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UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000026103
Receipt No. 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

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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
Email 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
Email hira_to_ber-trialregistry@yahoo.co.jp

Sponsor
Institute Hospital Care Research Unit, Hyogo Prefectural Amagasaki General Medical Center, Higashi-Naniwa-Cho 2-17-77, Amagasaki, Hyogo 660-8550, Japan.
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029995

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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