How accurately do consecutive cohort audits predict Phase III multisite clinical trial recruitment in palliative care?

McCaffrey, Nikki, Fazekas, Belinda, Cutri, Natalie and Currow, David C. 2016, How accurately do consecutive cohort audits predict Phase III multisite clinical trial recruitment in palliative care?, Journal of pain and symptom management, vol. 51, no. 4, pp. 748-755, doi: 10.1016/j.jpainsymman.2015.11.022.

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Title How accurately do consecutive cohort audits predict Phase III multisite clinical trial recruitment in palliative care?
Author(s) McCaffrey, NikkiORCID iD for McCaffrey, Nikki
Fazekas, Belinda
Cutri, Natalie
Currow, David C.
Journal name Journal of pain and symptom management
Volume number 51
Issue number 4
Start page 748
End page 755
Total pages 8
Publisher Elsevier
Place of publication Philadelphia, Pa.
Publication date 2016-04
ISSN 0885-3924
Keyword(s) randomized controlled trial
palliative care
Summary Context. Audits have been proposed for estimating possible recruitment rates to randomized controlled trials (RCTs), but few studies have compared audit data with subsequent recruitment rates.

Objectives. To compare the accuracy of estimates of potential recruitment from a retrospective consecutive cohort audit of actual participating sites and recruitment to four Phase III multisite clinical RCTs.

Methods. The proportion of potentially eligible study participants estimated from an inpatient chart review of people with life-limiting illnesses referred to six Australian specialist palliative care services was compared with recruitment data extracted from study prescreening information from three sites that participated fully in four Palliative Care Clinical Studies Collaborative RCTs. The predominant reasons for ineligibility in the audit and RCTs were analyzed.

Results. The audit overestimated the proportion of people referred to the palliative care services who could participate in the RCTs (pain 17.7% vs. 1.2%, delirium 5.8% vs. 0.6%, anorexia 5.1% vs. 0.8%, and bowel obstruction 2.8% vs. 0.5%). Approximately 2% of the referral base was potentially eligible for these effectiveness studies. Ineligibility for general criteria (language, cognition, and geographic proximity) varied between studies, whereas the reasons for exclusion were similar between the audit and pain and anorexia studies but not for delirium or bowel obstruction.

Conclusion. The retrospective consecutive case note audit in participating sites did not predict realistic recruitment rates, mostly underestimating the impact of study-specific inclusion criteria. These findings have implications for the applicability of the results of RCTs. Prospective pilot studies are more likely to predict actual recruitment.
Language eng
DOI 10.1016/j.jpainsymman.2015.11.022
Field of Research 111799 Public Health and Health Services not elsewhere classified
Socio Economic Objective 920499 Public Health (excl. Specific Population Health) not elsewhere classified
HERDC Research category C1.1 Refereed article in a scholarly journal
ERA Research output type C Journal article
Copyright notice ©2016, American Academy of Hospice and Palliative Medicine
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Document type: Journal Article
Collections: Faculty of Health
School of Health and Social Development
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