Trial Outcomes & Findings for Practice Guidelines Grading Systems (NCT NCT00940290)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

216 participants

Primary outcome timeframe

One day

Results posted on

2010-01-20

Participant Flow

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.

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.

Participant milestones

Participant milestones
Measure	GRADE System A clinical recommendation built and graded with the GRADE working group system	SIGN Grading System A clinical recommendation built and graded with the Scottish Intercollegiate Guidelines Network system	NICE Grading System A clinical recommendation built and graded with National Institute of Clinical Excellence grading system	CEBM-Oxford A clinical recommendation built and graded with the Centre for Evidence-Based Medicine grading system
Overall Study STARTED	54	53	55	54
Overall Study COMPLETED	54	53	55	54
Overall Study NOT COMPLETED	0	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Practice Guidelines Grading Systems

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	GRADE System n=54 Participants A clinical recommendation built and graded with the GRADE working group system	SIGN Grading System n=53 Participants A clinical recommendation built and graded with the Scottish Intercollegiate Guidelines Network system	NICE Grading System n=55 Participants A clinical recommendation built and graded with National Institute of Clinical Excellence grading system	CEBM-Oxford n=54 Participants A clinical recommendation built and graded with the Centre for Evidence-Based Medicine grading system	Total n=216 Participants Total of all reporting groups
Age Continuous	30 years n=5 Participants	34 years n=7 Participants	31 years n=5 Participants	38 years n=4 Participants	32 years n=21 Participants
Sex: Female, Male Female	25 Participants n=5 Participants	27 Participants n=7 Participants	25 Participants n=5 Participants	25 Participants n=4 Participants	102 Participants n=21 Participants
Sex: Female, Male Male	29 Participants n=5 Participants	26 Participants n=7 Participants	30 Participants n=5 Participants	29 Participants n=4 Participants	114 Participants n=21 Participants
Years of practice Years of practice	4 Years n=5 Participants	5 Years n=7 Participants	4 Years n=5 Participants	9 Years n=4 Participants	5 Years n=21 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	GRADE System n=54 Participants A clinical recommendation built and graded with the GRADE working group system	SIGN Grading System n=53 Participants A clinical recommendation built and graded with the Scottish Intercollegiate Guidelines Network system	NICE Grading System n=55 Participants A clinical recommendation built and graded with National Institute of Clinical Excellence grading system	CEBM-Oxford n=54 Participants A clinical recommendation built and graded with the Centre for Evidence-Based Medicine grading system
Change in Behavior in Physicians Attitude Towards a Decision to Give a Medication	2.18 Mean change in centimeters Interval 1.48 to 2.88	0.31 Mean change in centimeters Interval -0.41 to 1.05	0.04 Mean change in centimeters Interval -0.68 to 0.77	0.08 Mean change in centimeters Interval -0.52 to 0.69

Adverse Events

GRADE System

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

SIGN Grading System

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

NICE Grading System

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

CEBM-Oxford

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Carlos A. Cuello-García

ITESM

Phone: +52 (81)88882154

Email: [email protected], [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place