BMJ  2005;331:1271-1272 (26 November), doi:10.1136/bmj.331.7527.1271-c

Letter

Including care home residents in clinical research is fraught

EDITOR—Funders need to take account of issues related to including older people in clinical trials,¹ but including care home residents poses additional problems.

We have just completed a large clinical trial of a pharmacist conducting clinical medication reviews of elderly residents of care homes. Obtaining consent presented particular problems in this population with an average age of 85 and a standardised mini-mental state test score of 13. Even those residents who seemed to understand what was being asked of them had often forgotten all about it when our research assistant returned the following day to seek their signature. We needed to seek the assent of the nearest relative for half of our study population.

Not only is obtaining consent time consuming, but we also needed the agreement of home managers before we could even approach their residents. Arranging to see the residents was fraught because of the limited time window in their short day when they are not eating, sleeping, dressing, or washing, or attending outpatients. The interview process is also prolonged, because of the time the residents take to walk to their room, as well as the communication difficulties during interview. We also had to exclude some patients who had given consent from the trial because their doctor did not agree to their inclusion. This interfered with the autonomy of patients who had agreed to participate.

The implications for our (already generously funded) project were that we had to seek additional finance to complete the recruitment process and still failed to achieve our recruitment target of 1600 after approaching virtually all elderly care home residents in Leeds. Interpretation of results is further complicated by the high mortality of this population—in six months, over 14% of our population had died (in intervention and control groups). Research in care homes is essential but surprisingly expensive in both time and money.

School of Healthcare Studies, University of Leeds, Leeds LS2 9UT
zermansky{at}btinternet.com

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The three other authors of this letter are Duncan R Petty, David K Raynor, and David P Alldred.

Competing interests: AGZ and two of the other authors (DKR and DPA) are currently engaged in a study of medication errors in care homes.

References

1. McMurdo MET, Witham MD, Gillespie ND. Including older people in clinical research. BMJ 2005;331: 1036-7. (5 November.)[Free Full Text]

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Including older people in clinical research

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