Trial document




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  DRKS00007480

Trial Description

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Title

Validity and reliability of a mini-checklist for assessment of guidelines.

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Trial Acronym

MiChe

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URL of the Trial

[---]*

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Brief Summary in Lay Language

The mini-checklist enables a time-saving good overview of the quality and completeness of a guideline and its recommendations. Ten selected guidelines, which have been assessed by the validated instrument AGREE II will be given to ten GPs. After a training they perform an assessment based on the mini-checklist of those 10 guidelines. The primary aim of this study is to examine if the mini-checklist gets comparable results as AGREE II.

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Brief Summary in Scientific Language

The mini-checklist enables a time-saving good overview of the quality and integrity of a guideline and its recommendations. Ten selected guidelines, which have been assessed by the validated instrument AGREE II will be given to ten GPs. After a training they perform an assessment based on the mini-checklist of those 10 guidelines. The primary objective of this work is to assess the validity and reliability of the mini-checklist.

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Organizational Data

  •   DRKS00007480
  •   2014/11/18
  •   [---]*
  •   yes
  •   No approval required according to EC
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Secondary IDs

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Health Condition or Problem studied

  •   Valdiation study of the mini-checklist
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Interventions/Observational Groups

  •   1. Training course for 10 GPs (what are guidelines, which assessment instruments do exist, how does the mini-checklist work)

    2. Assessment of 10 guidelines by 10 trained GPS according the mini-checklist

    3. Comparison of the results of the mini-checklist with the results of AGREE II (assessment performed by two authors independently from each other from the IQWiG)
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Characteristics

  •   Non-interventional
  •   Other
  •   Single arm study
  •   Open (masking not used)
  •   [---]*
  •   Uncontrolled/Single arm
  •   Other
  •   Single (group)
  •   N/A
  •   N/A
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Primary Outcome

Validation of the overall rating scale of AGREE II (gold standard) with the overall rating scale of the mini-checklist.

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Secondary Outcome

1. Inter-Rater-Reliability for "Endorsement" between different guideline assessors using the mini-checklist
2. User satisfaction of the mini-checklist users
3. Feedback for improvement of the mini-checklist
4. Time duration for assessment of the Mini-Checklist (estimated in minutes)

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Doctor's Practice 
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Recruitment

  •   Actual
  •   2014/11/19
  •   10
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   no minimum age
  •   no maximum age
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Additional Inclusion Criteria

All participants (n=10) are general practitioners. and will be invited per mail.

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Exclusion Criteria

Excluded will be general practitioners with experience in guideline assessment or guideline development.

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Addresses

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    • Institut für Allgemeinmedizin, Goethe Universität Frankfurt
    • Ms.  Prof. Dr.  Andrea  Siebenhofer-Kroitzsch 
    • Theodor-Stern-Kai 7
    • 60590  Frankfurt
    • Germany
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    • Philipps-Universität
    • Ms.  Prof. Dr.  Ina  Kopp 
    • Karl-von-Frisch-Straße 1
    • 35043  Marburg
    • Germany
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    • Institut für Allgemeinmedizin; Goethe Universität Frankfurt
    • Ms.  Prof. Dr.  Andrea  Siebenhofer-Kroitzsch 
    • Theodor- Stern Kai 7
    • 60590  Frankfurt
    • Germany
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    • Institut für Allgemeinmedizin, Goethe Universität Frankfurt
    • Ms.  Prof. Dr.  Andrea  Siebenhofer-Kroitzsch 
    • Theodor- Stern Kai 7
    • 60590  Frankfurt
    • Germany
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Sources of Monetary or Material Support

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    • Institut für Allgemeinmedizin Goethe Universität Frankfurt am Main
    • Theodor Stern Kai 7
    • 60590  Frankfurt
    • Germany
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    •   [---]*
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Status

  •   Recruiting complete, follow-up complete
  •   2015/04/15
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Trial Publications, Results and other Documents

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