151108 edanz primary care osaka

Writing a Clinical Manuscript that Has Impact

Japan Primary Care Association

8 November 2015

Dr Trevor Lane

Dr Eri Kinoshita

S

Be an effective communicator

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

Developing advanced writing skills

Logically communicating your ideas in your manuscript

Making the best first impression

Avoiding common peer reviewer complaints

Increasing the impact of your research

Section 1


Coverage and Staffing Plan Writing skills

Where to start?

Your findings form the basis of your manuscript

First organize your findings

Logic, then English language

Figure 1

Figure 2

Table 1

Figure 3

Logical flow • Chronology • Least to most

important • General to

specific • Whole+parts

Is anything missing?

? Additional analyses?

Use your illustrations to structure your manuscript

Coverage and Staffing Plan Writing skills Use reporting guidelines

PRISMA Systematic reviews &

Meta-analyses

STROBE Observational studies

CARE Case reports

CONSORT Randomized controlled

trials

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

clinicaltrials.gov; who.int/ictrp/network/en; controlled-trials.com; umin.ac.jp/ctr

Coverage and Staffing Plan Writing skills Use reporting guidelines

CONSORT


Coverage and Staffing Plan Writing skills Prepare an outline

I. Introduction A. General background B. Related studies C. Problems in the field D. Aims

II. Methods A. Subjects/Samples/Materials B. General methods C. Specific methods D. Statistical analyses

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

IV. Discussion A. Major conclusion B. Key findings that support conclusion C. Relevance to published studies D. Limitations E. Unexpected results F. Implications G. Future directions

Write down key ideas in bullet points, as IMRaD (=Intro, Methods, Results and Discussion)

Use reporting guidelines

No need for full sentences or correct English yet

Then, draft the title/abstract

List information from your reading in the appropriate section: Paraphrase with citations!

Coverage and Staffing Plan Writing skills Journal Selector

www.edanzediting.co.jp/journal_selector

Insert your proposed abstract/title or keywords


Filter/sort by: • Field of study • Impact factor • Indexed in SCI • Open access • Publishing frequency

Journal Selector www.edanzediting.co.jp/journal_selector

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

• Author guidelines • Journal website

Similar abstracts

Coverage and Staffing Plan Writing skills Get feedback

Write your manuscript section-by-section – Less stressful – Get feedback after each section; set deadlines – Easier for your colleagues to review

Revise for content, overall logic, and journal style (see guidelines/past papers)

Edit for conciseness, clarity, consistency & accuracy

Get feedback from pre-submission peer review

Get language assistance


Write logical sentences!

A is 4 times larger than B A is 4-fold larger than B A is 4 times as large as B

B is 4 times smaller than A

B is 75% smaller than A; B is 25% the size of A

A B

Avoid mistakes 1


Write logical sentences!

A is 4 times larger than B A is 4-fold larger than B A is 4 times as large as B

B is 4 times smaller than A

B is 75% smaller than A; B is 25% the size of A

A B

Comparing data, Method–Purpose, Condition–Effect, Reason–Result, Cause–Effect, Contrast, Similarity, Sequence, Addition, Concession, Exemplification

Avoid mistakes 1

Coverage and Staffing Plan Writing skills Avoid mistakes 2

Keep it simple!

Use short sentences 15–20 words; one idea per sentence

Prefer simpler/shorter words

Use active voice Simpler, more direct, and easier to read

Most writing style guides and journals prefer it… “Nature journals prefer authors to write in the active voice”

(http://www.nature.com/authors/author_resources/how_write.html)

Coverage and Staffing Plan Writing skills Avoid mistakes 2

Prefer Enough Clear Determine Begin Try Very Size Keep Enough End Use

Avoid Adequate Apparent Ascertain Commence Endeavor Exceedingly Magnitude* Retain Sufficient Terminate* Utilization *OK in certain fields (magnitude of earthquakes, to terminate gene expression)


“A number of studies have shown that the charged group...”

“...as described in our previous study.”

“...at a flow rate of 1.0 mL/min.”

