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Table 7 Results in relation to hypotheses

From: Monitoring adverse social and medical events in public health trials: assessing predictors and interpretation against a proposed model of adverse event reporting

Hypothesis 1: poorer psycho-social status and health at baseline will be associated with higher reported rates of both Medical and Social AEsMain predictors of Social AEs: younger age at recruitment, more likely to receive benefits, having a higher antisocial behaviour score. Main predictors of Medical S/AEs: ill health at baseline (limiting long-term illness and poorer mental health)
Hypothesis 2: poorer psycho-social status at baseline will more likely be associated with Social rather than Medical AEsHypothesis supported. Main predictors of Social AEs (related to poorer psycho-social status): younger age at recruitment, more likely to receive benefits. No baseline indicators of poorer psycho-social status remained in the model for the Medical S/AEs
Hypothesis 3: AEs reports will be more likely for those in the trial intervention armHypothesis partially supported. Allocation to the intervention arm of the trial was associated with increased likelihood of Medical S/AE but not with Social AE reporting
Hypothesis 4: rate of AE reporting will vary by trial sitePartially supported although we have been unable to fully explore this
  1. AE adverse event, SAE serious adverse event