Planning a Research Project

 

This document provides an overview of the process of planning a research project in Emergency Medicine at Saint John Regional Hospital.

How to write a structured abstract

 

 The Research Committee

A subcommittee reporting to the academic council will meet to discuss research projects and planning on a quarterly basis.

The executive of committee will be chaired by the Site Director of Research and will comprise of representatives from the academic council (EM), the hospital department of research services, the Site director for EM (nursing). Other ex-officio members will include research nurses and administrative assistants, and faculty members and nursing staff who have registered an interest in the research program or who are lead investigators for ongoing or proposed projects.

Research projects

Any research project requiring data collection or enrolment of patients in the emergency department must have prior written approval of the research committee / chairman. An overview should be submitted in writing, with the option of the proposer making a short presentation to the committee.

All proposals must demonstrate that the following considerations have been made in the planning process:

The research question

In developing a research project the first issue is the research question. Whether the question is a good one can be summed up in the mnemonic FINER – meaning

  • feasible
  • interesting to the investigator
  • novel
  • ethical
  • relevant

Whether the question is novel and relevant has to be assessed through a literature search and the question put in context. Does a study need repeating? Is there a new relevant slant? A discussion then with an expert in that particular field will enable a valued judgement to be made.

A well defined question will make a good protocol easier to write, enable focused data collection and manipulation, and facilitate clearer conclusions.

Try to phrase your question in the PICO format:

  • Population
  • Intervention
  • Control/Comparison
  • Outcome

The study protocol

The study protocol will represent the way in which the answers to the question will be sought.This overview is necessary for ethical approval, funding applications, registering the project with the DEM research committee as well as the hospital research services department and other formal communications about the study. It is critical therefore to take time and effort to get this right before starting. It is often extremely difficult, sometimes impossible, to rescue a project from a poor protocol. This enforced discipline is extremely important for the successful completion of the study and will constitute much of the content of any subsequent publications. The prior literature review may help in indicating the methods and techniques that could gainfully be used in your methodology.

research planning

The challenge will be to find an efficient, effective, ethical, and workable process. It has to be emphasised that statistical issues are better addressed at the planning stage.

Data collection

There is occasionally a temptation to collect too much data in the hope that it will be useful. Great care needs to be taken as this can lead to a loss of focus in the project and it increases the amount of work needed, which is likely to be fruitless. The researcher also has to be wary of running into problems with multiple hypothesis testing and finding a statistically significant result where a real difference is not present. No more data should be collected than are relevant to the interpretation of the study in the context of the research question. The data collection forms need to be concise, clear, and understood.

Clearly the logistical issues with working through the study have to be addressed before starting. Will there be enough patients recruited in your environment considering patient refusal and others lost to follow up (if applicable)? Will you be able to complete the project in the time frame needed? Are there enough people conducting the study who are technically able to obtain measurements? Is there enough money or any other insurmountable reason why the scope of the study may be beyond the local capabilities? Where such difficulties might arise it is important be tenacious in the pursuit of their solutions.

Collaborators involved early intellectually buy into the design of the project and are later in a better position to satisfy criteria for paper authorship. The overall learning from the study is also enhanced. Nevertheless someone has to lead the project and have the final say on important issues.

Good teamwork will lighten the load.

Funding

A good research question and a good protocol will assist greatly in submitting the relevant information and making the application competitive. The advocacy of a supervisor with an established research record is likely to help. National and regional funding organisations include

  • CIHR
  • CAEP.ca
  • NB Trauma (NB)
  • HIRF.ca (Horizon)
  • HRF(NB)
  • Chesley (Dal/Horizon)

Look also beyond funding organisations to commercial enterprises, charities and foundations, research prizes, grants as well as within the hospital, which may have monies allocated to support research projects.  The director of research and the research services department may offer valuable advice.

The role of the pilot study

A pilot study does not answer the research question but can assess the methodology proposed for the full study. It is better to find fault before the full scale study is implemented. A pilot study can also make it easier to write submissions for funding or approval and have them accepted because the probable direction and difficulties of the study are better understood:

Examples where pilot studies may help

  • Assessing the ease of recruitment or follow up of subjects.
  • Assessing issues around taking measurements; accuracy, consistency,
  • Practical issues?
    • for example, is the information reliably recorded in the patient charts?
  • Ensuring data record forms are useable, filled in as intended, and legible.
  • Survey methods
    • Questionnaire design—legibility, ambiguity, understanding, gaps and validity, refining questions.
    • Interview methods—similar issues around question development
  • Where a number of people are conducting the study are they conducting the research in the same way? A dress rehearsal is offered.
  • Getting more knowledge about the issues being studied, for example, to assist with estimating the number of cases needed for the study.
  • Data management. Having some data to manage will help identify features that could make the final analysis more difficult.

Do not leave organisational issues to chance.

It might be better to assess different aspects of the study through different pilots. With the knowledge gained you are in a better position to consider the optimal technique or process required to carry out the study.

Note that if the results from the pilot are to be incorporated into the larger study there are statistical implications.

Working through the study

This is the difficult stage, where commitment, patience, and hard work are required It is quite possible that there will be unforeseen problems with the conduct of the study and these will need to be managed as they develop.

Do not miss opportunities to help the study along. The full knowledge of other members of staff that the study is under way (and for example their assistance in recruiting subjects) can be very useful. Feeding back the results of local research and the demonstration of the benefit of applied results in that setting can help to develop a culture to facilitate research. Be sure to keep your data collection forms in a safe and accessible place, not where they might be thrown out!

Meet with the research team on a regular basis to review progress against the study plan.

References

Khan CR. Picking a research problem. The critical decision. N Engl J Med1994;330:1530–3. [FREE Full text]

Good A, Driscoll P. Clinical research in emergency medicine: putting it together. Emerg Med J 2002;19:242-246