Preparing for publication in Lancet journals

Richard HendersonSenior Editor, The Lancet HIV

APACC, June 28, 2019

Declaration of interests

Employed by Elsevier as an editor for The Lancet HIV. Virology Education reimbursed my airfare and accommodation.

To inform, to reform, to entertain"A lancet can be an arched window to let in the light or it can be a sharp surgical

instrument to cut out the dross and I intend to use it in both senses".

Thomas Wakley

Founded 1823

10 000th issue October 2015

Pre-acceptance

Title of slide here

▪ Blue: (Leaders), Comment, Correspondence, ADR, World

report, Perspectives, Obituaries, Media, Culture

▪ Red: Articles, Clinical picture

▪ Green: Reviews, Seminars, Series, Essay

Case Report, Public health, Viewpoint

▪ http://www.thelancet.com/authors/lancet/authorinfo

▪ http://ees.elsevier.com/thelancet

What we publish – The Lancet

What we publish - The Lancet HIV (1)

• Launched in autumn 2014

• Exclusively online journal, monthly

• Impact Factor 14·753®

• Original research: translational, epidemiological,

clinical, operational, and implementation studies

• Comments and Correspondence

What we publish - The Lancet HIV (2)

• Features and Profiles

• Culture

• Leaders

• Evidence-based Reviews and Viewpoints

• Submit your manuscripts at

http://ees.elsevier.com/thelancethiv

• The time to think about submitting your research is when you

first plan that research

• Question – novel, meaningful, answerable

• Protocol – publication strategy

• Design – include reporting requirements

• Conduct – focus on publishable data

• Design and conduct research with publication in mind

Planning

• Research that is going to change clinical practice

• Interest to a wide audience

• ‘First’ and ‘last’

• Ethically sound

• Robust methods

• Reported fully

What do editors look for? (1)

• Does the topic or article type fall within the scope of the journal?

• Are the results (both positive and negative) important and timely?

• Does the study have a sound hypothesis and design?

• Is it appropriately statistically powered?

• Robust methodology, fully reported?

• Are the data analysed properly?

What do editors look for? (2)

• Are missing data handled appropriately?

• Is the interpretation a fair reflection of the results?

• For trials: does study have a protocol?

• For trials: are main analyses presented protocol-defined?

• For trials: are non-protocol (exploratory) analyses signposted?

• For trials: is it registered?

What do editors look for? (3)

CHECK WHICH GUIDELINES ARE APPROPRIATE FOR YOUR STUDY AND WHICH ARE REQUIRED BY YOUR JOURNAL OF CHOICE

• CONSORT Randomized clinical trials• STROBE Observational studies in epidemiology• PRISMA Systematic reviews and meta-analyses• STARD Diagnostic accuracy• COREQ Qualitative research: interviews and focus groups• ENTREQ Synthesis of qualitative research• SQUIRE Quality improvement in healthcare• CARE Clinical cases• SAMPL Basic statistical reporting• SPIRIT Standard protocol items for clinical trials• SAGER Sex and Gender Equity in Research

www.equator-network.org

Reporting guidelines

• Prospective registration essential for RCTs

Examples…

• WHO International Clinical Trials Registry (ICTRP) http://www.who.int/ictrp/en/• US NIH Clinical Trials http://www.clinicaltrials.gov• Australia and New Zealand's (ANZCTR) http://www.anzctr.org.au• Chinese Clinical Trial Registry (ChiCTR) http://www.chictr.org• Clinical Research Information Service (CRiS), South Korea http://cris.cdc.go.kr • Clinical Trials Registry - India (CTRI) http://ctri.nic.in• EU Clinical Trials Register (EU-CTR) https://www.clinicaltrialsregister.eu/• German Clinical Trials Register (DRKS) http://www.drks.de • Iranian Registry of Clinical Trials (IRCT) http://www.irct.ir/• Japan's UMIN-CTR http://umin.ac.jp • The Netherlands National Trial Register http://www.trialregister.nl • The International ISRCTN http://isrctn.org/

Clinical trial registration

• Structured (250 words or 300 words for RCTs)

• Background – introduction and aim

• Methods – design, setting, participants, intervention, main outcome, type of analysis, method of randomisation, who was masked, trial registration number

• Findings – account for dropouts, primary endpoint or main findings, appropriate statistics, adverse events

• Interpretation – must be a balanced statement of clinical significance of findings rather than repetition of results

• Funding

• Check CONSORT list if RCT

Summary

• Why you did the study

• Why the answers are important

• Up to date literature, but not an extensive review

• Do not describe methods, results, or conclusions

Introduction

• Explain how the data were collected

• Appropriately subdivided (eg, study design/ participants /procedures/statistical analysis/role of the funding source)

• Study population described (no results though)

• Statement on consent and ethics committee approval

• Name and manufacturer of all drugs, reagents/equipment

• Primary and secondary endpoints clearly stated (if appropriate)

