1. 10 Easy Tips For Producing Quality Research
Mary Ellen Wechter, MD, MPH, FACOG
Gynecologic Surgery/MIGS
Baptist Medical Center
North Florida OBGYN
Jacksonville, FL
High quality research advances the science as well as the skills of the researcher.
Poor quality research only clutters the literature, may do harm, and will follow you. And it’s equally hard to do. So don’t do it.
In the end, as for most things, an investment in learn how to do research correctly and well, from the beginning, pays off a lot better than the immediate reward of just getting something in print.
But Perfect is also not the goal or you’ll never finish anything.
Rather, I challenge you as new researchers, if you are, to make your best attempt to get right the key pieces of a quality contribution and learn anew tool or skill each time you do a project or publish

2. Disclosure
I have no financial relationships to disclose.

3. Objectives
To give practical tips for completing and publishing a research project
Provide resources and tools for research

4. #1 A “good” research question/objective guides your methods
Keep a running list of obstacles or uncertainties that trip you in clinical practice
Apply FINER criteria
Write an answerable question
A good research question guides your hypothesis, objective, and your study design
How do you find your question: keep a file/running list of the questions you encounter while reading, doing clinical work, or reviewing journal articles
Apply finer criteria FINER: feasible, interesting, novel, ethical, relevant
:E.g. should I use Lupron for this patient ? Is this fibroid growth rate worrisome? Can I make my incisions heal better? Is there a way to do this surgical step more safely or efficiently? Should I give vaginal estrogen during healing after hysterectomy? Does a vaginal approach to hysterectomy have more risks for future prolapse? Does this cystocele need repair? Will repair of this rectocele last? Does vaginal laser improve sexual satisfaction, etc…
Then write a good, answerable question

5. A “good” research question is detailed
Specific measurable outcome
Well-defined population and intervention groups
Intervention, time frame and setting
The hypothesis and objective are written from the question
The more specific the question, the more appropriate your design and the more certain your conclusion
A good research question is detailed to the point where you know for sure when you’ve answered it
PICOT: population, intervention, comparison group, outcome and timing as well as setting and other variables
Not “improve pain” but “significantly reduce the postop VAS pain score”
Not “in postop patients” but “in women age who underwent robotic hysterectomy for benign disease with uterus <250 g and stage 1 or less endometriosis
Eg “By fellowship trained staff gynecologic surgeons with experience with at least 100 prior robotic hysterectomies, performed at a tertiary care setting between january 1, 2014 and december 31, 2016”
The more specific the question, the more appropriate your design and the more certain you are that you have answered your question

6. #2 Your research’s value is dependent foremost on study design
Comparative studies are stronger than descriptive
Guidelines for study reporting are a roadmap
Do a sample size calculation first
Check your analysis plan with a statistician
Comparative studies give much more information than descriptive.
Consider the difference between describing a treatment effect versus describing it as more effective than the placebo or existing treatment.
In some cases, descriptive studies could be dangerously misleading. Consider a new intervention published as a case series associated with disease resolution of 70%. That might seem pretty good, and unsophisticated clinicians might assume it works. But What if a comparative study showed the placebo group to have a disease resolution of 80%? Then the new intervention is actually harmful.
Unless the disease is new or the finding is dramatic, case series and case reports have little place in valuable literature. Please consider this your last resort.
Guidelines exist for all study types. Use them, cite them. They will improve the quality of your study, act as a checklist, indicate to reviewers that you are a legit, savvy researcher, and help teach you how to do that study type correctly.
Do your sample size calculation. You need alpha, beta, the difference you expect to find, the standard deviation. There’s no reason not to have a sample size.
You need help with your study design before you begin. Look at your question. What is the best design (RCT). What is a feasible design? Get help before you start from an epidemiologist and a statistician-primarily so you can collect covariables and limit bias before it’s too late

7. Study designs Case control Retrospective cohort Prospective cohort
Descriptive: case reports, case series, correlational
Analytical or comparative studies
Case control
Retrospective cohort
Prospective cohort
Cross-sectional survey
Clinical trials
US Preventative Services Task force levels of Evidence
Level I: at least one RCT
Level II-1: well-designed controlled trials without randomization
Level II-2: well-designed cohort of case-control, preferably >1 center
Level II-3: multiple time series with or without intervention
Level III: opinions of respected authorities

