Writing a Scientific Article

1
Writing a Scientific Article

• Henrik Ekberg
• Professor Transplantation Surgery, UMAS, Malmö
• Associate Editor American Journal of
  Transplantation 2003-
• Editorial Board Member
• Transplantation 2004 -
• Transplant International 2004 -
• Clinical Transplantation 2008 -
• Journal of Transplantation 2008 - 2009

2

• What is written without effort
• is in general
• read without pleasure
• Samuel Johnson

3
The Importance of Publishing

• The nature of science
• Public
• Objective
• Predictive
• Reproducible
• Systematic
• Cumulative

• Science must be communicated to exist
• Published articles are the medium
• Results do not become scientific evidence without
  being published

4
Peer Review in AJT
5
Peer Review in AJT
Decision
6
Rejection of submitted manuscript- various
reasons

• Outright rejection No good, or wrong journal
• Rejected on priority grounds Maybe a good study
• but not a topic of interest, or done before
• Rejected, no resubmission
• a bad study design problems, cannot be
  re-written to become good
• Rejected but allowed resubmission
• no serious design problems, interesting topic,
  but needs to be rewritten for language,
  discussion, figures, tables, etc.

7
Research Essentials

• Hypothesis generation and testing
• Trial design
• Statistical analysis plan
• Trial registration
• Publishing

8
A Brief Timeline in Scientific Publishing

• 1658 First scientific journal, Journal des
  Scavans
• 1812 First medical journal, the New England
  Journal of Medicine and Surgery
• 1860's Pasteur introduces the IMRD format
  (Introduction, Materials and Methods, Results,
  and Discussion)
• 1957 JAMA begins to publish abstracts
• 1972 American National Standards Institute
  establishes IMRD as a norm for reporting
  scientific information
• 1978 Uniform Requirements for Manuscripts
  Submitted to Biomedical Journals (International
  Committee of Medical Journal Editors)
• 1987 Introduction of structured abstracts
• CONSORT Statement for reporting randomized trials
  adopted by JAMA

9
CONSORT

• Consolidated Standards of Reporting Trials
• A detailed website that includes translations in
  many major languages

10
(No Transcript)
11
The CONSORT Guidelines for Reporting of Clinical
Trials

• Title and abstract
• Introduction
• Materials and Methods
• Results
• Discussion
• Flow diagram

12
The CONSORT Guidelines for Reporting of Clinical
Trials

• Scientific background and explanation of
  rationale
• Specific hypotheses and objectives
• How participants are allocated to interventions,
  including method used to generate and implement
  the random allocation sequence
• Eligibility criteria for participants
• Details of the interventions intended for each
  group
• Statistical methods used to compare groups for
  outcomes, including how sample size was
  determined
• Explanation of any interim analyses and stopping
  rules

13
The CONSORT Guidelines for Reporting of Clinical
Trials

• Baseline demographic and clinical characteristics
  of each group
• Number of participants (denominator) in each
  group included in each analysis and whether the
  analysis was by "intention-to-treat.
• For each outcome, a summary of results for each
  group, and estimated effect size and its
  precision (e.g., 95 confidence interval)
• Address any other analyses performed, including
  subgroup analyses, indicating those pre-specified
  and those exploratory
• All important adverse events or side effects in
  each intervention group

14
The CONSORT Guidelines for Reporting of Clinical
Trials

• Interpretation of the results, taking into
  account study hypotheses, sources of potential
  bias or imprecision and the dangers associated
  with multiplicity of analyses and outcomes
• Generalizability of the trial findings
• General interpretation of the results in the
  context of current evidence

15
Consort advice - simple things

• Their golden rules for reporting numbers
• for example, numbers less than 10 are written as
  words (e.g. nine) and larger numbers are written
  as the number (e.g.12)
• do not use decimal places if the sample size is
  less than 100
• etc

16
Clinical Trial Registration Why Register?

• The registration of all interventional trials is
  a scientific, ethical and moral responsibility.
• World Health Organization
• Required by law in the United States
• Efficacy trials for IND studies for serious
  diseases or conditions (FDA)
• Required by the International Committee of
  Medical Journal Editors for publishing clinical
  trial research

17
Clinical Trial Registration Why Register?

• Increases transparency and strength/validity of
  scientific database
• Increases public awareness and access to trials
• Assigns trial identifier

18
Clinical Trial Registration www.clinicaltrials.
gov

• Eligibility all clinical trials (observational
  or interventional)
• Approved by Institutional Review Board
• Conforming to appropriate national health
  authority
• Timing At any time, but may be required before
  patient enrollment

• Requirements
• Description
• Patient recruitment information
• Location and contact description
• Administrative information

19
(No Transcript)
20

• Of the Introduction, Methods, Results and
  Discussion sections of a scientific manuscript,
  which section(s)
• Usually contain the most flaws?
• Is most often responsible for outright rejection?
• Is usually too short?
• Is usually too long?

