Practice Guidelines Grading Systems

January 12, 2010 updated by: Instituto Tecnologico y de Estudios Superiores de Monterey

Different Grading Systems to Grade Evidence and Recommendations in Clinical Practice Guidelines: Does it Influence the Clinicians´ Behavior?

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

216

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Mexico
    • NL
      • Monterrey, NL, Mexico, 64710
        • Escuela de Medicina y Biotecnologia del ITESM

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Pediatricians and residents in pediatrics

Exclusion Criteria:

  • Less than six months in clinical practice

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 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
Other: 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
Other: 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
Other: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Behavior in Physicians Attitude Towards a Decision to Give a Medication
Time Frame: One day
A fictitious clinical case of a child with acute diarrhea was presented. The physician read the case and then answered the question "would you recommend racecadotril to this patient?" A zero to 10 visual-analog scale and a Likert scale were used to measure the decision of the physician related to the clinical case presented (from zero="definitely no" to 10="definitely yes"). Mean differences before-after and among groups were measured on the 10 centimeters scale.
One day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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 and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2009

Primary Completion (Actual)

October 1, 2009

Study Completion (Actual)

November 1, 2009

Study Registration Dates

First Submitted

July 13, 2009

First Submitted That Met QC Criteria

July 15, 2009

First Posted (Estimate)

July 16, 2009

Study Record Updates

Last Update Posted (Estimate)

January 20, 2010

Last Update Submitted That Met QC Criteria

January 12, 2010

Last Verified

November 1, 2009

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • CMBE-ITESM-1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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