Process evaluation for complex interventions in health services research: Analysing context, text trajectories and disruptions

Background: Process evaluations assess the implementation and sustainability of complex healthcare interventions within clinical trials, with well-established theoretical models available for evaluating intervention delivery within specific contexts. However, there is a need to translate conceptualisations of context into analytical tools which enable the dynamic relationship between context and intervention implementation to be captured and understood. Methods: In this paper I propose an alternative approach to the design, implementation and analysis of process evaluations for complex health interventions through a consideration of trial protocols as textual documents, distributed and enacted at multiple contextual levels. As an example, I conduct retrospective analysis of a sample of field notes and transcripts collected during the ESTEEM study - a cluster randomised controlled trial of primary care telephone triage. I draw on theoretical perspectives associated with Linguistic Ethnography to examine the delivery of ESTEEM through staff orientation to different texts. In doing so I consider what can be learned from examining the flow and enactment of protocols for notions of implementation and theoretical fidelity (i.e. intervention delivered as intended and whether congruent with the intervention theory). Results: Implementation of the triage intervention required staff to integrate essential elements of the protocol within everyday practice, seen through the adoption and use of different texts that were distributed across staff and within specific events. Staff were observed deploying texts in diverse ways (e.g. reinterpreting scripts, deviating from standard operating procedures, difficulty completing decision support software), providing numerous instances of disruption to maintaining intervention fidelity. Such observations exposed tensions between different contextual features in which the trial was implemented, offering theoretical explanations for the main trial findings. Conclusions: The value of following how trial protocols produce new texts is that we can observe the flow of 'the intervention as intended' across a series of events which are enacted to meet specific demands of intervention delivery. Such observations are not solely premised on identifying routines or practices of implementation, but where 'protocols as intended' breaks down. In doing so, I discuss whether it is here where we might expose the 'active ingredients' of interventions in action

Appreciative inquiry in medical education*

The practice of medicine, and also medical education, typically adopts a problem-solving approach to identify "what is going wrong" with a situation. However, an alternative is Appreciative Inquiry (AI), which adopts a positive and strengths-based approach to identify "what is going well" with a situation. The AI approach can be used for the development and enhancement of the potential of both individuals and organizations. An essential aspect of the AI approach is the generative process, in which a new situation is envisioned and both individual and collective strengths are mobilized to make changes to achieve the valued future situation. The AI approach has been widely used in the world of business and general education, but is has an exciting potential for medical education, including curriculum development, faculty development, supporting learners through academic advising and mentoring, but also for enhancing the teaching and learning of both individuals and groups. This AMEE Guide describes the core principles of AI and their practical application in medical education

Consensus on circulatory shock and hemodynamic monitoring. Task force of the European Society of Intensive Care Medicine.

OBJECTIVE: Circulatory shock is a life-threatening syndrome resulting in multiorgan failure and a high mortality rate. The aim of this consensus is to provide support to the bedside clinician regarding the diagnosis, management and monitoring of shock. METHODS: The European Society of Intensive Care Medicine invited 12 experts to form a Task Force to update a previous consensus (Antonelli et al.: Intensive Care Med 33:575-590, 2007). The same five questions addressed in the earlier consensus were used as the outline for the literature search and review, with the aim of the Task Force to produce statements based on the available literature and evidence. These questions were: (1) What are the epidemiologic and pathophysiologic features of shock in the intensive care unit ? (2) Should we monitor preload and fluid responsiveness in shock ? (3) How and when should we monitor stroke volume or cardiac output in shock ? (4) What markers of the regional and microcirculation can be monitored, and how can cellular function be assessed in shock ? (5) What is the evidence for using hemodynamic monitoring to direct therapy in shock ? Four types of statements were used: definition, recommendation, best practice and statement of fact. RESULTS: Forty-four statements were made. The main new statements include: (1) statements on individualizing blood pressure targets; (2) statements on the assessment and prediction of fluid responsiveness; (3) statements on the use of echocardiography and hemodynamic monitoring. CONCLUSIONS: This consensus provides 44 statements that can be used at the bedside to diagnose, treat and monitor patients with shock

Augmentation index assessed by applanation tonometry is elevated in Marfan Syndrome

<p>Abstract</p> <p>Background</p> <p>To examine whether augmentation index (AIx) is increased in Marfan syndrome (MFS) and associated with increased aortic root size, and whether a peripheral-to-central generalised transfer function (GTF) can be applied usefully in MFS.</p> <p>Methods</p> <p>10 MFS patients and 10 healthy controls (matched for sex, age and height) were studied before and after 400 μg sub-lingual GTN. Arterial waveforms were recorded using applanation tonometry. AIx and pulse pressure (PP) were determined for the radial and carotid arteries. Pulse wave velocity (PWV) was measured between carotid and femoral arteries. GTFs were generated to examine the relationship between radial and carotid waveforms.</p> <p>Results</p> <p>AIx was greater in MFS compared to controls at radial (mean -31.4 (SD 14.3)% v -50.2(15.6)%, p = 0.003) and carotid (-7.6(11.2)% v -23.7(12.7)%, p = 0.004) sites. Baseline PP at all measurement sites, and PWV, did not differ between subject groups. Multivariate analysis demonstrated that PWV and carotid AIx were positively correlated with aortic root size (p < 0.001 and p = 0.012 respectively), independent of the presence of MFS. PP was not associated with aortic root size. GTN caused similar decreases in AIx in both controls and patients. Significant differences were found in GTFs between MFS and control subjects, which changed following GTN administration. However, when an independent GTF was used to derive carotid waves from radial waves, no differences were found in the degree of error between MFS and controls.</p> <p>Conclusion</p> <p>AIx is sensitive to the vascular abnormalities present in MFS, and may have a role as an adjunct to measurement of central PP and PWV. Differences between MFS and controls in the nature of the peripheral-to-central GTF are present, although have little effect on the pulse contour.</p