“As a matter of fact, such a low-temperature reaction…”

“That is another reason why, we believe…”

“It is well known that most of the intense diffraction peaks...” “It is well known that Most of the intense diffraction peaks...”

“As a matter of fact, such a This low-temperature reaction…”

“A number of studies have shown that The charged group...”

“That is thus another reason why Therefore, we believe…”

“...as described previously in our previous study.”

“...at a flow rate of 1.0 mL/min.”

Avoid mistakes 3

Delete extra words!


Avoid At a concentration of 2 g/L At a temperature of 37C In order to In the first place Four in number Green color Subsequent to Prior to Future plans; past history

Prefer At 2 g/L At 37C To First Four Green After Before Plans; history

Avoid mistakes 3


Estimate Estimation

Decide Decision

Assess Assessment

We made a/an… We conducted a/an… Extra verb

We decided… Clear, short, and direct

Avoid mistakes 4

Don’t hide verbs inside nouns!


Respectively is used for corresponding list items

The two values were 143 and 21, respectively.

The values for groups A and B were 143 and 21, respectively.

The two values were 143 and 21.

Avoid mistakes 5


Compared with is for saying how things are different

The toxicity of the new scaffold was reduced

compared to the previous scaffold.

The toxicity of the new scaffold was reduced compared with that of the previous scaffold.

The toxicity of the new scaffold was lower than that of the previous scaffold.

Avoid mistakes 6


Due to means “caused by” or “attributable to”

Due to the heavy rain, the patients did not return.

Owing to the heavy rain,… Because it rained heavily,…

The patients’ failure to return was due to the heavy rain.

Avoid mistakes 7


Readers expect…

old/given/familiar information to appear first new information to appear last

An increasing number of people are relying on medical information sources that they find on the Internet. Hence, governments could conduct public campaigns to promote healthy lifestyles via online media.

The Internet is being used as a source of medical information by an increasing number of people. Hence, online media campaigns could be used by governments to promote healthy lifestyles among the public. / Hence, the public could benefit from government online campaigns to promote healthy lifestyles.

Avoid mistakes 8


Readers expect…

verbs to closely follow their subjects heavy ends (not starts) of clauses

Subject

The viral infection that the patient caught on a trip to an outbreak-prone area in Africa spread among the hospital staff quickly.

The patient caught a viral infection on a trip to an outbreak-prone area in Africa. This infection spread quickly among the hospital staff.

Verb

Avoid mistakes 9


After we considered the results of the clinical tests, all patients were given analgesic drugs.

Cell vitality was generally not affected much by pure EGCG…

“Cell viability was reduced by only 3.5% by pure EGCG…” ?

After considering all of the relevant patient parameters from their clinical work-up, all of the patients were then finally put on painkillers.

Be accurate and concise!

After we considered the results of the clinical tests, all patients were given analgesic drugs. / After considering the results of the clinical tests, we gave analgesic drugs to all patients.

Avoid mistakes 10

Activity 1

Please see Activity 1 in your workbook

Section 2


Manuscripts with impact The ‘write’ order

How does your study contribute to your field?

What did you find?

What did you do?

Why did you do the study?

Title/Abstract

Introduction

Methods

Results

Discussion

Manuscripts with impact

Title/Abstract

Introduction

Methods

Results

Discussion

Title/Abstract

Methods

Results

Discussion

Introduction

Abstract /Title

write

Title/Abstract

Intro: Aim

Figures/ Results {Methods}

Discussion: Conclusion

[Intro / IMRaD]

read

The ‘write’ order

Manuscripts with impact Introduction

Why is your study needed?

Current state of the field

Background information

Specific aim/approach Aim

Problem in the field

Previous studies

Current study

General

Specific Importance/Hypothesis

Worldwide relevance? Broad/specialized?

Up-to-date International


“Health workforce shortages may be felt most keenly by developing nations, but are a concern for all. Developed nations are particularly worried about the number of general practitioners (GPs) available to service their ageing populations…”

BMC Family Practice: Worldwide relevance

Dwan et al. BMC Fam Prac. 2014; 15: 154.

