Siriraj Thailand 20141021

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Writing a Clinical Research Manuscript that Has Impact: Clinical Research Design and Ethics Siriraj Hospital 21 October 2014 Download at: edanzediting.com/siriraj2014 Dr Jeffrey Robens Senior Research Consultant Education Group Leader

Transcript of Siriraj Thailand 20141021

Page 1: Siriraj Thailand 20141021

Writing a Clinical Research Manuscript that Has Impact:

Clinical Research Design and EthicsSiriraj Hospital

21 October 2014

Download at: edanzediting.com/siriraj2014

Dr Jeffrey RobensSenior Research Consultant

Education Group Leader

Page 2: Siriraj Thailand 20141021

S

Be an effective communicator

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

Good research design

Research and publication ethics

Logically present your research in your manuscript

Convey the significance of your work to journal editors

Properly revise your manuscript after peer review

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Section 1.1

Clinical research design

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Customer ServiceClinical researchdesign

What do journal editors want?

Increase impact

High quality research

Interesting to journal’s readership

Original and novel research Well-designed study

Transparent reportingClinical applications

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Customer ServiceClinical researchdesign

Clinical relevance

Technical quality

Novelty

Surgical resections of 500 Thai HCC patients

What do journal editors want?

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Customer ServiceClinical researchdesign

Clinical relevance

Technical quality

Novelty Surgical resections of Thai HCC patients raised in the US

What do journal editors want?

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Customer ServiceClinical researchdesign

Clinical relevance

Technical quality

Novelty

Surgical resections of normal vs. diabetic Thai HCC patients

What do journal editors want?

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Customer ServiceClinical researchdesign

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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Customer ServiceClinical researchdesign

“Hierarchy of evidence”

Randomized controlled trials

Observational studies

Cohort/case-controlled studies

Case reports

Laboratory research

Systematic reviews& meta-analyses

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Customer ServiceClinical researchdesign Meta-analyses

Determine clinical efficacy/safety of an intervention based on what has already been done

• Integrates published and unpublished studies• Improves power by increasing sample size• Improves robustness by increasing heterogeneity of

sample population (broader generalization)

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Customer ServiceClinical researchdesign Searching for trials

http://onlinelibrary.wiley.com/cochranelibrary/search/

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Customer ServiceClinical researchdesign Clinical trials

Prospectively determines clinical efficacy/safety of a new intervention

• Single- or multi-center study?• Appropriate sample population?• Single- or double-blinded?• Placebo or active comparator control?

Consult a statistician!

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Customer ServiceClinical researchdesign

Searching for drug-related trials

http://adis.springer.com

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Customer ServiceClinical researchdesign

Clinical trial registration

Retrospective registration is sometimes possible

Should be registered before journal submission

Where to register? Thai Clinical Trials Registrywww.clinicaltrials.in.th

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Customer ServiceClinical researchdesign Observational study

Determine clinical efficacy/safety of a currently used intervention

• Intervention not assigned by investigator• Does not need to be publically registered• Usually retrospective, but can be prospective• Bias can result from lack of randomization and

patient is usually not blinded

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Customer ServiceClinical researchdesign

Cohort/longitudinal studies

Determine risk factors for a disease

• Often prospective, but can be retrospective• Compare two similar healthy populations with

different exposures• Calculate incidence of disease• Can take a long time, risk of missing data

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Customer ServiceClinical researchdesign

Case-controlled studies

Retrospectively determine risk factors for a (rare) disease

• Compare sample population that has a diseases with a similar sample that does not

• Compare histories and calculate odds ratio• Sample sizes much smaller than cohort studies• Unlike cohort studies, cannot calculate incidence

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Customer ServiceClinical researchdesign Case reports

Describes patient with unique presentation

• Needs to be an important unreported case• Tells a story, a timeline of events• Short, 500–1500 words• Needs to have educational value in addition to

novelty• Improves clinical reasoning skills

• Supports case-based learning

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Customer ServiceClinical researchdesign Laboratory research

Determine underlying mechanism of disease or treatment

• Performed under ideal (laboratory) conditions• Important in understanding pathogenesis and drug

development• Often difficult to translate to clinical relevance

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Customer ServiceClinical researchdesign 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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Section 1.2

Research and publication ethics

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Coverage and Staffing PlanEthics Transparent

reporting

It needs to be very clear how your study was conducted

• How patients were enrolled• Inclusion and exclusion criteria• How patients were randomized into treatment groups• Used intention-to-treat (all enrolled patients analyzed)

or per-protocol analysis (only patients that complete the study analyzed)

