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HANDOUT Accompaniment to Webinar

“APPROACH:How to Write The Section

That Correlates Most Closely With Your Overall Score”

March 16, 2016

Dr. Margaret Bouvier

All materials for this training Copyright© 2016

Meg Bouvier Medical Writing, LLC.

No portion of this booklet, or the presentations, or any other materials pertaining to this training may be reproduced in part or whole in any way or for any reason.

Copyright © 2016 Meg Bouvier Medical Writing, LLC 2

APPROACH: How to Write The Section That Correlates Most Closely With Your Overall Score

Research Plan: Significance, Innovation, Approach (3 main subheaders)6 pages (R03, R21; some projects within larger P & U awards) 12 pages (R01, R15, R34, some U01s)

APPROACHNIH INSTRUCTIONS FROM SF424: (the underlining is Meg’s)

•Describe the overall strategy, methodology, and analyses to be used to accomplish the specific aims of the project. Unless addressed separately in Item 15 (Resource Sharing Plan), include how the data will be collected, analyzed, and interpreted as well as any resource sharing plans as appropriate. •Discuss potential problems, alternative strategies, and benchmarks for success anticipated to achieve the aims.•If the project is in the early stages of development, describe any strategy to establish feasibility, and address the management of any high risk aspects of the proposed work. •Point out any procedures, situations, or materials that may be hazardous to personnel and precautions to be exercised. A full discussion on the use of select agents should appear in Item 11, below.

If an applicant has multiple Specific Aims, then the applicant may address Significance, Innovation and Approach for each Specific Aim individually, or may address Significance, Innovation and Approach for all of the Specific Aims collectively. As applicable, also include the following information as part of the Research Strategy, keeping within the three sections listed above: Significance, Innovation, and Approach.

Preliminary Studies for New Applications: For new applications, include information on Preliminary Studies. Discuss the PD/PI’s preliminary studies, data, and or experience pertinent to this application. Except for Exploratory/Developmental Grants (R21/R33), Small Research Grants (R03), and Academic Research Enhancement Award (AREA) Grants (R15), preliminary data can be an essential part of a research grant application and help to establish the likelihood of success of the proposed project. Early Stage Investigators should include preliminary data (however, for R01 applications, reviewers will be instructed to place less emphasis on the preliminary data in application from Early Stage Investigators than on the preliminary data in applications from more established investigators).


FROM NCI GRANT APPLICATION GUIDELINES: Purpose: The purpose of the approach section is to describe how the research will be carried out. This section is crucial to how favorably an application is reviewed. Recommended Length: The maximum recommended length of the approach section is 9-10 pages. Content: The research design and methods section should include the following:

• PI’s preliminary studies, data, and experience relevant to the application and the experimental design; • the overview of the experimental design; • description of methods and analyses to be used to accomplish the specific aims of the project; • discussion of potential difficulties and limitations and how these will be overcome or mitigated; • expected results, and alternative approaches that will be used if unexpected results are found; • a projected sequence or timetable (work plan); • if the project is in the early stages of development, describe any strategy to establish feasibility, and address the management of any high risk aspects of the proposed work; • detailed discussion of the way in which the results will be collected, analyzed, and interpreted; • description of any new methodology used and why it represents an improvement over the existing ones;

SuggestionsNumber the sections in this part of the application to correspond to the numbers of the Specific Aims. 1. Preliminary data, or a progress report, may be included before the Specific Aims sections. Alternatively, integrate preliminary data with the methods description for each Specific Aim. Preliminary data can be an essential part of a research grant application and helps establish the likelihood of success of the proposed project.

2. Avoid excessive experimental detail by referring to publications that describe the methods to be employed. Publications cited should be by the applicants, if at all possible. Citing someone else's publication establishes that you know what method to use, but citing your own (or that of a collaborator) establishes that the applicant personnel are experienced with the necessary techniques.

3. If relevant, explain why one approach or method will be used in preference to others. This establishes that the alternatives were not simply overlooked. Give not only the "how" but the "why."

