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

Abstract

BackgroundThe 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.MethodsFifty 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.ResultsPIL 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.ConclusionsWithdrawal 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.

An embedded mixed-methods study highlighted a lack of discussions on retention in clinical trial consultations

“…Our findings resonate with data from a recent study that analysed 50 patient information leaflets (PILs) for clinical trials across a cohort of publically funded UK based RCTs [7]. This analysis of PILs identified that retention is often poorly described within this written information with an unbalanced focus on the patients right to withdraw (present in 98% of the PILs analysed) without having to give a reason (90%) [7]. Contrastingly, only 16% of the PILs analysed included statements on the value and importance of retention [7].…”

“…Analysis first took a deductive approach and entailed coding data transcripts into predefined categorical descriptions (such as 'presence of discussion of retention', discussion of questionnaires', 'discussion of withdrawal', etc) taking a constant comparative approach. The pre-defined codes were developed by all members of the research team based on research aims and informed by existing literature on information that may be important for retention [7].…”

“…A recent study analysed the information potential trial participants are provided with when considering trial participation and focussed on information about retention [7]. Within the sample analysed, only 16% included statements about the value of retention yet 98% frequently reiterated the patients right to withdraw [7]. Investigations of written trial information certainly provide a great starting point to offer improvements.…”

Community pharmacist counseling in early pregnancy—Results from the SafeStart feasibility study

“…Conditional lottery tickets and monetary incentives have been successful in increasing response rates to online questionnaires and retention in randomized trials [30]. Another possibility is to emphasize the importance of retention and how the participants can make valuable contributions to improve care for pregnant women in the Patient Information Leaflet [31].…”

Clinical Trials in Portugal: How Can we Improve?

“…The failure of retaining recruited participants can lead to potentially biased results. 9 Effective retention strategies can be based on influencing participants' behaviour through incentives, reminders, or alleviating participants' burden, and should include the improvement in participant's understanding of the importance of retention 9 . The schedule of too many visits/procedures, a long-distance between participants' home and study site, and doubts/questions about the frequency/occurrence of adverse events are some of the reasons for participant's withdrawal.…”