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.
Trial 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. Read more about this study
- 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
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 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.
- 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)
Sponsor and investigators
- Lead sponsor
- Instituto Tecnologico y de Estudios Superiores de Monterey
- Sponsor type
- University, hospital or other
- Investigators
- Carlos A Cuello-Garcia, MD, Principal investigator, Instituto Tecnologico y de Estudios Superiores de Monterey
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
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.
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.
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
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.
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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.