Patients

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Coverage and Staffing PlanEthics Transparent

reporting

It needs to be very clear how your study was conducted

• Unclear data (blue vs. blue-ish)• Uninterpretable data (glucose levels in patients who

did not fast overnight)• Missing data• Why missing? E.g., outliers or lost to follow-up?• Imputed methods (e.g., last observation carried

forward, multiple imputation methods, sensitivity analyses)

Data

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Coverage and Staffing PlanEthics Transparent

reporting

It needs to be very clear how your study was conducted

• How you analyzed your data (levels of measurement)?

• Continuous (e.g., systolic pressure in mmHg)• Nominal categories (unranked: e.g., normal vs.

abnormal blood pressure)• Ordinal categories (ranked; e.g., hypotensive, normal,

and hypertensive)

Data

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Coverage and Staffing PlanEthics Transparent

reporting

It needs to be very clear how your study was conducted

• How you categorized continuous data

• Continuous: height of your patients in cm• Subjective ranking: short <150 cm, normal 151–175

cm, tall >176 cm• Logical ranking: short <1 SD of the mean, normal ±1

SD of the mean, tall >1 SD of the mean

Data

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Coverage and Staffing PlanEthics Treatment

of participants

Informed consent

Participants in a study need to be informed of the:

• Study objectives• Potential benefits or risks involved• Confidentiality

This is usually written informed consent

Templates: http://www.who.int/rpc/research_ethics/informed_consent/en/

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Coverage and Staffing PlanEthics Data manipulation

Never

Fabricate data Move data on a graph

Manipulate images

Hide bad results

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Coverage and Staffing PlanEthics Four criteria

for authorship

1. Significantly involved in study design, data collection/analysis

2. Writing and revising the manuscript

3. Approval of final version

4. Responsible for the content (accuracy and integrity)

http://www.icmje.org/recommendations/browse/roles-and-responsibilities/defining-the-role-of-authors-and-contributors.html

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Coverage and Staffing PlanEthics Gift/ghost

authorshipMaking someone an author when they do

not deserve it (friends, colleagues, etc.)Gift

authorship

• Try to make paper more prestigious by adding a ‘big name’• Adding the department head to every paper from their department• Thanking someone for a contributed material

Not making someone an author when they do deserve it

Ghost authorship

• Hide conflict of interest (e.g., company employee)• If someone did not conduct the study, but wrote the paper (e.g.,

‘ghost writer’)

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Coverage and Staffing PlanEthics

Professional, financial, or personal relationships that may bias your research Declare any conflicts of interest to the journal Disclose all sources of funding Disclose all personal and financial relationships Declaration of the role of the study sponsor:• study design• collection, analysis, and interpretation of data• writing of the manuscript

Conflicts of interest

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Coverage and Staffing PlanEthics Conflicts of interest

form

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Coverage and Staffing PlanEthics

Makes readers think others’ words or ideas are your own

Plagiarism

Copying published text

Stating ideas of someone else without citing the source

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Coverage and Staffing PlanEthics ‘Salami publishing’

You cannot divide one larger paper into two or more smaller ones

• Makes readers think that these are two independent studies

• Relevant information from one paper not available to reader of other paper

• Interferes with the critical evaluation of the study

One larger paper will have more impact for the field (and more citations!)

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Thank you!

Any questions?

Follow us on Twitter@EdanzEditing

Like us on Facebookfacebook.com/EdanzEditing

Download and further readingedanzediting.com/siriraj2014

Jeffrey Robens: [email protected]

Page 35: Siriraj Thailand 20141021

Writing a Clinical Research Manuscript that Has Impact:

Manuscript StructureSiriraj Hospital

21 October 2014

Download at: edanzediting.com/siriraj2014

Dr Jeffrey RobensSenior Research Consultant

Education Group Leader

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Logically organizing your ideas

Section 2.1

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Coverage and Staffing Plan

Logical organization Prepare an outline

I. IntroductionA. General backgroundB. Related studiesC. Problems in the fieldD. Aims

II. MethodsA. Subjects/Samples/MaterialsB. General methodsC. Specific methodsD. Statistical analyses

III. ResultsA. Key points about Figure 1B. Key points about Table 1C. Key points about Figure 2D. Key points about Figure 3E. Key points about Figure 4

IV. DiscussionA. Major conclusionB. Key findings that support conclusionC. Relevance to published studiesD. LimitationsE. Unexpected resultsF. ImplicationsG. Future directions

Knowing what you need to discuss, write down the key ideas

Use short bullet points to list ideas

Don’t let “writing correct English sentences” get in the way of outlining your ideas

Use the reporting guidelines to help you structure your outline!