Analysis of the effects of exposure to acute hypoxia on oxidative lesions and tumour progression in a transgenic mouse breast cancer model

<p>Abstract</p> <p>Background</p> <p>Tumour hypoxia is known to be a poor prognostic indicator, predictive of increased risk of metastatic disease and reduced survival. Genomic instability has been proposed as one of the potential mechanisms for hypoxic tumour progression. Both of these features are commonly found in many cancer types, but their relationship and association with tumour progression has not been examined in the same model.</p> <p>Methods</p> <p>To address this issue, we determined the effects of 6 week <it>in vivo </it>acute hypoxic exposure on the levels of mutagenic lipid peroxidation product, malondialdehyde, and 8-oxo-7,8-dihydro-2'-deoxyguanosine DNA (8-oxo-dG) lesions in the transgenic polyomavirus middle T (PyMT) breast cancer mouse model.</p> <p>Results</p> <p>We observed significantly increased plasma lipid peroxidation and 8-oxo-dG lesion levels in the hypoxia-exposed mice. Consumption of malondialdehyde also induced a significant increase in the PyMT tumour DNA lesion levels, however, these increases did not translate into enhanced tumour progression. We further showed that the <it>in vivo </it>exposure to acute hypoxia induced accumulation of F4/80 positive tumour-associated macrophages (TAMs), demonstrating a relationship between hypoxia and macrophages in an experimental model.</p> <p>Conclusion</p> <p>These data suggest that although exposure to acute hypoxia causes an increase in 8-oxo-dG lesions and TAMs in the PyMT tumours, these increases do not translate into significant changes in tumour progression at the primary or metastatic levels in this strong viral oncogene-driven breast cancer model.</p

Rapid Accumulation of Polymorphonuclear Neutrophils in the Corpus luteum during Prostaglandin F2α-Induced Luteolysis in the Cow

Prostaglandin F2α (PGF2α) induces luteolysis within a few days in cows, and immune cells increase in number in the regressing corpus luteum (CL), implying that luteolysis is an inflammatory-like immune response. We investigated the rapid change in polymorphonuclear neutrophil (PMN) numbers in response to PGF2α administration as the first cells recruited to inflammatory sites, together with mRNA of interleukin-8 (IL-8: neutrophil chemoattractant) and P-selectin (leukocyte adhesion molecule) in the bovine CL. CLs were collected by ovariectomy at various times after PGF2α injection. The number of PMNs was increased at 5 min after PGF2α administration, whereas IL-8 and P-selectin mRNA increased at 30 min and 2 h, respectively. PGF2α directly stimulated P-selectin protein expression at 5–30 min in luteal endothelial cells (LECs). Moreover, PGF2α enhanced PMN adhesion to LECs, and this enhancement by PGF2α was inhibited by anti-P-selectin antibody, suggesting that P-selectin expression by PGF2α is crucial in PMN migration. In conclusion, PGF2α rapidly induces the accumulation of PMNs into the bovine CL at 5 min and enhances PMN adhesion via P-selectin expression in LECs. It is suggested that luteolytic cascade by PGF2α may involve an acute inflammatory-like response due to rapidly infiltrated PMNs

Delinquent Behavior of Dutch Rural Adolescents

This article compares Dutch rural and non-rural adolescents’ delinquent behavior and examines two social correlates of rural delinquency: communal social control and traditional rural culture. The analyses are based on cross-sectional data, containing 3,797 participants aged 13–18 (48.7% females). The analyses show that rural adolescents are only slightly less likely to engage in delinquent behavior. Furthermore, while rural adolescents are exposed more often to communal social control, this does not substantially reduce the likelihood that they engage in delinquent behavior. Concerning rural culture, marked differences appeared between rural and non-rural adolescents. First, alcohol use and the frequency of visiting pubs were more related to rural adolescents’ engagement in delinquent behavior. Second, the gender gap in delinquency is larger among rural adolescents: whereas rural boys did not differ significantly from non-rural boys, rural girls were significantly less likely to engage in delinquent behavior than non-rural girls. However, the magnitude of the effects of most indicators was rather low. To better account for the variety of rural spaces and cultures, it is recommended that future research into antisocial and criminal behavior of rural adolescents should adopt alternative measurements of rurality, instead of using an indicator of population density only