Ahhh….December! While some people look forward to christmas music, jingle bells, Jack Frost and New Years, most of us (well maybe just me) see December as one of the most evidenced based times of the year! Yes every December the classic and so-very –British tongue in cheek version of the BMJ comes out to delight our EBM fancy. This year provides no less disappointment. But how do you choose just one morsel of EBM goodness?! Well I say no to choosing just one this time!
- THE PARACHUTE TRIAL
Back in 2003 a systematic review of trials with a goal of determining whether or not parachutes would enhance safety when jumping from an airplane. Sadly this trial was inconclusive “We were unable to identify any randomised controlled trials of parachute intervention…As with many interventions intended to prevent ill health, the effectiveness of parachutes has not been subjected to rigorous evaluation by using randomised controlled trials” (1). Advocates of evidence based medicine have criticised the adoption of interventions evaluated by using only observational data”. Obviously this cheeky study suggested that some interventions just don’t need an RCT to realize there is a benefit. However, 2018 has gifted us with the first RCT of people randomized to jumping out of an airplane with either a parachute or an empty back pack. Cardiologists, possibly prompted by the amount of windbags in said field, while on business trips asked adjacent passengers if they would participate in this study. “Owing to difficulty in enrolling patients at several thousand meters above the ground, we expanded our approach to include screening members of the investigative team, friends, and family. For the private aircraft, the boarding of aircraft was done for the explicit purpose of participating in the trial.” (2)The investigators screened 92 passengers and 64 declined while 5 were deemed “unfit” (I’d love to hear about those 5!). 23 were randomized with 9 in the final intervention group and 11 in the control group. No deaths occurred in either group (spoiler alert: A small plane or helicopter was used and was still on the ground). The authors concluded “Parachute use did not significantly reduce death or major injury (0% for parachute v 0% for control; P>0.9). This finding was consistent across multiple subgroups. Compared with individuals screened but not enrolled, participants included in the study were on aircraft at significantly lower altitude (mean of 0.6 m for participants v mean of 9146 m for non- participants; P<0.001) and lower velocity (mean of 0 km/h v mean of 800 km/h; P<0.001).” (2). While landmark in its attempt, this paper will likely be relegated to the category of “inconclusive”. Maybe next year will be the golden parachute year…I know it will be for me.
- Key opinion leaders’ guide to spinning a disappointing clinical trial result
Big Pharma needs money and they will hire doctors with questionable ethics to further their cause! Not only will some doctors cover up the monies they get for research (See this New York Times post) but they will also take money to give their opinions on trial results. In the world of big pharma these doctors that are hired to sell (or spin) the results of drug company sponsored trials are called “Key opinion leaders”. Because you can’t spell spinning without sinning..pharmaceutical companies need a way to keep money rolling in whether or not their trial was positive or negative. In this how-to-guide for making the results sound better no matter what, the authors give insight to the world of spin. The authors “reviewed five years of reports from the world’s three largest cardiology annual scientific congresses—European Society of Cardiology, American Heart Association, and American College of Cardiology—examining remarks made to large news organisations that maintain a database: Medscape and MedPage Today.”(3). The authors found comments on 321 trials from 15 international scientific congresses held between 2013 to 2017. Of these trials 40% had a negative result and received a total of 438 comments from key opinion leaders. Excuses were provided for 85% of negative trials, with a mean of 2.5 published excuses per trial. The authors found phrases like …
1. The study was too small (31%)
2. The study was too mild disease (9%)
3. The study was too inclusive (17%)
4. The endpoint too subjective (6%)
5. The wrong dose used (16%)
6. The intervention too late (6%)
7. The intervention too early (1%)
- Golf habits among physicians and surgeons: observational cohort study
Finally, in this last piece the importantly held belief of physicians and golf the authors look at patterns of golfing among physicians: the proportion who regularly play golf, differences in golf practices across specialties, the specialties with the best golfers, and differences in golf practices between male and female physicians.
The authors found that men accounted for 89.5% of physician golfers. The highest proportions of physician golfers were in orthopedic surgery (8.8%), urology (8.1%), plastic surgery (7.5%), and otolaryngology (7.1%), whereas the lowest proportions were in internal medicine and infectious disease (<3.0%). Physicians in thoracic surgery, vascular surgery, and orthopedic surgery were the best golfers. Emergency Medicine made the list with the 5th best(?) handicap at 15.0. Sadly, I for one am a failure: My name is Jesse and I’m a Jewish doctor, I don’t golf…no wonder my parents aren’t proud…
- Smith GC, Pell JP. Parachute use to prevent death and major trauma related to gravitational challenge: systematic review of randomised controlled trials. BMJ 2003;327:1459-61. doi:10.1136/ bmj.327.7429.1459
- Yeh Robert W, Valsdottir Linda R, Yeh Michael W, Shen Changyu, Kramer Daniel B, Strom Jordan B et al. Parachute use to prevent death and major trauma when jumping from aircraft: randomized controlled trial BMJ 2018; 363 :k509.
- Hartley Adam, Shah Mit, Nowbar Alexandra N, Rajkumar Christopher, Howard James P, Francis Darrel P et al. Key opinion leaders’ guide to spinning a disappointing clinical trial result BMJ 2018; 363 :k5207
- Koplewitz Gal, Blumenthal Daniel M, Gross Nate, Hicks Tanner, Jena Anupam B. Golf habits among physicians and surgeons: observational cohort study BMJ 2018; 363 :k4859