Centre For Clinical Research And Biostatistics (CCRB)

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1 Unique Trial Number (assigned by CCRB)

CUHK_CCRB00518

2 Trial Registration Date

2016-07-18

i Registration Status

Prospective

3 Secondary IDs

4054258

4 Source(s) of Funding

Direct Grant, The Chinese University of Hong Kong

5 Primary Sponsor

The Chinese University of Hong Kong

6 Secondary Sponsor

N/A

Function

Not Applicable

Please specify

7 Responsible Contact Person (public contact person for patients interested in participating)

i Name

Chung, Chi Ho Vincent

ii Address

4/F, School of Public Health Building, Prince of Wales Hospital, Shatin, NT, HK.

iii Phone

852-2252-8453

iv Email

vchung@cuhk.edu.hk

v Affiliation

JC School of Public Health and Primary Care, the Chinese University of Hong Kong

vi Country

China

8 Research Contact Person (person to contact for scientific inquiries)

i Name

Dr Vincent Chi Ho Chung

ii Address

4/F, School of Public Health Building, Prince of Wales Hospital, Shatin, NT, HK.

iii Phone

21457489

iv Email

vchung@cuhk.edu.hk

v Affiliation

JC School of Public Health and Primary Care, the Chinese University of Hong Kong

vi Country

China

9 Official Scientific Title of the Study

A comparison on the reliability of two quality of clinical evidence assessment approaches: a randomized controlled trial

10 Public Title

A comparison on the reliability of two quality of clinical evidence assessment approaches: a randomized controlled trial

i Public Title in Chinese 研究名稱

兩個临床證據質量評估工具的可靠性比較：隨機對照試驗

11 Short Title (Optional)

12 Countries of Recruitment

China

13 Research Ethic Review

i Has the study received appropriate ethics approval?

Yes

ii When is the approval date?

2016-05-23

iii Full Name of IRB/IEC

Joint CUHK-NTEC Clinical Research Ethics Committee

Please specify

iv IRB/IEC approval reference number

2016.233

14 Medical Condition Being Studied

N/A

15 Intervention

i Types of intervention

Other

Please specify

Clinical and Health Intervention Meta-analysis Evidence RAting System (CHIMERAS)

ii Description/ name of Intervention/article

Clinical and Health Intervention Meta-analysis Evidence RAting System (CHIMERAS) is a newly developed approach for grading quality of evidence from clinical literature.

iii Dosage form of the intervention

N/A

iv Dosage of the intervention

N/A

v Duration of the intervention

Participants will receive a training course (2 hours) for using CHIMERAS.

vi Frequency of the intervention

N/A

16 Comparative Treatments

i Description/ name of comparative treatments

The Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) Framework.

ii Dosage form of the comparative treatments

N/A

iii Dosage of the comparative treatments

N/A

iv Duration of the comparative treatments

Participants will receive a training course (2 hours) for using GRADE.

v Frequency of the comparative treatments

N/A

17 Key Inclusion and Exclusion Criteria

i Inclusion Criteria

The inclusion criterion for the recruited raters in this study is medical / public health / nursing or pharmacy students who have no prior experience either in performing SRs or quality of evidence assessment. Under this inclusion criterion, we will recruit raters from undergraduate or postgraduate students from Faculty of Medicine in the Chinese University of Hong Kong.

ii Exclusion Criteria

Students with prior experience either in performing SRs or quality of evidence assessment will be excluded from this study.

iii Age Minimum

No age restriction as long as they are undergraduate or postgraduate students.

iv Age Maximum

No age restriction as long as they are undergraduate or postgraduate students.

v Gender

Both Male and Female

18 Study Type

Interventional

19 Study Design

i Randomization

Randomized

Please specify

Participants will be randomly allocated by computer generated number.

ii Nature of control

Not Applicable

iii Degree of masking

Open label

If Single-blind, who will be masked?

iv Group Assignment

Parallel

v Study Phase

Other

Please specify

This clinical intervention.

vi Study Objectives (Optional)

20 Anticipated trial start date

2016-08-08

21 Target Sample Size

8

22 Recruitment Status

Not Yet Recruiting

23 Primary Outcome

i The Name of the outcome

Inter-rater reliability among individual raters.

ii The metric or method of measurement used

Fleiss’ Κappa

iii The timepoint(s) of primary interest

After all the raters finish the assessment of quality of evidence.

24 Secondary Outcome

i The Name of the outcome

Inter-rater reliability across pairs of raters

ii The metric or method of measurement used

Weighted Κappa.

iii The timepoint(s) of primary interest

After all the raters finish the assessment of quality of evidence.

25 Study Information/Publication

i Study Information/Publication Available?

No

ii Link to Study Information/Publication

26 Last Update Date

2017-08-25

27 Primary Registry and Trial Identifying Number

ChiCTR-IOR-16008898

28 Date of Registration in Primary Registry

2016-07-18

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Trial History Detail on 2016-09-02