CTN WEB SEMINAR SERIES: A FORUM TO EXCHANGE RESEARCH KNOWLEDGE

Produced by: CTN Training

This training has been funded in whole or in part with federal funds from the National Institute on Drug Abuse, National Institutes of Health, Department of Health and Human Services, under Contract No.HHSN271201000024C

PUBLICATIONS PLANNING AND PREPARATION

Presented by:

George Bigelow, PhDDikla Blumberg, PhD

January 28, 2015

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Learning Objectives

• Describe what a Publication Plan is, the importance of an effective strategy, and when and how to incorporate it into a clinical investigation plan.

• Identify the various types of papers to produce from CTN study data and introduce other resources for sharing network data that contributes to analyses and publications.

• Discuss the role of the CTN Publications Committee and the process and materials needed for review.

• Discuss suggestions, based on experience of the Publications Committee, regarding ways to enhance the quality of CTN reports.

PLANNING AND PREPARATION

Dikla (Dee) BlumbergProtocol Specialist, Clinical Coordinating Center at EMMES

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Publication Planning

• Begins as early as the development of study concept.

• Proposed publications documented in an official plan.

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Publication Plan – What is it?

• A comprehensive list, often designed as a spreadsheet, that indicates all the planned papers the study team would like to pursue.

• Includes the general research question(s), data source, lead author, and proposed co-authors, target journal and more.

• The publication plan serves as a guide that allows for planning, assessing progress, and general organization of ideas.

Note: The Publication Plan serves as a prompt for the Lead Investigator to organize and track progress.

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Publication Plan - SampleEncourage co-authorship from the research site staff.

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Timing of Data Availability

•Data captured in AdvantageEDC

•Database lock

•Study data set (raw data)

•Publication

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Authorship/Co-Authorship

• Writing teams should involve Investigators, Lead Team, and research site staff who participated in the study. – The Lead Author has primary responsibility for timely

preparation of the manuscript.– To qualify as a co-author, individuals must have made

substantial contributions to study design, implementation, or data analysis as well as drafting of the article or revising it critically.

• Study participants outside the writing workgroup (e.g., research assistants, clinic directors, etc.) who do not meet qualifications for co-authorship should be acknowledged by name and role at the end of the article.

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Submitting the Publication Plan

• When should the plan be submitted?– The Lead Investigator (LI) will submit a publication

plan to the Publications Committee(PC) when 50% of the target sample is enrolled.

– Within six months after database lock, the LI will review and revise the publication plan and resubmit the plan to the PC.

– Thereafter, the publication plan will be reviewed and revised semi-annually.

(CTN Policies & Procedures, Section 9.0)

TYPES OF MANUSCRIPTS AND DATA RESOURCES

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Types of Manuscripts

Baseline Papers

Primary Outcome

Secondary Outcome(s)

Ancillary/ Platform Studies

Methods Papers

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Types of Manuscripts

• Primary Outcome paper:– Main outcome variable for the study.

• Research hypothesis based on this measure.• Used to power study and determine statistical significance of

any treatment effect.

– Should be completed and submitted within six months of database lock.

– Consolidated Standards of Reporting Trials (CONSORT)

• Set of recommendations for reporting randomized trials• Website: http://www.consort-statement.org/

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CTN Dissemination Library

http://ctndisseminationlibrary.org

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CTN Dissemination Library

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Types of Manuscripts

• Secondary Outcome paper(s):– Papers summarizing any other (non-primary) outcome

measures.– Any other analyses, for example:

• Sensitivity analysis of primary outcome measure with respect to missing data.

• Subgroups by age, race, gender, ethnicity, disease severity, etc.• Pooling data across studies.

– All secondary papers listed in the plan should be submitted to appropriate journals within one year after submission of the primary outcome paper.

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NIDA Data Share

• Website: https://datashare.nida.nih.gov/• An electronic environment that allows data from

completed clinical trials to be distributed to investigators and the public:– Promotes new research.– Encourages further analyses.– Disseminates information to the community.

• Secondary analyses produced from data sharing multiply the scientific contribution of the original research.

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NIDA Data Share

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Assessments

Data

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Other Types of Manuscripts

• Methodology– Papers that describe experimental design, methods for

conducting particular tests or interventions, and statistical analyses.

• Example: – Achieving Cannabis Cessation -- Evaluating N-Acetylcysteine

Treatment (ACCENT): Design and Implementation of a Multi-Site, Randomized Controlled Study in the National Institute on Drug Abuse Clinical Trials Network.

– Contemporary Clinical Trials 2014;39(2):211-223. – Protocol CTN-0053, LI Dr. Kevin Gray

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Other Types of Manuscripts

• Baseline– Papers that describe characteristics at the beginning of a

study, such as population demographic, clinical, product, or other variables before an intervention has been administered.