21

• Of the Introduction, Methods, Results and
  Discussion sections of a scientific manuscript,
  which section(s)
• Usually contain the most flaws? M
• Is most often responsible for outright rejection?
  M
• Is usually too short? M R
• Is usually too long? I D

22

• Of the following deficiencies in studies, which
  is most often responsible for outright rejection
  of a manuscript?

Weak discussion Poor formatting
Inadequate results Weak conclusion
Lack of originality Poor methods
Poor statistical analysis Poor presentation
23

• Of the following deficiencies in studies, which
  is most often responsible for outright rejection
  of a manuscript?

1. Poor methods 4. Poor statistical analysis
2. Inadequate results 5. Weak conclusion
3. Poor presentation 5. Lack of originality
4. Weak discussion 6. Poor formatting
24
Title

• Most important part of the article the part most
  often read and often the only part read
• Keep precise and brief (85-character limit is
  typical)
• Must stand alone no abbreviations
• Indicate whether subjects were animals (for
  clinical journals)

25
Title

• Attempt to incorporate the following elements
• Patients
• Intervention
• Comparator
• Outcome
• Design
• Setting
• Example
• Reduction of acute rejection rate by basiliximab
  induction in a randomized, placebo-controlled,
  multicenter study after renal transplantation

26
Authorship and Affiliations

• Authorship credit should be based on
• substantial contributions to conception and
  design, or acquisition of data, or analysis and
  interpretation of data
• drafting the article or revising it critically
  for important intellectual content
• List in order of greatest contribution to the
  work from most to least
• Some journals may require specific assignment of
  role of authors in the publication
• Provide full contact information for each author
• Identify conflicts-of-interest

27
Abstract

• Purpose to help readers decide whether to read
  the full article
• Second most important part of the article
• Types
• Descriptive
• Structured follow headings used by the journal
• Word limit - usually 250 words for structured
  abstracts
• Must stand alone
• Provide 3 to 6 key words

28
Introduction

• Purpose to establish the need and importance of
  the study
• Defines the scientific problem that stimulated
  the work
• Explains the technical approach or hypotheses
• States the purpose and scope of the study
• Introduces and defines terms and abbreviations

29
Materials and Methods

• Purpose To permit readers to judge the validity
  of the study and to permit others to replicate
  the study
• Study Design
• Identify the interventions and outcomes studied
• Identify the unit of analysis (e.g., rejection,
  renal function)
• Provide measurable ("operational") definitions
• Describe the methods of data collection and
  measurement
• Specify the type of study
• Retrospective (case-control) study
• Prospective (cohort or longitudinal) study
• Randomized controlled clinical trial

30
Materials and Methods

• Describe the population studied
• Define the eligibility criteria
• Indicate IRB approval or compliance with Animal
  Welfare Act
• Explain how subjects were assigned to groups
• Define cases and controls in retrospective trials
• Define exposures or diagnoses in prospective
  trials
• Give the dates or time periods of data collection
• Identify the statistical methods
• Identify at least the primary comparisons to be
  made
• Describe how the sample size was determined
• Intention-to-treat vs. on-protocol analysis
• Identify the statistical software package used in
  the analysis

31
Results

• Purpose To tell what happened during the study
  and to present the findings of the study
• Explain any deviations from the study as planned
• Use Tables and Figures that are stand alone,
  including detailed title and legends
• Provide a schematic summary of the study to
• Show the study design
• Indicate the flow of subjects throughout the
  study
• Account for all subjects or observations

32
Results

• Present the results of the study
• Figure 1 Enrollment and Outcomes

33
(No Transcript)
34
Results

• Present the results of the study
• Figure 1 Enrollment and Outcomes
• Table 1 compares groups at baseline, i.e.
  demographics
• Focus on the primary comparisons first and
  provide
• The actual change or difference between groups
  (i.e. the estimated treatment effect)
• The 95 confidence interval for this estimate
• The test used in the statistical analysis
• Assurance that assumptions of analysis were met
• Acknowledge post hoc and subgroup analyses (avoid
  data dredging)

35
Discussion

• Purpose to explain the nature and importance of
  the findings
• Begin by summarizing the study and the main
  results.
• Interpret the results and suggest an explanation
  for them
• Describe how the results compare with what else
  is known about the problem review the literature
  and put the results in context
• Suggest how the results might be generalized
• Discuss the implication of the results
• State the limitations of the study
• Distinguish between clinical and statistical
  significance
• In studies with low statistical power, do not
  mistake inconclusive results for negative results
• Absence of evidence
• is not Evidence of absence

36
References

• Purpose to allow readers to verify authors
  claims and arguments
• Format according to the Uniform Requirements for
  Manuscripts Submitted to Biomedical Journals or
  to the journal's Guidelines for Authors
• Abbreviate journal titles according to National
  Library of Medicine guidelines
• Verify that the references are cited in the text
  and are numbered correctly
• Avoid unnecessary references

37

• Of the following writing problems in manuscripts,
  which is most common?

