Abstract
BackgroundAlthough adverse event (AE) monitoring in trials focusses on medical events, social outcomes may be important in public or social care trials. We describe our approach to reporting and categorising medical and other AE reports, using a case study trial. We explore predictors of medical and social AEs, and develop a model for conceptualising safety monitoring.MethodsThe Building Blocks randomised controlled trial of specialist home visiting recruited 1618 first-time mothers aged 19 years or under at 18 English sites. Event reports collected during follow-up were independently reviewed and categorised as either Medical (standard Good Clinical Practice definition), or Social (trial-specific definition). A retrospectively developed system was created to classify AEs. Univariate analyses explored the association between baseline participant and study characteristics and the subsequent reporting of events. Factors significantly associated at this stage were progressed to binary logistic regressions to assess independent predictors.ResultsA classification system was derived for reported AEs that distinguished between Medical or Social AEs. One thousand, three hundred and fifteen event reports were obtained for mothers or their babies (1033 Medical, 257 Social). Allocation to the trial intervention arm was associated with increased likelihood of Medical rather than Social AE reporting. Poorer baseline psycho-social status predicted both Medical and Social events, and poorer psycho-social status better predicted Social rather than Medical events. Baseline predictors of Social AEs included being younger at recruitment (OR = 0.78 (CI = 0.67 to 0.90), p = 0.001), receiving benefits (OR = 1.60 (CI = 1.09 to 2.35), p = 0.016), and having a higher antisocial behaviour score (OR = 1.22 (CI = 1.09 to 1.36), p < 0.001). Baseline predictors of Medical AEs included having a limiting long-term illness (OR = 1.37 (CI = 1.01 to 1.88), p = 0.046), poorer mental health (OR = 1.03 (CI = 1.01 to 1.05), p = 0.004), and being in the intervention arm of the trial (OR = 1.34 (CI = 1.07 to 1.70), p = 0.012).ConclusionsContinuity between baseline and subsequent adverse experiences was expected despite potentially beneficial intervention impact. We hypothesise that excess events reported for intervention-arm participants is likely attributable to surveillance bias. We interpreted our findings against a new model that explicates processes that may drive event occurrence, presentation and reporting. Focussing only upon Medical events may miss the well-being and social circumstances that are important for interpreting intervention safety and participant management.Trial registrationISRCTN, ID: ISRCTN23019866. Registered on 20 April 2009.
Highlights
Adverse event (AE) monitoring in trials focusses on medical events, social outcomes may be important in public or social care trials
Aim 1: classification system for reported adverse event (AE) A classification system was derived for reported AEs (Fig. 1)
Our finding that over 19% of events were Social AEs supports the idea that the Good Clinical Practice (GCP) definition of AEs and serious adverse event (SAE) cannot capture all events related to wellbeing and social circumstances that might be important for a public health or social care trial
Summary
Adverse event (AE) monitoring in trials focusses on medical events, social outcomes may be important in public or social care trials. Safety monitoring in clinical trials has been standardised using AE and serious adverse event (SAE) reporting protocols; for example, The Medicines for Human Use (Clinical Trials) Regulations 2004, which focus on medical events of varying severity Such AEs may or may not be associated with the intervention. Monitoring unintended or unexpected outcomes in such trials and participant well-being in general will involve outcomes which are social and psychological in nature in addition to medical Systems for monitoring these events are underdeveloped and inconsistent in public health, social care, and psychotherapy trials; for example, Duggan et al (2014) found that the recording of AEs in a trial of psychological intervention was either not attempted/reported, or used definitions not entirely suitable to the intervention or condition being studied [2]. While some authors have attempted to expand on the Good Clinical Practice (GCP) definition of AEs and SAEs to incorporate other types of events [3,4,5,6], none of these have included social events
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