140829 Edanz Mie

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Jeffrey Robens, PhD Senior Research Consultant Education Group Leader Publishing Clinical Research: Increasing your chances of acceptance Mie University 29 August 2014

Transcript of 140829 Edanz Mie

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Jeffrey Robens, PhD Senior Research Consultant

Education Group Leader

Publishing Clinical Research: Increasing your chances of acceptance

Mie University

29 August 2014

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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

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Section 1

Good experimental design

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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 Clinical applications

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Experimental design

What do international journal editors want?

Clinical relevance

Technical quality

Novelty

CT scans of 1000 patients with gliomas

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Experimental design

What do international journal editors want?

Clinical relevance

Technical quality

Novelty CT scans of Japanese glioma patients raised in Japan or the US

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Experimental design

What do international journal editors want?

Clinical relevance

Technical quality

Novelty

CT scans of younger and older Japanese glioma patients

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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?

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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)

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Section 2

Manuscript structure

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Manuscript structure Reporting guidelines

CONSORT Randomized clinical trials

PRISMA Systematic reviews &

Meta-analyses

CARE Case reports

STROBE Observational studies

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

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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

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Manuscript structure Introduction

General introduction

Specific aims Aims

Current state of the field

Problem in the field

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Manuscript structure

Molecular markers help clinicians manage metastatic breast cancer systemically by indicating when endocrine therapy, chemotherapy, or HER2–targeted therapy

(such as trastuzumab or lapatinib) is appropriate.

However, previous studies have suggested the possibility of discordant HER2 status between primary and metastatic tumors.

Furthermore, to the best of our knowledge, there have been no previous studies evaluating

whether clinical factors affect these discordance rates.

Aims: Determine the discordance rates of HER2 in primary and metastatic tumors and determine if they are influenced by trastuzumab and/or chemotherapy

Niikura et al. J Clin Oncol 2011; 30: 593–599.

Introduction – Structure of ideas

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Manuscript structure

Aims: Determine the discordance rates of HER2 in primary and metastatic tumors and determine if they are influenced by trastuzumab and/or chemotherapy

Importance of biomarkers for determining appropriate therapy

Potential difference between primary and metastatic tumors

Not known what causes this difference

Study objectives

Niikura et al. J Clin Oncol 2011; 30: 593–599.

Introduction – Structure of ideas

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Manuscript structure Methods

How the study was done

Treatments (controls) Patient management

Follow-up

Quantification methods Statistical tests

Participants used

Demographics Enrollment procedure

Inclusion/exclusion criteria

Data analysis

Study design

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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

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Manuscript structure Discussion

Summary of findings

Relevance of findings

Clinical implications

Similarities/differences Unexpected results Negative results Limitations

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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

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Manuscript structure

Case reports – essential elements

Presents an important unreported case

Tell a story, a timeline of events

Short, 500–1500 words

Needs to have educational value in addition to novelty

Kukreja et al. BMJ Case Reports 2011.

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Manuscript structure

Background Concise description of

the disease or treatment

Case presentation

Patient information Diagnostic tests and results

Interventions Follow-up

Discussion Interpret the findings

Relationship with other cases Implications for the field

Case reports – structure of ideas

• Clinical implications • Educational value • Future directions

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Section 3

Communicating with journals

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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

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Coverage and Staffing Plan

Communicating with journals Evaluating significance

How new are your findings? Novelty

How broadly relevant are your findings? Relevance

What are the important clinical implications? Appeal

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Coverage and Staffing Plan

Communicating with journals

Journal Selector www.edanzediting.co.jp/journal_selector

Insert your proposed abstract

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Coverage and Staffing Plan

Communicating with journals

Recommended journals

Filter by: • Impact factor • Publishing frequency • Open access

Journal Selector www.edanzediting.co.jp/journal_selector

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Coverage and Staffing Plan

Communicating with journals

Journal’s aims & scope, IF, and publication frequency

Are they currently publishing similar articles?

Similar published articles

Have you cited any of these articles?

Journal Selector www.edanzediting.co.jp/journal_selector

www.biomedcentral.com/authors/authorfaq/findout

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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

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Coverage and Staffing Plan

Communicating with journals

Recommending reviewers

Where to find them?

From your reading/references, networking at conferences

How senior? Aim for mid-level researchers

Who to avoid? Collaborators (past 5 years),

researchers from same institution

International list: 1 or 2 from Asia, 1 or 2 from Europe, and 1 or 2 from North America

Have they published in your target journal?

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Acceptance checklist

Well-designed study with proper controls

Publically registered trial

Logically organized manuscript

Appropriate journal selection

Cover letter (+ CONSORT/STROBE)

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Thank you!

Any questions?

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Download and further reading www.edanzediting.co.jp/mie_2014

Jeffrey Robens: [email protected]