discussion
The BMJ (formerly the British Medical Journal) published a tongue-in-cheek study on Parachute use to prevent death and major trauma related to gravitational challenge: systematic review of randomised controlled trials (Links to an external site.) . While somewhat humorous, the post brings up an important consideration, “Advocates of evidence based medicine have criticized the adoption of interventions evaluated by using only observational data.” Is this a fair criticism? What are your thoughts on the subject? What do we do in a case where the treatment for the control group might result in death or injury to the subjects?
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In my opinion, the adoption of any intervention evaluated by either using RCT or observational data depends on the circumstances study by study. There should not be a fixed rule defining what method needs to be used to ascertain the finding of the hypothesis. Because each study has its own nature and level of difficulties and challenges to answer the hypothesis. Some studies are easier to design, evaluate and analyze the patient outcomes. Some studies have the ease of sampling cases and controls. Therefore, RCT design can be employed for those circumstances. Even though, the RCT is considered methodologically as the gold standard due to the design contributes less biases and able to control for confounding. However, it is not the case for every study. The observational study design is more suitable for some circumstances such as studying about rare exposures, rare outcomes and harmful outcomes. For example, the rare cancer diseases, it is difficult to conduct a RCT in the rare cancer populations due to limitations of available patients that causes an inadequate sample size for a trail. Panageas (Links to an external site.), (2016) suggested a new approach by incorporating uncontrolled studies and/or utilizing observational evidences. There is another study discussing and a RCT being unnecessary in a lung metastatic cancer study because patients have such dramatic effects from some treatments that biases can be ruled out without randomized trials (Glasziou et al., 2007).
Discussing the usage of parachutes to prevent death and major trauma related to gravitational challenge (Links to an external site.) , the observational study in humans is considered safer than a RCT. There has been a RCT conducting by using rag dolls instead of human to understand the effectiveness of a parachute when falling from great height. It was clearly that using a parachute caused less injury in the experiment. (Czorlich et al., 2016).
From my perspective for this subject, it is unethical to conduct RCT to demonstrate the effectiveness of a parachute in generalized human population. Particularly, randomizing in all age groups because the younger age, such as children or young teenagers might not realize all the substandard effects in long-term if the case ever occurs. In the case where the treatment for the control group might result in death or injury, we need to have the best balance between efficiency and safety conducting a study. Utilizing observational evidence is a better ethical approach. Because all the studies’ main purpose is for improving the quality of life. The study should not cause harmful or life threatening outcomes to anyone.
ANOTHER ONE ::
1. Is this a fair criticism?
Yes, criticizing the intervention because they used observational data is justifiable since there are high chances for subjective bias when using observational data (Jonas, 2017). This is so because the researcher might be having formed decisions about the data he will like to see during the research which means the researcher will want to see what is in his mind and not the actual results of the study (Jonas, 2017). This will lead to biased data that is not based on the results of the research. Therefore, there are high chances that the interventions developed and adopted based on the observational data are not effective hence the justification for criticism. Also, the researcher has no control over the observational data. This is so because the research is only allowed to observe and record data but not to alter it. his means that the observational data used to develop the interventions were not justified by time or the cost of the research.
2. What are your thoughts on the subject
From my assessment of the subject, I find it to be shallow. The first reason that shows the subject is shallow is that trauma resulting from the gravitational challenge cannot be reduced through the use of the parachute. This is so because some people are phobic to heights. Therefore, the horrible experience of flying with a parachute after an accident occurrence will still result in trauma in most of the people.
3. What do we do in a case where the treatment for the control group might result in death or injury to the subjects?
The first thing to be done in such scenarios is to seek the informed consent of the subjects. Informed consent requires that the subjects participate in the research with their full knowledge of the benefits and the disbenefits that are involved (Fain , 2017). Therefore, it's important to obtain the informed consent of the subjects before subjecting them into the treatment that will result in serious injuries if not death. Doing this means that the subjects accepted to be involved in the research willingly and knowing that there is a possibility of them dying or getting serious injuries.