• Example:– Clinically Relevant Characteristics Associated with Early

Treatment Drug Use Versus Abstinence.– Addiction Science & Clinical Practice 2014;9:6. – Protocol CTN-0044, LI Edward Nunes

Reference: http://www.consort-statement.org/resources/glossary#B

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Other Types of Manuscripts

• Ancillary– An ancillary study is a supplementary study to a larger CTN parent study.

• Usually has its own protocol.• Generally uses data or specimens obtained from participants already

enrolled in the parent study.• Typically supported with CTN funding.

– Example: • The Multi-Site Prescription Opioid Addiction Treatment Study: 18-

Month Outcomes.• Sharpe Potter et al. (2015)• Journal of Substance Abuse Treatment;48(1):62-69.

Reference: http://grants.nih.gov/grants/guide/notice-files/NOT-DA-11-014.html

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Other Types of Manuscripts

• Platform – Platform studies utilize the CTN’s infrastructure for

research facilitating practice improvement processes or development/refinement of research tools (e.g., measurement instruments)

• May be stand-alone projects or add-ons to existing studies

• Typically supported with external funding

Reference: http://grants.nih.gov/grants/guide/pa-files/PA-06-497.html

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Questions – Use Chat Feature

PUBLICATIONS COMMITTEE (PC)

George BigelowChair, CTN Publications Committee

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Goal of PC Review

To improve clarity, accuracy, effective communication.

If reviewers don’t fully understand and appreciate the message, it can probably be

said better.

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Publications Committee Members

George BigelowJack Blaine

Genie BaileyDennis Donovan

Jeff KorteTiffany Kyle

John RollGeorge Woody

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Publication Opportunities

• CTN encourages multiple publications.• We want to learn as much as possible.• Large-n, diverse, multi-site studies.• Broad study teams with diverse interests.• Extensive investment in assessments.• Repeated assessments over time.• Assessment commonalities across studies.

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Review Process

• Please submit early to allow time for PC review.

• PC Reviews – 2-3 week turnaround.• Then keep the PC informed of the status of

manuscripts and of reviewers’ comments as manuscripts progress through journal review:

jblaine@nida.nih.govbigelow@jhmi.edu

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What Does/Doesn’tNeed PC Review?

What Does:• Reports with new CTN data

or analyses• Posters and slide

presentations • Abstracts or proposals for

presentations• Ancillary studies• Single site studies

What Doesn’t:• Reports of previously

approved material• Reviews that cite or

summarize CTN publications• Reports without data • Descriptive reports of local

node activities

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PC Review Activity Past 7 months

Goal: Clarity, accuracy, relevance

• 24 manuscripts, about 3-4 per month

• 88% approved with comments & suggestions

• 12% request revision and re-review

• Plus abstracts, posters, oral/slide presentations

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Diverse Venues of CTN Reports

23 different journals for 29 publications

Most frequent (5): J Substance Abuse Treatment

Top tier:• JAMA Internal Medicine; Bogenschutz et al SMART-ED primary outcome report• Addiction; McPherson et al

Statistical handling of missing data

Presentations at 11 different meetings

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Diverse Publication

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Advice to Authors

• Representing the whole CTN program.• State directions and magnitudes of relationships.• Avoid overstating relationships & conclusions.• Avoid causality statements about correlations.• Acknowledge the limitations of

studies & findings.• Read, and have co-authors read,

the manuscript.

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Meeting Presentations

• Typically precede publication.

• Can serve as model and initial steps.

• PC reviews abstracts and final posters and slides.

• Plan ahead for timely review.

• Submit final version 1 month prior to meeting.

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Posters

• Avoid “wall of words.”• Use bullet points,

graphics, clear headings.

• Try to capture and engage attention.

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Size and Contrast Matter in Slides

Can you read this?

Can you read this?

Can you read this? Can you read this? Can you read this?Can you read this?Can you read this?

Can you read this? Can you read this? Can you read this? Can you read this? Can you read this? Can you read this? Can you read this?

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PC Review is Useful & Usually Appreciated

“Special thanks... a great edit … really makes it read better”

“Timely turnaround and helpful comments”

“Thank you! We will fix these ... I forgot …”

“Many thanks … helpful comments”

“Forward my thanks to the reviewers”

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Responding to Reviewer Suggestions

• Goal is to improve the paper or presentation.

• Use good judgment.

• Incorporate good suggestions.

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Conclusion

CTN is producing many good, important publications and presentations, and having

significant impact on field.

Everyone involved is contributing to the quality and the value of CTN reports.

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Open the Lines for Questions / Comments

Alternatively, questions can be directed to the presenter(s)by sending an email to CTNtraining@emmes.com.

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http://ctndisseminationlibrary.org

A copy of this presentation will be available electronically.

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