Promoting informed decision making for comparative effectiveness randomized trials

JAMA Pediatrics

Volumn 169, Issue 9, 2015, Pages 803-804

  Weiss, Elliott M ^a,b   Joffe, Steven ^a,b  

^a CHILDREN S HOSPITAL OF PHILADELPHIA   (United States)

^b UNIVERSITY OF PENNSYLVANIA   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ACUTE GRAFT VERSUS HOST DISEASE; BONE MARROW TRANSPLANTATION; CLINICAL EFFECTIVENESS; CLINICAL EVALUATION; CLINICAL RESEARCH; COMPARATIVE EFFECTIVENESS; DISEASE ASSOCIATION; DISEASE COURSE; DISEASE SEVERITY; FOSTER CARE; GRAFT VERSUS HOST REACTION; HEALTH CARE QUALITY; HIGH RISK PATIENT; HUMAN; INFORMED CONSENT; MEDICAL INFORMATION; PATIENT DECISION MAKING; PATIENT EDUCATION; PATIENT SAFETY; PERIPHERAL BLOOD STEM CELL TRANSPLANTATION; PRACTICE GUIDELINE; PREMATURITY; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL (TOPIC); RELAPSE; RISK ASSESSMENT; SHORT SURVEY; SURVIVAL RATE; TREATMENT OUTCOME; DECISION MAKING; PROCEDURES;

COMPARATIVE EFFECTIVENESS RESEARCH; DECISION MAKING; HUMANS; INFORMED CONSENT; PATIENT EDUCATION AS TOPIC; RANDOMIZED CONTROLLED TRIALS AS TOPIC; RISK ASSESSMENT;

EID: 84941220924     PISSN: 21686203     EISSN: 21686211     Source Type: Journal    
DOI: 10.1001/jamapediatrics.2015.0906     Document Type: Short Survey

References (4)

1. Office for Human Research Protections of the Department of Health and Human Services. Draft guidance on disclosing reasonably foreseeable risks in research evaluating standards of care. Fed Regist. 2014;79(206):63629-63634.
2. BMT Clin ical Trials Network. A phase III randomized, multicenter trial comparing G-CSF mobilized peripheral blood stem cell with marrow transplantation from HLA compatible unrelated donors. https://web.emmes.com/study/bmt2/protocol/0201-protocol/0201-Consen ts-v8.pdf. Published 2006. Accessed June 1, 2015.
3. Joffe S,Wertheimer A. Determiningminimal risk for comparative effectiveness research. IRB. 2014; 36(3):16-18.
4. Anasetti C, Logan BR, Lee SJ, et al; Blood and Marrow Transplant Clinical Trials Network. Peripheral-blood stem cells versus bone marrow from unrelated donors. N Engl J Med. 2012;367(16): 1487-1496.