International journal – Writing the Introduction

Effect of ageing populations on healthcare workforce


“All citizens in Japan are covered by a national health insurance system in which there are no official “gatekeepers”. Patients can freely choose between attending a local physician’s office (clinic) or a hospital and Japanese physicians can freely practice internal medicine. But recently, Japan has faced the problems of a rapidly aging population…”

Asia-Pacific Family Medicine: Regional focus

Tsukamoto et al. Asia Pac Fam Med. 2014; 13: 9.

Regional journal – Writing the Introduction

Effect of ageing populations on healthcare workforce


Cardiovascular disease (CVD) is the most important cause of morbidity and mortality in the developed world, and atherosclerosis is the central underlying pathology. Atherogenesis is a life-long process involving a range of mechanisms including lipid peroxidation and inflammation affecting the vascular wall. The clinically most relevant results of this pathology are myocardial infarction and stroke. Evidence for acute cardiovascular effects of air pollution has substantially increased in recent years…

PLOS ONE: ‘atherosclerosis and pollution’

Künzli et al. PLoS ONE 2010; 5: e9096.

Broad-focused journal – Writing the Introduction

Broad background information Important for context


Atherosclerosis is an inflammatory disease that accounts for nearly 50% of deaths in western societies. Initiation of atherosclerotic plaque formation is a complex process. It involves secretion of chemokines such as the Monocyte Chemoattractant Protein–1 (MCP-1) and expression of adhesion molecules on the surface of monocytes and endothelial cells. Circulating monocytes are recruited to sites of injured endothelial cells, adhere to them, and migrate into the subendothelial space. Monocytes in the arterial wall differentiate into activated macrophages…

BMC Cardiovascular Disorders: ‘atherosclerosis and pollution’

Adar et al. BMC Cardiovas Disord. 2013; 10: e1001430..

Specialized journal – Writing the Introduction

Broad background information not necessary

Manuscripts with impact Writing the Introduction

Currently, the standard procedure used to evaluate hepatic steatosis is the histopathological examination of cross-liver sections… …this is an invasive practice that presents inherent risks... Therefore, it is essential to establish new non-invasive approaches to accurately determine hepatic fat concentration…

Aims

The purpose of our prospective study…was to evaluate the potential of multi-echo MRI to quantitate the hepatic triglyceride concentration.

Problem

Jiménez-Agüero et al. BMC Med. 2014; 12:137.

The aims should directly address the problem


Study design

Methods



How the study was done

• Processes, treatments, measurements, follow-up

• Variables (direct/proxy) • Outcome/endpoints (1o, 2o)

• Quantification/models • Statistical tests (& P level) • Consult a statistician

Who/what was studied

• Participants, controls • Enrollment, N & “power” • Materials, databases

Data analysis

Describe all aspects of the design

Methods

Manuscripts with impact Methods

Describe all aspects of the design

Established techniques

• Cite previously published studies • Briefly state modifications

• Enough detail for reproducibility • Use Supplementary Information

Organization • Arrange in subsections • Parallel order with the figures

New techniques

Manuscripts with impact Results

• Efficacy/safety • Group/subgroups • Uni-/bi-/multivariable

• Each subsection corresponds to one figure and method

• What you found, not what it means

• Use Supplementary Information

• Data accessibility

Logical presentation

Subsections

Factual description

Present results logically and factually


Independent variable

Table formatting

Muñoz et al. New Engl J Med. 2003; 348: 518−527.

Clear and concise table caption

Abbreviations defined

Dependent variable

Manuscripts with impact Graph formatting

Use colors and shapes to differentiate lines

Dependent variable



Bar graphs/charts for normal data

Slight et al. J Clin Invest. 2013; doi: 10.1172/JCI65728.

CXCR5+ T helper cells mediate protective immunity against tuberculosis

Figure 7 Adoptive transfer of B6 but not Cxcr5-/- CD4+ T cells rescues T cell localization and protection in Cxcr5-/-Mtb-infected mice... (B) The average size of B cell lymphoid follicles in FFPE lung sections on day 50 using the morphometric tool of the Zeiss Axioplan microscope… *** P = 0.0005.

