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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

Hypotheses

Results

Hypothesis 1: poorer psycho-social status and health at baseline will be associated with higher reported rates of both Medical and Social AEs

Main 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 AEs

Hypothesis 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 arm

Hypothesis 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 site

Partially supported although we have been unable to fully explore this

  1. AE adverse event, SAE serious adverse event