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Ethics of recruiting participants for research studies when they are undergoing difficult treatment or are at the end of life

November 25, 2008, Karin Scou, music therapist, Aalborg (schou@hum.aau.dk)

In the process of recruiting participants for my PhD project different factors have proven to influence this recruitment process. This project is investigating the effects of a guided relaxation and music intervention on psychosocial and subjective physical aspects of heart valve surgery patients in their first postoperative phase. The patients may undergo either a single procedure of a heart valve operation, typically a replacement of the Aorta valve, or a double procedure of a heart valve and a bypass operation at the same time. In general anxieties of outcome and of pain are dominant emotions in these patients’ experiences.

The process of recruiting participants relies very much on the production of surgeries in the hospital. At times the operation rate may be slow due to illness among staff, holidays or the budget of the year has been spent before the end of the calendar year. Operations may be cancelled or postponed due to an infection, new diagnosis found, or a full schedule in the operating room when acute surgeries have to be performed.

The other important factor is that patients do give their signed consent to partake in the project. Some patients say no thank you for various reasons. In this project the following reasons for not wanting to participate have been given:

  • Patients admitted on a Friday (for surgery on the following Monday) want to stay at home with their family for the week-end as long as possible, as they want to return to the hospital no sooner than absolutely necessary. This way they will not be able to receive the preoperative session.
  • Some patients express that it is enough for them as it is to handle the situation. They do not feel that they can handle a project on top
  • Some express explicitly that they feel too anxious to deal with a project on top of everything else happening which is plenty for them to deal with
  • Some (in their late seventies) express that they feel to old for ‘such modern stuff’ and that answering a lot of questions seem too demanding for them considering what they a re going through
  • Some patients express the need for them to be with family and close relatives as much as possible during the hospitalisation – and the interventions in this project are offered during visiting hours. The hospital involved is a regional hospital administering these types of operations for patients in a geographically large area resulting in long distances between the patients’ / relatives’ homes and the hospital.

All these reasons I find totally understandable and I have respect for the patients’ choices of priority. At the same time this challenges the speed of recruiting participants and provides some frustration as a PhD project has a time limit. The data collection period may have to be stretched quite a bit in order to meet the aimed number of participants in a project.

The written and oral information has provided the patient with information of possible challenges in terms of filling in questionnaires – particularly in the first postoperative session – in order to prepare them that they did not need to worry about the fact that they may not feel up to writing themselves. So far the largest drop out from the study (11 of 37 participants) at the first post operative session (second session of four). At this point trying to collect data the research requires participants to answer questions that they find it very difficult to give, especially because it is at the time when participants feels most vulnerable, feeble, and distracted (on the day they are transferred from the ICU to the heart and lung surgical unit). Participants have expressed that they could not cope with the questionnaires in relation to this particular session and therefore wanted to withdraw their consent. Recently this questionnaire has been postponed to the second postoperative session as the questionnaire proved stressful and therefore contraindicative to the treatment of relaxation.

Several questions may be posed in this regard:Is it possible to provide the patient with sufficient information so that they may feel safe and okay with agreeing to participate in a project (and stay with it)?

Should the age range of participants recruited for research be limited to (much) less than 80 years (the top limit in this project)? Or should all be included if they want to and are well functioning mentally?

How to include the relatives so that visiting hours are not taken from them? – Running a study at a hospital unit with no tradition of music therapy limits the times and rooms available for sessions.

The question is also whether it would be appropriate to consider the numbers of questions carefully, that we ask participants and the ways in which questions are asked.

The slow recruitment of participants affects the study such that the period of data collection for this study has been extended with six months to last 1½ years.

There is no question that both a slow recruitment and a large drop out affect the morale and pace of work of the researcher. A large amount of patience and flexibility is called for. It can be difficult at times to keep up the engagement. Especially for the research assistants it may feel quite discouraging when one participant after the other drop-out after the first session (preoperative).

Further, complications and return to ICU affect the planning and cause changes in the session schedule, which puts a demand of flexibility on the research staff. This job may not get the first priority when the research assistant time after time experiences cancellations caused by drop outs, whether the reason is complications, postponed operation or the participant’s decision.

These factors, no to participation, drop-outs and slow recruitment all need to be taken into consideration when planning a study.

One way of increasing the recruitment process could be to include more than one hospital unit in a study in order to have a larger recruitment potential. This would have financial and practical consequences such as training and employing research personnel in the region of the other hospitals.

The inclusion criteria might be widened to other types of heart surgery. This would affect the level of comparison as bypass diseases are more closely linked to lifestyle and strongly influenced by smoking, rich food, lack of exercise than heart valve diseases specifically. The latter may be genetically caused or be a result of other diseases such as rheumatic fever at a young age. This type of fever is not an influencing factor nowadays.

It could be argued that the first phase of heart (valve) surgery rehabilitation is too vulnerable a time for the patient to partake in a study. In reducing the number of dependent variables and the battery of questionnaires the strain on the participant would be less.

© 2008. Nordic Journal of Music Therapy. All right reserved This page was last updated by Rune Rolvsjord November 25, 2008.