Jeffrey Robens, PhD Senior Research Consultant

Education Group Leader

Writing a Clinical Research Paper that has Impact

The 67th Annual Scientific Meeting of the

Japanese Association for Thoracic Surgery

30 September 2014

Be an effective communicator

S

Your goal is not only to be published, but also to be widely read/cited

Good experimental design

Logically present your work in your manuscript

Choose the best journal to reach your target audience

Convey the significance of your work to journal editors

Section 1

Good experimental design

Experimental design

What do international journal editors want?

Interesting to journal’s readership

Increase impact

High quality research

Original and novel research Well-designed study

Transparent reporting Clinical applications

Experimental design

What do international journal editors want?

Clinical relevance

Technical quality

Novelty

Surgical resections of 500 Japanese lung

cancer patients

Experimental design

What do international journal editors want?

Clinical relevance

Technical quality

Novelty

Surgical resections of younger and older Japanese

lung cancer patients

Experimental design

Clinical research that has impact

1. Read primary literature

2. Read systematic reviews and meta-analyses

3. Identify an important question

• Is the question focused? • Do you have the expertise/resources? • What is new? • How is it clinically useful?

Experimental design Clinical trial registration

Not required for observational studies

Retrospective registration is sometimes possible

Should be registered before journal submission

Treatments/interventions are not assigned by the investigator

Where to register? ClinicalTrials.gov

UMIN Clinical Trials Registry (umin.ac.jp)

Experimental design Publication ethics

Conflicts of interest

Plagiarism

Author contribution

Data fabrication or falsification

Consequences of unethical behavior

• Unable to publish • Loss of employment

Section 2

Manuscript structure

Manuscript structure Reporting guidelines

CONSORT Randomized clinical trials

PRISMA Systematic reviews &

Meta-analyses

CARE Case reports

STROBE Observational studies

http://www.equator-network.org/ http://www.equator-network.org/library/translations-of-reporting-guidelines/#Japanese

Manuscript structure Writing clinical abstracts

Background Why does this trial/case

need to be reported?

Results Treatment outcomes

Adverse events

Conclusion Clinical relevance Learning points

Patients and methods

Patient information Interventions given

Concise summary of your study

List source of funding and trial registration number after abstract

Manuscript structure Introduction

General introduction

Specific aims Aims

Current state of the field

Problem in the field

Manuscript structure Specific aims

Aims

…we examined the effect of the severity of kidney dysfunction on the risks of death, cardiovascular events, and hospitalization among a large, diverse group of adults.

Problem …whether chronic kidney disease independently increases the risk of any type of cardiovascular disease has not been established. In addition, few studies have investigated the association between chronic kidney disease and the risk of hospitalization…

Identify an important problem State aims that directly address this problem

Go et al. N Engl J Med. 2004; 351: 1296–1305.

Manuscript structure Methods

How the study was done

Treatments (controls) Patient management

Follow-up

Quantification methods Statistical tests

Consult a statistician

Participants used

Demographics Enrollment procedure

Inclusion/exclusion criteria

Data analysis

Study design

Manuscript structure Results

1. Study design 2. Treatment efficacy 3. Safety

Each subsection corresponds to

one figure

What you found, not what it means

Logical presentation

Subsections

Factual description

Manuscript structure Discussion

Summary of findings

Relevance of findings

Clinical implications

Similarities/differences Unexpected results Negative results Limitations

Manuscript structure

Writing a strong conclusion

Why your study is important

In conclusion, we found an independent, graded association between lower levels of the estimated GFR and the risks of death, cardiovascular events, and hospitalization. These risks were evident at an estimated GFR of less than 60 ml per minute per 1.73 m2 and substantially increased with an estimated GFR of less than 45 ml per minute per 1.73 m2. Our findings support the validity of the National Kidney Foundation staging system for chronic kidney disease but suggest that the system could be further refined, since all persons with stage 3 chronic kidney disease (GFR, 30 to 59 ml per minute per 1.73 m2) may not be at equal risk for each outcome. Our findings highlight the clinical and public health importance of chronic kidney disease that does not necessitate dialysis.

Conclusion

Key finding

Implications

Future directions

Clinical importance

Go et al. N Engl J Med. 2004; 351: 1296–1305.

Manuscript structure Linking your ideas

General background

Objectives

Methodology

Results and figures

Summary of findings

Clinical implications

Clinical relevance

Problem in the field

Logically links your ideas throughout your manuscript

Current state of the field Introduction

Methods

Results

Discussion

Section 3

Communicating with journals

Coverage and Staffing Plan

Communicating with journals Evaluating significance

How new are your findings? Low vs. high impact journal

Novelty

How broadly relevant are your findings? International/regional & general/specialized

Relevance

What are the important clinical implications? Appeal

Coverage and Staffing Plan

Communicating with journals Factors to consider

Aims & scope Readership

Open access Impact factor

Which factor is most important to you?

Indexing

Coverage and Staffing Plan

Communicating with journals

Dear Dr Lippman,

Please find enclosed our manuscript entitled “Evaluation of the Glasgow prognostic score in patients undergoing curative

resection for breast cancer liver metastases,” which we would like to submit for publication as an Original Article in the Breast

Cancer Research and Treatment.

The Glasgow prognostic score (GPS) is of value for a variety of tumours. Several studies have investigated the prognostic value of the GPS in patients with metastatic breast cancer, but few studies have performed such an investigation for patients undergoing liver resection for liver metastases. Furthermore, there are currently no studies that have examined the prognostic value of the modified GPS (mGPS) in these patients. The present study evaluated the mGPS in terms of its prognostic value for postoperative death in patients undergoing liver resection for breast cancer liver metastases.

A total of 318 patients with breast cancer liver metastases who underwent hepatectomy over a 15-year period were included in this study. The mGPS was calculated based on the levels of C-reactive protein and albumin, and the disease-free survival and cancer-specific survival rates were evaluated in relation to the mGPS. Prognostic significance was retrospectively analyzed by univariate and multivariate analyses. Overall, the results showed a significant association between cancer-specific survival and the mGPS and carcinoembryonic antigen level, and a higher mGPS was associated with increased aggressiveness of liver recurrence and poorer survival in these patients. This study is the first to demonstrate that the preoperative mGPS, a simple clinical tool, is a useful prognostic factor for postoperative survival in patients undergoing curative resection for breast cancer liver metastases. This information is immediately clinically applicable for oncologists treating such patients. As a premier journal covering the broad field of cancer, we believe that the Breast Cancer Research and Treatment is the perfect platform from which to share our results with the international medical community.

Give the background to the research

What was done and what was found

Interest to journal’s readers

A good cover letter

We would also like to suggest the following reviewers for our manuscript…

Editor’s name Manuscript title

Publication type

Recommend reviewers

Publication ethics disclaimers

Coverage and Staffing Plan

Communicating with journals

Disclaimers about publication ethics

“Must-have” statements

Not submitted to other journals

Registration Informed consent

Authors agree on paper/journal

Original and unpublished

Conflicts of interest/funding

Authorship contributions

Additional forms: CONSORT/STROBE statements

Acceptance checklist

Well-designed study with proper controls

Publically registered trial

Logically organized manuscript

Appropriate journal selection

Cover letter (+ CONSORT/STROBE)

Any questions?

Thank you!

Jeffrey Robens: jrobens@edanzgroup.com

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