8. Guidelines for study reporting
CONSORT: randomized controlled trials
Register your trial: ClinicalTrials.gov
TREND: nonrandomized trials
STROBE: observational studies
PRISMA (formerly QUOROM) or MOOSE: systematic reviews and meta-analysis
Consider registering your systematic review: PROSPERO
STARD: studies of diagnostic accuracy
Consort: consolidated standards or reporting trials
Strobe: strengthening the reporting of observational studies in epidemiology
QUOROM: quality of reporting meta-analyses
PRISMA: preferred reporting items for systematic reviews and meta-analyses
MOOSE: meta-analysis of observational studies in epidemiology

9. #3 Decide your author order early and clarify a formula for making any changes
Senior author: usually last, usually the mentor
First author: does the most work, had the idea
Second and third author: contribute paragraphs, edit, check your analysis, contribute to the plan
Check journal for authorship requirements on number of authors and criteria for authorship
Author order should be determined up front as you ask others for participation
First author should know the journal’s guidelines for authorship and limit number for authors
Some general guidelines: first and last. if multicenter, alphabatize the rest .
Best if lead author describes expected contributions and author order rationale as he/she invites other authors.

10. #4 Write your methods and make your tables before you begin
Specify study design (correctly!)
Describe sample size calculation: 1 paragraph
Describe your design with enough detail to reproduce
Describe your analysis plan thoroughly
What software did you use
Did a statistician help
What tests did you use
How did you deal with confounding/bias
Writing the paper is often the most daunting
My advice here is two things: 1. use templates. Find a paper from the journal you’re targeting that is done very well. Use that as your template. Save it with blanks as a template for each type of study. Template your letter to editors, request for using another author’s tables, etc
2. as you design your study, fill in your template with your question, objective, methods, tables. Check this with your mentor, statistician, epidemiologist before you begin.

11. #5 Become an expert in the area of your research
You must know the literature well to write a good introduction and discussion
Do a comprehensive literature review:
Use help from librarian and track your search method
Confirm that your research is novel and important
Adding a narrative review clutters your study’s message
Become an expert: why?
1) You MUST know the literature in an area quite well to write a good intro and discussion section and to interpret the impact of your finding and identify any outlying, surprising results.
2)You’ll use your knowledge to present.
Do a comprehensive lit review so you wont miss any relevant papers and won’t have surprises. 3) Use this as an investment in doing a systematic review perhaps. Don’t include the review in your paper though!! Narrative reviews are to reviews as case series are to true research. A real review is a systematic review and or meta-analysis and that is a separate paper

12. #6 Collect a file of “research tools and ideas”
Obtain 1-2 thorough general references
The Lancet: handbook of Essential Concepts in Clinical Research (Schulz and Grimes)
SGS Research Handbook-
Female Pelvic Med Reconstr Surg Jul;17(4): SGS Research Handbook-2nd Edition.Gala R1, Hamilton-Boyles S, Sung VW.
Keep hard copy of reporting guideline (e.g. STROBE)
Keep track of validated questionnaires
Keep examples of studies and study questions that are done well
Keep a copy of good reviews of your work so you can make sure not to make the same mistakes

13. #7 Digest your results for the reader
Results: spend time to understand your results very well then tell the “story”
It is your job to make your reader understand
Avoid providing excess raw data
Provide the most informative measure of effect
If you can calculate relative risk (RCT) then do
Use OR and 95% C.I. NOT just p values
Your tables should stand alone (informative title, thorough legend)
Readers do NOT want to do math
Table 1 is expected and describes your population
One of the most common mistakes is to do all the work and then to write the paper without understanding what you’ve just learned.
spend quality time with your results and tables. Challenge yourself to Know your top 3 results by heart so that when someone asks you what you found, you can answer well from memory.
Send out your tables and raw results to your authors and mentor and get their thoughts and questions. If you’ve done the analysis yourself, ask yourself important thought questions: now why would the heaviest patients slide least and does that make any sense. Could this be from bias. Ask yourself what else you’d want to know (this is your next project perhaps)
Your tables and figures should be able to stand alone and there are expected tables/figures for certain studies. Table 1 is demographics, if rct, you don’t need p values. Table 2 is usually bivariable analysis, tables 3 and 4 multivariable or stratified results.
Figure 1 in rct is the participants flow diagram (again consort guidelines). Figure 1 in systematic review is how you arrived at your included studies. If you don’t include an expected table, reviewers will balk.