4. If employing a complex technology for the first time, take extra care to demonstrate familiarity with the experimental details and potential pitfalls. Add a co-investigator or consultant experienced with the technology, if necessary.

5. Explain how the research data will be collected, analyzed, and interpreted as well as any resource sharing plans as appropriate.

6. Develop alternative strategies for potential problems.

7. Document proposed collaborations and offers of materials or reagents of restricted availability with letters from the individuals involved.

8. Point out any procedures, situations, or materials that may be hazardous to personnel and precautions to be exercised (i.e., use of Select Agents)


MEG’S ADDITIONAL THOUGHTS:

No prescribed structure. There are many ways to write an effective Approach section.

Avoid long paragraphs. They are especially difficult to read on a monitor.

Tell a story. Build as you go along, adding facts that build on the previous facts. Make sure it is logical to an outside reader. (Have several, carefully chosen outside readers look at it.)

OK to use acronyms as long as you spell the word out at the beginning of each new section. “We treated cultures with platelet-derived growth factor (PDGF). The PDGF-treated cultures exhibited positive staining.” If many acronyms, provide a legend on the first page in a text box.

Citation strategy: SF424 is silent on this issue. Choose numbered superscripts (saves space) or the authors, year strategy (emphasizes that you or members of your team conducted seminal or key studies in the field).

Make it skimmable! Only your reviewers will read it, and they are unlikely to spend hours and hours on it. Format with care.

OrganizationFormatting and PresentationFigures and Tables (can use 9- or 10-pt font)

Use all your allowable space—your competitors sure will.

No contractions. You must spell the words out (ex: cannot vs. can’t) One of five scoring criteria. It is typically the worst score, and the one that correlates most

closely with the overall score.

A word about verb tenses:

”We performed these experiments…” (past tense)BUT “Our data show that…” (present tense because part of body of knowledge)

WHO IS YOUR AUDIENCE?Peers. The only people who are likely to read every word of your Approach section are your three assigned reviewers from the Study Section. Everyone else will skim during review.

Instructions to Reviewers: Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed? If the project involves human subjects and/or NIH-defined clinical research, are the plans to address 1) the protection of human subjects from research risks, and 2) the inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion (exclusion) of children, justified in terms of the scientific goals and research strategy proposed?


Elements typically included (not necessarily in this order)BEGINNING

• Background

• Overview

• Team

• Preliminary data (if global)

• Methods (if global)

MIDDLE• Aims

Hypothesis

Methods, preliminary data (if not global)

Data analysis

Expected results

END Potential problems/alternative strategies

• Timeline

• Future directions


Same Overview paragraph:

“Our goal in this study is to determine the stress levels of faculty writing NIH grant submissions. In this pre-post design, we will recruit 100 men and women between 30 and 65 years old to examine change in stress level in the month leading up to a major NIH submission. We will obtain baseline measures of… 6 months prior to submission. We will measure … on days 7, 14, 21, and 28 in the month leading to submission. We chose this dose and timing because… Our outcome measures are… We will analyze the data using… We will examine sex, age, race, and ethnicity as outcome measures. Data will be stratified based on number of unsuccessful submissions prior to the current submission to ascertain effect of repeat failure on stress levels. Ultimately, our goal is to shed light on the factors influencing stress in this demographic in order to inform interventions in this under-examined, highly stressed cohort.”

Sample of Team information in paragraph form (Of course, this sample is completely hypothetical. No experienced NIH grantee would ever leave that much white space between lines of text.)

MULTIDISCPLINARY TEAM

Alexander Hamilton, PhD (PI). Associate Professor, University of Scandal, New York, NY. Dr. Hamilton is expert in scandalmongering, and will lend his considerable experience in creating crisis and chaos throughout the project period.

John Adams, MD PhD (Co-I). Professor, University of High Morals, Quincy, MA. Dr. Adams is renowned for moralizing to others. He will bring his well-known obstreperous nature to bear on the experiments in Aim 2.