Excessive abstraction Wordiness
Compressed thought Wrong words
Poor syntax Complexity
Needless repetition Unnecessary qualification
Poor flow of ideas
38

• Of the following writing problems in manuscripts,
  which is most common?

1. Wordiness 6. Excessive abstraction
2. Poor flow of ideas 7. Wrong words
3. Poor syntax 8. Compressed thought
4. Needless repetition 9. Unnecessary qualification
5. Complexity
39
Reader-Based Writing

• Write at the service of your reader
• Words Less is more
• Phrasing Simpler is better
• Editing Rewrite for clarity

40
IMRD
Section Question Tense
Introduction Why? Present
Methods How? Past
Results Findings? Past
Discussion So what? Present
41
85 of biomedical manuscripts eventually get
published
42
www.icmje.org

• Review the Uniform Requirements published by
  International Committee of Medical Journal
  Editors
• Manuscript Preparation useful section

43
(No Transcript)
44
Select the Most Appropriate Journal

• Consider the audience
• Determine if your research matches journals
  stated purpose
• Evaluate the quality of the journal and
  probability of acceptance

45
Journal Considerations

• Citation rates metrics evaluate importance, but
  not necessarily quality
• Immediacy index citations/number of articles
  published
• Cited half-life number of previous years
  accounting for 50 of citations
• Impact factor Number of citations/number of
  published articles (previous 2 years)
• Journals with higher immediacy indexes, shorter
  half-lives and higher impact factors are believed
  to be better journals

46
Understand and Follow Journal Guidelines

• Provide all requested information at first
  submission
• Follow all format guidelines, including page
  length
• Follow CONSORT guidelines for clinical trial
  reporting
• Follow the Uniform Requirements by icmje

47
(No Transcript)
48
Understand What Editors Want

• New
• True/hypothesis driven
• Important - How will medicine be different as a
  result of your research?
• Clearly reported
• Manuscripts prepared in accordance with the
  journal's Guidelines for Authors

49
Top Reasons for Rejection

1. Wrong journal - focus is not within scope of the
   journal
2. Redundant topic of research
3. Poorly written - poor grammar, style and syntax
4. Problem/hypothesis not adequately stated
5. Fatal flaws with study design - inadequate sample
   size, bias, insufficient detail

50
Top Reasons for Rejection

• 6. Over-interpretation of results
• 7. Incorrect statistical analysis
• Faulty conclusions
• Figure and tables confusing
• 10. Inappropriate review of literature
• 11. Failure to address reviewers suggestions

51
Summary

• Formulate research questions
• Design studies carefully so they can
• Test hypotheses
• Answer questions
• Publish the results so that
• They enter the scientific body of knowledge
• Can be replicated
• Can generate new research hypotheses

52
Summary

• Utilize the journals Guidelines to Authors
• Adhere to IMRD format, CONSORT statement and
  Uniform Requirements of ICMJE
• Incorporate all elements into the first
  submission
• Careful editing and proofreading
• Attention to submission requirements

53
CORC Review Criteria

• Credible is the science accurate?
• Original are the findings new?
• Relevant does the study connect with current
  issues?
• Clear can we understand the writing and
  graphics?

54
Read More

• www.clinicaltrials.gov
• www.consort-statement.org
• www.icmje.org
• Schold J Design and Analysis of Clinical Trials
  in Transplantation Principles and Pitfalls
• AJT 2008 8 1779

55
Scientific Writing easy when you know how

• by J Peat, E Elliott, L Baur, and V Keena (Pp
  312 22.50)
• BMJ Books, 2002.

56
What is your own strategy?

• Authorship before starting
• Methods (while performing the study)
• Major findings in Tables and Figures
• Results text
• Introduction
• Discussion
• Abstract
• References

57
How much time do you need to do some work on the
paper?

• A week?
• A day?
• Half a day?
• An hour?
• Half an hour?

58
Enjoy writing your paper !

• Writing a paper is creative, productive,
  artistic, inventive, inspiring, stimulating,
  exciting, reviving,
• and sometimes quite fun

59
Professional Help

• San Fransisco Edit
• www.sfedit.net
• Newsletters very good advice
• English language revision
• - 29 USD/page
• - done in one week