Sleep, Glucose, Regulation, and Diabetes

6/22/2016

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Constructing Research Proposals, Abstracts, and Publishable Papers:

Nuts and Bolts…..

Nancy S. Redeker, PhD, RN, FAHA, FAAN

Beatrice Renfield Term Professor of Nursing

Editor, Heart & Lung, the Journal of Acute & Critical Care

Objectives

At the conclusion of this presentation, participants will:

• Describe effective strategies for preparing abstracts, publications and research proposals

• Explain common pitfalls and how to address them

Personal Resources Needed to be Successful

• Perseverance******************

• Sense of humor

• Openness to new ideas

• Tolerance for criticism

• Willingness to negotiate

• Ethical principle

• Organization

• Knowledge/education

• Work ethic

• Commitment to team work, interdependence

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“Writing is easy. All you have to do is stare at a blank sheet of paper until drops of

blood form on your forehead."— Gene Fowler (1890-1960)

General Guidelines: Abstracts, Papers, Research Proposals..

• Follow directions

• Clear, concise writing

• Good organization – use outlines!

• Professional writing style

– Avoid colloquialism, informal language, jargon

– Use active voice whenever possible

• Appropriate fit with the focus of the journal, funder, etc.

• Adhere to ethical principles PAPERS

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Choose the Focus of the Paper

• Original research

• Review

– Systematic reviews: Various types

• Clinical topic

• Policy

• Theoretical/concept

• Editorial/opinion

• BE CLEAR ABOUT THE PURPOSE

Journal Selection

• Disciplinary/interdisciplinary perspective – audience?

• Promotion/tenure criteria

• Peer reviewed vs. non peer reviewed

• Impact factor

• Format, style, length

• Focus: research/clinical/policy

• Online vs. print/online

• Audience

• Open access vs. traditional

Strategies for success

• Good match with journal

– Topic

– Style

– Expertise level

• Set aside consistent time for writing

• Be organized

• Seek & accommodate feedback

• Volunteer to be a journal reviewer

• Use a bibliographic database (e.g., Endnote/RefWorks)

• Write the results first

• Use an editor

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Traditional and Open-Access Publishing

• Federal requirement: PMCID numbers for open access

• Traditional Model

– Payment: Subscriptions (library/individuals)

– Criticism: One has to pay for the information

– Papers only freely available after a year or more

• Open-Access

– Payment: Author pays up to $6000

– Paper immediately available to the public

– Variable peer review quality

– Predatory publishing emerginghttp://scholarlyoa.com/2015/01/02/bealls-list-of-predatory-publishers-2015/

Publishing Ethics

• Plagiarism

• Authorship

• Duplicate Publication

• “Salami” publication

• Competing financial Interests

• Conflict of interest

• Clinical Trial Registration

• International Council of Medical Journal Editors (ICMJE)

http://www.icmje.org

Common Mistakes

• Lack of time

• Procrastination

• Lack of organization

• Poorly developed writing skills

• Lack of well developed idea

• Poor organization

• Poor fit with journal content and focus

• Failure to edit

• Lack of collaborators’ input

http://www.icmje.org

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Addressing Critiques

• Manage your emotional response

• Reconcile divergent reviews

• Edit carefully

• Systematically address the comments

• Defend your ideas when it is justified

• Write a cogent letter

• Persevere!

How to be a good journal reviewer

• Critical thinking, thoughtful

• Knowledgeable

• Clinical issue

• Content

• Methods

• Good writing skills

• Editing skills Nancy S. Redeker, PhD, RN, FAHA, FAAN

Editor

[email protected]

http://www.heartandlung.org

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RESEARCH PROPOSALS

Research proposals

• Plan/outline for the study

• Presents the case – “sells” the project

– Funders

– Human subjects committees

– Academic advisors

– Community of patients and/or providers

Research Proposal Components

• Abstract

• Aims

• Research Plan

• Budget

• Biosketches of Investigators

• Available Facilities and Resources

• Human subjects considerations

• NIH:

