Amy J. Markowitz, JD amyjmarkowitz@alum.wellesley 415-307-0391

1. Publishing and Presenting Clinical Research 2012 Amy J. Markowitz, JDamyjmarkowitz@alum.wellesley.edu415-307-0391 Week Four

2. The Discussion • Answers the question that got the whole ball rolling • Explains what it all means

3. The Issue - Set Up in the Intro DOT #1Breastfeeding protects against gastroenteritis, lower respiratory infection, and other infectious diseases in infancy. DOT #2 Longer duration of exclusive breastfeeding is associated with greater benefit. Low breastfeeding confidence in the first week of life predicts early breastfeeding discontinuation, and DOT #3 poor infant weight gain has been associated with reduced breastfeeding confidence.

4. Remind them of the question; Signal that it has been answered THE QUESTION POSED IN THE INTRO: First-day weight loss is routinely measured for newborns, but no studies have examined whether greater weight loss in the first day predicts subsequent weight loss. THE ANSWER THAT OPENS THE DISCUSSION: Our study reveals that newborn weight loss in the first 24 hours is a strong predictor of eventual weight loss during birth hospitalization.

5. Oh yeah? Prove it. • Infants with weight loss ≥4.5% by 24 hours have an OR of 3.57 (1.75, 7.28) for total weight loss ≥10% prior to hospital discharge in multivariate analysis. • Even weight loss of 4% by 24 hours is associated with a 2-fold increase in odds of eventual weight loss ≥ 10%.

6. S-P-E-L-L I-T O-U-T I-N W-O-R-D-S DOT #1: Since exclusive breastfeeding is an important preventive intervention, and DOT #2 since weight loss of ≥ 10% is often considered an indication for formula supplementation, CONNECTION OF DOTS 1 & 2: infants with high early weight loss should be considered a priority for lactation assistance to promote continued exclusive breastfeeding.

7. Framing the Wrap-Up • What grabbed you about your results? • Was there an expected or unexpected finding? • If you are presenting something new, build the case in a logical order – eg, is this study the result of a long line of similar research that is “confirmatory, but”? • Is it presenting a new theory to explain an old phenomenon? Is it rebutting a long-held belief in the field? • Does it have implications for research policy or social policy? • Will it be a useful “tear-out” with pragmatic clinical utility?

8. Segues About Context and Other Interesting Things • These results are consistent with… • Our result suggest… • We believe our findings… • Why might our results differ from…? • We made several other observations…

9. ARRON’S RULE AVOID GIVING THE REVIEWER THE OPPORTUNITY TO REVIEW THE PAPER YOU DIDN’T WRITE, AS OPPOSED TO THE PAPER YOU DID WRITE

10. Limitations • Careful, not defensive, explanation • Anticipate critique of your methodology or study design and present the reasoning behind your choices • Your design and study criteria were well thought out in the beginning – now is not the time to have a crisis of confidence • This is notMea Culpa, Mea Culpa, Mea Maxima Culpa

11. Reasonable minds could differ, but… • If you could do it over… • Be reasonable: Don’t suggest a randomized double-blind placebo-controlled trial in 20,000 patients if it’s not appropriate • Problems in design, sample, measurements, analysis, interpretation, and why these matter • Alternatives that you did not address

12. Our study has several important limitations. First, we examined inpatient weights only. Since greater early weight loss could lengthen hospital stay, and since longer length of stay would capture weight nadir for more infants, our results could be biased toward a relationship between early weight loss and subsequent in-hospital weight nadir.

13. Walk through the alternative If this were the case, we would expect that infants with higher early weight loss would be more likely to have weights documented subsequently during birth hospitalization.

14. Confirm that the alternative is not plausible, or less plausible However, our study showed that infants with higher weight loss at <24 hours were less likely to have a weight recorded at 24-48 hours, and we found no relationship between weight loss at <24 hours and whether or not infants had a measured weight at 48-72 hours, 72-96 hours, or 96-120 hours.

15. Conclude With An Implication and the Road Ahead Infants with high weight loss at <24 hours appear to be at increased risk of greater subsequent weight loss. These infants should be considered for priority lactation support if resources are limited. Further research should explore the relationship between weight changes early in hospitalization and infant inpatient and outpatient outcomes, adjusting for clinical predictors available early in hospitalization.

16. Choosing a journal • Strategy 1 • Ask senior colleagues for likely, possible, and reach suggestions • Send to one of the “possibles” • Send to a “likely” if in a hurry • Strategy 2 • Find the most equivalent published article • Aim a notch lower

17. What happens at a journal? • Log-in; administrative review • Editorial review • Yea or nay from 1-2 “screening” editors • Directly to associate editor in that area • Unanimous “nays” = rejection

18. Why an initial rejection? • T not true • R not relevant • A not appropriate • I not interesting • N not novel

19. Reviews, internal and external • Read through the reviews twice • You will be offended by everything the first time, and begin to appreciate some of the merits by the second time • Consult with your co-authors

20. Take a step-wise approach • Begin the explanatory Response to Editor letter simultaneously with your revisions • The tone should be respectful but not obsequious • Address each comment, in numeric order, citing to the page and line where you’ve made the revisions - as relevant, add the actual text to the letter once it is finalized in the manuscript • Where logical, group comments so that they are more easily addressed, eg, comments from each of three reviewers that address the same issue in methods, results, or discussion

