Presentation for 5th Edinburgh Clinical research Methodology Course, February 2016

1. Reporting research:
Writing papers, responding to reviewers,
and appealing
5th Edinburgh Clinical Research Methodology Course
February 2016
Dr Trish Groves
Head of research, BMJ

2. I’m editor in chief of BMJ Open and Head of Research at the BMJ, a wholly
owned subsidiary of the British Medical Association (BMA)
Part of the revenue for BMJ (the company) comes from drug & device
manufacturers through advertising, reprint sales, & sponsorship. The BMJ and
BMJ Open are open access journals that charges author fees for research
I’m working on a strategy to see how BMJ might help to build health
research capabilities in emerging economies. I’m editorial lead for the BMJ
Research to Publication eLearning programme (by subscription)
My annual bonus scheme is based partly on the overall financial
performance of both BMJ and The BMJ
Competing interests

3. http://rtop.bmj.com

4. Stages of waste in the production and reporting of research evidence relevant to
clinicians and patients; from Chalmers and Glasziou, The Lancet 2009
REWARD Alliance http://researchwaste.net/about/

5. International Committee of Medical Journal Editors
recommendations for manuscripts submitted to
biomedical journals http://www.icmje.org/
Reporting guidelines for research, at the EQUATOR
network http://www.equator-network.org/
Core guidance on writing papers

6. Authorship credit must be 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 recommendations on authorship

7. Introduction: why ask this research question?
Methods: what did I do?
Results: what did I find?
And
Discussion: what might it mean?
IMRaD structure for research papers
Hill AB. The reasons for writing. BMJ 1965;4: 870

8. Brief background for this audience
• 3-4 paragraphs only
• what’s known/not known on research question – citing
systematic reviews where possible
• don’t bore readers, editors, reviewers
• don’t cram in your whole literature review
The research question
• state it clearly in last paragraph of introduction
• say why the question matters
Introduction

9. Use best study design to answer research Q
Descriptive studies answer “what’s happening?”
Analytic observational studies answer “why or how is it happening?”
Analytic experimental studies answer “can it work?”
Adapted from:
Centre for
Evidence Based
Medicine,
Oxford, UK
www.cebm.net

10. Like a recipe: most important section for informed readers
• describe PECO/PICO elements of the study
• follow reporting guidelines eg CONSORT Statement
• describe measures to ensure ethical conduct
• fully describe and give references for lab/stats methods
• provide study protocol if required
Methods

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

12. Lang TA, Altman DG. Basic Statistical
Reporting for Articles Published in
Biomedical Journals: The “Statistical
Analyses and Methods in the
Published Literature” or
“The SAMPL Guidelines”
Smart P, Maisonneuve H, Polderman A (eds).
Science Editors' Handbook, European Association
of Science Editors, 2013.
SAMPL guidelines
http://www.equator-network.org/wp-content/uploads/2013/07/SAMPL-Guidelines-6-27-13.pdf

13. • report results fully & honestly, as pre-specified
• text (story), tables (evidence), figs (highlights)
• report primary outcomes first
• give confidence intervals for main results
• report essential summary statistics
• leave out non-essential tables and figures
• share data, code, and/or metadata if required
• don’t start discussion here
Results

14. “The proportion of submitted manuscripts reporting statistically
significant results far outnumbered those reporting statistically
non-significant results, corroborating previous findings that
suggest investigators may fail to submit negative studies. [5,7,9]
In none of the sensitivity analyses (accepted v rejected outright,
accepted v rejected after peer review) did statistical significance
of results appear to increase the chance of publication,
suggesting that studies with statistically significant results are
not more likely to be published.”
Study results don’t have to be positive
Lee KP, Boyd EA, Holroyd-Leduc JM, Bacchetti P, Bero LA. Predictors of publication:
characteristics of submitted manuscripts associated with acceptance at major
biomedical journals. Med J Aust 2006; 184 (12): 621-6.

15. Abstract
Should be accurate and clear for:
Readers, systematic reviewers, and web search tools:
• it may be the only part of the paper that is accessible to all
• it will be the only part visible at bibliographic indexes such as Medline
• a good abstract will encourage selection and reading of the full paper
Editors and reviewers:
• many editors screen and reject articles by reading only the abstract
• peer reviewers are often invited with a link only to the abstract
Authors:
• because the abstract is so important all authors must approve it
• use reporting guidelines eg CONSORT or PRISMA for abstracts

16. Don’t simply repeat the introduction. Include:
• 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
Structured discussion

17. “The title provides a distilled description of the complete article and should include
information that, along with the Abstract, will make electronic retrieval of the
article sensitive and specific.
Reporting guidelines recommend, and some journals require, that information
about the study design be a part of the title (particularly important for randomized
trials and systematic reviews and meta-analyses).
Some journals require a short title, usually no more than 40 characters (including
letters and spaces) on the title page or as a separate entry in an electronic
submission system. Electronic submission systems may restrict the number of
characters.”
ICMJE recommendations for article titles
http://www.icmje.org/recommendations/browse/manuscript-preparation/preparing-for-submission.html#b

18. 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
Clear writing
Orwell G. Politics and the English language. 1946

19. • inappropriate or incomplete statistics
• overinterpretation of results
• inappropriate or suboptimal instrumentation
• sample too small or biased
• text difficult to follow
• insufficient problem statement [research question]
• inaccurate or inconsistent data reported
• incomplete, inaccurate, or outdated review of the literature
• insufficient data presented
• defective tables or figures
Why do journals reject research?
Bordage G. Reasons reviewers reject and accept manuscripts: the strengths and
weaknesses in medical education reports. Acad Med 2001 76(9):889–896

20. Traditional journals’ acceptance rates in 2014-15:
~ 5% NEJM, The Lancet, , Lancet Neurology, JAMA, The BMJ
5-10% Annals of Internal Medicine, Nature
10-15% Circulation, Heart, Gut
Megajournals
50% BMJ Open
70% PLOS ONE
46% average acceptance rates for journals on health*
How often is research accepted and rejected?
* Sugimoto C, Lanviere V, Ni C, Cronin B. Journal acceptance rates: A cross-
disciplinary analysis of variability and relationships with journal measures.
Journal of Informetrics 2013; 7(4): 897-906

21. • ensure all authors of the paper know about the rejection and
are ready to work together on preparation for the next journal
• carefully consider all feedback from editors and reviewers
• use constructive comments to revise and improve the paper
• do this in line with scope and requirements of next journal
• some of the suggested revisions may not be relevant
• in the cover letter for the next journal mention that the paper
has been revised following rejection; share reviews
How to cope with rejection

22. “If it is thought that the appeal is warranted, the article, reviewers’
comments, and author’s response will be reviewed internally by the
editorial team. The editor will decide whether to invite a resubmission,
send it to another external reviewer, or uphold the original decision. In
all cases, the editor's decision is final.” BMJ Journals
“All appeals will be discussed with at least one other editor. If those
editors do not agree the appeal will be discussed at a full editorial
meeting. We may or may not then seek external advice on the appeal.
We do not consider second appeals.” PLOS Medicine
How editors handle appeals

23. tgroves@bmj.com
Twitter @trished @BMJRtoP
Thanks and
good luck