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Practice Guidelines Grading Systems

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00940290
Enrollment
216
Registered
2009-07-16
Start date
2009-08-31
Completion date
2009-11-30
Last updated
2010-01-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Decision Making

Keywords

practice guideline as topic, decision making, evidence based medicine

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.

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.

Interventions

OTHERGraded Clinical Recommendation

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

Sponsors

Instituto Tecnologico y de Estudios Superiores de Monterey
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
NONE

Eligibility

Sex/Gender
ALL
Healthy volunteers
Yes

Inclusion criteria

* Pediatricians and residents in pediatrics

Exclusion criteria

* Less than six months in clinical practice

Design outcomes

Primary

MeasureTime frameDescription
Change in Behavior in Physicians Attitude Towards a Decision to Give a MedicationOne dayA 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.

Countries

Mexico

Participant flow

Recruitment details

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.

Pre-assignment details

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.

Participants by arm

ArmCount
GRADE System
A clinical recommendation built and graded with the GRADE working group system
54
SIGN Grading System
A clinical recommendation built and graded with the Scottish Intercollegiate Guidelines Network system
53
NICE Grading System
A clinical recommendation built and graded with National Institute of Clinical Excellence grading system
55
CEBM-Oxford
A clinical recommendation built and graded with the Centre for Evidence-Based Medicine grading system
54
Total216

Baseline characteristics

CharacteristicGRADE SystemSIGN Grading SystemNICE Grading SystemCEBM-OxfordTotal
Age Continuous30 years34 years31 years38 years32 years
Sex: Female, Male
Female
25 Participants27 Participants25 Participants25 Participants102 Participants
Sex: Female, Male
Male
29 Participants26 Participants30 Participants29 Participants114 Participants
Years of practice
Years of practice
4 Years5 Years4 Years9 Years5 Years

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
EG003
affected / at risk
deaths
Total, all-cause mortality
— / —— / —— / —— / —
other
Total, other adverse events
0 / 00 / 00 / 00 / 0
serious
Total, serious adverse events
0 / 00 / 00 / 00 / 0

Outcome results

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.

Time frame: One day

ArmMeasureValue (MEAN)
GRADE SystemChange in Behavior in Physicians Attitude Towards a Decision to Give a Medication2.18 Mean change in centimeters
SIGN Grading SystemChange in Behavior in Physicians Attitude Towards a Decision to Give a Medication0.31 Mean change in centimeters
NICE Grading SystemChange in Behavior in Physicians Attitude Towards a Decision to Give a Medication0.04 Mean change in centimeters
CEBM-OxfordChange in Behavior in Physicians Attitude Towards a Decision to Give a Medication0.08 Mean change in centimeters
Comparison: After reading the clinical practice guideline, the median response from the four groups were compared using the Kruskal-Wallis statisticp-value: 0.007Kruskal-Wallis

Source: ClinicalTrials.gov · Data processed: Mar 29, 2026