Debra Wujcik, PhD, RN, AOCN®, FAANVanderbilt Ingram Cancer Center

Nashville, TN

Presentation OverviewPart one – the writing process

Getting startedResearching the topicWriting adviceProduction process

Part two – clinical trial registrationICJMEPolicyRegistration of trials

Getting StartedWhat do you have to say?Where is the most appropriate place to say

it?

Consider the Publication Types• Books/Book Chapters• Peer reviewed article

– Clinical focus– Research report

• Clinical tip/anecdote/case study• Newsletter

– National– Local chapter– SIG

Getting Started: What do you read?How do you make your decision?

A few journals (or TOC) are read cover to coverA newspaper or internet articleOr based on

Title Author Journal Abstract

Journal Article(Book, Book Chapters)Select the journal before you begin writingRead articles in the journal you are consideringGet the author guidelines before you begin

writing Style, format, references are important

http://www.biosemantics.org/jane/

Researching Your Topic• Organized approach• Journal article are the easiest, most

accessible, and current source of information• http://www.nlm.nih.gov/siteindex.html• MEDLINE http://igm.nm.nih.gov• PUBMED

www://www.ncbi.nlm.nih.gov/PubMed• Cumulative Index of Nursing and Allied

Health Literature www.cinahl.com (free trial, fee)

Researching Your Topic (cont.)Don’t just read the abstracts: may miss

important information or misinterpret the findings

Primary source, secondary source, or reviewAll types of publications have a format:

For example, research reports include an Introduction, Methods, Result, Discussion

Starting to Write• Just do it!• Use an outline to

start OR to finish• Can start in the

middle if needed• Title and abstract

are last• Finish the draft,

leave it for a few days, read again

Getting it Right• Paraphrase – restatement of a passage from

the original work; must be cited• Mosaic – practice of moving words or word

groupings• Plagiarism – copying original works without

crediting; includes sequence of ideas, arrangement of material and patterns of thought

General Writing AdviceAvoid redundancyBe conciseShort sentences and paragraphsOne paragraph = one thoughtA summary of the thought is the first or last

sentenceElaborate in logical order (pro then con; most

to least important evidence; chronological)

General Writing Advice (cont.)Minimize jargonDefine abbreviations earlyUse the simpler word – use not utilize or in

not withinReduce repetitionDo not editorializeActive, not passive

ReferencesCite references correctly – don’t rely on

someone else’s reference listProper format (Reference Manager,

EndNote)References are not needed for factual

information in the public domain and commonly held knowledge e.g. ONS was founded in 1974 or venous

access devices are used to deliver chemotherapy

References (cont.)Internet resources include title, url, and date

accessed References – should be < 5 years unless a

classicPrimary versus secondary references

Reprinted/Reproduced InformationReproducing Tables and Figures

Often expensive and difficult to obtain permission

Usually easier to create your ownUsed with permission or adapted require

written permissionTables have no linesFigures are drawings or

have curved lines

Peer ReviewTwo to three peer reviewers are given the

manuscriptContent expertsExperienced authors

Blinded peer review Editor makes final decision

Publication Process (cont.)Feedback sent to author

Usually clear what has to be done nextIf resubmitting, be sure to address every

reviewer comment; you may disagree but do not ignor

If not going to make the changes and resubmit, ask the editor to release your paper

Don’t take it personally!Put it down and look at it a few days later

Production ProcessEditor assigns a publication dateMake sure you note and respond to every

request and every due dateGalleys are sent for final approval; you are

checking only for accuracy, not changing the content

If new information is available, talk with the editor before making substantive changes.

Writing with OthersPublishing standards require authorship

credit based on substantial contributionsConception and design, acquisition of data or

analysis and interpretation of dataPreparation of the manuscript

Decide first who is lead author and order of names of multiple authorsLead author takes the lead

Find a Mentor

Registration of Clinical Trials:ICMJE guidelines and implications for clinical researchers

What is ICMJE?International Committee of Medical Journal Editors

(URM – Uniform Requirements for Manuscripts Submitted to Biomedical Journals)

History of ICMJE1979 URM First Edition (format)

1982 URM Second Edition (duplicate publications)

1987 Retraction of Research Findings

1988 Editorial Freedom and Integrity

1988 URM Third Edition (Authorship)

1989 Confidentiality; The Role of the Correspondence Column

1991 Competing Manuscripts Based on the Same Study; Order of Authorship; Guidelines for the Protection of Patients’ Rights to Anonymity

1991 URM Fourth Edition; revised in 1993 and 1994

1992 Definition of a Peer-Reviewed Journal

1993 Medical Journals and the Popular Media; Conflicts of Interest (editorial comment, 2001)

1994 Advertising; Supplements

1997 URM Fifth Edition; revised in 1999, 2000, and 2001

2000 Project-Specific Industry Support for Research

2001 Policies for Reporting Biomedical Journal Information on the Internet

2003 Extensive URM revision(http://www.icmje.org/index.html)

2004 Clinical trial registration policy

Source: Huth EJ, Case K. The URM: Twenty-five Years Old. Science Editor 2004;27:17-21.

Statement on Clinical Trial RegistrationCall for comprehensive registration of trials as the first step in alleviating selective data presentation on clinical trials in medical literature

ICMJE Policy on Clinical Trial Registration1. Which trial should be registered if it is planned to

publish the results in a medical journal?

