Effect of a clinical pathway on antibiotic prescribing and outcomes for acute bacterial skin and skin structure infections.
Advanced Search Abstract Two reasons for the lack of success of programs or interventions are poor alignment of interventions with the causes of the problem targeted by the intervention, leading to poor efficacy theory failureand failure to implement interventions as designed program failure.
These failures are important for both public health programs and randomized trials. In this article, we present the SHINE PIP including definitions and measurements of key mediating domains, and discuss the implications of this approach for randomized trials.
Operationally, the PIP can be used for monitoring and strengthening intervention delivery, facilitating course-correction at various stages of implementation. Analytically, the PIP can facilitate a richer understanding of the mediating and modifying determinants of intervention impact than would be possible from an intention-to-treat analysis alone.
One area in which its added value is most apparent is through embedding theory-driven process evaluation directly into evaluation studies, including randomized trials [ 45 ].
This typically entails conceptually articulating how an intervention has been designed to work ie, the program theory and elucidating and measuring intermediate outcomes that need to be achieved for it to work as intended [ 6—8 ].
Such theory-driven approaches can provide generalizable knowledge and explain positive, modest, and insignificant results in a single intervention study. Moreover, they can help to identify the intervention components most responsible for the observed effects [ 910 ], as well as inform the scale-up of efficacious interventions and programs [ 31112 ].
Within the growing body of literature in this area [ 13—20 ], 2 published examples in particular illustrate the value of theory-driven process evaluation in nutrition research.
The first is a cluster-randomized trial CRT of an educational intervention in Peru, demonstrated to have had a positive impact on both ponderal and linear growth [ 21 ]. Consistent with the linkages laid out in the a priori program theory and therefore strengthening the plausibility of the results, the authors demonstrated that better health center implementation of the intervention positively influenced caregiver exposure, which was in turn positively associated with caregiver message recall, which was in turn positively associated with key feeding behaviors [ 22 ].
This raises the possibility that even larger effects might be possible if better implementation could be achieved. In the second illustrative example, no differential growth effect was observed in a multisite Guatemala, Pakistan, Zambia, and Democratic Republic of the Congo trial of 2 child feeding interventions daily meat intake compared with an equicaloric micronutrient fortified cereal in contexts with prevalent stunting [ 24 ].
A theory-driven process evaluation confirmed that there were no differences in visits, deliveries of the study foods, message recall, or rates of consumption of study foods between the treatment groups [ 25 ].
This process evaluation, and high fidelity of implementation observed, increased confidence that the trial's null finding was not due to differences or inconsistencies in protocol implementation.
Additionally, message recall was associated with linear growth velocity irrespective of treatment group. This underscored the importance of the study messages, suggesting that targeted infant feeding education for low-literacy populations, for whom message recall was lower, could be efficacious [ 25 ].
The Sanitation Hygiene Infant Nutrition Efficacy SHINE Trial is designed to test the independent and combined effects of 2 village health worker VHW —delivered intervention packages to improve water, sanitation, and hygiene WASH and infant feeding behaviors with the aim of improving length and hemoglobin concentration or reducing stunting and anemia respectively at 18 months of age.
The design is a cluster-randomized, 2-factorial, community-based intervention trial in 2 rural districts of Zimbabwe. Whereas the factorial design allows for efficient comparison of 2 interventions with hypothesized independent and additive effects, the cluster-randomized design is necessitated by the theoretical eg, health behavior is in part socially constructed and practical eg, cost and implementation feasibility considerations of delivering sustained behavior change communication to rural communities [ 26 ].
The unit of randomization is a group of households within the geographically contiguous catchment area of 1—4 VHWs. VHWs are trained to visit participants monthly, deliver messages in accordance with behavior change intervention modules relevant to their randomized arm, and deliver corresponding inputs such as soap, water chlorination agents, and small-quantity lipid-based nutrient supplements LNSs.
Evaluating and understanding the impact of such an intervention is challenging because the pathways to impact are multiple and subject to effect modification [ 8 ].
Intention-to-treat ITT analysis of the main outcomes is the standard approach for statistical tests of the hypothesis of null effects of treatment in a randomized trial [ 30 ] and is the primary analysis approach of the SHINE Trial [ 31 ].
The ITT estimates the effect of treatment as randomly allocated, which may substantially differ from the treatment effect for those who actually both received and took up the intervention [ 3032 ].
Second, we describe how we are measuring the key mediating domains at each step in the PIP.
Third, we describe how we use the PIP operationally. Finally, we discuss its application in 2 broad analytic approaches:Getting a Job as a Pharmacist. Contents. The Application, Interview; Looking for a Job; Beyond making your own connections -- and leveraging your graduate program's -- putting in your application online is the most common way to go.
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