Dependent variable


Statistical significance


Box plots for non-normal data

Hijikata et al. Hum Genetics. 2012; 131: 675−682.

Figure 2 Dual luciferase reporter assays. The ratios of Firefly luciferase activity (signal S) to Renilla luciferase (control C) are displayed using box and whisker plots…

Minimum

25%

Median

75%

Maximum


Drug A reduced tumor volume by 32.7%, increased blood pressure by 12.3%, and increased the patient’s weight by 7.3 kg. Drug B reduced tumor volume by 22.3%, increased blood pressure by 15.6%, and increased the patient’s weight by 2.4 kg. Drug C reduced tumor volume by 38.1%, increased blood pressure by 6.9%, and increased the patient’s weight by 9.2 kg.

Describe relationships among your results


Patients treated with Drug C showed the greatest reduction in tumor volume (28.1%) compared with those treated with Drug A (32.7%) or Drug B (22.3%). Drug C also had the lowest increase in blood pressure (6.9%) compared with that seen after treatment with Drug A (12.3%) or Drug B (15.65). However, patients treated with Drug C had the highest weight gain among the three groups (Drug A, 7.3 kg; Drug B, 2.4 kg; Drug C, 9.2 kg).

Describe relationships among your results

Manuscripts with impact Discussion

Summary of findings

Relevance

Conclusion

Similarities/differences Unexpected/negative results Limitations (validity, reliability)

Implications

Previous studies

Current study

Future studies

Specific

General

How do you advance your field?


GPER is an E2 binding, G-protein coupled membrane receptor that was reported to be overexpressed in breast, endometrial, ovarian and thyroid cancers. However, it is currently unclear if different types of lung cancers including adenocarcinomas, squamous cell carcinoma and large cell carcinomas express higher GPER than normal lung tissue. Here, we demonstrate for the first time that GPER is overexpressed in lung tumors and lung adenocarcinoma cell lines relative to normal lung and immortalized normal lung cell lines, although the expression of GPER transcript in HPL1D cells is higher than HBECs.

Re-introduction

Conclusion

Modified from: Rao Jala et al. BMC Cancer 2012; 12: 624.

State the major conclusion of the study

Restate problem

Discussion – Beginning


Important limitations of our study include an inadequate sample size and duration to detect differences in the incidence of diabetes complications, such as myocardial infarction, stroke, or death. The protocol specifies further follow-up at 5 years for all patients, which should allow additional assessment of even longer-term efficacy and safety. Despite these limitations, we conclude that bariatric surgery represents a potentially useful strategy for the management of type 2 diabetes, allowing many patients to reach and maintain therapeutic targets of glycemic control that otherwise would not be achievable with intensive medical therapy alone.

Identify limitations

Modified from: Schauer et al. New Engl J Med. 2014; 370: 2002–2013.

Address limitations

End positively: Good news last & in long, main clause!

Include limitations

Manuscripts with impact Discussion – End

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

Importance

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

Why is your study important?

Manuscripts with impact Link your ideas

General background

Aims

Methodology

Results and figures

Summary of findings

Implications for the field

Relevance of findings

Problem in the field

Current state of the field Introduction

Methods

Results

Discussion

Solution

Situation/Problem

Evaluation/Comment

Activity 2


Section 3


Customer Service Marketing your work Title and abstract

First impression of paper: clear/concise/convincing

Importance of your results

Validity of your conclusions

Relevance of your aims

It sells your work: Readers judge your style & credibility

Often first/only part that is read by

readers & reviewers

Your title & abstract summarize your study


Title

Important points

Only the main idea Accurate, simple Population/model Include keywords Fewer than 20 words Hanging title:

method/study type

Avoid

Unneeded words (a/the, A study of) Complex or sensational words Complex word order Abbreviations “New” or “novel”


Interrogative Can ischemic preconditioning

improve prognosis after coronary artery bypass surgery?

