Definition of Sample Size in Randomized Clinical Trial Assessing Liver DiseaseNCT01604720
Sample Size Definition in Cochrane Hepato-Biliary Trials
An observational study of Definition of Sample Size in Randomized Clinical Trial Assessing Liver Disease, run by Azienda Ospedaliera di Lecco at 1 site in Italy.
Trial summary
Sample size definition provides important information, allowing the groundwork for transparent reporting. The sample predefinition allows the trial to be large enough to be able to address the question that is being asked. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Definition of Sample Size in Randomized Clinical Trial Assessing Liver Disease
- How many people
- 250 participants
- Where
- 1 siteItaly
- Study dates
- Jul 2012to Apr 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
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
- No healthy volunteers
- Child, Adult, Older adult
Study population: Randomized clinical trials included in systematic reviews of the hepato-biliary Group of the Cochrane Collaboration
Who may be able to join
- Two arms, parallel group superiority randomised controlled trials with a single primary outcome,
Who cannot join
- Reports for which the study design was factorial, cluster, or crossover
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Medicine Department A.Manzoni Hospital
Lecco, I 23900
agostino colli, MD, +390341489670, a.colli@ospedale.lecco.it
pietro pozzoni, MD, +390341489687, pozzoni@ospedale.lecco.it
About this study
Official title: Review: Analysis of the Sample Size Definitions in the Randomized Clinical Trials Included in Systematic Reviews of the Hepato-biliary Group of the Cochrane Collaboration
Sample size definition provides important information, allowing the groundwork for transparent reporting. The sample predefinition allows the trial to be large enough to be able to address the question that is being asked.
The aim of the present study is to assess, in all the randomized controlled trials (RCT) included in the Cochrane Hepato-Biliary Group (CHBG) systematic reviews, the quality of reporting sample size the accuracy of the calculations, the accuracy of the a priori assumptions and the effect on the agreement with pooled results in meta-analyses.
Read the detailed description
The investigators aim to answers to these questions
Questions
- How large a proportion of recent hepato-biliary RCTs does report an adequate sample size estimation?
- Primary outcome is clearly defined ? and clinical meaningful ?
- Is the sample size calculation based on the primary outcome ?
- Does the predicted control event rate coincide with the actual one?
- What is the predicted intervention effect?
- Are confidence intervals of primary outcome results reported? Is there evidence of difference between the two arms?
- Is the effect size so large (> 50%) to suggest post hoc definition ?
- What is the accepted error alpha and beta?
- How many study do not comply with the usual rule of alpha = 5% beta = 20%?
- Do trials with planned sample size do better than those without ? Is the overlap between CI results less frequent ? Are their results more frequently "statistical" significant ?
- Do trials with planned sample more frequently agree with pooled results in meta-analysis ?
- Has the protocol been published in a public register before inclusion of participant?
- How often is intention-to-treat analyses employed as primary analysis?
- How often is the trial results resting upon subgroup analysis?
Methods:
All the randomized clinical trials included in a systematic review of the Cochrane Hepato-biliary group (according to my search 272) were detected and retrieved. Only two arm, parallel group superiority randomised controlled trials with a single primary outcome.
The investigators excluded reports for which the study design was factorial, cluster, or crossover For all selected articles, the investigators systematically retrieved and assessed the full published report of the trial, any extra material or appendices available online, the study design article, if cited, and the details of online registration of the trial, if mentioned. A standardised data collection form was generated on the basis of a review of the literature and a priori discussion and tested by the research team.
