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Practice Guidelines Grading Systems

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ClinicalTrials.gov Identifier: NCT00940290
Recruitment Status : Completed
First Posted : July 16, 2009
Results First Posted : January 13, 2010
Last Update Posted : January 20, 2010
Sponsor:
Information provided by:
Instituto Tecnologico y de Estudios Superiores de Monterey

Brief Summary:
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 or disease Intervention/treatment Phase
Decision Making Other: Graded Clinical Recommendation Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 216 participants
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?
Study Start Date : August 2009
Actual Primary Completion Date : October 2009
Actual Study Completion Date : November 2009

Arm Intervention/treatment
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




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


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Ages Eligible for Study:   Child, Adult, Older Adult
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

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

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 Posted: July 16, 2009    Key Record Dates
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