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Coverage and Staffing Plan

Logical organization Introduction

General introduction

Specific aimsAims

Current state of the field

Problem in the field

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Coverage and Staffing Plan

Logical organization 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 the problem

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

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Coverage and Staffing Plan

Logical organization Methods

How the study was done

Treatments (controls)Patient management

Follow-up

Quantification methodsStatistical tests

Consult a statistician

Participants used

DemographicsEnrollment procedure

Inclusion/exclusion criteria

Data analysis

Study design

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Coverage and Staffing Plan

Logical organization Results

1. Study design2. Treatment efficacy3. Safety

Each subsection corresponds to

one figure

What you found, not what it means

Logical presentation

Subsections

Factual description

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Coverage and Staffing Plan

Logical organization Discussion

Summary of findings

Relevance of findings

Implications for the field

Similarities/differencesUnexpected resultsNegative resultsLimitations

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Coverage and Staffing Plan

Logical organization

Writing a strong conclusion paragraph

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.

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Coverage and Staffing Plan

Logical organization Linking your ideas

General background

Objectives

Methodology

Results and figures

Summary of findings

Implications for the field

Relevance of findings

Problems in the field

Logically link your ideas throughout your manuscript

Current state of the fieldIntroduction

Methods

Results

Discussion

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Coverage and Staffing Plan

Logical organization Linking your ideas

New ways to treat or prevent lung cancer are therefore needed.

This study explored the hypothesis that inhibition of TNKS…would inhibit lung cancer growth…

Pharmacological or genetic inhibition of TNKS1 and TNKS2…reduces lung cancer proliferation...

Problem

Objectives

Conclusion

Discussion

Introduction

Busch et al. BMC Cancer. 2012;13:211.

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Titles and abstracts

Section 2.2

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Customer ServiceTitles and abstracts

Important points

Summarize key finding Study design Contains keywords Less than 20 words

Avoid

Effective titles

Your title should be a concise summary of your most important finding

QuestionsDescribing methodsAbbreviations“New” or “novel”

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Customer ServiceTitles and abstracts Abstract

First impression of your paper

Importance of your results

Validity of your conclusions

Relevance of your aims

Judge your writing style

Probably only part that will be read

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Customer ServiceTitles and abstracts

Writing clinical abstracts

Background Why does this trial/case need to be reported?

Results Treatment outcomesAdverse events

Conclusion Clinical relevanceLearning points

Patients and methods

Patient informationInterventions given

List source of funding and trial registration number after abstract

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Customer ServiceTitles and abstracts

Unstructured abstract

ErbB-2 has been implicated as a target for cancer-initiating cells in breast and other cancers. ErbB-2-directed peptide vaccines have been shown to be effective in prevention of spontaneous tumorigenesis of breast in neu transgenic mouse model, and cellular immunity is proposed as a mechanism for the anti-tumor efficacy. However, there has been no explanation as to how immunity suppresses tumorigenesis from the early stage carcinogenesis, when ErbB-2 expression in breast is low. Here, we investigated a peptide-based vaccine, which consists of two MHC class II epitopes derived from murine ErbB-2, to prevent the occurrence of spontaneous tumors in breast and assess immune impact on breast cancer stem cells. Female MMTV-PyMT transgenic mice were immunized with either ErbB-2 peptide vaccine, or a peptide from tetanus toxoid, or PBS in immune adjuvant. ErbB-2 peptides vaccine completely suppressed spontaneous breast tumors, and the efficacy was correlated with antigen-specific T-cell and antibody responses. In addition, immune serum from the mice of ErbB-2 vaccine group had an inhibitory effect on mammosphere-forming capacity and signaling through ErbB-2 and downstream Akt pathway in ErbB-2 overexpressing mouse mammary cancer cells. We provide evidence that multi-epitope class II peptides vaccine suppresses tumorigenesis of breast potentially by inhibiting the growth of cancer stem cells. We also suggest that a strategy of inducing strong immune responses using multi-epitope ErbB-2-directed helper vaccine might be useful in preventing breast cancer recurrence.

