The2018 parachute RCT authors report on 23 friends and family who were randomized to jump from an aircraft with a parachute as part of the intervention group or with an empty back pack as part of the control group. Randomization is described in detail and the intervention and control group characteristics are listed in a table including history of broken bones, acrophobia, parachute use, and family history of parachute use. Data was collected at the time of the jump and in follow up 30 days post jump. Outcomes of interest included death and major traumatic injury as measured by the validated Injury Severity Score. Proper statistical analysis was performed with the conclusion that there was no significant difference in outcomes for the intervention versus the control group.
Dr. Hall suggests that pragmatic clinical trials are needed to include vulnerable patient populations who may be excluded from traditional RCTs. Pragmatic clinical trials occurring in typical health care settings may identify interventions that work in certain geographies with the use of new tools such as telehealth technologies.
Dugan Maddux, MD, FACP, is the Vice President for CKD Initiatives for FMC-NA. Before her foray into the business side of medicine, Dr. Maddux spent 18 years practicing nephrology in Danville, Virginia. During this time, she and her husband, Dr. Frank Maddux, developed a nephrology-focused Electronic Health Record. She and Frank also developed Voice Expeditions, which features the Nephrology Oral History project, a collection of interviews of the early dialysis pioneers.
With much delight and interest, I have been listening to various interviews conducted as a part of the Oral History of Nephrology. I am an ESRD patient, currently with transplant, and started on dialysis in 1976 when I was 14 years old. I dialyzed in a pediatric unit at Albert Einstein in the Bronx, under Dr. Ira Greifer.
The study was a systematic review of randomized controlled trials. Medline, Web of Science, Embase, the Cochrane Library databases, appropriate internet sites and citation lists were examined for studies showing the effects of using a parachute during free fall. The primary outcome measure was death or major trauma, defined as an injury severity score > 15.
Case: A 32-year-old woman with no previous medical history calls you while a passenger on a crashing plane. She has been offered a parachute by the flight attendant but is unsure whether jumping from the plane is wise. You quickly scour the literature for evidence to inform her decision.
Different variants of parachutes have been used both for recreational and safety purposes; in either case aiming to avoid death in people falling from heights presumed to be lethal. Despite the near universal application, a systematic review from 2003 (Smith and Pell, BMJ) found no RCTs of parachute intervention.
That systematic review published in the BMJ is a classic paper and part of their annual holiday edition. It stated that there was observational data showing parachutes failed at times to prevent morbidity and mortality. There are also case reports of free falls that did not result in 100% mortality.
The authors suggested taking evidence-based medicine advocates up in a plane for a double blinded randomized control trial. The intervention would be a parachute and the control arm would be a sham parachute (backpack). To make it more rigorous, anyone who survived the first jump would cross over into the other arm of the study and jump again. Only then would we have definitive evidence that a parachute was effective in preventing death and major trauma related to gravitational challenges.
Talk Nerdy: There were many limitations to this study including a composite outcome for the primary outcome. However, we will only discuss five things that threaten the validity and interpretation of this trial.
Case Resolution: Despite the lack of high-quality evidence demonstrating the efficacy of parachutes, you advise your friend to use the parachute being offered by the flight attendant.
Clinical Application: Based on your understanding of physics and reality, you would recommend people use parachutes if jumping out of an aircraft that is flying. While it does not guarantee you will not be injured or die it is the best evidence we have on the topic. In addition, more research is not needed to determine if parachutes prevent morbidity or mortality due to gravitational challenges.
Considering the limitations of the study, the results suggest a benefit, with a decrease of one death per every 11 patients treated for respiratory diseases after the installation of an intensive care unit in our hospital. The results corroborate the benefits of the implementation of intensive care units in secondary hospitals.
Foi realizada coorte retrospectiva do banco de dados em um servio de medicina hospitalar. Selecionaram- se pacientes internados por doenas respiratrias no terminais. Caractersticas clnicas, fatores de risco associado mortalidade, como o escore de Charlson, e tempo de internao foram coletados. Foram realizados: anlise univariada com estratificao simples por Mantel Haenszel, e testes qui quadrado, t de Student e Mann-Whitney, alm de regresso logstica.
Respeitando as limitaes do estudo, conjetura-se benefcio na reduo de uma morte a cada 11 pacientes tratados por doenas respiratrias aps a implantao da unidade de terapia intensiva no hospital. Estes resultados corroboram a impresso do benefcio da implantao de unidades de terapia intensiva em hospitais de nvel secundrio.
