Have you developed and published a protocol? I am interested in this question. There have been too many underpowered studies with very different outcome measures.
Sir,
Indeed! My colleagues and I have both adapted and published a protocol. Please see the attached articles. The first provides the evidence to support the second. The results of the second confirm the first.
You mention "under powered studies", These articles do not constitute research rather implementation science regarding Postoperative Nausea and Vomiting "PONV" (in the post-anesthesia care unit). The concept is two fold: 1. preoperative risk assessment (utilizing the Apfel simplified risk score) and 2. targeted antiemetic prophylaxis based upon the risk score. We used an "enhanced" SAMBA (society of ambulatory anesthesia, January 2014) protocol. Low risk (0-1 risk factor) patients receive at least 1 antiemetic, Moderate risk (2 risk factors) receive at least 2 antiemetic interventions and High risk (3-4 risk factors) receive at least 3 antiemetic interventions. One intervention can be total intravenous anesthesia (TIVA) while the others consist of dexamethasone, ondansetron, haloperidol, metoclopramide, transdermal scopolamine, intramuscular ephedrine and diphenhydramine.
AS you will see in the second publication, we achieved a remarkable reduction in PONV incidence. If you examine the results located on my projects page, you will see that we were able to achieve further reductions, two years after implementation.
After you review the articles and project results, feel free to message me directly with any additional questions or comments.
Regards!
Article Reducing the Incidence of Postoperative Nausea and Vomiting ...
Article Improving the quality of post-anesthesia care: An evidence b...
The question of why many studies are "underpowered" is an interesting one. I would like to suggest some of the reasons:
1. The researcher(s) who have developed the protocol lack sufficient study participants in their own institution. This means that:
1.1 They may not have access to collaborating with researchers at other institutions even though they may indeed want to collaborate.
1.1.1 The reason why collaborators are not easy to find is itself complex:
1.1.1.a The researchers may not have enough experience as researchers to attract collaborators.
1.1.1.b The researchers may not have any way to access other collaborators.
1.1.1.c The research has costs, and the researchers may have enough funding to pay for data collection, etc., at their own institution, but not enough to help out collaborators at another institution.
2. Collaborators may not be attracted to the study objective.
3. Collaborators may not be attracted to the study methods.
4. There may be no way (no money to pay) for) data collection across a multi-site study.
5. There may be a lack of personnel to "put the data together and analyze the composite data from a multi-site study."
Dennis
Dennis Mazur
Factors such as multi-site project cost and willingness or unwillingness of potential collaborators to take on the costs of the project and/or the uncompensated workload of the project are key reasons for lack of collaborators and how such a lack impact the number of individuals in the total population studied. However, there are other factors that also need to be understood in the "underpowering" of research studies. Let us take the case of research studies involving human study participants, particularly, patient as human subject volunteers:
1. The collaborator must obtained approval of his or her IRB (institutional review board) do undertake the study in one or ore institutions over which the IRB has authority.
1.1 The potential collaborator's IRB may simply not approved the study protocol and study informed consent form.
2. Even if the potential collaborator secure approval of the study from the IRB, the patient approached for recruitment in the research study may simply not want to participate in the study.
Dennis
Dennis Mazur
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