UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026103 |
|---|---|
| Receipt number | R000029995 |
| Scientific Title | Epidemiology and Reporting Characteristics of Systematic Reviews for Prediction Modeling Studies of Clinical Research in PROSPERO |
| Date of disclosure of the study information | 2017/02/14 |
| Last modified on | 2017/03/18 15:28:30 |
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Basic information
Public title
Epidemiology and Reporting Characteristics of Systematic Reviews for Prediction Modeling Studies of Clinical Research in PROSPERO
Acronym
Reporting Characteristics of Systematic Reviews of Prediction Modeling Studies
Scientific Title
Epidemiology and Reporting Characteristics of Systematic Reviews for Prediction Modeling Studies of Clinical Research in PROSPERO
Scientific Title:Acronym
Reporting Characteristics of Systematic Reviews of Prediction Modeling Studies
Region
| Japan |
Condition
Condition
not applicable
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of our study is to investigate the epidemiological and reporting characteristics of PROSPERO registered systematic review of prediction model.
Basic objectives2
Others
Basic objectives -Others
We will compare characteristics of Cochrane protocol versus non-Cochrane review protocols, and the sample published prior to 2015 versus after 2015.
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
We plan to describe the reporting characteristics using the PRSIMA checklist. In addition, we plan to describe relevant items refered in CHARM checklist.
Key secondary outcomes
We will compare characteristics of Cochrane protocol versus non-Cochrane review protocols, and the sample published prior to 2015 versus after 2015.
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
PROSPERO (https://www.crd.york.ac.uk/PROSPERO/) registered published systematic reviews of prognostic modeling studies until 18th February in 2017.
We will include systematic reviews of prediction modeling studies consistent with the scope of CHARMS checklist.
We will include prediction model development studies without external validation aim to develop a prognostic or diagnostic prediction model from the dataset at hand; prediction model development studies with external validation in independent data; external model validation studies with or without model updating (1).
(1) Moons KGM, de Groot JAH, Bouwmeester W, Vergouwe Y, Mallett S, Altman DG, et al. Critical Appraisal and Data Extraction for Systematic Reviews of Prediction Modelling Studies: The CHARMS Checklist. PLoS Med. 2014;11(10).
Key exclusion criteria
We will exclude prediction studies exploring which predictors independently contribute to the prediction of a particular outcome as well as studies aimed at quantifying the impact of using a prediction model (1).
(1) Moons KGM, de Groot JAH, Bouwmeester W, Vergouwe Y, Mallett S, Altman DG, et al. Critical Appraisal and Data Extraction for Systematic Reviews of Prediction Modelling Studies: The CHARMS Checklist. PLoS Med. 2014;11(10).
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiraku Tsujimoto |
Organization
Hyogo Prefectural Amagasaki General Medical Center
Division name
Hospital Care Research Unit
Zip code
Address
Higashi-Naniwa-Cho 2-17-77, Amagasaki, Hyogo 660-8550, Japan.
TEL
06-6480-7000
hira_to_ber-trialregistry@yahoo.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiraku Tsujimoto |
Organization
Hyogo Prefectural Amagasaki General Medical Center
Division name
Hospital Care Research Unit
Zip code
Address
Higashi-Naniwa-Cho 2-17-77, Amagasaki, Hyogo 660-8550, Japan.
TEL
06-6480-7000
Homepage URL
hira_to_ber-trialregistry@yahoo.co.jp
Sponsor or person
Institute
Hospital Care Research Unit, Hyogo Prefectural Amagasaki General Medical Center, Higashi-Naniwa-Cho 2-17-77, Amagasaki, Hyogo 660-8550, Japan.
Institute
Department
Personal name
Funding Source
Organization
None
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
Address
Tel
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
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 02 | Month | 14 | 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
We identified 1058 published SR protocols in the PROSPERO. Of them, 101 protocols were in prognostic or diagnostic categories. We identified 45 records through the Web of Science citation search. Total seven SRs (0.66%) of over 65,000 patients' data were included. No Cochrane review was identified. The reporting characteristics were highly variable especially for relevant items of the CHARMS in their protocols. Over half of the reviews did not even pre-specify the outcome to be predicted. Moreover, one study multiplied the outcome at the review phase and did not mention the change in the review.
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
Completed
Date of protocol fixation
| 2017 | Year | 02 | Month | 14 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 02 | Month | 18 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
| 2017 | Year | 03 | Month | 14 | Day |
Date analysis concluded
| 2017 | Year | 03 | Month | 14 | Day |
Other
Other related information
<Data souse>
We will search the PROSPERO record (https://www.crd.york.ac.uk/PROSPERO/) using the prognostic and diagnostic filter as the type and method of review search filters and the published filter as the status of the review search filters. In addition, we searched for papers citing the CHecklist for critical Appraisal and data extraction for systematic Reviews of prediction Modelling Studies (CHARMS) using the Web of Science.
<Data synthesis>
We plan to describe the reporting characteristics using the PRSIMA checklist. In addition, we plan to describe relevant items refered in the CHARM checklist (1). We will compare characteristics of Cochrane protocol versus non-Cochrane review protocols, and the sample published prior to 2014 versus after 2015.
(1). Moons KGM, de Groot JAH, Bouwmeester W, Vergouwe Y, Mallett S, Altman DG, et al. Critical Appraisal and Data Extraction for Systematic Reviews of Prediction Modelling Studies: The CHARMS Checklist. PLoS Med. 2014;11(10).
Management information
Registered date
| 2017 | Year | 02 | Month | 12 | Day |
Last modified on
| 2017 | Year | 03 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029995
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