Reporting research: How to survive peer review & get published 2014 Edinburgh Clinical Research Methodology Course

Dr Trish Groves

Head of research, BMJ

& Editor-in-Chief, BMJ Open

Competing interests

• I am editor in chief of BMJ Open and Head of Research at the BMJ, which is a wholly owned subsidiary of the BMA

• I chair the BMJ’s weekly manuscript committee meeting where we decide which research to publish

• I helped to develop and, in some instances, coauthored some of the published guidance that I’ll be discussing in this talk

• BMJ (the company) receives revenues from drug & device manufacturers through advertising, reprint sales, & sponsorship

• I receive a bonus based partly on the financial performance of the BMJ. The BMJ is an open access journal that charges author fees for publication of research articles, as does BMJ Open

What I aim to cover

Research questions & study designs

Research ethics and publication ethics

How to write a research paper

Choosing a journal

Surviving peer review

Match the question & design

Population (P) Outcomes (O) Interventions (I) or Exposures (E)

Centre for Evidence Based Medicine, Oxford, UK www.cebm.net

What’s going on?

Can it/does it work?

How/why/when is it happening?

Research ethics

http://www.hra.nhs.uk/resources/research-legislation-and-governance/

http://www.wma.net/en/30publications/10policies/b3/

2013 Declaration of Helsinki

This covers:

• risks, burdens and benefits

• vulnerable groups and individuals

• scientific requirements and research protocols

• Research Ethics Committees

• privacy and confidentiality

• informed consent

• use of placebos

• post-trial provisions

• research registration, publication, dissemination of results

• unproven interventions in clinical practice

To get published in an ICMJE journal: • trials randomising human participants to investigate the cause and effect relationship between a medical intervention and a health outcome that commenced after 1 July 2005 must have been registered prospectively, ie before enrolment of any participants • trials of other interventions , including health services and behavioural interventions to evaluate the effects on health outcomes, that commenced after 1 July 2008 must have been registered prospectively, ie before enrolment of any participants

Writing a research paper

Who can be an author?

Based on substantial contributions to:

• conception or design of the work; or the acquisition, analysis, or interpretation of data for the work; and

• drafting the work or revising it critically for important intellectual content; and

• final approval of the version to be published; and

• 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.

ICMJE definition of authorship: details

Authors

• should be able to identify which co-authors are responsible for specific other parts of the work

• should have confidence in the integrity of the contributions of their co-authors

• must fulfil the criteria; no one who fulfils the criteria should be excluded

• participated sufficiently in the work to take public responsibility for appropriate portions of the content.

Acquiring funding, collecting data, generally supervising group

do not alone constitute authorship

General guidance on writing papers

International Committee of Medical Journal Editors Uniform

Requirements For Manuscripts submitted to Biomedical Journals

www.icmje.org

Reporting guidelines for research, at the EQUATOR network

www.equator-network.org

Centre for Evidence Based Medicine, Oxford

www.cebm.net

BMJ advice to authors

resources.bmj.com/bmj/authors

http://www.equator-network.org/

CONsolidated Standards of Reporting Trials

Bradford-Hill A. The reasons for writing. Br Med J 1965;ii:870–1.

IMRaD format

Introduction

Methods

Results

Discussion

Scientific method

Ask question, do background research, develop hypothesis

Test hypothesis

Analyse your data

Interpret your findings

Introduction

brief background for this audience 3-4 paragraphs only: mind the word limit

what’s known, and what’s not, about your research question

don’t bore readers, editors, reviewers

don’t boast about how much you have read

the research question state it clearly in the last paragraph of the introduction

say why it matters

Methods

• like a recipe

• most important section for informed readers

• describe: – inclusion and exclusion criteria

– outcome measures: define primary outcome(s)

– intervention or exposure

– randomisation/stratification

– sample size calculation

• give references for lab/stats methods

• follow reporting guidelines

http://www.equator-network.org/

• describe measures to ensure ethical conduct

Results

• report results fully and honestly

– don’t cherry pick

– report primary outcome first

• confidence intervals

• essential summary statistics

• leave out non-essential tables and figures

• text (story), tables (evidence), figs (highlights)

• don’t start discussion here

Structured discussion

Don’t simply repeat the introduction

• statement of principal findings

• strengths & weaknesses of the study

• strengths & weaknesses in relation to other studies (especially systematic reviews), & key differences

• possible mechanisms & explanations for findings

• potential implications for clinicians or policymakers

• unanswered questions and future research

Abstract: general rules

Important

All authors must

approve it

Editors may screen by

abstract

for BMJ:

• structured abstract

• usually 300-400 words

• use active voice

• p values need data too

• %s need denominators

• no references

• trial registration details

Clear writing

Never use a metaphor, simile or other figure of speech

which you are used to seeing in print [a cliché]

Never use a long word where a short one will do

If it is possible to cut out a word, always cut it out

Never use the passive where you can use the active

Never use a foreign phrase, a scientific word or a

jargon word if you can think of an everyday [English]

equivalent

Orwell G. Politics and the English language. 1946

How to survive peer review & be an ethical author

Chipperfield L et al. Authors’ submission toolkit: A practical guide to getting your research published. CMRO. 2010;26(8):1967-1982.

http://www.icmje.org/coi_disclosure.pdf

A person has a competing interest when he or she has an attribute that is invisible to the reader or editor but which may affect his or her judgment Always declare a competing interest, particularly one that would embarrass you if it came out afterwards

Misconduct in research and publication (U.S. ROI)

Fabrication: making up data or results and recording or reporting them (through publication or presentation)

Falsification: manipulating research materials, equipment, or processes, or changing or omitting data or results such that the research is not accurately represented in the research record

Plagiarism: the appropriation of another person's ideas, processes, results, or words without giving appropriate credit

CrossCheck for plagiarism

Lancet 2006;367:1882-4

Selective reporting

“If one assesses the sins they have ranked in terms of their potential for harm to patients, biased reporting of research surely has far more serious practical consequences than undeserved authorship or plagiarism.” Chalmers I. Lancet 2006;368:450

Thank you tgroves@bmj.com @trished