2. Which registration database should I choose?

3. Which data do I have to register?

4. Which journals subscribe to the ICMJE trial registration policy?

Which trial should be registered if it is planned to publish the results in a journal?All clinically directive trials which test any

clinical hypothesis about health intervention and its outcomes

No need for registrationPhase 1 trialsTrials investigating disease biologyTrials providing preliminary data

The best answer to doubts about reporting – register it!

Which registration database should I use? must be accessible to the public at no charge

must be open to all prospective registrants (meaning that investigators are able to register without restriction by geographic location, academic affiliation, patient demographics, or clinical condition)

must be managed by a not-for-profit organization

there must be a mechanism to ensure the validity of the registration data

should be electronically searchable

must include all data from the minimal data set

Which registration database?Clinical Trials database of the NLM

(http://www.clinicaltrials.gov) International Standard Randomised Controlled

Trial Number, UK (http://isrctn.org) The Australian Clinical Trials Registry

(http://www.actr.org.au)University Hospital Medical Information

Network, Japan (http://www.umin.ac.jp)Dutch Cochrane Centre

(http://www.trialregister.nl/trialreg/index.asp) International Clinical Trials Registry Platform

(ICTRP) of the WHO – international norms and standards for trial registration

www.clinicaltrials.com

www.clinicaltrials.comTotal: 51047 registrations

Which data do I have to register?

Minimal data set for trial registration defined by the World Health Organization and adopted by the ICMJE

Which data do I have to register?Unique trial number

The unique trial number will be established by the primary registering entity (the registry).

Trial registration date

The date of registration will be established by the primary registering entity.

Secondary IDs

May be assigned by sponsors or other interested parties.

Funding source(s)

Name of the organization(s) that provided funding for the study.

Which data do I have to register?Primary sponsor

The main entity responsible for performing the research.

Secondary sponsor(s)

Secondary entities responsible for performing the research.

Responsible contact

Public contact person for the trial person for patients interested in participating.

Research contact person

Person to contact for scientific inquiries about the trial.

Title of the study

Brief title chosen by the research group (can be omitted).

Official scientific title This title must include the of the study name of the intervention, the

condition being studied, and theoutcome (e.g. The InternationalStudy of Digoxin and Death fromCongestive Heart Failure).

Research ethics review Has the study at the time ofregistration received appropriateethics committee approvalyes/no)?

(It is assumed that all registered trials will be approved by an ethics board before commencing.)

Condition Medical condition being studied (asthma, myocardial infarction).

Which data do I have to register?Intervention(s) A description of the study and comparison/control intervention(s) (For a drug or otherproduct registered for public sale anywherein the world, this is the generic name; for anunregistered drug the generic name orcompany serial number is acceptable). Theduration of intervention(s) must be specified.

Key inclusion and Key patient characteristics that determine exclusion criteria eligibility for participation in the study.

Study type Database should provide drop-down lists forselection, icluding choices for randomizedvs. non-randomized, type of masking, type

ofcontrols, and group assignment.

Anticipated trial Estimated enrollment date of start date the first participant.

Target sample size Total number of subjects the investigatorsplan to enroll before closing the trial tonew participants.

Recruitment status Is this information available (yes/no)

Primary outcome Primary outcome that the study was designed to evaluate (e.g. blood pressure at 12 months)

Key secondary The secondary outcomes specified in theoutcomes protocol. Description should include time

of measurement (e.g. creatinine clearance at 6 months).

New ICMJE statement, released on June 4, 2007New definition of a clinical trial: any research study that prospectively assigns human participants or groups of humans to one or more health-related interventions to evaluate the effects on health outcomes.

September 2008US Public Law 110-85, Title VIII

Mandates submission of basic results data for certain trials of drugs, biologics, and devices

Summary results must be submitted within 12 months of the completion of data collection for primary outcome measures

Next StepsGet started writing you manuscript using the

resources and suggestions provided in this presentation

Find a writing mentorBecome familiar with ICMJE registration and

publishing requirements for clinical trials

Thank you!

Selected ReferencesChipperfield L, Citrome, L, Clark, J, et al. (2010) Authors’

submission toolkit: A practicacl guide to gettng your research published. Curr Med Res Opin. ;26(8):1967-82. doi: 10.1185/03007995.2010.499344.

• Kapoor, S, Sikka P, Saxena K. (2013).Publication of research articles: an art or science? Ann Med Health Sci Res. 3(1):96-8. doi: 10.4103/2141-9248.109459.

• Happell B. (2008). Conference presentations: a guide to writing the abstract. Nursing Research. 15: 79-87.

• Happell B. (2007). Hitting the target! A no tears approach to writing an abstract for a conference presentation. International Journal of Mental Health Nursing. 16(:447-52. 

• Heinrish K. (2007). A Nurse's Guide to Presenting and Publishing: Dare to Share. Boston: Jones and Bartlett Publishers, Inc.

Selected ReferencesKotz, D, Cals, JW (2013). Effective writing and publishing

scientific papers – part I: how to get started. J Clin Epidemiol; 66(4):397. doi: 10.1016/j.jclinepi.2013.01.002.

• Morton PG. Challenging writer's block. How experienced authors make time to write. AAOHN Journal. 48:512-4.

• Ruth-Sahd L & King CA. (2006) Diamond in the rough, to a polished gemstone ring: writing for publication in a nursing journal. Dimensions in Critical Care Nursing. 25:113-20.

• Schulmester L, Editor. (2001). Writing for Publication: Advice from the Experts. Clinical Journal of Oncology Nursing 5: 3-28 (Suppl)

• Zilm G. (2002) The write time. Canadian Journal of Nursing Leadership. 15:25-30.