- Keywords
- sample size, liver disease
- Medical subject headings
- Liver Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
proportion of reported sample size definitions
number of included studies with explicit sample size definition/ number of included studies
Measured: up to three months after retrievement and inclusion of all studies
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2012 (estimated)
- Study startJul 2012
- Primary completionDec 2015 (estimated)
- Study completionApr 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Definition of Sample Size in Randomized Clinical Trial Assessing Liver DiseaseStudies 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
- Observational
- Time perspective
- Prospective
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Azienda Ospedaliera di Lecco
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Agostino Colli, Azienda Ospedaliera di Lecco
- Investigators
- agostino colli, MD, Principal investigator, AO provincia di lecco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01604720
- Sponsor's protocol ID
- AOLecco002
- Status last verified
- Jan 2015
- First submitted
- 14 May 2012
- Last updated
- 14 Jan 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Review: Analysis of the Sample Size Definitions in the Randomized Clinical Trials Included in Systematic Reviews of the Hepato-biliary Group of the Cochrane Collaboration
- ClinicalTrials.gov ID
- NCT01604720
- Acronym / sponsor ID
- AOLecco002
- Keywords
- sample size, liver disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Azienda Ospedaliera di LeccoUniversity, hospital or other
- Study start
- Jul 2012
- Primary completion
- Dec 2015 (estimated)
- Study completion
- Apr 2016 (estimated)
- First posted
- 24 May 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Sample size definition provides important information, allowing the groundwork for transparent reporting. The sample predefinition allows the trial to be large enough to be able to address the question that is being asked.
The aim of the present study is to assess, in all the randomized controlled trials (RCT) included in the Cochrane Hepato-Biliary Group (CHBG) systematic reviews, the quality of reporting sample size the accuracy of the calculations, the accuracy of the a priori assumptions and the effect on the agreement with pooled results in meta-analyses.
Detailed description
The investigators aim to answers to these questions
Questions
- How large a proportion of recent hepato-biliary RCTs does report an adequate sample size estimation?
- Primary outcome is clearly defined ? and clinical meaningful ?
- Is the sample size calculation based on the primary outcome ?
- Does the predicted control event rate coincide with the actual one?
- What is the predicted intervention effect?
- Are confidence intervals of primary outcome results reported? Is there evidence of difference between the two arms?
- Is the effect size so large (> 50%) to suggest post hoc definition ?
- What is the accepted error alpha and beta?
- How many study do not comply with the usual rule of alpha = 5% beta = 20%?
- Do trials with planned sample size do better than those without ? Is the overlap between CI results less frequent ? Are their results more frequently "statistical" significant ?
- Do trials with planned sample more frequently agree with pooled results in meta-analysis ?
- Has the protocol been published in a public register before inclusion of participant?
- How often is intention-to-treat analyses employed as primary analysis?
- How often is the trial results resting upon subgroup analysis?
Methods:
All the randomized clinical trials included in a systematic review of the Cochrane Hepato-biliary group (according to my search 272) were detected and retrieved. Only two arm, parallel group superiority randomised controlled trials with a single primary outcome.
The investigators excluded reports for which the study design was factorial, cluster, or crossover For all selected articles, the investigators systematically retrieved and assessed the full published report of the trial, any extra material or appendices available online, the study design article, if cited, and the details of online registration of the trial, if mentioned. A standardised data collection form was generated on the basis of a review of the literature and a priori discussion and tested by the research team.
Study design
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Randomized clinical trials included in systematic reviews of the hepato-biliary Group of the Cochrane Collaboration
Key inclusion criteria (1 listed)
- Two arms, parallel group superiority randomised controlled trials with a single primary outcome,
Key exclusion criteria (1 listed)
- Reports for which the study design was factorial, cluster, or crossover
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
proportion of reported sample size definitions
Time frame: up to three months after retrievement and inclusion of all studies
number of included studies with explicit sample size definition/ number of included studies
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2015.
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.
agostino colli, MD principal investigator
AO provincia di lecco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Definition of Sample Size in Randomized Clinical Trial Assessing Liver Disease, run by Azienda Ospedaliera di Lecco at 1 site in Italy.
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: status not confirmed, as of the sponsor's last update on 14 Jan 2015. 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 Italy. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact agostino colli, MD (+390341489670, a.colli@ospedale.lecco.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
proportion of reported sample size definitions (time frame: up to three months after retrievement and inclusion of all studies). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Jan 2015.