Patient-reported outcome alerts: Ethical and logistical considerations in clinical trials

JAMA

Volumn 310, Issue 12, 2013, Pages 1229-1230

  Kyte, Derek ^a   Draper, Heather ^a   Calvert, Melanie ^a,b  

^a UNIVERSITY OF BIRMINGHAM   (United Kingdom)

^b MEDICAL RESEARCH COUNCIL   (United Kingdom)

Author keywords

[No Author keywords available]

Indexed keywords

CLINICAL PROTOCOL; CLINICAL TRIAL (TOPIC); DISTRESS SYNDROME; HUMAN; LEGAL LIABILITY; MEDICAL ETHICS; MEDICAL LIABILITY; MEDICAL RESEARCH; OUTCOME ASSESSMENT; PATIENT ATTITUDE; PATIENT CARE; PATIENT PARTICIPATION; PATIENT REPORTED OUTCOME; PATIENT SAFETY; PERSONNEL; PRIORITY JOURNAL; QUESTIONNAIRE; RESEARCH ETHICS; RISK ASSESSMENT; SELF REPORT; SHORT SURVEY;

EID: 84884623034     PISSN: 00987484     EISSN: 15383598     Source Type: Journal    
DOI: 10.1001/jama.2013.277222     Document Type: Short Survey

References (6)

1. Snyder CF, Jensen R, Courtin SO, Wu AW; Website for Outpatient QOL Assessment Research Network. Patient Viewpoint: a website for patient-reported outcomes assessment. Qual Life Res. 2009;18(7):793-800.
2. Kyte D, Draper H, Ives J, Keeley T, Calvert M. Inconsistencies in health-related quality of life (HRQL) data-collection in clinical trials - a potential source of bias? interviews with research nurses and trialists [abstract]. Qual Life Res. doi:10.1007 /s11136-013-0480-2.
3. Kyte D, Ives J, Draper H, Keeley T, Calvert M. Inconsistencies in quality of life data collection in clinical trials: a potential source of bias? interviews with research nurses and trialists. PLoS One. doi:10.1371/journal. pone.0076625.
4. Sackett DL. Clinician-trialist rounds, 5: cointervention bias - how to diagnose it in their trial and prevent it in yours. Clin Trials. 2011;8(4):440-442.
5. Fayers PM, Hopwood P, Harvey A, Girling DJ, Machin D, Stephens R; MRC Cancer Trials Office. Quality of life assessment in clinical trials - guidelines and a checklist for protocol writers: the UK Medical Research Council experience. Eur J Cancer. 1997;33(1):20-28. (Pubitemid 27099561)
6. Basch EM, Abernethy A, Mullins CD, Tiglao MR, Tunis SR. Development of a guidance for including patient-reported outcomes (PROs) in post-approval clinical trials of oncology drugs for comparative effectiveness research (CER). Value Health. 2011;14(3):A10.