Decision MakingNCT00940290

Practice Guidelines Grading Systems

A study testing Graded Clinical Recommendation in people with Decision Making, run by Instituto Tecnologico y de Estudios Superiores de Monterey at 1 site in Mexico.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Any ageHealthy volunteers can take part
Conditions the study is for: Decision Making
What is being tested?: Graded Clinical Recommendation
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 216 participants
Where: 1 siteMexico
Study dates: Aug 2009to Nov 2009
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages Any age
All sexes
Healthy volunteers accepted
Child, Adult, Older adult

Who may be able to join

Pediatricians and residents in pediatrics

Who cannot join

Less than six months in clinical practice

Trial locations and contacts

1 site in 1 country.

Mexico1 site

Escuela de Medicina y Biotecnologia del ITESM
Monterrey, Nuevo León, 64710

Other trials in Mexico

About this study

Official title: 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.

Read the 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.

Conditions: Decision Making
Being tested: Graded Clinical Recommendation
Keywords: practice guideline as topic, decision making, evidence based medicine

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT00940290
Study group	Role	What they receive
GRADE system	Other	A clinical recommendation built and graded with the GRADE working group system Receives: Other: Graded Clinical Recommendation
SIGN grading system	Other	A clinical recommendation built and graded with the Scottish Intercollegiate Guidelines Network system Receives: Other: Graded Clinical Recommendation
NICE grading system	Other	A clinical recommendation built and graded with National Institute of Clinical Excellence grading system Receives: Other: Graded Clinical Recommendation
CEBM-Oxford	Other	A clinical recommendation built and graded with the Centre for Evidence-Based Medicine grading system Receives: Other: Graded Clinical Recommendation

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: One day

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Aug 2009Nov 2009

First posted16 Jul 2009 (estimated)
Study startAug 2009
Primary completionOct 2009
Study completionNov 2009

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Decision MakingStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 216 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00940290
Sponsor's protocol ID: CMBE-ITESM-1
Status last verified: Nov 2009
First submitted: 13 Jul 2009
Last updated: 20 Jan 2010
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

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.
PubMed 21596725

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingEarly Phase 1
Developing Transcranial Neuromodulation Protocols for Learning and Decision-Making
Normal Physiology
Recruiting
Patient Priorities Aligned Discrete Decision Making for Older Adults With Multiple Chronic Conditions.
Hernia
RecruitingObservational study
Olfactory Function and Model-Based Behavior in People Living With HIV and SUD
HIV, Substance Use Disorder
Active, not recruiting
Developing and Testing an Online Pathway From Screening to Treatment for Depression in Oncology: iPath*D (Aim 2)
Cancer, Depression
Not yet recruiting
A Multidimensional Intervention to Improve Ethical Decision-Making Competence Among Nursing Student Interns: A Randomized Controlled Trial
Ethical Decision-Making Competence in Nursing Student Interns

All Decision Making trials

Study at a glance

From the registry record, last updated by the sponsor on 20 Jan 2010. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Different Grading Systems to Grade Evidence and Recommendations in Clinical Practice Guidelines: Does it Influence the Clinicians´ Behavior?
ClinicalTrials.gov ID: NCT00940290
Acronym / sponsor ID: CMBE-ITESM-1
Conditions: Decision Making
Keywords: practice guideline as topic, decision making, evidence based medicine
Study type: Interventional
Recruitment status: Completed
Enrolment: 216 participants (actual)
Lead sponsor: Instituto Tecnologico y de Estudios Superiores de MontereyUniversity, hospital or other
Study start: Aug 2009
Primary completion: Oct 2009 (actual)
Study completion: Nov 2009 (actual)
First posted: 16 Jul 2009 (estimated)
Results: Posted 13 Jan 2010

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 4

Arm	Type	Receives
GRADE system	Other	Other: Graded Clinical RecommendationA clinical recommendation built and graded with the GRADE working group system
SIGN grading system	Other	Other: Graded Clinical RecommendationA clinical recommendation built and graded with the Scottish Intercollegiate Guidelines Network system
NICE grading system	Other	Other: Graded Clinical RecommendationA clinical recommendation built and graded with National Institute of Clinical Excellence grading system
CEBM-Oxford	Other	Other: Graded Clinical RecommendationA clinical recommendation built and graded with the Centre for Evidence-Based Medicine grading system

Who may qualify

Sex: All
Healthy volunteers: Accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (1 listed)

Pediatricians and residents in pediatrics

Key exclusion criteria (1 listed)

Less than six months in clinical practice

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Graded Clinical RecommendationGraded recommendation in reference to a clinical condition written as it would be in a clinical practice guideline	Other	CEBM-Oxford, GRADE system, NICE grading system, SIGN grading system

Primary outcome

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.

Results and safety

Results posted to the registry on 13 Jan 2010, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
GRADE System	54	54
SIGN Grading System	53	53
NICE Grading System	55	55
CEBM-Oxford	54	54

Primary outcome: Change in Behavior in Physicians Attitude Towards a Decision to Give a Medication

Time frame: One day. Mean (95% Confidence Interval). Unit: Mean change in centimeters

Measure	GRADE System n = 54	SIGN Grading System n = 53	NICE Grading System n = 55	CEBM-Oxford n = 54
Value	2.18 (1.48 to 2.88)	0.31 (-0.41 to 1.05)	0.04 (-0.68 to 0.77)	0.08 (-0.52 to 0.69)

GRADE System vs SIGN Grading System vs NICE Grading System vs CEBM-Oxford: p = 0.007, Kruskal-Wallis

Adverse events

Time frame: Do not apply. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
GRADE System	0 of 0	0 of 0	Not reported
SIGN Grading System	0 of 0	0 of 0	Not reported
NICE Grading System	0 of 0	0 of 0	Not reported
CEBM-Oxford	0 of 0	0 of 0	Not reported

Limitations and caveats (from the sponsor): The outcome was measured in only one topic and could be not expanded to other areas of pediatrics or even other specialties in medicine.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2010.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 21596725Cuello 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.

Related trials for Decision Making

RecruitingEarly Phase 1
Developing Transcranial Neuromodulation Protocols for Learning and Decision-Making
Normal Physiology
Recruiting
Patient Priorities Aligned Discrete Decision Making for Older Adults With Multiple Chronic Conditions.
Hernia
RecruitingObservational study
Olfactory Function and Model-Based Behavior in People Living With HIV and SUD
HIV, Substance Use Disorder
Active, not recruiting
Developing and Testing an Online Pathway From Screening to Treatment for Depression in Oncology: iPath*D (Aim 2)
Cancer, Depression
Not yet recruiting
A Multidimensional Intervention to Improve Ethical Decision-Making Competence Among Nursing Student Interns: A Randomized Controlled Trial
Ethical Decision-Making Competence in Nursing Student Interns

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Carlos A Cuello-Garcia, MD principal investigator

Instituto Tecnologico y de Estudios Superiores de Monterey

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Graded Clinical Recommendation in people with Decision Making, run by Instituto Tecnologico y de Estudios Superiores de Monterey at 1 site in Mexico.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Jan 2010. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 13 Jan 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Behavior in Physicians Attitude Towards a Decision to Give a Medication (time frame: One day). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00940290, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jan 2010.