14. #8 Write a paper you would want to read
Topic sentences!
Speak simply and in active voice
Use only accepted acronyms (e.g. RHWIGSAC is not an acronym)
Avoid “this”, “that” or “it”
Be consistent with terminology throughout
Be succinct: sentences, paragraphs, and the paper
Topic sentences: you should be able to understand the research idea by reading only the first sentences
Shorter is better. Think as if you were writing your paper in bullet points. Or write it that way.
Your discussion has a formula (roughly 5 paragraphs)
Para 1: summarize major findingsNO NUMBERS. Just qualitative summary that tells the story very briefly and puts it into the larger context.
Para 2: relates your findings to existing literature: what was known previously – typically in more detail than in the introduction – and relating your findings to the previous knowledge. If there are major differences, seek to identify the potential sources for the differences.
Para 3: highlight the importance of your findings. If your results are very similar to existing literature, justify what you're adding to the literature.
Para 4: identify important limitations: After relating the discussion back to the existing literature and identifying the important contributions of your study, discuss the limitations of your work AND the potential effect of your limitations
begin the limitations section (if there is a "section) by highlighting one of the most important limitations or a limitation that follows naturally from the preceding paragraph.Preferably, the discussion of limitations can be woven into the discussion of the contribution of the paper to the existing knowledge.
Avoid simply listing the limitations. Almost always a limitation requires at least two – usually 3 - sentences – state the limitation, discuss its potential effect (i.e. the direction of the bias), discuss why it is or is not a significant problem in your paper.

15. #9 Finishing research requires momentum
Keep up to date: look at your work at least weekly
Give co-authors specific instructions and tasks
Return edits to the journal within 48hours
Re-submit to a new journal within 24hours if rejected

16. #10 Volunteer to peer review
Why:
You learn how to and how not to do research
You contribute to the journal quality
Follow a template for your reviews
Be respectful
Be helpful: a thoughtful rejection is more valuable in the long run than a careless “yes”
Keep writing. You get better each time. Include people who you trust to be ethical and to get work done. Try to work with those people again and again. Don’t be the weak link. And remember: Even small (comparative) studies done well can has the potential for great impact.

17. References
Schulz KF, Altman DG, Moher D, for the CONSORT Group. CONSORT 2010 Statement: updated guidelines for reporting parallel group randomised trials. Ann Int Med 2010;152. Epub 24 March
Des Jarlais DC, Lyles C, Crepaz N, and the TREND Group. Improving the reporting quality of nonrandomized evaluations of behavioral and public health interventions: The TREND statement. Am J Public Health. 2004;94:
von Elm E, Altman DG, Egger M, Pocock SJ, Gøtzsche PC, Vandenbroucke JP; STROBE Initiative. The Strengthening the Reporting of Observational Studies in Epidemiology (STROBE)statement: guidelines for reporting observational studies. J Clin Epidemiol Apr;61(4):
Moher D, Liberati A, Tetzlaff J, Altman DG, The PRISMA Group (2009) Preferred Reporting Items for Systematic Reviews and Meta-Analyses: The PRISMA Statement. PLoS Med 6(7): e
Stroup DF, Berlin JA, Morton SC, Olkin I, Williamson GD, Rennie D, Moher D, Becker BJ, Sipe TA, Thacker SB. Meta-analysis of observational studies in epidemiology: a proposal for reporting. Meta-analysis Of Observational Studies in Epidemiology (MOOSE) group. JAMA. 2000; 283(15):
Bossuyt PM, Reitsma JB, Bruns DE, Gatsonis CA, Glasziou PP, Irwig LM, Lijmer JG, Moher D, Rennie D, de Vet HC. Towards complete and accurate reporting of studies of diagnostic accuracy: the STARD initiative. Standards for Reporting of Diagnostic Accuracy.
Clinicaltrials.gov
Female Pelvic Med Reconstr Surg Jul;17(4): SGS Research Handbook-2nd Edition.Gala R1, Hamilton-Boyles S, Sung VW.