Methodological Issues in the Design of Analgesic Clinical Trials

This overview draws out the main conclusions from the 4 workshops focused on incorporating the patient perspective into outcome assessment at the 10th Outcome Measures in Rheumatology (OMERACT 10) conference. They raised methodological issues about the choice of outcome domains to include in clinical trials, the development or choice of instruments to measure these domains, and the way these instruments might capture the impact of a disease and its treatment. The need to develop a more rigorous conceptual model of quantifying the way conditions affect health, and the need to ensure patients are directly involved in the decisions about domains and instruments, emerged clearly. The OMERACT participants voted to develop guidelines for domain and instrument selection, and conceptual and experimental work will be brought forward to revise and upgrade the OMERACT Filter.

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Methodological Issues in Clinical Trials of Antidepressant Medications: Perspectives from Psychotherapy Outcome Research

Psychotherapy and Psychosomatics ◽

10.1159/000082022 ◽

2004 ◽

Vol 74 (1) ◽

pp. 17-25 ◽

Cited By ~ 25

Author(s):

Brandon A. Gaudiano ◽

James D. Herbert

Keyword(s):

Clinical Trials ◽

Outcome Research ◽

Psychotherapy Outcome ◽

Methodological Issues ◽

Antidepressant Medications ◽

Psychotherapy Outcome Research

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Methodological Issues of Patient Utility Measurement Experience From Two Clinical Trials

Medical Care ◽

10.1097/00005650-199509000-00004 ◽

1995 ◽

Vol 33 (9) ◽

pp. 922-937 ◽

Cited By ~ 69

Author(s):

MAUREEN ◽

RUTTEN-VAN MÖLKEN ◽

CARLA H. BAKKER ◽

EDDY K. A. ◽

VAN DOORSLAER ◽

...

Keyword(s):

Clinical Trials ◽

Methodological Issues ◽

Utility Measurement ◽

Patient Utility

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Ethical Considerations for Nurses in Clinical Trials

Nursing Ethics ◽

10.1191/0969733006ne836oa ◽

2006 ◽

Vol 13 (2) ◽

pp. 180-186 ◽

Cited By ~ 21

Author(s):

Kathleen Oberle ◽

Marion Allen

Keyword(s):

Clinical Trials ◽

Moral Obligation ◽

Potential Problem ◽

Ethical Issues ◽

Methodological Issues ◽

Ethical Considerations ◽

Ethical Concerns ◽

Principal Investigators ◽

Research Nurses ◽

Trial Failure

Ethical issues arise for nurses involved in all phases of clinical trials regardless of whether they are caregivers, research nurses, trial co-ordinators or principal investigators. Potential problem areas centre on nurses’ moral obligation related to methodological issues as well as the notions of beneficence/non-maleficence and autonomy. These ethical concerns can be highly upsetting to nurses if they are not addressed, so it is imperative that they are discussed fully prior to the initiation of a trial. Failure to resolve these issues can place both the conduct and the results of research in jeopardy.

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