157. Thankful For Well Done Studies & Errors In Lab Values

Questioning Medicine

www.bmj.com/content/368/bmj.m149 No one wants to get pregnant two minutes after having a baby. And also agrees that an IUD is most effective form of conception. However placing IUD after delivering a child seems to be a point of debate as the risk of expulsion seems to be significantly higher immediately post pregnancy In this study titled Averbach SH, Ermias Y, Jeng G, et al. Expulsion of intrauterine devices after postpartum placement by timing of placement, delivery type, and intrauterine device type: a systematic review and meta-analysis. Am J Obstet Gynecol 2020;223:177-188. They looked at the different rates of IUD expulsion postpartum. As you can imagine the rates vary based on if the IUD was placed within 3 minutes of child delivery or 3 weeks after child delivery. There also seemed to be a difference between hormonal IUD (LNG-IUD) compared with a copper T-shaped IUD. Finally there was a difference whether she had a C-section or a vaginal delivery as you can imagine the vaginal delivery was associated with significant less rates of expulsion which is the numbers we are going to talk about going forward as the rates of expulsion following C-section were significantly lower around 0-2%. Brand progesterone IUD are called Skyla, Liletta, Mirena -- but in this study they only included those papers which she used MIRANA. Copper IUD goes by paragard Ultimately the authors looked at 3 different timeframes for placement of the IUD. 1-immediate placement within 10 minutes postpartum, or IUD placement anywhere from 10 minutes postpartum to 72 hours postpartum or early outpatient placement somewhere between 72 hours to 4 weeks postpartum So let’s break them down by timeframe- Those individuals who had an IUD placed immediately following delivery had a 27% exposure rate with Mirena and a 12% exposure rate with ParaGard Those individuals who had an IUD placed not immediately but within the first 72 hours the exposure rate was 37% with the hormonal IUD and 7% for the copper IUD And finally for those women who had an IUD placed in the outpatient setting at some point between 72 hours in 4 weeks there was no expulsion that occurred for either the hormonal or copper IUD. I think the final answer here is for a woman who has a vaginal delivery and would like to have IUD placement following delivery there is almost no way we can justify placing hormonal IUDs within the first 72 hours as the expulsion rate of 30ish percent is way too high to justify. The ideal situation would be IUD placement in the outpatient setting at sometime point between 72 hours in 4 weeks however if you’re patient is insisting on IUD placement while still in the hospital then it appears the best option would be a copper IUD and this likely should be placed as close to discharge as possible because even those individuals who had a copper IUD placed prior to 72 hours still had a 7% exposure rate which seems a little high. If you’re going to use this paper and practice I think important thing to remember is that it was for woman with vaginal deliveries and not for women with C-sections as those individuals had near 0% expulsion rates. The next our article talks about one of the most irritating conditions to treat and of course that is irritable bowel syndrome. In this randomized double-blind placebo controlled trial titled Hamatani T, Fukudo S, Nakada Y, Inada H, Kazumori K, Miwa H. Randomised clinical trial: minesapride vs placebo for irritable bowel syndrome with predominant constipation. Aliment Pharmacol Ther 2020;52(3):430-441. Author still just over 400 patients with a history of severe irritable bowel syndrome predominant constipation who were having less than 3 spontaneous bowel movements per week and randomized them to placebo or minesapride 10 mg, 20 mg, or 40 mg daily for 3 months. The primary endpoint—an increase in one or more complete spontaneous bowel movements and in the end it didn’t matter what dose of minesapride you got because it was no better than placebo. All groups had about a 40% improvement in their rates of spontaneous bowel movement. Irritable bowel is irritating to treat because pooping and bowel movement are so mental. Anxiety and stress and tension can back you up like a hoover damn and then a magical pill even if it is placebo can put you at ease and open the flood gates…running a trial is hard because you need to beat placebo and speaking of things that didn’t beat placebo This paper titled Boesen AP, Boesen MI, Hansen R, et al. Effect of platelet-rich plasma on nonsurgically treated acute achilles tendon ruptures: a randomized, double-blinded prospective study. Am J Sports Med 2020;48(9):2268-2276. Looked to see if platelet rich plasma could be placebo in the treatment of acute Achilles tendon rupture. In this randomized double-blind placebo controlled trial of 40 patient’s with acute Achilles rupture confirmed on ultrasound- All patients were treated with a continuously worn ankle casts that kept the foot plantar flexed for 8 weeks. Every 2 weeks, the researchers lessened the degree of plantarflexion. After 9 weeks, all patients began an ankle rehabilitation program But half were randomized to placebo or and half platelet rich plasma injections. The patient’s were injected every 2 weeks starting within 4 days of the injury they then evaluated patient function via the Achilles tendon total rupture score at the time of removing the cast and then again at 3, 4-1/2, 6, 9, and 12 months after injury. In the end there was no difference between whether patient was randomized to receive platelet rich plasma injections or saline injections. Granted this study was only 40 patient’s and too small to determine differences such as the re-rupture rate but this was a really well done study that I think is hard to refute, they did a lot of things exactly how you want to see them done. For example, None of the patient’s nor