Monitoring treatment fidelity in a randomised controlled trial of a complex intervention.

Aim. This paper is a report of a study to describe how treatment fidelity is being enhanced and monitored, using a model from the National Institutes of Health Behavior Change Consortium. Background. The objective of treatment fidelity is to minimize errors in interpreting research trial outcomes, and to ascribe those outcomes directly to the intervention at hand. Treatment fidelity procedures are included in trials of complex interventions to account for inferences made from study outcomes. Monitoring treatment fidelity can help improve study design, maximize reliability of results, increase statistical power, determine whether theory-based interventions are responsible for observed changes, and inform the research dissemination process. Methods. Treatment fidelity recommendations from the Behavior Change Consortium were applied to the SPHERE study (Secondary Prevention of Heart DiseasE in GeneRal PracticE), a randomized controlled trial of a complex intervention. Procedures to enhance and monitor intervention implementation included standardizing training sessions, observing intervention consultations, structuring patient recall systems, and using written practice and patient care plans. The research nurse plays an important role in monitoring intervention implementation. Findings. Several methods of applying treatment fidelity procedures to monitoring interventions are possible. The procedure used may be determined by availability of appropriate personnel, fiscal constraints, or time limits. Complex interventions are not straightforward and necessitate a monitoring process at trial stage. Conclusion. The Behavior Change Consortium’s model of treatment fidelity is useful for structuring a system to monitor the implementation of a complex intervention, and helps to increase the reliability and validity of evaluation findings.

Inscribir el declive en el tiempo. Detroit: Auge y crisis de la ciudad industrial

A comienzos del siglo XX, Detroit era una ciudad dinámica en pleno desarrollo. Pronto se convirtió en la cuarta ciudad de Estados Unidos, la capital de la naciente industria automovilística. El crecimiento se prolongó hasta finales de los años 50, cuando, a pesar del auge económico de Estados Unidos y de su área metropolitana, Detroit comenzó a mostrar los primeros signos de estancamiento. La crisis se ha prolongado hasta hoy, cuando Detroit constituye el paradigma de la ciudad industrial en declive. Estas dos imágenes contrapuestas, el auge y la crisis, no parecen explicar por sí mismas las causas de la intensidad y persistencia del declive de Detroit. Analizar las interacciones entre crecimiento económico, políticas públicas locales y desarrollo urbano a lo largo del tiempo permitirá subrayar las continuidades y comprender en qué medida el declive de Detroit ancla sus raíces en el modelo planteado durante la etapa de auge.

Vision and reality: community involvement in Irish urban regeneration

This article examines the processes and outcomes of community involvement in six Irish urban regeneration case studies, three in Dublin and three in Belfast. The findings are part of a wider study using a Complex Adaptive Systems perspective to analyse public sector decision making. Key points included: (1) the community ‘vision’ of the regeneration as an emergent property, which converged towards the vision held by the implementing agencies in the four most successful programmes; and (2) the identification of three features that contribute to non-linear (unpredictable) behaviour: a history of community involvement; the availability of resources; and the intervention of key individuals at crisis points.

Identifying strategies to maximise recruitment and retention of practices and patients in a multicentre randomised controlled trial of an intervention to optimise secondary prevention for coronary heart disease in primary care.

Background Recruitment and retention of patients and healthcare providers in randomised controlled trials (RCTs) is important in order to determine the effectiveness of interventions. However, failure to achieve recruitment targets is common and reasons why a particular recruitment strategy works for one study and not another remain unclear. We sought to describe a strategy used in a multicentre RCT in primary care, to report researchers’ and participants’ experiences of its implementation and to inform future strategies to maximise recruitment and retention. Methods In total 48 general practices and 903 patients were recruited from three different areas of Ireland to a RCT of an intervention designed to optimise secondary prevention of coronary heart disease. The recruitment process involved telephoning practices, posting information, visiting practices, identifying potential participants, posting invitations and obtaining consent. Retention involved patients attending reviews and responding to questionnaires and practices facilitating data collection. Results We achieved high retention rates for practices (100%) and for patients (85%) over an 18-month intervention period. Pilot work, knowledge of the setting, awareness of change in staff and organisation amongst participant sites, rapid responses to queries and acknowledgement of practitioners’ contributions were identified as being important. Minor variations in protocol and research support helped to meet varied, complex and changing individual needs of practitioners and patients and encouraged retention in the trial. A collaborative relationship between researcher and practice staff which required time to develop was perceived as vital for both recruitment and retention. Conclusions Recruiting and retaining the numbers of practices and patients estimated as required to provide findings with adequate power contributes to increased confidence in the validity and generalisability of RCT results. A continuous dynamic process of monitoring progress within trials and tailoring strategies to particular circumstances, whilst not compromising trial protocols, should allow maximal recruitment and retention.