130628 Edanz Japan Breast Cancer Society

Jeff Robens, PhD

Senior Editor

Publishing clinical research: Increasing your chances of acceptance

Japanese Breast Cancer Society

28 June 2013

Download at: edanzediting.co.jp/jbcs1306

Section One: Experimental design

Section Two: Manuscript structure

Section Three: Communicating with journals

Today’s presentation …

Section 1

Experimental design


Experimental design Clinical trial design

Only studies with approved protocols are likely to be accepted for publication

Trial type • Randomized controlled trial • Observational • Single/double-blind

Controls • Active comparator • Placebo-controlled

Well-outlined protocol

Experimental design Clinical trial registration

Declaration of Helsinki: “Every clinical trial must be registered in a publicly accessible database before recruitment of the first subject.”

WHO: “The registration of all interventional trials is considered to be a scientific, ethical and moral responsibility…”

ICMJE: “The ICMJE member journals will require, as a condition of consideration for publication in their journals, registration in a public trials registry.”

This includes all interventional trials

ClinicalTrials.gov

www.umin.ac.jp/ctr/index-j.htm

Experimental design Clinical trial registration

Not required for observational studies

Retrospective registration is often possible

Should be registered before journal submission

Treatments/interventions are not assigned by the investigator

Experimental design Publication ethics

Declare conflicts of interest

Don’t plagiarize

Proper author contribution

Don’t fabricate or falsify data

Consequences of unethical behavior

• Unable to publish • Loss of employment

Section 2

Manuscript structure


Manuscript structure Structuring your ideas

General background

Objectives

Methods

Results and figures

Summary of findings

Implications for the field

Relevance of findings

Knowledge gaps

Logically links your ideas throughout your manuscript

Current state of the field Introduction

Methods

Results

Discussion

Manuscript structure Structure of ideas

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.

Manuscript structure Structure of ideas

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.

Manuscript structure Writing clinical abstracts

Background Why was this trial conducted or why does this case need to be reported?

Patient information

Age, gender, ethnicity, enrollment procedure/ eligibility criteria

Observations Treatment outcomes, adverse events

Conclusion Clinical impact, learning points

Interventions/ Treatment

Treatment given, patient management, follow-up


What is publishable?

New or emerging disease

New treatment or diagnosis

Unusual presentation of

disease

New or unusual adverse effect of

treatment

Case studies


Case reports – essential elements

Short, 500–1500 words

Write simply and concisely Don’t use “he” and “she” when referring to patient’s

family members or other patients

Needs to have educational value in addition to novelty

Kukreja et al. BMJ Case Reports 2011.


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

Section 2



Coverage and Staffing Plan

Communicating with journals

Before writing Title, Abstract, Introduction, Discussion, and References

Journal selection

After key results have been obtained

When to choose the journal?


Communicating with journals Factors to consider

Aims and scope

Readership

Open access

Impact factor

Publication type

Which factor is most important to you?


Communicating with journals Evaluating significance

How new are your findings? Incremental or conceptual advances?

Novelty

How broadly relevant are your findings? Population or geographically specific?

Relevance

What are the important real-world applications? Can they be used now to treat patients?

Appeal


Communicating with journals Journal Selector

Input your abstract or selected keywords

Filter your results


Communicating with journals What do journal editors want?

Interesting to journal’s readership

Increase impact

High quality research

Original and novel research Clear and concise

English



Dear Dr Harris,

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 a Full Paper in the British Journal

of Cancer.

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 British Journal of Cancer 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

Cover letters

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

Editor’s name Manuscript title

Publication type

Recommend reviewers

CONSORT or STROBE checklists



CONSORT – clinical studies

Optimize reporting of randomized controlled trials (RCTs)

www.consort-statement.org



CONSORT – clinical studies

Recommended flow chart of the passage

of participants through an RCT

www.consort-statement.org



STROBE – observational studies

Strengthening the reporting of observational studies in epidemiology

Five available checklists

• Cohort studies • Case-control studies • Cross-sectional studies • Combined • Conference abstracts

www.strobe-statement.org

Acceptance checklist

Well-designed study with proper controls

Publically registered trial

Well-written manuscript

Appropriate journal selection

Cover letter (+ CONSORT or STROBE checklists)


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130628 Edanz Japan Breast Cancer Society

Health & Medicine

Transcript of 130628 Edanz Japan Breast Cancer Society