China Obstetrics and Gynecology Journal Club (COG-JOCS)

October 24, 2013 updated by: Richard S. Legro, M.D., Milton S. Hershey Medical Center

An English Language Obstetrics and Gynecology Journal Club to Improve Medical English in China: A Randomized Controlled Trial

The purpose of this study is to determine if an intensive journal club based on articles and materials provided on the journal Obstetrics and Gynecology Website improves written and spoken comprehension of medical English in a population of Chinese medical professionals.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This will be a randomized educational trial of an intensive journal club compared to a self study journal club (1:1 randomization). Randomization will take place after baseline.

The population will consist of 50 medical professionals at Heilongjiang University in Harbin China, who agree to participate in an 8 week educational intervention.

This study will assess the impact of applying English for Specific Purposes(ESP) pedagogy to foreign medical education and specifically evaluate learning in the field of obstetrics and gynecology(Ob-Gyn). ESP is a subdivision of a wider field, Language for Specific Purposes(LSP), defined as the area of inquiry and practice in the development of language programs for people who need a language to meet a predictable range of communicative needs. ESP emphasizes teaching language in context and designs a curriculum around the results of a needs assessment, to more accurately determine which language skills are of priority: listening, reading, speaking, and writing. Part of the theory behind ESP suggests that being able to use the vocabulary and structures that students learn in a meaningful context reinforces what is taught and increases motivation. Further, findings from a study by Okamura (2006) that examined how learners succeed in mastering scientific discourse in English showed that they focused on reading academic texts in their field to learn typical writing patterns. This is as opposed to junior learners who focused on mastering the English language by reading English texts written by authors from a breadth of fields. This application of ESP thus reflects how content-specific source articles could serve as rhetorical models and suggests that source articles are able to mediate scholarly writing and learning within the zone of proximal developmental; that is, learners are simultaneously gaining new content knowledge while increasing their skill base.

The proposed intervention is to design an ESP curriculum for medical professionals, specifically Ob-Gyn physicians and researchers at a Chinese Medical University, based on the journal club format and source articles. The study will quantitatively assess the impact of this model on student's ESP language comprehension as well as determine the necessity of the traditional "facilitator" role for a journal club whose purpose is to foster language literacy in non-English speaking universities.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
50

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Harbin, China
        • First Affiliated Hospital Heilongjiang University of Chinese Medicine
  • United States
    • Pennsylvania
      • Hershey, Pennsylvania, United States, 17033-0850
        • Penn State Hershey Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Chinese medical professional

Exclusion Criteria:

  • English speaking fluency
  • Non-Chinese speaking medical professional

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Self Study Journal Club
25 Chinese Medical Professionals that will be participating in Self Study Journal Club Meetings three times a week for one hour for 8 weeks with interactive questions and answers and discussion of the journal articles.
Behavioral: Self Study Journal Club
This Self Study Journal Club will read articles and prepare written answers to the study questions on their own time. The participants will read 24 articles; 12 gynecology and 12 obstetrics, based on monthly journal clubs available online at the Obstetrics and Gynecology website. The first and last article will serve as a basis for the oral and written exam in which they will be tested on comprehension, verbal and written Medical English.
Experimental: Intensive Journal Club
25 Chinese Medical Professionals that will be participating Face to Face Journal Club Meetings three times a week for one hour for 8 weeks along with a native English speaking mentor.
Behavioral: Intensive Journal Club
This Intensive Journal Club will read articles and prepare written answers to the study questions along with a fluent English speaker. The participants will read 24 articles; 12 gynecology and 12 obstetrics, based on monthly journal clubs available online at the Obstetrics and Gynecology website. Participants will prepare oral presentations of the studies and answers to the study questions. They will have interactive sessions with this fluent English speaking monitor 3 times a week, one hour sessions for 8 weeks. The first and last article will serve as a basis for the oral and written exam in which they will be tested on comprehension, verbal and written Medical English.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Change in score from baseline on a 30 question multiple choice exam (questions and answers will be read to the participants) based on APGO-CREOGH shelf exams.
Time Frame: Baseline to 8 weeks
Baseline to 8 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Change in score from baseline on a written (short answer) exam and on an oral exam.
Time Frame: Baseline to 8 weeks
Baseline to 8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Milton S. Hershey Medical Center

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
First Affiliated Hospital of Heilongjiang Chinese Medicine University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Richard S Legro, M.D., Milton S. Hershey Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2013

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2013

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2013

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 29, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 29, 2013

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 1, 2013

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 25, 2013

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 24, 2013

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 42338

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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