Thomas Jefferson, MD MPH (Consultant). Associate Professor, University of VA. Dr. Jefferson will soothe the conflicts between the PI and Co-I during Aim 3 experiments with his dulcet violin pieces.


Hypothetical example of a team table for a multi-site study:

Table X: Westerosi Translational Research and Behavior Redirection Design (WTRBRD) Multidisciplinary Research Team. Our experienced, highly diverse team of investigators has extensive expertise in human behavior research, manipulation science clinical trials, and swordsmanship techniques. (See biosketches for qualifications, Budget Justification for a description of complementary roles.)

WINTERFELL UNIVERSITY (WU)Eddard Stark MD PhD (PI), Associate Professor of Rigid Morality. He has collaborated with team members at the other four sites for several decades. Dr. Stark is a board-certified behaviorist with training in gullibility; he has published >110 papers on the topic and currently is PI of a project to assess gullibility in a variety of race/ethnicities and ages. These projects are funded by the United States Agency for Political Intrigue. His experience as a successful swordsman, his previous collaboration with the project sites, and his experience in developing multidisciplinary collaborations make him the ideal leader of this research team.Robb Stark PhD (Co-I), Professor, Department of Hubris, School of Public Humiliation. Dr. R. Stark has expertise in youthful folly and will lead a team of sycophants in Aim 1 studies.

THE WALL HEALTH SCIENCE PROGRAM (WHSP)Jon Snow MD (Site PI) is WHSP Chief Medical Officer. Dr. Snow has been a human behavior investigator since 1998 and directs WHSP’s wolf breeding program. He was the youngest director ever appointed. He will oversee Aim 2 studies.Samwell Tarley MD, PhD (Co-I) is The Wall’s lab director and resident aviary behaviorist. He is currently completing a second PhD at King’s Landing on susceptibility to manipulation in political situations, and how it is influenced by exposure to attractive rulers with high cheekbones.

KING’S LANDING UNIVERSITY (KLU)Cersei Lannister PhD (Co-I). Dr. C. Lannister provides expertise in behavioral, cellular, molecular, and genetic forms of manipulation of the human species, especially those humans who direct other clinical sites. She has worked in the field for over 30 years.Tyrion Lannister, MD PhD MPH JD (Co-PI). Dr. T. Lannister lends his talents and wealth of experience to directing the KLU. He will serve as Co- PI and oversee all work within the KLU. He is world renowned for his knowledge of the influence of height on political behavior and power. He is the only team member with expertise in pyromancy (see Protection of Human Subjects section) and will oversee all pyromancy studies in Aim 3a.

HIGH GARDEN COLLEGE (HGC)Margaery Baratheon PhD (Site PI), Professor and Director of Infectious Laughter. She is an expert in utilizing feminine wiles to manipulate behavior, with 18 years experience performing studies in southern regions of the Kingdom.Loras Tyrell MS (Consultant) has worked with the team for 8 years and is an expert in artistic presentations of the scientific material. As in the past, he will create a museum exhibit at the HGC Children’s Museum describing the study aims and outcomes.

DOTHRAKI INTRAMURAL PROGRAMDaenerys Targaryen PhD (Co-I), Senior Investigator, Head of the highly prestigious International Dragon Transgenic Facility (IDTF). Targaryen will oversee the dragon transgenic animals used in the study and all dragon in vivo studies in Aim 3b. She is the Director of the NIH International Center for Excellence in Dragon Research (I-CEDR), and has won numerous awards for her pioneering work in the field.


A strategy for formatting pilot data (my favorite):

Pilot Study 1: The use of our novel smartphone app appears to be feasible in the target population. Method: We implemented…. We analyzed… Results: We found that… Our pilot data suggest that… Next Step: In the proposed project, we plan to deploy the use of our novel app in a larger cohort by…

Pilot Study 2: Our team is able to recruit more than sufficient numbers in this cohort to power the proposed study. Method: In an unrelated study in the same demographic in our medical center, we… Our recruitment method in our medical center included… We enrolled people by… Our retention strategy was… Results: We were able to successfully recruit and enroll xxx individuals for a prior study… Next Step: We anticipate using the same successfully strategies in the proposed project to…

An example of headers/subheaders for the Aims

AIM 1: Evaluate the influence of writing an NIH grant submission on self-reports of stress among grantees aged 30-65 years.