– Innovation

– Inclusion of minorities, children, women

– Public health relevance

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Successful Proposals

• Significant problem

• Innovative idea – approach, conceptualization of problem

• Fit with funders’ interests

• Rigorous research plan

• Access to appropriate resources

– Personnel with expertise

– Institutional commitment

– Budget

– Other resources: Facilities, Programs

– Human subjects

• Realistic and feasible approach

Strategies for Success

• Budget your time

– “Proposal writing is like a sponge” (M.Grey)

• Carefully follow the guidelines

• Make connections with the funder

• Have others review

• Edit, edit, edit

• Develop partnerships

– Expertise

– Mentorship

• Access to resources

Team Building

• Good research is not a solo enterprise

• Develop and nurture a strong team

– Other scientists

– Clinicians

– Mentors

– Patients

– Families

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Purpose

• What is the goal of your study?

– Be explicit

• Include measureable specific aims

• Hypotheses or research questions

• Example….

Cognitive Behavioral Therapy forInsomnia in Stable Heart Failure (NR011387)

Redeker NS, Andrews L, Cline J, Mohsenin V, Jacoby, D, Anderson G

• Evaluate the feasibility and preliminary efficacy of CBT-I for patients with stable HF

– Develop and manualize treatment and attention-control conditions

– Conduct pilot 2 group RCT: Group-based 8 week intervention (4 meetings, 4 telephone calls)

• CBT-I

• Attention-control: Heart failure education

– Evaluate preliminary efficacy: insomnia, sleep, daytime symptoms, functional performance

Significance

• Why is the study important?

• How many people have the problem to be addressed?

– Epidemiology?

• How will your study change science, practice, or patient outcomes?****

• If you are successful, what will be different?

• How does the study fit with the funder’s priorities?

• Use direct and bold language

• Make the case… “sell” the study

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Background

• What has previously been done?

– Focus on last 5 years

– Use primary evidence-based references

• What gaps will your study address?

• Be focused

• Be critical

• Synthesize the literature

Organizing framework

• Usually graphical + narrative

• Roadmap

• Based on theory, concept and/or empirical data

• Helps the reviewer to visualize the study and its concepts

• Example….

Functional Performance

6 Min walk Test

Daily activity (Actigraph)

SF-36 Physical Function

Fatigue

Excessive

Daytime

sleepiness

Mood

Disturbance

Demographic

Variables

Age

Gender

Clinical Covariates

Ejection fraction

NYHA Functional

Class

Atrial fibrillation

Co-morbidity

Medications

Sleep Disorder Variables

Apnea/Hypopnea Index

Central Apnea/AHI Index

Time @ O2 Sat < 90%

Periodic Limb Movement

Index

Sleep Disturbance

Continuity

Duration

Quality

Insomnia Sx

Nocturnal Symptoms

Parox Noct Dyspnea

Nocturia

Orthopnea

R01 NR 008022

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Self Management of Sleep

DisturbancePredisposing/Precipitating/

Perpetuating Factors

Genetics/Biology

Primary sleep disorders

Age, Gender

Medical/Psychiatric

Comorbidity/Injury

Medications

Cognitions/Beliefs/Perceptions

Behavior/stress

Outcomes

Self-Management

Daytime Function

Daytime

sleepiness/Symptoms

Morbidity – injury, illness

Mortality

Quality of Life

Health Care

Utilization/Costs

Sleep Disturbance

Preliminary Studies

• Your own and your collaborator’s work

• Make the case for

– The approach to the problem

– The team’s experience

– Pilot datas

• Use tables for clarification.

• Include collaborators who complement your experience

CBT-I (N = 25) Attention-Control (N = 19) P-value

Pre Post Pre Post

Fatigue 28.16 (12.74) 19.94 (10.33) 23.41 (11.21) 24.38 (9.94)

Pre/post (paired t-test) p = .0268 p = .9003 .1365

Sleepiness 7.16 (5.16) 6.56 (4.15) 7.65 (4.65) 6.84 (4.48) .6549

Pre/post (paired t-test) p = .4466 p = .3612

Depression 13.72 (9.24) 12.33 (11.20) 16.76 (10.47) 15.00 (8.17) .6192


Anxiety (STAI) 36.27 (12.01) 34.82 (14.41) 37.91 (13.80) 37.13 (10.47) .7510


Physical Funct Comp (SF-36) 26.86 (2.02) 27.46 (1.96) 27.11 (2.24) 27.11 (2.19) .3517