providers nor the statistician’s nor the outcome assessors were aware of Whether the patient had received saline or platelet rich plasma. There is only one person who did the injections which was an experience sports medicine physician and injected all patients under ultrasound but this provider had no other influence on the patient’s outcome or care and was also blinded to saline or platelet rich plasma injections as a sheeth was placed over the syringe and the help of the needle. This in all actuality was a very well done trial and methadone neurologically was one of the most sound trials I have read in a long time, if he ever want to read how a method section should be written then he should read this paper. The methods were given in such extreme detail right down to the exact gauge of the needle and to the to the brand of ultrasound machine was used. If you doubt this trial then there is more than enough information in the method section you could easily repeat it in your office tomorrow without any questions. But otherwise said placebo was not nothing placebo is hard to be especially if you’re trying to be treated with platelet rich plasma for an Achilles tendon rupture The man noticed that I said they did a method section really well and if he doesn’t agree with the outcome then you can repeat the study yourself in your clinic. I notice when he comes a cold literature as well as vitamin D literature and other such literature which is borderline terrible those individuals who believe in something so powerful such as mask refuses to believe the outcome of the well done trial regardless of how well the trial was done. However the most important part of the paper size for the results is the method section. If you know exactly what gauge needle, what size syringe, what lab assay, what number years of experience the provider giving the intervention has you can almost do an exact simulation in your office and see if you, with the exact results because sometimes the results very just based on something he would never think of like the laboratory which is no more clearly seen in this article titled Potter JM, Hickman PE, Oakman C, Woods C, Nolan CJ. Strict preanalytical oral glucose tolerance test blood sample handling is essential for diagnosing gestational diabetes mellitus. Diabetes Care 2020;43(7):1438-1441. Which looked at the effect of processing and oral glucose tolerance test with either delayed or early centrifuge protocol. There is a total of just over 12,000 women in this study approximately 7000 women received delayed centrifuge protocol and approximately 5000 women received in early centrifuge protocol. The lumen that had the delayed centrifuge protocol Heather blood collected but then it was sent off to a central laboratory for blood glucose analysis those when that had a early centrifuge protocol underwent the same oral glucose tolerance testing but when they had their blood drawn for analysis but glucose testing was performed immediately. All things being equal they’re really shouldn’t be much of a difference here the results showed that those individuals who had immediate glucose testing rales twice as likely to be diagnosed with gestational diabetes than those individuals with delayed glucose testing Fasting- with fasting there was a difference of 4 mg/dl 1-hour samples 6.1 mg/dL and the two hour measurement was a difference of - 2.8 mg/dL (0.16 mmol/L; 2.3%).. this may sound very small change in the overall glucose but remember the fasting blood glucose concentration is less than 95 so a difference of 4 just based on higher lab processes the blood draw is almost a 5% error in the test.. Likely in the United States for many oral glucose tolerance test we use Accu-Chek monitors however the same question in the same importance and relevant supplies to the calibration and accuracy of the monitor being used. We have a chance grab 2 different brand monitors and check the same person at the exact same time just with different fingers and all certainly you’ll come up with a slight difference in their blood sugar. I’m not surprised by these findings which is a constant reminder that will be due in medicine is small. Nothing is a parachute. Nothing is absolute. I recently heard someone compare a certain intervention to Russian Roulette which implies a 1-6 chance of dying, this is follow-up taking that gives us an over his zealous and heightened sense of our work almost nothing that we do as a number needed to treat of 6 and especially not for death. We have to keep this in mind make sure that our patients are also aware of the inconsistencies in our practice of medicine which is also clearly seen in this paper titled McCormack JP, Holmes DT. Your results may vary: the imprecision of medical measurements. BMJ 2020;368:m149. doi: 10.1136/bmj.m149 Which looked at the variation or error that surrounds laboratory testing. This paper found much of what I mentioned previously on questioning medicine about laboratory findings such as a single HbA1c test result of 6.3% (45 mmol/L) could actually be as low as 5.5% (39 mmol/mol) or as high as 7.1% (51 mmol/mol). The lab findings are thrown off by variability in the analytic or lab process (4.3%), as well as biologic variability meaning the variation in the same person over the course of days caused by physiologic changes. Combined, these challenges to precision can make a single iron, bilirubin, or triglyceride level be inaccurate by as much as 50%. That means you would require at least a 50% change in the levels to be considered valid true actual change and not just a stastical variability. I have put a link to the office calculator as the very first piece of information in this podcast and think everyone should save it to their favorites to either bring up with the patient sitting in clinic or to discuss with your colleagues at the next zoom conference Let’s recap the articles discussed today before this ship set sale in the sea of evidence