Practices, patients and (im)perfect data--feasibility of a randomised controlled clinical drug trial in German general practices.
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Practices, patients and (im)perfect data--feasibility of a randomised controlled clinical drug trial in German general practices. / Gágyor, Ildikó; Bleidorn, Jutta; Wegscheider, Karl; Hummers-Pradier, Eva; Kochen, Michael M.
in: TRIALS, Jahrgang 12, 2011, S. 91.Publikationen: SCORING: Beitrag in Fachzeitschrift/Zeitung › SCORING: Zeitschriftenaufsatz › Forschung › Begutachtung
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TY - JOUR
T1 - Practices, patients and (im)perfect data--feasibility of a randomised controlled clinical drug trial in German general practices.
AU - Gágyor, Ildikó
AU - Bleidorn, Jutta
AU - Wegscheider, Karl
AU - Hummers-Pradier, Eva
AU - Kochen, Michael M
PY - 2011
Y1 - 2011
N2 - Randomised controlled clinical (drug) trials supply high quality evidence for therapeutic strategies in primary care. Until now, experience with drug trials in German general practice has been sparse. In 2007/2008, the authors conducted an investigator-initiated, non-commercial, double-blind, randomised controlled pilot trial (HWI-01) to assess the clinical equivalence of ibuprofen and ciprofloxacin in the treatment of uncomplicated urinary tract infection (UTI). Here, we report the feasibility of this trial in German general practices and the implementation of Good Clinical Practice (GCP) standards as defined by the International Conference on Harmonisation (ICH) in mainly inexperienced general practices.
AB - Randomised controlled clinical (drug) trials supply high quality evidence for therapeutic strategies in primary care. Until now, experience with drug trials in German general practice has been sparse. In 2007/2008, the authors conducted an investigator-initiated, non-commercial, double-blind, randomised controlled pilot trial (HWI-01) to assess the clinical equivalence of ibuprofen and ciprofloxacin in the treatment of uncomplicated urinary tract infection (UTI). Here, we report the feasibility of this trial in German general practices and the implementation of Good Clinical Practice (GCP) standards as defined by the International Conference on Harmonisation (ICH) in mainly inexperienced general practices.
KW - Adult
KW - Germany
KW - Humans
KW - Male
KW - Aged
KW - Female
KW - Middle Aged
KW - Aged, 80 and over
KW - Adolescent
KW - Young Adult
KW - Treatment Outcome
KW - Risk Assessment
KW - Sample Size
KW - Double-Blind Method
KW - Patient Selection
KW - Cooperative Behavior
KW - Feasibility Studies
KW - Attitude of Health Personnel
KW - Interdisciplinary Communication
KW - Therapeutic Equivalency
KW - Anti-Infective Agents/adverse effects/therapeutic use
KW - Anti-Inflammatory Agents, Non-Steroidal/adverse effects/therapeutic use
KW - Ciprofloxacin/adverse effects/therapeutic use
KW - General Practice
KW - Ibuprofen/adverse effects/therapeutic use
KW - Urinary Tract Infections/drug therapy
KW - Workload
KW - Adult
KW - Germany
KW - Humans
KW - Male
KW - Aged
KW - Female
KW - Middle Aged
KW - Aged, 80 and over
KW - Adolescent
KW - Young Adult
KW - Treatment Outcome
KW - Risk Assessment
KW - Sample Size
KW - Double-Blind Method
KW - Patient Selection
KW - Cooperative Behavior
KW - Feasibility Studies
KW - Attitude of Health Personnel
KW - Interdisciplinary Communication
KW - Therapeutic Equivalency
KW - Anti-Infective Agents/adverse effects/therapeutic use
KW - Anti-Inflammatory Agents, Non-Steroidal/adverse effects/therapeutic use
KW - Ciprofloxacin/adverse effects/therapeutic use
KW - General Practice
KW - Ibuprofen/adverse effects/therapeutic use
KW - Urinary Tract Infections/drug therapy
KW - Workload
U2 - 10.1186/1745-6215-12-91
DO - 10.1186/1745-6215-12-91
M3 - SCORING: Journal article
VL - 12
SP - 91
JO - TRIALS
JF - TRIALS
SN - 1745-6215
ER -