Indicative/ Descriptive*

Prognostic effects of ischemic preconditioning in coronary artery

bypass patients

* + Method (subtitle)

Xxxxxxx: randomized controlled trial

Assertive/ Declarative*

Ischemic preconditioning improves prognosis after coronary artery

bypass / Improved prognosis after coronary artery bypass by ischemic

preconditioning

Title


Search Engine Optimization

Identify 7–8 keywords (include synonyms, use Medical Subject Headings [MeSH]*)

Use 2 in your title, 5–6 in the keyword list

Use 3 keywords 3–4 times in your abstract

Use keywords in headings when appropriate

Be consistent throughout your paper

Cite your previous publications when relevant

*Or standard terms from PsycINFO, BIOSIS, ChemWeb, ERIC Thesaurus, GeoRef, etc


Context Background, problem, aim

Results Outcomes, effects,

properties, statistics

Conclusion Relevance, implications Learning points, future

Methods Patients/materials/animals Treatments, measurements

No references, unusual abbreviations, figures/tables Clinical: funding & trial registration number after abstract

Abstract

Customer Service Marketing your work Unstructured abstract

Modified from: Cannegieter et al. Blood. 2015; 125: 229‒235.

Numerous systemic treatment options exist for patients with mycosis fungoides (MF) and Sézary syndrome (SS); however, the comparative efficacy of these treatments is unclear. We performed a retrospective analysis of our cutaneous lymphoma database to evaluate the treatment efficacy of 198 MF/SS patients undergoing systemic therapies. The primary end point was time to next treatment (TTNT). Patients with advanced-stage disease made up 53%. The median follow-up time from diagnosis for all alive patients was 4.9 years (range 0.3‒39.6), with a median survival of 11.4 years. Patients received a median of 3 lines of therapy (range 1‒13), resulting in 709 treatment episodes. Twenty-eight treatment modalities were analyzed. We found that the median TTNT for single- or multiagent chemotherapy was only 3.9 months (95% confidence interval [CI] 3.2‒5.1), with few durable remissions. α-interferon gave a median TTNT of 8.7 months (95% CI 6.0-18.0), and histone deacetylase inhibitors (HDACi) gave a median TTNT of 4.5 months (95% CI 4.0‒6.1). When compared directly with chemotherapy, interferon and HDACi both had greater TTNT (P < .00001 and P = .01, respectively). In conclusion, this study confirms that all chemotherapy regimens assessed have very modest efficacy; we recommend their use be restricted until other options are exhausted.

Customer Service Marketing your work

Modified from: Cannegieter et al. Blood. 2015; 125: 229‒235.

Numerous systemic treatment options exist for patients with mycosis fungoides (MF) and Sézary syndrome (SS); however, the comparative efficacy of these treatments is unclear. We performed a retrospective analysis of our cutaneous lymphoma database to evaluate the treatment efficacy of 198 MF/SS patients undergoing systemic therapies. The primary end point was time to next treatment (TTNT). Patients with advanced-stage disease made up 53%. The median follow-up time from diagnosis for all alive patients was 4.9 years (range 0.3‒39.6), with a median survival of 11.4 years. Patients received a median of 3 lines of therapy (range 1‒13), resulting in 709 treatment episodes. Twenty-eight treatment modalities were analyzed. We found that the median TTNT for single- or multiagent chemotherapy was only 3.9 months (95% confidence interval [CI] 3.2‒5.1), with few durable remissions. α-interferon gave a median TTNT of 8.7 months (95% CI 6.0‒18.0), and histone deacetylase inhibitors (HDACi) gave a median TTNT of 4.5 months (95% CI 4.0‒6.1). When compared directly with chemotherapy, interferon and HDACi both had greater TTNT (P < .00001 and P = .01, respectively). In conclusion, this study confirms that all chemotherapy regimens assessed have very modest efficacy; we recommend their use be restricted until other options are exhausted. How does your study contribute to your field?

What did you find?

What did you do?

Why did you do the study?