Methods (1)

• Statistical information present (power/details of comparative analyses/type of analysis, etc)

• Trial registration details and number at end of methods

• Check CONSORT list if RCT

• Role of funding source

Methods (2)

• Key results without interpretation

• Trial profile

• Table of baseline characteristics (no p values, 95% CI, etc)

• Outcome tables (adjusted for baseline variables, etc)

• Exact p values given as appropriate (unless p<0·0001)

• Actual numbers given as well as %

Results (1)

• Point estimates + measure of precision of difference between groups (95% CI) provided

• No repetition between figures/tables and text

• Data/information in text concurs with that in tables and figures

• Highlight important negative results

• Kaplan-Meier curves (never break axes, follow-up appropriate for primary endpoint, numbers at risk/censored present)

• SI units

Results (2)

• What do the results mean

• Should start with a summary of main findings (without repeating actual data)

• No repetition between Introduction and Discussion

• Include results for interpretation only

• Discussion of limitations and strengths of study

Discussion (1)

• Details of sources of bias or imprecision

• General interpretation of data in view of published work given

• Mechanisms for findings, if appropriate

• Clinical implications

Discussion (2)

• Figures should be standalone and self-explanatory

• Figures in editable format

• All figures redrawn by in-house illustrators

• Formatting guidelines on website

Figures

• Correct use/order of footnote symbols

• Create/combine figures when necessary

• Ensure every axis has a unit of measure

• Ensure every symbol/abbreviation is explained

• Ensure figure is appropriate size

• No repetition of legend and main text

• Axes should start at zero (with break if necessary)

Figure checks

• Appropriate main heading

• Data checked?

• Correct use/order of footnote symbols

• Appropriate stats included (ie, mean [SD], median [range/IQR], exact p values when necessary)

• Ensure every symbol/abbreviation is explained

• Ensure every column/row has a unit of measure

Table checks

• Peer-reviewed

• Data checked against Article text

• We do not edit or format (upload as submitted)

Appendices

The Lancetformatting guide for RCTs

The Lancetformatting guide for systematic reviews/meta-analyses

ICMJE Guidelines

www.icmje.org

Authorship

• Substantial contributions to the conception or design of the work; or the acquisition, analysis, or interpretation of data for the work

• Drafting the work or revising it critically for important intellectual content

• Final approval of the version to be published

• Agreement to be accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved.

www.icmje.org

Who is an author?

• A person who provided purely technical help, writing assistance, or a department chairperson who provided only general support

• Anyone who has contributed to a paper, but whose contributions do not justify authorship.

• Medical writers or editors

Other people who contribute to a study but are not authors

• Exists when an author or the author’s institution has financial or personal relationships with other people or organisations that inappropriately influence (bias) his or her actions

• Financial interests include employment, consultancies, stock ownership, and honoraria

• Conflicts can occur for other reasons (eg, personal relationships or academic competition)

• ICMJE common disclosure form: www.icmje.org/coi_disclosure.pdf

Conflicts of interest and disclosure

▪ Submission

▪ Peer review

▪ Post acceptance

▪ Production

▪ http://ees.elsevier.com

/thelancet

Elsevier Editorial System

Cover letter (1)

• The main purpose of a cover letter is to get your

manuscript read

• Compose the letter to answer what the editor needs to

know

• Make the reader want to learn more

• Why are the findings of interest to readers?

• Is it novel?

Cover letter (2)

• Is the methodology appropriate and robust?

• Will it change practice?

• Be brief (<300 words)

• Demonstrate an understanding of the journal

• Summarise the abstract within the context of the journal

(but do NOT repeat the abstract)

Editorial review in houseDecision to review at manuscript meeting

Peer reviewAs fast as possible: reviewers asked to return comments within 7 days (usually takes longer)

Statistical review

Review

• Editor personally identifies an expert

• Editorial search of a database for keywords of previous manuscripts and ask the authors of these papers to review

• Use one of the preferred reviewers listed by the authors

• Editor selects name that is cited in the reference list –prominently or repeatedly

• One reviewer from country of origin

Peer reviewer selection

Invitation to revise

• Include a detailed letter addressing reviewers’ critiques

• Address all reviewers’ comments if possible in the text

• For those points you cannot address, explain why

• Do not forget to address all the editors’ points as well

• May be subject to re-review by all/subset of reviewers

• A reject might include an invitation for a journal transfer

• Check that science is correct

• Data presented clearly and concisely

• Use of English and grammar is correct

• Readable to international audience

• House style provides consistency and clarity

• A consistent approach to editing across all journals

Why edit post acceptance?

• Comprehensive style guide

• Consistent style across all

titles

• Consistent reporting across

all titles

• Online

• Press release for papers of interest to wider audience

• Promotion via Twitter

• Podcast

Publication

Questions?

Thank you