Debra Wujcik, PhD, RN, AOCN®, FAAN Vanderbilt Ingram Cancer Center Nashville, TN.
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Transcript of Debra Wujcik, PhD, RN, AOCN®, FAAN Vanderbilt Ingram Cancer Center Nashville, TN.
Presentation OverviewPart one – the writing process
Getting startedResearching the topicWriting adviceProduction process
Part two – clinical trial registrationICJMEPolicyRegistration of trials
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
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
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
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.