | Cardiovascular diseases | Cardiology | Epidemiology | Heart attacks | Funding | Pragmatism | Mortality | Cardiovascular disease | Patients | Blood clots | Studies | Womens health | Quality | Infrastructure | Data collection | Intubation | Clinical medicine | Pharmaceutical industry | Research centers
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12. Full Text The opportunities and challenges of pragmatic point-of-care randomised trials using routinely collected electronic records : evaluations of two exemplar trials
by van Staa, Tjeerd-Pieter and Dyson, Lisa and McCann, Gerard and Padmanabhan, Shivani and Belatri, Rabah and Goldacre, Ben and Cassell, Jackie and Pirmohamed, Munir and Torgerson, David and Ronaldson, Sarah and Adamson, Joy and Taweel, Adel and Delaney, Brendan and Mahmood, Samhar and Baracaia, Simona and Round, Thomas and Fox, Robin and Hunter, Tommy and Gulliford, Martin and Smeeth, Liam
Health Technology Assessment, ISSN 1366-5278, 07/2014, Volume 18, Issue 43, pp. 1 - 146
BACKGROUND: Pragmatic trials compare the effects of different decisions in usual clinical practice. OBJECTIVES: To develop and evaluate methods to implement... 
GASTROINTESTINAL TOXICITY | INFORMED-CONSENT | DECISION-MAKING | QUALITATIVE RESEARCH | CLINICAL-TRIALS | HEALTH CARE SCIENCES & SERVICES | ACUTE MYOCARDIAL-INFARCTION | EMPIRICAL-EVIDENCE | GENERAL-PRACTICE | HEALTH-CARE | CARDIOVASCULAR RISK | Simvastatin - therapeutic use | General Practitioners | Heptanoic Acids - therapeutic use | Humans | Middle Aged | Male | Pragmatic Clinical Trials as Topic - methods | Ambulatory Care | Feasibility Studies | Patient Selection | Atorvastatin Calcium | Anticholesteremic Agents - therapeutic use | Adult | Female | Pyrroles - therapeutic use | Electronic Health Records | Evaluation Studies as Topic | Databases, Factual
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13. KCE Trials» : innovation based on practice oriented clinical trials
by Hulstaert, F and Verleye, L and Harrison, J and Nevens, H and Vrijens, F and Devis, M and Briat, G and Rondia, K
Revue medicale de Liege, ISSN 0370-629X, 09/2018, Volume 73, Issue 9, p. 447
Many questions in healthcare can only be answered after the conduct of clinical trials. For medicinal products and medical devices the industry finances most... 
Comparative Effectiveness Research | Belgium | Humans | Pragmatic Clinical Trials as Topic
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14. Full Text Exploring the ethical and regulatory issues in pragmatic clinical trials
by Califf, Robert M and Sugarman, Jeremy
Clinical Trials, ISSN 1740-7745, 10/2015, Volume 12, Issue 5, pp. 436 - 441
The need for high-quality evidence to support decision making about health and health care by patients, physicians, care providers, and policy-makers is well... 
cluster-randomized trial | Clinical trials | learning health-care system | ethics | patient-centered outcomes research | evidence-based medicine | pragmatic clinical trial | MEDICINE, RESEARCH & EXPERIMENTAL | PRACTICE GUIDELINES | RANDOMIZED-TRIALS | WAREHOUSE | AMERICAN-COLLEGE | PART II | PRINCIPLES | RELEVANT | RECOMMENDATIONS | SCIENTIFIC EVIDENCE | National Institutes of Health (U.S.) | Biomedical Research - ethics | Biomedical Research - legislation & jurisprudence | Clinical Trials as Topic - legislation & jurisprudence | Decision Making - ethics | United States | Humans | Research Design - standards | Surveys and Questionnaires | Clinical Trials as Topic - ethics | Clinical Trials as Topic - standards | Biomedical Research - standards | Evidence-based medicine | Medical ethics | Pragmatic clinical trial | Ethics | Patient-centered outcomes research | Cluster randomized trial | Learning healthcare system
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15. Full Text Barriers to the conduct of randomised clinical trials within all disease areas
by Djurisic, Snezana and Rath, Ana and Gaber, Sabrina and Garattini, Silvio and Bertele, Vittorio and Ngwabyt, Sandra-Nadia and Hivert, Virginie and Neugebauer, Edmund A.M and Laville, Martine and Hiesmayr, Michael and Demotes-Mainard, Jacques and Kubiak, Christine and Jakobsen, Janus C and Gluud, Christian
Trials, ISSN 1745-6215, 08/2017, Volume 18, Issue 1, pp. 360 - 10
Background: Randomised clinical trials are key to advancing medical knowledge and to enhancing patient care, but major barriers to their conduct exist. The... 
Evidence based clinical practice | Hindrances | Barriers | Challenges | Randomised clinical trials | Evidence based medicine | Bottlenecks | MEDICINE, RESEARCH & EXPERIMENTAL | PERSPECTIVE | REDUCING WASTE | EVIDENCE-BASED MEDICINE | PRIMARY BILIARY-CIRRHOSIS | INCREASING VALUE | OUTCOMES | ETHICS | Attitude of Health Personnel | Equipment and Supplies | Pragmatic Clinical Trials as Topic - legislation & jurisprudence | Randomized Controlled Trials as Topic - methods | Europe | Humans | Cooperative Behavior | Randomized Controlled Trials as Topic - legislation & jurisprudence | Evidence-Based Medicine | Health Knowledge, Attitudes, Practice | Pragmatic Clinical Trials as Topic - methods | Multicenter Studies as Topic - economics | Research Support as Topic | Multicenter Studies as Topic - methods | Nutrition Therapy | Research Design - legislation & jurisprudence | Rare Diseases - therapy | Research Personnel | Confidentiality | Multicenter Studies as Topic - legislation & jurisprudence | Randomized Controlled Trials as Topic - economics | Pragmatic Clinical Trials as Topic - economics | Medical research | Care and treatment | Meetings | Privacy, Right of | Clinical trials | Medicine, Experimental | Research | Evidence-based medicine | Patients | Life Sciences
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16. Full Text Pragmatic clinical trials in CKD: Opportunities and challenges
by De Boer, Ian H and Kovesdy, Csaba P and Navaneethan, Sankar D and Peralta, Carmen A and Tuot, Delphine S and Vazquez, Miguel A and Crews, Deidra C and Amer Soc Nephrol Chronic Kidney and American Society of Nephrology Chronic Kidney Disease Advisory Group
Journal of the American Society of Nephrology, ISSN 1046-6673, 2016, Volume 27, Issue 10, pp. 2948 - 2954
Randomized controlled trials in CKD lag in number behind those of other chronic diseases, despite the high morbidity and mortality experienced by patients with... 
READMISSION | INFORMED-CONSENT | PRIMARY-CARE | RANDOMIZED-TRIALS | GUIDELINES | UROLOGY & NEPHROLOGY | RISK | CHRONIC KIDNEY-DISEASE | ASSOCIATION | AFRICAN-AMERICAN | ATTITUDES | Renal Insufficiency, Chronic - therapy | Humans | Pragmatic Clinical Trials as Topic - standards | clinical trial | Up Front Matters | chronic kidney disease | outcomes
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