Lasse S Vestergaard

There is increasing recognition among trialists of the challenges in understanding how particular ‘real-life’ contexts influence the delivery and receipt of complex health interventions. Evaluations of interventions to change health worker and/or patient behaviours in health service settings exemplify these challenges. When interpreting evaluation data, deviation from intended intervention implementation is accounted for through process evaluations of fidelity, reach, and intensity. However, no such systematic approach has been proposed to account for the way evaluation activities may deviate in practice from assumptions made when data are interpreted. A collective case study was conducted to explore experiences of undertaking evaluation activities in the real-life contexts of nine complex intervention trials seeking to improve appropriate diagnosis and treatment of malaria in varied health service settings. Multiple sources of data were used, including in-depth interviews with investigators, participant-observation of studies, and rounds of discussion and reflection. From our experiences of the realities of conducting these evaluations, we identified six key ‘lessons learned’ about ways to become aware of and manage aspects of the fabric of trials involving the interface of researchers, fieldworkers, participants and data collection tools that may affect the intended production of data and interpretation of findings. These lessons included: foster a shared understanding across the study team of how individual practices contribute to the study goals; promote and facilitate within-team communications for ongoing reflection on the progress of the evaluation; establish processes for ongoing collaboration and dialogue between sub-study teams; the importance of a field research coordinator bridging everyday project management with scientific oversight; collect and review reflective field notes on the progress of the evaluation to aid interpretation of outcomes; and these approaches should help the identification of and reflection on possible overlaps between the evaluation and intervention. The lessons we have drawn point to the principle of reflexivity that, we argue, needs to become part of standard practice in the conduct of evaluations of complex interventions to promote more meaningful interpretations of the effects of an intervention and to better inform future implementation and decision-making.

Accurately characterizing a drug’s safety profile is essential. Trial harm and tolerability assessments rely, in part, on participants’ reports of medical histories, adverse events (AEs), and concomitant medications. Optimal methods for questioning participants are unclear, but different methods giving different results can undermine meta-analyses. This study compared methods for eliciting such data and explored reasons for dissimilar participant responses.

Background: The planning and assessment of malaria interventions is complicated due to fluctuations in the burden of malaria over time. Recently, it has been reported that the burden of malaria in some parts of Africa has declined. However, community-based longitudinal data are sparse and the reasons for the apparent decline are not well understood. Methods: Malaria prevalence and morbidity have been monitored in two villages in north-eastern Tanzania; a lowland village and a highland village from 2003 to 2008. Trained village health workers treated presumptive malaria with the Tanzanian first-line anti-malarial drug and collected blood smears that were examined later. The prevalence of malaria parasitaemia across years was monitored through cross-sectional surveys. Results: The prevalence of malaria parasitaemia in the lowland village decreased from 78.4% in 2003 to 13.0% in 2008, whereas in the highland village, the prevalence of parasitaemia dropped from 24.7% to 3.1% in the same period. Similarly, the incidence of febrile malaria episodes in the two villages dropped by almost 85% during the same period and there was a marked reduction in the number of young children who suffered from anaemia in the lowland village. Conclusion: There has been a marked decline in malaria in the study villages during the past few years. This decline is likely to be due to a combination of factors that include improved access to malaria treatment provided by the trained village helpers, protection from mosquitoes by increased availability of insecticide-impregnated bed nets and a reduced vector density. If this decline in malaria morbidity is sustained, it will have a marked effect on the disease burden in this part of Tanzania.