Hypothesis:

Methods:

Preliminary Data:

Data Analysis:

Expected Results:

AIM 2: Measure the effect of writing an NIH grant submission on cortisol levels in grantees.

Hypothesis:

Methods:

Preliminary Data:

Data Analysis:

Expected Results:


Sample Timelines


Year 1 Year 2 Year 3 Year 4 Year 5F Sp S F Sp S F Sp S F Sp S F Sp S

AIM 1 Pilot test/feasibility X X Train assistants X X Recruitment X X Data collection X X X Data Analysis X X XAIM 2 Analysis X X X Dissemination X X XAIM 3 Collect Time 2 X X Collect Time 3 X X Data Analysis X X X Dissemination X X XPrepare/Submit next R01 X X X X

Another Sample TimelineMilestone 1a corresponds to Specific Aim 1a.)

Timeline of quantitative milestones by quarter during the four-year project period

Milestone 1.a: Track thrombi in real-time using 3D Transesophageal Echocardiography in beating phantom heart model and pig heartQ1 Q2 Q3 Q4 Q5 Q6 Q7 Q8 Q9 Q10 Q11 Q12 Q13 Q14 Q15 Q16

Milestone 1.b: Add imaging capabilities through or on the robot’s end-effector

Milestone 1.c: Develop and test in phantom and pig heart imaging protocols for intraoperative real time X‐ray and Cone Beam CT imaging of heart and surgical instruments.

Milestone 2.a: Develop a rigid/stable robotic system to access the chest cavity

Milestone 2.c: Develop a flexible/dexterous system for intracardiac operation

Milestone 3.a: Develop interactive intervention planning system to manually select the target in live images (Aim 1) and automatically control the robot (Aim 2) to reach the target.

Milestone 3.b: Develop quantifiable measures of performance of the imaging, robotic, and control systems in phantom and animal model. Perform phantom tests of the entire system. Perform animal test of the entire system.


NEW Scored Criteria for Reviewers

APPROACH• Have the investigators presented strategies to ensure a robust & unbiased approach, as

appropriate for the work proposed?• Have the investigators presented adequate plans to address relevant biological variables, such

as sex, for studies in vertebrate animals or human subjects?

SAMPLE: R-series grant app submitted Cycle I 2016Written by Marc Adams PhD, MPH, Arizona State University

Reproducibility and Transparency: We will aim to make this study transparent and reproducible by schools and by other researchers in several ways to enhance rigor and external validity. First, we will purchase salad bars that are commonly used by Let’s Move Salad Bars to Schools from commercial vendors, which makes the equipment easily accessible to schools and comparable to the most common program promoting salad bars. Second, instead of designing our own marketing materials, we will adopt and adapt existing low- or no-cost materials. Third, we will aim to thoroughly describe our interventions and plate waste methodology in future publications so that schools and researchers can reproduce the interventions and measurement approach. We have published two papers describing our plate waste methods and several researchers cited our papers as guiding their own use of plate waste methodology. Fourth, the primary aim of this application is to replicate the salad bar intervention across elementary, middle and high schools. Although we will be reproducing our own work, this application will conduct systematic replication to answer whether salad bars work differentially by grade level. Finally, we will make these datasets available on request to journals for publication of research and we will establish a committee of the Co-I’s to share data with others researchers interested in publishing secondary analyses not proposed by our primary and secondary aims.