Gil et al. Breast Cancer Res Treat. 2014; 147: 69‒80.

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Customer ServiceTitles and abstracts

Unstructured abstract

Gil et al. Breast Cancer Res Treat. 2014; 147: 69‒80.

ConclusionWe provide evidence that multi-epitope class II peptides vaccine suppresses tumorigenesis of breast potentially by inhibiting the growth of cancer stem cells. We also suggest that a strategy of inducing strong immune responses using multi-epitope ErbB-2-directed helper vaccine might be useful in preventing breast cancer recurrence.

ResultsErbB-2 peptides vaccine completely suppressed spontaneous breast tumors, and the efficacy was correlated with antigen-specific T-cell and antibody responses. In addition, immune serum from the mice of ErbB-2 vaccine group had an inhibitory effect on mammosphere-forming capacity and signaling through ErbB-2 and downstream Akt pathway in ErbB-2 overexpressing mouse mammary cancer cells.

MethodsHere, we investigated a peptide-based vaccine, which consists of two MHC class II epitopes derived from murine ErbB-2, to prevent the occurrence of spontaneous tumors in breast and assess immune impact on breast cancer stem cells. Female MMTV-PyMT transgenic mice were immunized with either ErbB-2 peptide vaccine, or a peptide from tetanus toxoid, or PBS in immune adjuvant.

Background

ErbB-2 has been implicated as a target for cancer-initiating cells in breast and other cancers. ErbB-2-directed peptide vaccines have been shown to be effective in prevention of spontaneous tumorigenesis of breast in neu transgenic mouse model, and cellular immunity is proposed as a mechanism for the anti-tumor efficacy. However, there has been no explanation as to how immunity suppresses tumorigenesis from the early stage carcinogenesis, when ErbB-2 expression in breast is low.

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Customer ServiceTitles and abstracts Writing your abstract

Gil et al. Breast Cancer Res Treat. 2014; 147: 69‒80.

ErbB-2 has been implicated as a target for cancer-initiating cells in breast and other cancers. ErbB-2-directed peptide vaccines have been shown to be effective in prevention of spontaneous tumorigenesis of breast in neu transgenic mouse model, and cellular immunity is proposed as a mechanism for the anti-tumor efficacy. However, there has been no explanation as to how immunity suppresses tumorigenesis from the early stage carcinogenesis, when ErbB-2 expression in breast is low. Here, we investigated a peptide-based vaccine, which consists of two MHC class II epitopes derived from murine ErbB-2, to prevent the occurrence of spontaneous tumors in breast and assess immune impact on breast cancer stem cells. Female MMTV-PyMT transgenic mice were immunized with either ErbB-2 peptide vaccine, or a peptide from tetanus toxoid, or PBS in immune adjuvant. ErbB-2 peptides vaccine completely suppressed spontaneous breast tumors, and the efficacy was correlated with antigen-specific T-cell and antibody responses. In addition, immune serum from the mice of ErbB-2 vaccine group had an inhibitory effect on mammosphere-forming capacity and signaling through ErbB-2 and downstream Akt pathway in ErbB-2 overexpressing mouse mammary cancer cells. We provide evidence that multi-epitope class II peptides vaccine suppresses tumorigenesis of breast potentially by inhibiting the growth of cancer stem cells. We also suggest that a strategy of inducing strong immune responses using multi-epitope ErbB-2-directed helper vaccine might be useful in preventing breast cancer recurrence.

Clinical relevance

Treatment outcomes

Interventions

Why the study needed to be done

Page 53: Siriraj Thailand 20141021

Thank you!

Any questions?

Follow us on Twitter@EdanzEditing

Like us on Facebookfacebook.com/EdanzEditing

Download and further readingedanzediting.com/siriraj2014

Jeffrey Robens: [email protected]

Page 54: Siriraj Thailand 20141021

Writing a Clinical Research Manuscript that Has Impact:Communicating with Journals

Siriraj Hospital21 October 2014

Download at: edanzediting.com/siriraj2014

Dr Jeffrey RobensSenior Research Consultant

Education Group Leader

Page 55: Siriraj Thailand 20141021

Journal selection

Section 3.1

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Journal selection

Author guidelines• Manuscript structure• Word limits• Reference style

Aims and scope• Topics• Readership• Be sure to emphasize

Relevant references Writing style

When to choose a journal?

