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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000042464
Receipt No. R000048472
Scientific Title A Meta-epidemiological Study about How Standardized Mean Difference Is Computed, Reported and Interpreted in Randomized Controlled Trials
Date of disclosure of the study information 2020/11/16
Last modified on 2020/11/16

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Basic information
Public title How Is Standardized Mean Difference Computed, Reported and Interpreted in Randomized Controlled Trials
Acronym How Is SMD Computed, Reported and Interpreted in RCTs
Scientific Title A Meta-epidemiological Study about How Standardized Mean Difference Is Computed, Reported and Interpreted in Randomized Controlled Trials
Scientific Title:Acronym A Meta-epidemiological Study about How SMD Is Computed, Reported and Interpreted in RCTs
Region
Japan

Condition
Condition Not limited. General medicine, internal medicine, surgery, psychiatry, psychology.
Classification by specialty
Medicine in general Surgery in general Psychiatry
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 We aim to investigate currently how the term "effect size" is used, how standardized mean difference (SMD) is computed and reported in randomized controlled trials, and how different the values would be if using different approaches to calculate it.
Basic objectives2 Others
Basic objectives -Others Whether the reported SMD is reproducible based on available data.
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes (1) Study characteristics of RCTs that report SMD; (2) The term and method used to compute the reported SMD; (3) Comparison between reported SMD and SMD which we calculate based on different approaches
Key secondary outcomes (1) How RCTs interpret the results in terms of SMD: focusing on whether it is comparable with previous studies (based on same method), and whether it is compared to a standard. (2) Relationship between reporting condition, calculation method and sub-discipline, journal.

Base
Study type Others,meta-analysis etc

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria We will include RCTs published on high-impact journals, which report any SMDs for any continuous outcomes. We restrict the eligible studies to those published on high-impact journals, because we consider that the method used compute the SMD would be better addressed, and results would be more comprehensively provided. Multifactorial RCTs, and crossover RCTs that report results of the first period are eligible.
Key exclusion criteria We will exclude RCTs which use the term "effect size" or "SMD" in a nonspecific way (i.e. sample size calculation), but not for the outcome. We will exclude cluster randomization, quasi-randomized trials, and crossover RCTs whose first period result is not available.
Target sample size 60

Research contact person
Name of lead principal investigator
1st name Yan
Middle name
Last name Luo
Organization Kyoto University Graduate School of Medicine
Division name Department of Health Promotion and Human Behavior
Zip code 606-8501
Address Yoshida Konoe-cho, Sakyo-ku, Kyoto, Japan
TEL +81-75-753-9491
Email lilacluo@gmail.com

Public contact
Name of contact person
1st name Yan
Middle name
Last name Luo
Organization Kyoto University Graduate School of Medicine
Division name Department of Health Promotion and Human Behavior
Zip code 606-8501
Address Yoshida Konoe-cho, Sakyo-ku, Kyoto, Japan
TEL +81-75-753-9491
Homepage URL
Email lilacluo@gmail.com

Sponsor
Institute Department of Health Promotion and Human Behavior, Kyoto University Graduate School of Medicine
Institute
Department

Funding Source
Organization Department of Health Promotion and Human Behavior, Kyoto University Graduate School of Medicine
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Kyoto University Ethics Commitee
Address Kyoto University Graduate School of Medicine, Yoshida Konoe-cho, Sakyo-ku, Kyoto
Tel +81-75-753-4680
Email ethcom@kuhp.kyoto-u.ac.jp

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions Kyoto University (Kyoto)

Other administrative information
Date of disclosure of the study information
2020 Year 11 Month 16 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Preinitiation
Date of protocol fixation
2020 Year 11 Month 01 Day
Date of IRB
Anticipated trial start date
2020 Year 11 Month 10 Day
Last follow-up date
2021 Year 04 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Eligible studies: We will include RCTs published on high-impact journals*, which report any SMDs for any continuous outcomes. We restrict the eligible studies to those published on high-impact journals, because we consider that the method used compute the SMD would be better addressed, and results would be more comprehensively provided. Multifactorial RCTs are eligible, while cluster randomization or quasi-randomized trials will be excluded. As for crossover RCTs, we will only include those whose SMD for the first period is reported.
*General medicine: New England Journal of Medicine, Lancet, JAMA, BMJ, PLoS Medicine, BMC Medicine; Internal medicine: Annals of Internal Medicine, JAMA Internal Medicine; Surgery: JAMA Surgery, Annals of Surgery; Psychiatry: Lancet Psychiatry, JAMA Psychiatry (Archives of General Psychiatry), World Psychiatry, American Journal of Psychiatry, British Journal of Psychiatry; Psychology: Psychological Bulletin, Behavioral and Brain Sciences, Psychological Inquiry, Trends in Cognitive Sciences, Perspectives on Psychological Science.

Data collection: (1) General information of the study; (2) The term, modeling and calculation methods, point estimate and 95% CI, and its interpretation of SMD; (3) Necessary data for us to calculate SMDs using different approaches.

Data analysis: We will calculate SMDs based on different approaches (using endpoint mean or change score mean, endpoint SD or change score SD or baseline SD, when data is available). We will compare the calculation results with the reported SMD.

Management information
Registered date
2020 Year 11 Month 16 Day
Last modified on
2020 Year 11 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048472

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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