22. What if the reviewer has completely missed the point? Consider whether: • You have presented the idea abstrusely; try rewriting unless this undermines the integrity of the idea • The reviewer (generally an expert in the field, wed to their point of view) a) has a vested interest in your being incorrect, b) has just been proven wrong by your results, or c) did not read the paper carefully

23. Re-consult • Check your intra-reviewer-rater reliability • What if MOM and DAD disagree???? • Get your gumption up, be thoughtful, and make a decision - you must resubmit - now’s the time…

24. Greg’s Reviewer’s Misread

25. Original Figure 3 and Legend

26. Abundance of Caution

27. Response and Lessons Learned • Dealing with easy fixes, eg, adding the “n=“ • Dealing with the complimentary bombshell

28. Praising with faint damn? Reviewer #2: 1. The manuscript is written well and makes appropriate use of tables and figures. 2. The methods are strong and the conclusions are supported by the results. • As noted by the authors, a significant deficiency of the study is the number of patients in whom coronary sinus samples could not be obtained and the drop-out rate during follow-up. I recognize the practical limitations of clinical studies and the challenges of acquiring data, but manuscript would be more robust if the authors were able to improve the follow-up data Thank you for your comments. We have not been able to obtain additional follow-up on the subjects enrolled in this study. As described, we made efforts to demonstrate that the baseline characteristics of those that did and did not follow-up (or those with and without coronary sinus blood) did not differ. In addition, we believe the addition of a comparison group that arises from the same general “study base” and that also underwent an ablation procedure should strengthen our findings. Ultimately however, we do certainly acknowledge these limitations.

29. Ralph’s Reviews Reviewer #4: First of all let me acknowledge that I appreciate the complexity of evaluating any mass media campaign, particularly one that is very short term with limited funding. This is an interesting and complex paper as currently constructed. I found many parts difficult to follow and lacking in methodological details necessary to properly interpret the results. Having said that, I think, with much revision, some parts merit publication (if not by Medical Care, perhaps elsewhere).I am trying to make my comments constructive. I absolutely disagree that this campaign is an example of a wide-scale MM campaign to affect office visit and antibiotic use... In summary, I think there is too much in this one paper. … The MM campaign does not fly with me at all.

30. Ralph’s Response The easy fix:

31. I absolutely disagree that this campaign is an example of a wide-scale MM campaign to affect office visit and antibiotic use... In summary, I think there is too much in this one paper. … The MM campaign does not fly with at all with me. • Please see response to Reviewer #4, Comment #7 regarding media exposure/impressions. • Both the preceding office and household educational intervention (Gonzales R et al. Health Services Research 2005;40:101-16) and the mass media campaigns were based on the logic that reducing office visits was one possible (and perhaps, most effective) means for reducing inappropriate antibiotic use; the other key means was increasing appropriate prescribing behavior by providers. The small media materials for households and patients incorporated information that was designed to assist families to make appropriate decisions about whether medical care was warranted for symptoms of colds or bronchitis, to challenge assumptions that antibiotics are required for colds or bronchitis, and to put the issue of antibiotic use for ARIs on the agenda for discussion with a provider. The mass media messages contained less detail than the household and clinic materials for patients, but were also designed to provoke questioning about the need for antibiotics for various respiratory symptoms and illnesses. We recognized that if a healthcare decision-maker in the family (e.g., the mother) no longer believed that antibiotics would help colds and coughs, she might be less likely to seek care. This is based on the multitude of studies that have found that desire and perceived need for antibiotics—for symptom relief—is a major reason that patients seek care for these illnesses. In social marketing terms, in this project a critical difference between doers and non-doers was the idea that antibiotics were necessary for treatment of ARIs (see W Smith references below; also, William Smith was the chief AED consultant on the Get Smart Campaign). • Smith, W. (1998). Social marketing: What's the big idea? Social Marketing Quarterly, Vol. IV, Number 2, 5-17. • AED. Social Marketing Lite: Ideas for Folks with Small Budgets and Big Problems. http://www.aed.org/ToolsandPublications/upload/Social%20Marketing%20Lite.pdf or at http://www.eric.ed.gov/ERICDocs/data/ericdocs2sql/content_storage_01/0000019b/80/17/30/ea.pdf

32. Response and Lessons Learned Dear Dr. Gonzales, I am pleased to inform you … *************************************************************** How many papers have we got here?

33. What if the reviewer has completely missed the point? • Tough. You must explain to the journal editors why it is that you have chosen not to revise in accordance with the reviewer’s comment, and be prepared to support your point of view.

34. Kathy’s DilemmaChest: Round 2 Reviewer: 1 • Yang et al have addressed my comments adequately. Reviewer: 2 • Yang and colleagues have made a very minor effort to revise their paper and to satisfactorily answer concerns that I had in the original paper. Most importantly, they have made no effort to look at the relationship between Pseudomonas aeruginosa surveillance cultures and the appropriateness of empiric therapy that was used. Reviewer: 3 • Dr Yang responded to all my previous comments.

35. Response and Lessons Learned • Submit elsewhere? • Change the focus? • Consult with a non-co-author colleague?

36. Shave and a Haircut • Address stylistic editorial comments after the substantive revisions • Stylistic issues frequently relate to length • Reduce to tabular or graphic form any appropriate demographic descriptions of study subjects, or less intrinsic data and descriptors • Do not repeat in text what is best presented in a table or figure • Give your co-authors one last shot, WITH A DEADLINE, then: pull the trigger