How Much Is the Lack of Retention Evidence Costing Trial Teams in Ireland and the United Kingdom?

BackgroundEvidence to support the use of many retention strategies in clinical trials is lacking. Despite this, trial teams still need to have some form of retention strategy in their trials to try and avoid high attrition rates. This study aimed to estimate how much this lack of retention evidence might be costing trials in Ireland and the United Kingdom.Methods We selected the top ten most routinely used retention strategies by Clinical Trial Units in the United Kingdom and made assumptions as to how each of these strategies was most likely to be conducted and the costs involved. We applied our costing model to a hypothetical trial scenario in both Ireland and the United Kingdom as well as to three published trial protocols. We developed the costing model and calculated the costs in Microsoft Excel.Results Retention strategies can be extremely expensive, some of the costliest interventions included “a timeline of participant visits for sites” (with integrated participant reminders) (€1,418.44 - €108,471.99), “routine site visits by CTU staff” (€777.67 - €14,753.48), and “data collection scheduled with routine care” (€900 - €32,503.25). Others such as “telephone reminders for questionnaire response” (€34.58 - €568.62), “inclusion of pre-paid envelopes” (€93.44 - €942.50), and “targeted recruitment of sites/GPs” (€30 - €1,620) were less costly compared to the other interventions. DiscussionThe resources invested in the use of some retention interventions may outweigh known or imagined benefits on retention. Where benefits are imagined, evaluation should be a priority. Conclusion More evaluation of the effectiveness and cost of trial retention strategies is needed to avoid widespread use of strategies that are both expensive and ineffective.

Protocol of a Multi-centric Randomized Controlled Trial to Evaluate Efficacy of Telephone-Based Psychosocial Interventions on Future Suicide Risk in Suicide Attempters

Background: Persons with previous history of a suicide attempt are at increased future risk of death by suicide. These vulnerable individuals, however, do not seek receive or seek help from mental health services. Telephone-based psychosocial interventions are potential strategies in augmenting mental health care in such persons. Methods: We aim to compare the efficacy of telephone-based psychosocial interventions (TBPI) with routine telephone reminders in persons with recent suicide attempts using a multi-site, parallel group, rater-blind, two-arm randomized controlled trial design in 362 participants. In the first group, participants will receive three sessions of TBPI comprising of brief supportive interventions, problem-solving strategies, and reminders for adherence to prescribed mental health treatment at weekly intervals. In the second group, participants will receive three telephone reminders for adherence to prescribed mental health treatment at weekly intervals. We will follow up participants for 6 months. Primary outcomes are suicidal ideation scores on Beck’s Scale for Suicide Ideation and number of repeat suicide attempts. Secondary outcomes are scores on Beck’s Hopelessness Scale, Beck’s Depression Inventory, Connor–Davidson Resilience Scale and Visual Analogue Rating Scales for acceptability of interventions. Outcomes will be assessed at 1, 3, and 6 months after receiving telephone interventions or reminders. Results: The trial is currently underway after prospective registration under Clinical Trials Registry of India and has recruited 260 participants till August 15, 2020. Conclusion: This study has potential to generate evidence on additional strategies for use along with standard mental health treatments in management of high-risk suicide behaviors.

Effectiveness of reminder strategies on cancer screening adherence: a randomised controlled trial

BackgroundFew randomised controlled trials (RCTs) have evaluated the different recalling approaches for enhancing adherence to faecal immunochemical test (FIT)-based screening.AimThe authors evaluated the effectiveness of two telecommunication strategies on improving adherence to yearly FIT screening.Design and settingA randomised, parallel group trial was performed in a primary care screening practice.MethodThe authors recruited 629 asymptomatic individuals aged 40–70 years with a negative FIT in 2015 to a population-based screening programme. On participation, they were invited to repeat their second round of FIT in 2016, 12 months after the first test. Each participant was randomly assigned to either interactive telephone reminder (n = 207), short message service reminder (SMS, n = 212), or control, where no additional interventions were delivered after the findings of their first FIT was communicated to the participants (n = 210). Reminders in the intervention groups were delivered 1 month before subjects’ expected return. Additional telephone reminders were delivered 2 months after the expected return date to all subjects who defaulted specimen return. The outcomes included rates of FIT collection and specimen return up to 6 months after their expected return.ResultsAt 6 months, the cumulative FIT collection rate was 95.1%, 90.4%, and 86.5%, respectively, for the telephone, SMS, and control groups (P = 0.010). The corresponding specimen return rate was 94.1%, 90.0%, and 86.0% (P = 0.022). When compared with the control, only subjects in the telephone group were significantly more likely to collect FIT tubes (adjusted odds ratio [AOR] 3.18, 95% confidence interval [CI] = 1.50 to 6.75, P = 0.003) and return completed specimens (AOR = 2.73, 95% CI = 1.35 to 5.53, P = 0.005).ConclusionInteractive telephone reminders are effective at securing previously screened subjects to repeat screening 1 year after a negative finding.