133. Effectiveness of Adenotonsillectomy, FDA and albuterol, Anti-Coag and hemodialysis, Tanning and Money

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3792273/
Does Rewording MRI Reports Improve Patient Understanding and Emotional Response to a Clinical Report?
Remember few weeks ago when I talked about 50% of people knew that broken bone and fracture were the same thing or that 1 in 5 pts couldn’t describe nonweight baring? Well this study looked o see what would happen if we changed the language in MRI reports
100pts-
list of all shoulder, elbow, wrist, and hand MR images ordered in 2011 was obtained from the radiology service-- The original reports were reworded to the recommended reading level for effective health education below the eighth-grade level
words such as “tear” were replaced by more descriptive and accurate words such as hole, signal change, or defect. They also used analogies (eg, gray hair, bald spot)
looked at bunch of outcomes but thing I care about was understanding—did the pt understand it and they used a 10 point scale- basically asked th pts. On 1-10 scale how did you understand that report-
The understanding score (mean ± SD) of all the original reports was lower (4.2 ± 2.3) compared with the reworded report (8.1 ± 2.6, p < 0.001)



https://www.bmj.com/content/368/bmj.m7
Objective To assess whether an association exists between financial links to the indoor tanning industry and conclusions of indoor tanning literature.
Results 691 articles were included in analysis, including empiric articles (eg, original articles or systematic reviews) (357/691; 51.7%) and non-empiric articles letters (eg, commentaries, letters, or editorials) (334/691; 48.3%). Overall, 7.2% (50/691) of articles had financial links to the indoor tanning industry; 10.7% (74/691) articles favored indoor tanning, 3.9% (27/691) were neutral, and 85.4% (590/691) were critical of indoor tanning. Among the articles without industry funding, 4.4% (27/620) favored indoor tanning, 3.5% (22/620) were neutral, and 92.1% (571/620) were critical of indoor tanning. Among the articles with financial links to the indoor tanning industry, 78% (39/50) favored indoor tanning, 10% (5/50) were neutral, and 12% (6/50) were critical of indoor tanning. Support from the indoor tanning industry was significantly associated with favoring indoor tanning (risk ratio 14.3, 95% confidence interval 10.0 to 20.4).

Listen to an interview with authors that basically point out the tanning industry is doing what the smoking industry was doing for years- trying to hide and bury and throw money at it

https://www.fda.gov/news-events/press-announcements/fda-approves-first-generic-proair-hfa
generic pro-air—problem is the drug and the delivery system!
give credit to the FDA
Under the Generic Drug User Fee Amendments (GDUFA), individual companies can meet with the FDA as part of its pre-Abbreviated New Drug Application (ANDA) program to support the development of such complex generic drug products. The FDA also publishes guidance documents describing the steps the FDA recommends companies take to submit complete applications for generic drug products.

In 2016, the FDA issued a revised draft product-specific guidance for proposed generic albuterol. the draft guidance provides bioequivalence recommendations.

And the article that has me the most stumped is this article titled
https://www.ncbi.nlm.nih.gov/pubmed/31976865
You see most of the time randomized trials of anticoagulation for atrial fibrillation exclude hemodialysis patients. However this analysis of observational studies including almost 72,000 dialysis patients sought to seek the risk and benefits of anticoagulation for those individuals with atrial fibrillation on dialysis. To me this would be no-brainer. Patient has a fibrillation makes you more prominent clot dialysis makes you more prone to clotting. Easily getting anticoagulation has to improve the rates of thrombotic events. However of the 16 studies only abixan 5 mg was associated with lower ALL CAUSE MORTALITY. Compared with placebo or no anticoagulation -warfarin and apixaban were not associated with fever embolic events. Warfarin was associated with higher risk for major bleeding then no anticoagulation

https://jamanetwork.com/journals/jamaotolaryngology/fullarticle/2766471

Effectiveness of Adenotonsillectomy vs Watchful Waiting in Young Children With Mild to Moderate Obstructive Sleep ApneaA Randomized Clinical Trial


Look to find if ‘Is adenotonsillectomy (ATE) more effective than watchful waiting for treating otherwise healthy children, between 2 and 4 years of age, with mild to moderate obstructive sleep apnea (OSA)?'

A total of 60 children, 2 to 4 years of age, with an obstructive apnea–hypopnea index (OAHI) score of 2 or greater and less than 10, were randomized to Adenotonsillectomy ATE (n = 29) or watchful waiting (n = 31).
The primary outcome was the difference between the groups in mean obstructive apnea–hypopnea index OAHI score change


THE SAY
“Both groups had a decrease in mean obstructive apnea–hypopnea index OAHI score, and the difference in mean obstructive apnea–hypopnea index OAHI score change between the groups was small (−1.0; 95% CI, −2.4 to 0.5), in favor of AdenotonsillectomyATE”

A difference of 2 in obstructive apnea–hypopnea indexOAHI score change was used as a minimally clinically important difference between the groups, with a standard deviation of 2.5.



The AdenotonsillectomyATE group had a mean obstructive apnea–hypopnea index OAHI score decrease of −2.9 (95% CI, −4.0 to −1.9; Cohen d = −1.14), the watchful waiting group had a mean decrease of −1.9 (95% CI, −3.0 to −0.9; Cohen d = −0.71), and the difference between the groups in mean change was small, −1.0 (95% CI, −2.4 to 0.5; Cohen d = −0.37)

“Both groups had a decrease in mean obstructive apnea–hypopnea index OAHI score, and the difference in mean obstructive apnea–hypopnea index OAHI score change between the groups was small (−1.0; 95% CI, −2.4 to 0.5), in favor of ATE”

– which is interesting because it didn’t reach stastical signifance or your end point so why you would say smal but favor of ATE was my first red flag and then

The authors go on to say


there were large differences between the groups in favor of ATE regarding the Obstructive Sleep Apnea–18 (OSA–18) questionnaire, OSA–18 questionnaire (eg, total OSA–18 score: −17; 95% CI, −24 to −10).

basically saying when questioned those that got surgery were happier-- those that had an invasive surgery FELT like they were doing better but we know that that there was no difference in those individuals

again not blinded THIS IS THE PROBLEM- blinding the pt. prevents you from bias prior to randomization and during the study.. blinding the provider prevents you from bias during and after randomization