* Analyses controlled for age and comorbidity

Effects of CBT-I on Symptoms and Daytime Functional Performance

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Methods: Key components

• Design

• Setting

• Sample

• Procedures

• Variables and measures – reliability/validity

• Data Analysis

– Qualitative or Quantitative

• Realistically discuss problems and strategies you will use to address them

Setting

• Describe characteristics of patient population and providers as relevant

– Number

– Demographics

• Evidence of support for access

– Letters if grant allows

– Be specific

Sample

• Inclusion criteria

• Exclusion criteria

• How will participants be identified and recruited?

-Where?

By whom?

Methods?

• Sample size

– Power analysis

– Effect size, power, alpha level

– Rationale even if qualitative study

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Inclusion/Exclusion Criteria: Example

• Stable NYHA Class II-IV HF

– No hospital admissions within 4 weeks of enrollment

– No unstable medical or psychiatric disorders

• Insomnia severity index > 7

• No more than mild sleep disordered breathing or adherent to CPAP (at least 6 hours/night > nights/week)

• Exclusions: renal failure, cognitive impairment, seizure disorder

Procedures

• Describe in detail so others could replicate

• If an intervention:

– Describe it in detail

– Describe control group or usual care in detail

• Should be replicable by others

Recruitmentvisit

(Clinic)

Assessment visit

(Clinic)

Home (3 days)

Conclusion of Actigraph

Assessment

Physician /NP screen and referralExplain studyConsentRe-screening

Health and sleep historyMedical record review6 Minute WalkQuestionnaires

Actigraph –3 daysDiaries – 3 days

NPSG – unattended in home environment

Protocol

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Variables Measures

Self-report sleep quality, duration, latency, efficiency

Pittsburgh Sleep Quality Index (PSQI

Insomnia Severity Insomnia Severity Index (ISI)

Sleep duration, latency efficiency Wrist actigraphy (Respironics Minimitter Actiwatch) – 2 weeks

Depression Centers for the Epidemiology of Depression Scale (CESD)

Fatigue Global Fatigue Scale

Anxiety Spielberger State Anxiety Scale

Excessive Daytime Sleepiness Epworth Sleepiness Scale

Functional Performance MOS SF-36

Data Analysis

• Quantitative

– Address in order of the study aims/hypotheses

– Use a statistician!

• Qualitative

– Methods to assure rigor and trustworthiness of data collection and analysis

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Timeline

• Provide sufficient detail so that reviewers can understand the progression

• Be realistic

• Don’t over commit

Timeline: Example

Activity Quarters of Year 1

Q1 Q2 Q3 Q4

Hire research assistant X

Recruit subjects X

Collect Data X X

Analyze Data X

Present/publish findings X

Writing style

• Use active voice

• Avoid anthroporphisms, e.g., “the study will…”

• Never assume that reviewers are familiar with the field, but don’t talk down to them.

• Use short clear sentences

• Use topic sentences and summaries

• Avoid jargon and abbreviations as much as possible

• Use plenty of white space

• Avoid excessive underlining or bolding

• Use recommended type face, spacing, margins

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Common pitfalls

• Lack of clear purpose, aims, hypotheses

• Lack of significant problem (or insufficient explanation that it is significant)

• Lack of innovation

• Under-powered sample

• Poorly chosen or unreliable measures

• Unsophisticated or inappropriate statistical methods

• Inconsistency between scope of work and available resources

Things that make reviewers mad

• Unclear or cluttered writing

• Lack of clear ideas

• Lack of familiarity with literature or other work in the field.

• Typos

• Lack of organization

• Having to look for things

• Over-com

Submitting the Grant

• Make connections with program staff

• Submit with a clear cover letter

– NIH: institute, study section

• Be on time

• Edit, edit, edit

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After submission

• Take a (short) break

• Keep working on other things

• Revise and resubmit

– Be comprehensive in response

– If disagree with reviewers, say so, but justify

SCIENTIFIC ABSTRACTS

Abstract Formats

• Follow directions!

• Explicit purpose

• Brief methods

• Key results

• Conclusions link with results

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Sleep, Glucose, Regulation, and Diabetes

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