Reducing attrition within clinical trials: The communication of retention and withdrawal within patient information leaflets

Kearney, Anna ORCID: 0000-0003-1404-3370, Rosala-Hallas, Anna ORCID: 0000-0001-8012-9995, Bacon, Naomi ORCID: 0000-0002-5876-3946, Daykin, Anne, Shaw, Alison RG, Lane, Athene J, Blazeby, Jane M, Clarke, Mike, Williamson, Paula R ORCID: 0000-0001-9802-6636 and Gamble, Cerrol ORCID: 0000-0002-3021-1955 (2018) Reducing attrition within clinical trials: The communication of retention and withdrawal within patient information leaflets. PLOS ONE, 13 (10). e0204886-.

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Abstract

<h4>Background</h4>The recruitment and retention of patients are significant methodological challenges for trials. Whilst research has focussed on recruitment, the failure to retain recruited patients and collect outcome data can lead to additional problems and potentially biased results. Research to identify effective retention strategies has focussed on influencing patient behaviour through incentives, reminders and alleviating patient burden, but has not sought to improve patient understanding of the importance of retention. Our aim is to assess how withdrawal, retention and the value of outcome data collection is described within the Patient Information Leaflets (PIL) used during consent.<h4>Methods</h4>Fifty adult or parent PIL from a cohort of trials starting between 2009-2012 and funded by the NIHR Health Technology Assessment programme were obtained from protocols, websites or by contacting trialists. A checklist of PIL content based on Health Research Authority (HRA) and ICH GCP Guidelines was supplemented with retention specific questions. Corresponding protocols were also evaluated to cross reference trial specific procedures with information communicated to patients.<h4>Results</h4>PIL frequently reiterated the patient's right to withdraw at any time (n = 49, 98%), without having to give a reason and without penalty (n = 45, 90%). However, few informed patients they may be asked to give a withdrawal reason where willing (n = 6, 12%). Statements about the value of retention were infrequent (n = 8, 16%). Consent documents failed to include key content that might mitigate withdrawals, such as the need for treatment equipoise (n = 3, 6%). Nearly half the trials in the cohort (n = 23, 46%) wanted to continue to collect outcome data if patients withdraw. However, in 70% of PIL using prospective consent, withdrawal was described in generic terms leaving patients unaware of the difference between stopping treatment and all trial involvement. Nineteen (38%) trials offered withdrawing patients the option to delete existing data.<h4>Conclusions</h4>Withdrawal and retention is poorly described within PIL and addressing this might positively impact levels of patient attrition, reducing missing data. Consent information is unbalanced, focussing on patient's rights to withdraw without accompanying information that promotes robust consent and sustained participation. With many citing altruistic reasons for participation it is essential that PIL include more information on retention and clarify withdrawal terminology so patients are aware of how they can make a valuable contribution to clinical studies. There is a need to determine how retention can be described to patients to avoid concerns of coercion. Future research is needed to explore whether the absence of information about retention at the time of consent is impacting attrition.

Item Type:	Article
Uncontrolled Keywords:	Humans, Withholding Treatment, Prospective Studies, Motivation, Parents, Comprehension, Patient Selection, Patient Rights, Informed Consent, Adult, Patients, Female, Male, Clinical Trials as Topic
Depositing User:	Symplectic Admin
Date Deposited:	06 Nov 2018 09:24
Last Modified:	19 Jan 2023 01:13
DOI:	10.1371/journal.pone.0204886
Open Access URL:	https://doi.org/10.1371/journal.pone.0204886
Related URLs:	Author Publisher
URI:	https://livrepository.liverpool.ac.uk/id/eprint/3028451

Available Versions of this Item

• Reducing attrition within clinical trials: The communication of retention and withdrawal within Patient Information Leaflets. (deposited 12 Oct 2018 10:33)
  • Reducing attrition within clinical trials: The communication of retention and withdrawal within patient information leaflets. (deposited 06 Nov 2018 09:24) [Currently Displayed]