Unstructured abstract


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

Cover letter to the editor

Editor’s name Manuscript title

Article type

Customer Service Marketing your work Cover letter to the editor

Other important information:

Recommended reviewers Author’s contact information

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

Reviewers

Contact information

Can also exclude reviewers


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:

Declarations related to publication ethics Source of funding Conflicts of interest

Ethics

Funding

Conflicts of interest


However, …an alternative approach… …a challenge …a need for clarification… …a problem/weakness with… …has not been dealt with… …remains unstudied …requires clarification …is not sufficiently (+ adjective) …is ineffective/inaccurate/inadequate/inconclusive/incorrect Few studies have… There is an urgent need to… There is growing concern that… Little evidence is available on… It is necessary to… Little work has been done on…

Key phrases: Problem statement (para 2)


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.

Why your study is interesting to the journal’s readership (para 4)

Target your journal – keywords from the Aims and Scope

Conclusion/importance

Relevance


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 your university

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

Choose reviewers who have published in your target journal

Section 4


Reviewer complaints

What reviewers are looking for

The science

The manuscript

Relevant hypothesis Good experimental design Appropriate methodology Good data analysis Valid conclusions

Logical flow of information Manuscript structure and formatting Appropriate references High readability ……Peer review is a positive process!

Reviewer complaints

Common complaints – Introduction

Ideas are not logically organized

Introduce topics that are not discussed later (Results/Discussion)

Not introduce important topics that are discussed later (topics in Results/Discussion)

Cited studies are not up-to-date

Cited studies are geographically biased

Why study needs to be done?

Keep focused

Write last

<5 years

International

Reviewer complaints

Common complaints – Methods

Transparency in study design

Sample size not large enough (no power calculation, 1-b)

Patient enrollment, exclusion, & randomization unclear

Interventions and assessments not clearly described

Unclear how missing data (lost to follow-up) were handled

Ethical approval and informed consent (x2 ) not clear

Consult a statistician

Use flowchart

Reproducibility

Imputation methods

Always required

Reviewer complaints

Distribution of data affects analysis and presentation

• Parametric tests (e.g., t-test and ANOVA) can be used only with continuous & normally distributed data with a large enough sample size

• The mean ± SD only for normally distributed data

Simple guide:

• If SD is ≥ mean, most likely not normally distributed • If SD is > 0.5 × mean, may not be normally distributed

Use Shapiro-Wilk’s W test for normality

Wrong statistical tests


Reviewer complaints

2 categorical endpoints

Paired (within sample)

Unpaired (between sample)

McNemar’s test

Fisher’s exact test 2 treatment groups

*for sample sizes > 60

Chi-square test* >2 treatment groups

du Prel et al. Dtsch Arztebl Int 2010; 107: 343–8.


Reviewer complaints

Continuous endpoints

Parametric Nonparametric

Paired Unpaired Paired Unpaired

2 groups: Paired t test

>2 groups: Repeated-

measures ANOVA

2 groups: Unpaired t test

>2 groups: ANOVA (F test)

2 groups: Wilcoxon signed-

rank test

>2 groups: Friedman

one-way ANOVA

2 groups: Mann–Whitney U test (Wilcoxon

rank-sum test )

>2 groups: Kruskal–Wallis

test

Lang and Secic 1997; 71.


Reviewer complaints

Statistical significance does not equal clinical significance!

“When possible, quantify findings and present them with appropriate indicators of measurement error or uncertainty (such as confidence intervals).”

http://www.icmje.org/recommendations/browse/manuscript-preparation/preparing-for-submission.html

“Avoid relying solely on statistical hypothesis testing, such as P values, which fail to convey important information about effect size and precision of estimates.”

Common complaints – Results

Reviewer complaints

“Drug A significantly reduced LDL cholesterol by 28% (p<0.05). Therefore, Drug A is effective in reducing cholesterol levels…”

• How much is 28%? Is this clinically relevant? • How does this effect generalize to the population? What is

the 95% CI?


Statistical significance does not equal clinical significance!

Reviewer complaints

“Drug A significantly reduced LDL cholesterol levels from 4.7±0.3 mmol/L to 3.4±0.6 mmol/L (p=0.02, 95% CI: 0.8–1.8). Because a minimal reduction of 1.4 mmol/L is required to be clinically effective, the efficacy of Drug A is still unclear.”