R34 SUBMITTED FEB 2016


R01 SUBMITTED FEB 2016

MEG’S SUMMARY OF RIGOR AND TRANSPARENCY CHANGES FOR 2016 AND BEYOND:


SAMPLES:

Very simple header and numbering strategy for Approach (one of my favorites)

APPROACH

OVERVIEW

TEAM

PRELIMINARY STUDIES

METHODS

AIM 1: Word exactly as in one-pager1.a Methods1.b Data analysis1.c Expected results1.d Potential problems, alternative strategies

AIM 2: Word exactly as in one-pager2.b Methods2.b Data analysis2.c Expected results2.d Potential problems, alternative strategies

TIMELINE

FUTURE DIRECTIONS


A slightly simplified header strategy used on a recent successful RCT

APPROACHPRELIMINARY STUDIESBegin text here

STUDY DESIGN

STUDY POPULATIONInclusion/Exclusion criteria. Begin text here..Study sample.

SURVEY METHODSPatient selection and enrollment.Survey administration.Retention.

PROPOSED MODELConstructs assessed at baseline.Demographics: Begin text here..Behavior:Health:Psychosocial:

Constructs assessed at all time pointsBehavior:Health:

AIM 1: Word identically to one-pagerHypothesis.Methods.Outcome assessment.Statistical analyses.

AIM 2: Word identically to one-pagerHypothesis.Methods.Outcome assessment.Statistical analyses.

LIMITATIONS AND CHALLENGES

TIMELINE

FUTURE DIRECTIONS


Same RCT sample, with a rather typical numbering scheme inserted

C. APPROACHC.1. PRELIMINARY STUDIESBegin text here

C.2. STUDY DESIGN

C.3. STUDY POPULATIONC.3.a Inclusion/Exclusion criteria. Begin text here..C.3.b Study sample.

C.4. SURVEY METHODSC.4.a Patient selection and enrollment.C.4.b Survey administration.C.4.c Retention.

C.5. PROPOSED MODELC.5.a Constructs assessed at baseline.Demographics: Begin text here.Behavior:Health:Psychosocial:

C.5.b Constructs assessed at all time pointsBehavior:Health:

C.6. AIM 1: Word identically to one-pagerC.6.a Hypothesis.C.6.b Methods.C.6.c Outcome assessment.C.6.d Statistical analyses.

C.7. AIM 2: Word identically to one-pagerC.7.a Hypothesis.C.7.b Methods.C.7.c Outcome assessment.C.7.d Statistical analyses.

C.8 LIMITATIONS AND CHALLENGES

C.9 TIMELINE

C.10 FUTURE DIRECTIONS


A. SIGNIFICANCESCIENTIFIC PREMISE- give the background info here, disease burden in terms of M&M and cost, etc.

STRENGTHS/WEAKNESSES OF PRIOR STUDIES- discuss the literature that directly relates to your proposed study. Review the strengths and weaknesses, and how the literature informs the current study design.IMPACT: B. INNOVATION

Competitive analysis—what’s different, better about your approach C. APPROACH

C.1. Overview. C.2. Research Team.

C.3. Preliminary Studies.

C.4. Study Design.

Sex & Other Biological Variables: Because the intervention focuses on pregnant women, the study is restricted only to women, and only to reproductive age. Maternal weight is an outcome measure of the study, given its importance in GDM.

Reproducibility and Transparency : We will make every effort in this application and resulting publications to give complete, detailed descriptions of methods & analyses, so that all work can be reproduced and extended.

C.5. Participant Recruitment Inclusion criteria

Include phrases like this “…has been proven to be a reliable and valid tool for XYZ and is often referred to as a ‘gold standard’ for detecting ABC.”

Exclusion criteria are listed in Fig X. Similarly, include phrases like this “ABC has been shown to be a very reliable and valid instrument.”Rationale for inclusion and exclusion criteria.

Recruitment & Enrollment.

Sample size, power calculation.

C.6 Methodology. Strategies to ensure a robust and unbiased approach: Aim 1: Describe refinement of intervention.

Aim 2:

Aim 3:

C.7. Data Analyses

C.8. Potential Problems, Alternate Strategies.

C.9. Timeline

C.10. Future Directions


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