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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GRADE system | Other | A clinical recommendation built and graded with the GRADE working group system |
|
| SIGN grading system | Other | A clinical recommendation built and graded with the Scottish Intercollegiate Guidelines Network system |
|
| NICE grading system | Other | A clinical recommendation built and graded with National Institute of Clinical Excellence grading system |
|
| CEBM-Oxford | Other | A clinical recommendation built and graded with the Centre for Evidence-Based Medicine grading system |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Graded Clinical Recommendation | Other | Graded recommendation in reference to a clinical condition written as it would be in a clinical practice guideline |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Carlos A Cuello-Garcia, MD | Instituto Tecnologico y de Estudios Superiores de Monterey | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Escuela de Medicina y Biotecnologia del ITESM | Monterrey | Nuevo León | 64710 | Mexico |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21596725 | Derived | 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. |
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Participants were not eligible for randomization if they refuse to participate in the trial or if they reported less than six months of clinical practice (residents). After randomization they were allocated to one of the four study groups. A survey was applied and no wash out was observed or desertions.
Pediatric residents, pediatricians and sub-specialists were recruited from their clinical practices to participate in the study. All in known teaching hospitals in Monterrey and Mexico city. Recruitment from September 1st to October 21st.
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| ID | Title | Description |
|---|---|---|
| FG000 | GRADE System | A clinical recommendation built and graded with the GRADE working group system |
| FG001 | SIGN Grading System | A clinical recommendation built and graded with the Scottish Intercollegiate Guidelines Network system |
| FG002 | NICE Grading System | A clinical recommendation built and graded with National Institute of Clinical Excellence grading system |
| FG003 | CEBM-Oxford | A clinical recommendation built and graded with the Centre for Evidence-Based Medicine grading system |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | GRADE System | A clinical recommendation built and graded with the GRADE working group system |
| BG001 | SIGN Grading System | A clinical recommendation built and graded with the Scottish Intercollegiate Guidelines Network system |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | 95% Confidence Interval | Mean change in centimeters | One day |
|
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As this is a survey in a randomized group of physicians, we do not expect to see adverse events
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | GRADE System | A clinical recommendation built and graded with the GRADE working group system |
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The outcome was measured in only one topic and could be not expanded to other areas of pediatrics or even other specialties in medicine.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Carlos A. Cuello-GarcÃa | ITESM | +52 (81)88882154 | carlos.cuello@gmail.com, carlos.cuello@itesm.mx |
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| BG002 | NICE Grading System | A clinical recommendation built and graded with National Institute of Clinical Excellence grading system |
| BG003 | CEBM-Oxford | A clinical recommendation built and graded with the Centre for Evidence-Based Medicine grading system |
| BG004 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Years of practice | Median | Inter-Quartile Range | Years |
|
A clinical recommendation built and graded with the Scottish Intercollegiate Guidelines Network system |
| OG002 | NICE Grading System | A clinical recommendation built and graded with National Institute of Clinical Excellence grading system |
| OG003 | CEBM-Oxford | A clinical recommendation built and graded with the Centre for Evidence-Based Medicine grading system |
|
|
|
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | SIGN Grading System | A clinical recommendation built and graded with the Scottish Intercollegiate Guidelines Network system | 0 | 0 | 0 | 0 |
| EG002 | NICE Grading System | A clinical recommendation built and graded with National Institute of Clinical Excellence grading system | 0 | 0 | 0 | 0 |
| EG003 | CEBM-Oxford | A clinical recommendation built and graded with the Centre for Evidence-Based Medicine grading system | 0 | 0 | 0 | 0 |
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