Increased healthcare costs have been a cause for concern for governments and the private sector. In the public health system - Unified Health System (Sistema nico de Sade - SUS) in the case of Brazil - this concern is greater owing to the high demands of health users and the limited availability of resources. A World Bank study investigated the 20-year implementation of SUS by the federal government and reported that at present, Brazil spends approximately 4% of its Gross Domestic Product (GDP) on healthcare and that since the early 2000s, this number has increased approximately 6% per year.(11 Gragnolati M, Lindelow M, Couttolenc B. Twenty years of health system reform in Brazil: an assessment of the Sistema nico de Sade. Direction in development: human development. Washington DC: World Bank Publications; 2013. [cited 2015 Jul 21]. Available from: -years-healthsystem-reform-brazil-assessment-sistema-unico-de-saude
)Furthermore, there is a worldwide trend of population aging. In Brazil, the percentage of citizens aged > 60 years increased from 6% to 10% between 1980 and 2010 and is expected to reach nearly 30% by 2050.(22 Leite F, Reis A. Envelhecimento populacional e a composio etria de beneficirios de planos de sade [Internet]. Rio de Janeiro: Instituto de Estudos de Sade Suplementar; 2011. [citado 2015 Jul 21]. Disponvel em:
) Therefore, the tendency is that these costs will increase even further in the coming years, and these costs will include the implementation of intensive care units (ICU).(33 Nunes A. O envelhecimento populacional e as despesas do Sistema nico de Sade. In: Camarano AA, organizador. Os novos idosos brasileiros: muito alm dos 60? 2a ed. Rio de Janeiro: IPEA; 2004. p. 427-49.) In parallel, the costs related to the installation and maintenance of ICU have reportedly increased.(44 Moerer O, Plock E, Mgbor U, Schmid A, Schneider H, Wischnewsky MB, et al. A German national prevalence study on the cost of intensive care: an evaluation from 51 intensive care units. Crit Care. 2007;11(3):R69.,55 Halpern NA, Pastores SM, Greenstein RJ. Critical care medicine in the United States 1985-2000: an analysis of bed numbers, use, and costs. Crit Care Med. 2004;32(6):1254-9.)
Intensive care units are implemented because of advancements in technology and the therapeutic arsenal. The patients assisted in these units include those in vulnerable conditions with limited physiological function, severe illnesses, and illnesses of complex management. The need for ICU implementation is clear, and the ability of ICU to decrease morbidity and mortality in the hospital setting has not been questioned. Perhaps for this reason, only a few studies have evaluated the impact of ICU on morbidity and mortality. Previous studies have reported increased mortality in subgroups of patients not admitted to ICU because of the unavailability of beds.(66 Checkley W. Mortality and denial of admission to an intensive care unit. Am J Respir Crit Care Med. 2012;185(10):1038-40.
7 Pirard S, Seldrum S, de Meester C, Pasquet A, Gerber B, Vancraeynest D, et al. Incidence, determinants, and prognostic impact of operative refusal or denial in octogenarians with severe aortic stenosis. Ann Thorac Surg. 2011;91(4):1107-12.-88 Durairaj L, Will JG, Torner JC, Doebbeling BN. Prognostic factors for mortality following interhospital transfers to the medical intensive care unit of a tertiary referral center. Crit Care Med. 2003;31(7):1981-6.) Other studies involving patients admitted to stroke treatment units indicated decreased morbidity and mortality and decreased length of stay in this specific population.(99 Iihara K, Nishimura K, Kada A, Nakagawara J, Toyoda K, Ogasawara K, Ono J, Shiokawa Y, Aruga T, Miyachi S, Nagata I, Matsuda S, Ishikawa KB, Suzuki A, Mori H, Nakamura F; J-ASPECT Study Collaborators. The impact of comprehensive stroke care capacity on the hospital volume of stroke interventions: a nationwide study in Japan: J-ASPECT study. J Stroke Cerebrovasc Dis. 2014;23(5):1001-18.
10 Al-Khaled M, Matthis C, Eggers J. The prognostic impact of the stroke unit care versus conventional care in treatment of patients with transient ischemic attack: a prospective population-based German study. J Vasc Interv Neurol. 2013;5(2):22-6.
11 Walter S, Kostopoulos P, Haass A, Keller I, Lesmeister M, Schlechtriemen T, et al. Diagnosis and treatment of patients with stroke in a mobile stroke unit versus in hospital: a randomised controlled trial. Lancet Neurol. 2012;11(5):397-404.-1212 Burgess NG, Vyas R, Hudson J, Browne O, Lee YC, Jayathissa S, et al. Improved stroke care processes and outcomes following the institution of an acute stroke unit at a New Zealand district general hospital. N Z Med J. 2012;125(1364):37-46.)
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