Why the exclusion of older people from clinical research must stop
BMJ 2012; 344 doi: https://doi.org/10.1136/bmj.e3445 (Published 21 May 2012) Cite this as: BMJ 2012;344:e3445
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We agree with Geoff Watts (1) that barriers to recruitment of older patients in randomised trials need to be addressed. This is a particular challenge in breast cancer where worldwide approximately a third of patients are =/> 65 years. The EORTC Cancer in the Elderly task force rightly identifies Quality of life (QoL) as an important endpoint for older patients. The proposed charter (2) for the rights of older people in clinical trials emphasises the need to make clinical trials as practical as possible. Our own experience in the PRIME (Postoperative Radiotherapy In Minimum-risk Elderly) QoL trial (3,4) in which patients treated with breast conserving surgery and adjuvant hormonal therapy were randomised to breast radiotherapy or no further treatment endorses the benefits of this approach. Completion of questionnnaires was very high (>98%) in the QoL study which we ascribe, in a large part, to a research nurse carrying out most of the quality of life assessments in the patient’s home.Initial slow recruitment was accelerated by surgeons specifically endorsing the trial at the patient’s first postoperative visit in advance of meeting the clinical oncologist explaining the trial and seeking written informed consent. The network of investigators in the first PRIME trial established a platform for successful recruitment to a much larger RCT, PRIME 2, (>1300 patients)[5] testing the impact of the omission of radiotherapy on local control in a similar population to the PRIME QoL trial. Recruitment to large elderly specific RCTs is feasible if age related issues for patients are anticipated.
References:
1.Watts G. Why the exclusion of older people from clinical research must stop. BMJ 2012;344:23-24.
2.PREDICT. Charter for the rights of older people in clinical trials.www.predict.org/PREDICT_Charter/predict_charter.html.
3.Prescott RJ, Kunkler IH, Williams LJ et al. A randomised controlled trial of postoperative radiotherapy following breast-conserving surgery in a minimum-risk older population. The PRIME trial.Health Technol Assess. 2007 11(31):1-149.
4.Williams LJ, Kunkler IH, King CC, et al. A randomised controlled trial of
post-operative radiotherapy following breast-conserving surgery in a minimum-
risk population. Quality of life at 5 years in The PRIME trial. Health Technol Assess. 2011;15: i-xi 1-57.
5.Kunkler I. PRIME II breast cancer trial. Clin Oncol 2004; 16:447-448.
Competing interests: No competing interests
A multi-facetted approach is required to end the systematic exclusion of older people from clinical research. However one simple measure could have a major impact – a zero tolerance policy from both funders and ethics committees for arbitrary upper age cut-offs. The use of such upper age limits is surprisingly common with 33% of papers published in four leading medical journals using explicit exclusions on the basis of age1. In many instances, researchers simply opt for an upper age limit on a purely arbitrary basis, without offering a scientific justification for why, for example, a 75 year old would be a suitable research participant, but why a 76 year old would not.
The Age and Ageing Specialty Group, supported by the NIHR Clinical Research Network Coordinating Centre has posted a statement on Equity on Clinical Research regarding the inclusion of older participants on the NIHR public and researcher websites2. It aims to redress the imbalance of older people in clinical research, not only in the interests of equity, but because of the need to draw on the results of good quality research to inform best practice in the management of our growing older population. This lead is one which other funders may wish to follow if ageism in clinical research is not to flourish.
Reference List
1. McMurdo ME, Witham MD, Gillespie ND. Including older people in clinical research. BMJ 2005;331:1036-7.
2. www.crncc.nihr.ac.uk/Resources/NIHR%20CRN%20CC/Documents/equity_in_clini...
Competing interests: I am Chair of the NIHR Age and Ageing specialty research group
Re: Why the exclusion of older people from clinical research must stop
We read with interest Geoff Watts’ feature on why the exclusion of older people from clinical research must stop [1].
We have run 2 RCTs at Guildford over 4 years (NCTs 18926278 and 01128088), one of which has been published already [2], pioneering the use of different analgesic modalities within an Enhanced Recovery Programme (ERP) for laparoscopic colorectal resection. We have recruited patients from every age group requiring colorectal resection.
Given the forecast demographic changes over the next two decades, we were very keen to ascertain whether or not it was appropriate or achievable for elderly patients to enter the ERP initiative. We have analysed our patients <80 years of age and compared those to those aged 80 years of age and over.
In spite of a higher mean age (82 vs 64 years) and higher co-morbidity as determined by the median P-POSSUM scores (29 vs 28 –p < 0.005), the median time taken until fit for discharge was not different between the two groups - 2.8 days in those aged 80 and over and 2.6 days in those aged under 80 (p = 0.336). We thus found that those aged over 80 derived similar benefits to their younger counterparts [3].
As a result we strongly encourage the recruitment of elderly people into ERPs and indeed other research. The patients welcomed it. In spite of a number of physiological and pathological changes that may be occurring in the elderly, it is essential that we offer this group of patients the opportunities to benefit from medical advances.
References
1. Watts G. Why the exclusion of older people from clinical research must stop. BMJ 2012;344:e3445
2. Levy BF, Scott WJ, Fawcett W, Fry C, Rockall TA. Randomized clinical trial of epidural, spinal or patient controlled analgesia for patients undergoing laparoscopic colorectal surgery. British Journal of Surgery 2011;98:1068-1078
3. Day A, Fawcett WJ, Scott MJP, Rockall TA. Fast-track surgery and the elderly
British Journal of Anaesthesia 2012 109: 124-124
Competing interests: No competing interests