• Use absolute values • State exact P-value • State 95% CI and minimal clinically relevant difference


Reviewer complaints

Patient parameters …improved significantly; it is significant that… X was correlated with Y The risk* of developing X in this case-control study…

Patient variables …improved considerably/markedly; it is important that… X was associated with/related to/linked to Y The odds of developing X in this case-control study…

Don’t misuse statistical words!


* OK in a retrospective study if disease is rare and causality is assumed; risk=x/total, odds=x/(total–x)

Reviewer complaints

Common complaints – Discussion

Unexpected/negative results not explained

Limitations not discussed

The results are repeated in the Discussion

Conclusions are overgeneralized

Reporting transparency

Establish credibility

Summarize/interpret results

We showed that tumor volumes in Groups A, B, and C were 34.6, 74.2, and 53.9 mm3, respectively, after a 4-month drug treatment, reflecting only a 8.6% decrease. However, after a 12-month drug treatment, the tumor volumes in Groups A, B, and C were 16.3, 18.7, and 16.9 mm3, respectively, which reflects a 45.2% decrease (p<0.05). This demonstrates that a 12-month treatment is necessary for the drug to effectively reduce tumor size among the three groups.

Reviewer complaints








The results presented in this study demonstrate that Drug X more effectively reduces tumor size after 12 months of treatment (45.2% reduction) than it does after 4 months (8.6% reduction).


Reviewer complaints








Based on presented findings

“Our results showing the efficacy of this treatment in preventing recurring myocardial infarctions in obese Japanese patients demonstrate that this treatment should be implemented in other populations with high cardiovascular risk.”


Reviewer complaints








Based on presented findings

“Our results showing the efficacy of this treatment in preventing recurring myocardial infarctions in obese Japanese patients suggest that this treatment may be useful in other obese populations with high cardiovascular risk.”


Section 5


Challenges on the path to publication success

Preparation

Journal Selection

Writing

Submission

Peer Review

Publication Success

• Read/manage references

• Write outline • Authorship • Peer feedback • Present at

conferences

• Assess research impact

• Compare journals/ publishers

• (Pre-) Submission strategy

• Write/edit in English without plagiarism

• Writing process • Follow journal

& reporting guidelines

• Publication ethics

• Display items, supplemental material

• Ethics declarations

• Abstract & cover letter

• Select reviewers • Navigate

submission systems

• Navigate review process

• Understand editor & reviewers

• Revise paper • Respond to

reviewers, point by point

• Resubmit or submit elsewhere

• Archive/share • Promote work

to (non)-academic community

• Next project/ budget/grant

• Collaborators • Track citations

and altmetrics • Patenting • Update CV

Coverage and Staffing Plan

Promoting your work Your multiple audiences

Everyone evaluates your study…and you

• Journal editors & reviewers • Readers, opinion/policy makers • Students, researchers, industry • Employers, schools, interest groups • (Science) Media, public, politicians • Conference/journal panels • Review boards, funders, donors

Quality, Impact & Relevance

Why your work is important!


Promoting your work

Presenting after you publish

Advantages

Actively promote your article

Advice on future directions

Networking with researchers…

Networking with journal editors

Conferences, Seminars, Press Conferences, Media Enquiries, Media Interviews,

Social Media, Open Days, Public Education


Promoting your work Publicizing your article

Increase the impact of your research after publication

• Presentations • Web, email • Social media • Press releases • Newsletters • Reports

Respect news embargo

Report clearly and accurately

Respect access/archive policies

Respect copyright/CC licenses

Respect journal publication policy

Check conference guidelines


Promoting your work Publicizing your article

Reaching different audiences

IMRaD research article

(journals,

posters, slides)

Hard news

(press

releases)

Hard news, delayed

lede

Hard news + kicker

Soft news +

explana-tions + kicker

Full feature + kicker

(news-letters)

Hard news, delayed lede + kicker

Soft news + explana-

tions

(news releases)

Only after journal publication!

Activity 3


S

Be an effective communicator

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






Thank you!

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Trevor Lane: [email protected] Eri Kinoshita: [email protected]