Choose the journal before you write your manuscript

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Journal selection Evaluating significance

How new are your findings?Low or high impact?Novelty

How broadly relevant are your findings?International or regional? Specialized or general?Relevance

What are the real-world clinical applications?Appeal

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Journal selection Factors to consider when choosing a journal

Which factor is most important to you?

Aims & scope Readership

Open access Impact factorIndexing

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Journal selection

Insert your proposed abstract

Journal Selector – www.edanzediting.com/journal_sele

ctor

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Journal selection

Matching journals

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

Journal Selector – www.edanzediting.com/journal_sele

ctor

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Journal selection

Journal’s aims and scope, IF, and frequency

Similar published articles

Have they published similar articles recently?Have you cited some of these articles?

Journal Selector – www.edanzediting.com/journal_sele

ctor

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Journal selection Tips to identify the most suitable journal

S

Identify the interests of the journal editor

Identify the interests of the

readers

• Editorials• Review articles• Special issues

• Most viewed• Most cited

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Cover letters

Section 3.2

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Cover letters

Abstract:First impression for readers

Cover letters are the first impression for the journal editor

SignificanceRelevance

Writing styleInteresting to their readers?

Is your work important?

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Cover letters

Marc Lippman, MDEditor-in-ChiefBreast Cancer Research and Treatment

3 September 2013

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 a Original Article in Breast Cancer Research and Treatment.

Journal editor’s name

Manuscript title

Article type

Building your cover letter

• Did you read the aims and scope?

• Did you read the author guidelines?

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Cover letters

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.

Second paragraph:

Current state of the field Problem researchers are facing

Introduction

Problem

Objectives

Building your cover letter

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Cover letters

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. Overall, the results showed a significant association between cancer-specific survival and the mGPS and carcinoembryonic antigen level. A higher mGPS was associated with increased aggressiveness of liver recurrence and poorer survival in these patients.

Third paragraph:

Briefly describe your methodology Summarize your key findings

Methods

Key results

Building your cover letter

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Cover letters

This study is the first to demonstrate that the preoperative mGPS, a simple clinical tool, is a useful prognostic factor for postoperative survival in breast cancer patients undergoing curative resection for liver metastases. This information is immediately clinically applicable for surgeons and medical oncologists treating such patients. As a premier journal covering breast cancer treatment, we believe that Breast Cancer Research and Treatment is the perfect platform from which to share our results with all those concerned with breast cancer.

Fourth paragraph:

Why interesting to the journal’s readership

Conclusion

Relevance

Building your cover letter

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Cover letters

This study is the first to demonstrate that the preoperative mGPS, a simple clinical tool, is a useful prognostic factor for postoperative survival in breast cancer patients undergoing curative resection for liver metastases. This information is immediately clinically applicable for surgeons and medical oncologists treating such patients. As a premier journal covering breast cancer treatment, we believe that Breast Cancer Research and Treatment is the perfect platform from which to share our results with all those concerned with breast cancer.

Fourth paragraph:

Why interesting to the journal’s readership

Target your journal –keywords from the Aims and Scope

Building your cover letter

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Cover letters

We confirm that this manuscript has not been published elsewhere and is not under consideration by another journal. All authors have approved the manuscript and agree with submission to the Breast Cancer Research and Treatment. This study was funded by the Japanese Ministry of Health, Labour and Welfare. The authors have no conflicts of interest to declare.

Last paragraph:

Disclaimers related to publication ethics Source of funding Conflicts of interest

Building your cover letter

Ethics

FundingConflicts of interest

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Cover letters

We would like to recommend the following reviewers to evaluate our manuscript: 1. Reviewer 1 and contact information2. Reviewer 2 and contact information3. Reviewer 3 and contact information4. Reviewer 4 and contact information Please address all correspondence to:

Reviewers

Contact information

Other important information:

Recommended reviewers Author’s contact information

Building your cover letter

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Cover letters A good cover letterMarc Lippman, MDEditor-in-ChiefBreast Cancer Research and Treatment

3 September 2013

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 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. Furthermore, we demonstrated that 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 breast cancer patients undergoing curative resection for liver metastases. This information is immediately clinically applicable for surgeons and medical oncologists treating such patients. As a premier journal covering breast cancer treatment, we believe that Breast Cancer Research and Treatment is the perfect platform from which to share our results with all those concerned with breast cancer. We confirm that this manuscript has not been published elsewhere and is not under consideration by another journal. All authors have approved the manuscript and agree with submission to Breast Cancer Research and Treatment. This study was funded by the Japanese Ministry of Health, Labour and Welfare. The authors have no conflicts of interest to declare. We would like to recommend the following reviewers to evaluate our manuscript: Reviewer 1 and contact informationReviewer 2 and contact informationReviewer 3 and contact informationReviewer 4 and contact information Please address all correspondence to: We look forward to hearing from you at your earliest convenience. Yours sincerely,

Manuscript information

Background

Key findings

RelevanceDisclaimers

Recommended reviewers

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Cover letters Why recommend reviewers?

