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Practice Guidelines Grading Systems

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00940290
First Posted: July 16, 2009
Last Update Posted: January 20, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Instituto Tecnologico y de Estudios Superiores de Monterey
  Purpose
Clinical practice guidelines (CPG) are systematically developed statements to assist practitioner and patient decisions about appropriate health care for specific clinical circumstances. They are developed to give a recommendation based on the best evidence available. Through a randomized trial, the investigators intend to provide information about which of the four grading systems most used today to grade evidence and recommendations in CPGs, could change physician´s behavior towards a common clinical situation in daily practice.

Condition Intervention
Decision Making Other: Graded Clinical Recommendation

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Official Title: Different Grading Systems to Grade Evidence and Recommendations in Clinical Practice Guidelines: Does it Influence the Clinicians´ Behavior?

Further study details as provided by Instituto Tecnologico y de Estudios Superiores de Monterey:

Primary Outcome Measures:
  • Change in Behavior in Physicians Attitude Towards a Decision to Give a Medication [ Time Frame: One day ]

Enrollment: 216
Study Start Date: August 2009
Study Completion Date: November 2009
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
GRADE system
A clinical recommendation built and graded with the GRADE working group system
Other: Graded Clinical Recommendation
Graded recommendation in reference to a clinical condition written as it would be in a clinical practice guideline
SIGN grading system
A clinical recommendation built and graded with the Scottish Intercollegiate Guidelines Network system
Other: Graded Clinical Recommendation
Graded recommendation in reference to a clinical condition written as it would be in a clinical practice guideline
NICE grading system
A clinical recommendation built and graded with National Institute of Clinical Excellence grading system
Other: Graded Clinical Recommendation
Graded recommendation in reference to a clinical condition written as it would be in a clinical practice guideline
CEBM-Oxford
A clinical recommendation built and graded with the Centre for Evidence-Based Medicine grading system
Other: Graded Clinical Recommendation
Graded recommendation in reference to a clinical condition written as it would be in a clinical practice guideline

Detailed Description:
Clinical practice guidelines (CPG) are used by professional and consumer organizations who are demanding more rigorous processes to ensure that health decisions are well informed by the best available research evidence. More than 60 different grading systems are used today to grade evidence and recommendations in CPGs. The investigators aimed to provide information about which of the four most common grading systems used today (GRADE, SIGN, NICE and CEBM-Oxford) could change physician´s behavior when reading a clinical recommendation in a CPG. The investigators will randomize 216 pediatricians and pediatricians in training into four groups (one for each grading system) to read a clinical case and to make a decision before reading the CPG statement graded with any of the four grading systems. After that they will re-consider their answer and post a new one based on the graded recommendation. The investigators will measure change in their decision and among groups.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Pediatricians and residents in pediatrics

Exclusion Criteria:

  • Less than six months in clinical practice
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00940290


Locations
Mexico
Escuela de Medicina y Biotecnologia del ITESM
Monterrey, NL, Mexico, 64710
Sponsors and Collaborators
Instituto Tecnologico y de Estudios Superiores de Monterey
Investigators
Principal Investigator: Carlos A Cuello-Garcia, MD Instituto Tecnologico y de Estudios Superiores de Monterey
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Carlos Alberto Cuello-Garcia, Instituto Tecnologico y de Estudios Superiores de Monterrey
ClinicalTrials.gov Identifier: NCT00940290     History of Changes
Other Study ID Numbers: CMBE-ITESM-1
First Submitted: July 13, 2009
First Posted: July 16, 2009
Results First Submitted: December 9, 2009
Results First Posted: January 13, 2010
Last Update Posted: January 20, 2010
Last Verified: November 2009

Keywords provided by Instituto Tecnologico y de Estudios Superiores de Monterey:
practice guideline as topic
decision making
evidence based medicine