NCT00940290

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
216

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2009

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 13, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 16, 2009

Completed
16 days until next milestone

Study Start

First participant enrolled

August 1, 2009

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2009

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2009

Completed
2 months until next milestone

Results Posted

Study results publicly available

January 13, 2010

Completed
Last Updated

January 20, 2010

Status Verified

November 1, 2009

Enrollment Period

2 months

First QC Date

July 13, 2009

Results QC Date

December 9, 2009

Last Update Submit

January 12, 2010

Conditions

Keywords

practice guideline as topicdecision makingevidence based medicine

Outcome Measures

Primary Outcomes (1)

  • Change in Behavior in Physicians Attitude Towards a Decision to Give a Medication

    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

Study Arms (4)

GRADE system

OTHER

A clinical recommendation built and graded with the GRADE working group system

Other: Graded Clinical Recommendation

SIGN grading system

OTHER

A clinical recommendation built and graded with the Scottish Intercollegiate Guidelines Network system

Other: Graded Clinical Recommendation

NICE grading system

OTHER

A clinical recommendation built and graded with National Institute of Clinical Excellence grading system

Other: Graded Clinical Recommendation

CEBM-Oxford

OTHER

A clinical recommendation built and graded with the Centre for Evidence-Based Medicine grading system

Other: Graded Clinical Recommendation

Interventions

Graded recommendation in reference to a clinical condition written as it would be in a clinical practice guideline

CEBM-OxfordGRADE systemNICE grading systemSIGN grading system

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Pediatricians and residents in pediatrics

You may not qualify if:

  • Less than six months in clinical practice

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Escuela de Medicina y Biotecnologia del ITESM

Monterrey, Nuevo León, 64710, Mexico

Location

Related Publications (1)

  • Cuello Garcia CA, Pacheco Alvarado KP, Perez Gaxiola G. Grading recommendations in clinical practice guidelines: randomised experimental evaluation of four different systems. Arch Dis Child. 2011 Aug;96(8):723-8. doi: 10.1136/adc.2010.199307. Epub 2011 May 19.

Limitations and Caveats

The outcome was measured in only one topic and could be not expanded to other areas of pediatrics or even other specialties in medicine.

Results Point of Contact

Title
Carlos A. Cuello-García
Organization
ITESM

Study Officials

  • Carlos A Cuello-Garcia, MD

    Instituto Tecnologico y de Estudios Superiores de Monterey

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 13, 2009

First Posted

July 16, 2009

Study Start

August 1, 2009

Primary Completion

October 1, 2009

Study Completion

November 1, 2009

Last Updated

January 20, 2010

Results First Posted

January 13, 2010

Record last verified: 2009-11

Locations