Things to consider when deciding on a formal project in Paediatric Intensive Care

Although research in paediatric intensive care is fundamentally no different to that in any other area of medicine, critically ill children are a challenging group on whom to arrange a research project. There are a number of aspects which need to be considered when arranging your project.

There are multiple options on the type of research which can be performed. The study can be of a retrospective nature, an audit, a prospective trial, or other research as per the college document. There are specific advantages and disadvantages of each type of research both from the point of ‘level of evidence’, but also from the point of view of the person completing the research. Any study is likely to take several hundred hours to complete (at least).

Remember that research is only useful (both to you as a CICM project, and also to the scientific community as a whole) if it is completed, and preferably also published or presented in a scientific forum. Embarking on a massive project which will take many years to complete is unlikely to be the optimal choice for the CICM project, although completing a part of a larger project is acceptable to the college.

It is imperative to have someone review your proposed project prior to embarking on it, to ensure it is done within a set time frame and will be of the required standard.

The guidelines for the college project are available on the CICM website: http://cicm.org.au/formalprojects.php

Choosing a style of study

Retrospective audits

Are a lower level of evidence than a prospective study, however can be significantly easier to perform than a prospective study.
The ethic committee’s requirements are often less stringent as no patients are formally enrolled, and often the requirement for consent is waived.
The ability to complete the research is more controlled as files need to be pulled for patients, but no patients need to be prospectively enrolled (which can take a very uncertain period of time to reach a specific number.

Experimental / clinical research studies

Experimental / clinical research studies are strongly supported by the college, both for the experience gained whilst performing them, and also due to the nature of the research produced. They are however the most challenging to arrange and complete, due to the multiple uncertainties involved in recruitment of patients, and how long this will take.

Issues to consider when deciding on a research project

Time

Research protocols can be slow to develop and have approved.
Institutional approval and ethics applications require many tens of hours work to achieve a successful result.
Time to recruit patients

Ensuring you have allowed a long enough study period to recruit sufficient patients to have an adequately powered study
Ensure you will be available at the necessary time to perform the research (i.e. when patients are present). This can be challenging if you are not working in the ICU at the time.
Consider how long the planned research will take per patient – this can add up quite easily.

Analysing the results – enlisting the help of a hospital statistician if this is available can reduce the workload / provide expert assistance when required.

Low patient numbers

The nature of PICU is for small numbers of patients, which can make recruitment for a large study very difficult. This can be overcome by including multiple sites, or enrolling over a longer period of time.
Ensure you speak to a statistician to do a power calculation prior to developing a research protocol. A research study that is likely to produce a statistically meaningful result is much more likely to be accepted both by the ethics committee, the hospital scientific committee, and also any potential funding body.
Many people find it difficult to ask patients to take part in a study when they are admitted to PICU, as the family are usually already very upset that the patient is critically ill.

Being aware of eligible patients

Attempt to set up a system where you can be informed that an eligible patient has been admitted. This can be particularly difficult if you are not working in the ICU at the time of your research study.
Being advised can be achieved by enlisting the help of research nurses, advertising your project, speaking to medical and nursing staff etc.

Funding is typically scarce. Options include:

Considering companies which might sponsor disposables / blood tests / costs involved in the study. Companies which already have a relationship with your unit are often a good place to start.
Departmental / hospital / university funding
Research grants (hospital / Government)

Ethics

Children, especially when critically ill, are seen as a very vulnerable group of patients. Consequently the justification / scientific rationale to perform a study must be particularly strong. You must be able to explain why the study cannot be performed in adults / on animals.
As children are unable to consent, a comprehensive parent information sheet is required. An additional ‘unable to consent’ form is often required for ethics.
It is a good idea to have the parent information sheet and consent form reviewed by research nurses / nurses in the unit. You will find they often provide extremely useful feedback / corrections. Also trial them on non medical friends or family to ensure they are understandable prior to submission.

General issues

Selecting a supervisor

It is ideal to have a supervisor who is interested in the area you are studying, has an understanding of and experience with the procedures required to get a project off the ground, who can troubleshoot either data collection or the experimental setup as required, and also one who has adequate time to read documents and give feedback. This latter issue is often the most difficult. Sometimes having two supervisors who fulfill different aspects of these ideal requirements can be useful.
Ensure that documents/protocols are checked by your supervisor early on so that much time is not wasted iterating a document/protocol which has deviated significantly from what is required.

Institutional Specific Requirements

In certain regions there are specific requirements which may be required during development or approval of a research study. It is always easier to ask prior to writing the research protocol and associated documents.

Medical Language

It is advisable to use simple language in the ethics application and also the parent information sheet. For the latter it is helpful to target a reading age of 9 years old. The ethics committee is much more likely to approve something that they can easily read and understand. This is also true for statistics. Ensure that what is described in the statistics section is something that the average research oriented person can understand (i.e. not a copy paste of what the statistician said which is often too complicated and detailed), otherwise this can be found to be unsatisfactory by the ethics committee.

Ask around your colleagues about people who do research. There will almost invariably be a research guru hiding in your department who can answer many of your questions. Seek that person out and befriend them!

When submitting your project, remember it may take several iterations until the project is considered satisfactory by the college. Don’t leave submission until the last minute, or it may delay your having fellowship awarded.

Good luck!