Reviewers recommended by authors are usually more favorable

1. Scharschimidt et al. J Clin Invest. 1994; 93: 1877–1880.

2. Earnshaw & Farndon. Ann R Coll Surg Engl. 2000; 82: 133–135.

3. Grimm. Science 2005; 309: 1974.

4. Wager et al. BMC Med. 2006; 4: 13.

5. Schroter et al. JAMA 2006; 295: 314–317.

6. Rivara et al. J Pediatr. 2007; 151: 202–205.

7. Bornmann & Daniel. Res Eval. 2009; 18: 262–272.

8. Bornmann & Daniel. PLoS One 2010; 5: e13345.

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Cover letters 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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Peer review

Section 3.3

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Peer review What reviewers are looking for

The study

The manuscript

Relevant hypothesis Good study design Appropriate methodology Good data analyses Valid conclusions

Logical flow of information Manuscript structure and formatting Appropriate references High readability

Abstract and IntroductionMethodsResults and FiguresDiscussion

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Peer review Writing response letters

Read by the journal editor, not the reviewers

Respond to every reviewer comment

Easy to see changes

Refer to line and page numbers

Use a different color font

Highlight the textHighlight the text

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Peer review

Dr Mark EllenbogenEditor-in-ChiefAnxiety, Stress & Coping: An International Journal

3 September 2013

Dear Dr Ellenbogen,

Re: Resubmission of manuscript reference No. WJS-07-5739

Please find attached a revised version of our manuscript originally entitled “Presenteeism among Turkish employees: Personality and job stress,” which we would like to resubmit for consideration for publication in the Anxiety, Stress & Coping: An International Journal.

The reviewer’s comments were highly insightful and enabled us to greatly improve the quality of our manuscript. In the following pages are our point-by-point responses to each of the comments.

Revisions in the manuscript are shown as highlighted text. In accordance with the first comment, the title has been revised and the entire manuscript has undergone substantial English editing. We hope that the revisions in the manuscript and our accompanying responses will be sufficient to make our manuscript suitable for publication in the Anxiety, Stress & Coping: An International Journal.

Address editor personally

Manuscript ID number

Thank reviewers

Highlight major changes

Writing response letters

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Peer review Agreeing with reviewers

Agreement

RevisionsLocation

Reviewer Comment: In your analysis of the data you have chosen to use a somewhat obscure fitting function (regression). In my opinion, a simple Gaussian function would have sufficed. Moreover, the results would be more instructive and easier to compare to previous results.

Response: We agree with the reviewer’s assessment of the analysis. Our tailored function, in its current form, makes it difficult to tell that this measurement constitutes a significant improvement over previously reported values. We describe our new analysis using a Gaussian fitting function in our revised Results section (Page 6, Lines 12–18).

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Peer review

Reviewer Comment: In your analysis of the data you have chosen to use a somewhat obscure fitting function (regression). In my opinion, a simple Gaussian function would have sufficed. Moreover, the results would be more instructive and easier to compare to previous results.

Response: Although a simple Gaussian fit would facilitate comparison with the results of other studies, our tailored function allows for the analysis of the data in terms of the Smith model [Smith et al., 1998]. We have now explained the use of this function and the Smith model in our revised Discussion section (Page 12, Lines 2–6).

Evidence

Revisions

Location

Disagreeing with reviewers

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Reviewer comment: Currently, the authors’ conclusion that this questionnaire is appropriate for cross-cultural analyses is not completely valid because their participants all resided in the Thailand. They should also show the questionnaire’s validity in participants living in other countries.

“Unfair” comments

Reasons why reviewers might make these comments Current results are not appropriate for the scope or impact

factor of the journal

Reviewer is being “unfair”

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What you should do

First, contact the journal editor if you feel reviewer is being unfair

Do the experiments, revise, and resubmit

Withdraw submission and resubmit current manuscript to a journal with a different scope or lower impact factor

“Unfair” comments

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Thank you!

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Jeffrey Robens: [email protected]