Practices, patients and (im)perfect data--feasibility of a randomised controlled clinical drug trial in German general practices.

Ildikó Gágyor; Jutta Bleidorn; Karl Wegscheider; Eva Hummers-Pradier; Michael M Kochen

doi:10.1186/1745-6215-12-91

Practices, patients and (im)perfect data--feasibility of a randomised controlled clinical drug trial in German general practices.

Standard

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, Vol. 12, 2011, p. 91.

Research output: SCORING: Contribution to journal › SCORING: Journal article › Research › peer-review

Harvard

Gágyor, I, Bleidorn, J, Wegscheider, K, Hummers-Pradier, E & Kochen, MM 2011, 'Practices, patients and (im)perfect data--feasibility of a randomised controlled clinical drug trial in German general practices.', TRIALS, vol. 12, pp. 91. https://doi.org/10.1186/1745-6215-12-91

APA

Gágyor, I., Bleidorn, J., Wegscheider, K., Hummers-Pradier, E., & Kochen, M. M. (2011). Practices, patients and (im)perfect data--feasibility of a randomised controlled clinical drug trial in German general practices. TRIALS, 12, 91. https://doi.org/10.1186/1745-6215-12-91

Vancouver

Gágyor I, Bleidorn J, Wegscheider K, Hummers-Pradier E, Kochen MM. Practices, patients and (im)perfect data--feasibility of a randomised controlled clinical drug trial in German general practices. TRIALS. 2011;12:91. https://doi.org/10.1186/1745-6215-12-91

Bibtex

@article{7356289e296f4206adfafaa80a35f5ea,

title = "Practices, patients and (im)perfect data--feasibility of a randomised controlled clinical drug trial in German general practices.",

abstract = "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.",

keywords = "Adult, Germany, Humans, Male, Aged, Female, Middle Aged, Aged, 80 and over, Adolescent, Young Adult, Treatment Outcome, Risk Assessment, Sample Size, Double-Blind Method, Patient Selection, Cooperative Behavior, Feasibility Studies, Attitude of Health Personnel, Interdisciplinary Communication, Therapeutic Equivalency, Anti-Infective Agents/adverse effects/*therapeutic use, Anti-Inflammatory Agents, Non-Steroidal/adverse effects/*therapeutic use, Ciprofloxacin/adverse effects/*therapeutic use, *General Practice, Ibuprofen/adverse effects/*therapeutic use, Urinary Tract Infections/*drug therapy, Workload, Adult, Germany, Humans, Male, Aged, Female, Middle Aged, Aged, 80 and over, Adolescent, Young Adult, Treatment Outcome, Risk Assessment, Sample Size, Double-Blind Method, Patient Selection, Cooperative Behavior, Feasibility Studies, Attitude of Health Personnel, Interdisciplinary Communication, Therapeutic Equivalency, Anti-Infective Agents/adverse effects/*therapeutic use, Anti-Inflammatory Agents, Non-Steroidal/adverse effects/*therapeutic use, Ciprofloxacin/adverse effects/*therapeutic use, *General Practice, Ibuprofen/adverse effects/*therapeutic use, Urinary Tract Infections/*drug therapy, Workload",

author = "Ildik{\'o} G{\'a}gyor and Jutta Bleidorn and Karl Wegscheider and Eva Hummers-Pradier and Kochen, {Michael M}",

year = "2011",

doi = "10.1186/1745-6215-12-91",

language = "English",

volume = "12",

pages = "91",

journal = "TRIALS",

issn = "1745-6215",

publisher = "Current Controlled Trials Ltd.",

}

RIS

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