Developing an Initial Program Theory to Explain How Patient-Reported Outcomes Are Used in Health Care Settings: Methodological Process and Lessons Learned

A central aspect of any theory-driven realist investigation (synthesis or evaluation) is to develop an initial program theory (IPT). An IPT can be used to frame and understand how, for whom, why, and under what contexts complex interventions work or not. Despite well-established evidence that IPTs are a central aspect to any realist investigation, there is wide variation and a lack of methodological discussion on how to develop an IPT. In this article, we present the approach that we used to develop an IPT of how patient-reported outcomes (PROs) are used in health care settings. Specifically, we completed a systematic review to extract tacit theories reported in the literature. The benefit of this approach was that it provided a rigorous review of the literature in the development of IPTs. The challenges included (1) rediscovering what is already well established in the theoretical literature, (2) generating an overabundance of partial candidate theories, and (3) extensive use of time and resources for what was the first stage to our larger funded research study. Our recommendations to other scholars considering this approach are to ensure that they (1) live within their means and (2) narrow the scope of the research question and/or develop a conceptual framework using middle-range theories. These methodological insights are highly relevant to researchers embarking on a realist investigation, tasked with developing an IPT

Friend or foe? The current epidemiologic evidence on selenium and human cancer risk.

Scientific opinion on the relationship between selenium and the risk of cancer has undergone radical change over the years, with selenium first viewed as a possible carcinogen in the 1940s then as a possible cancer preventive agent in the 1960s-2000s. More recently, randomized controlled trials have found no effect on cancer risk but suggest possible low-dose dermatologic and endocrine toxicity, and animal studies indicate both carcinogenic and cancer-preventive effects. A growing body of evidence from human and laboratory studies indicates dramatically different biological effects of the various inorganic and organic chemical forms of selenium, which may explain apparent inconsistencies across studies. These chemical form-specific effects also have important implications for exposure and health risk assessment. Overall, available epidemiologic evidence suggests no cancer preventive effect of increased selenium intake in healthy individuals and possible increased risk of other diseases and disorders

Policymakers\u27 experience of a capacity-building intervention designed to increase their use of research: A realist process evaluation

Background: An intervention’s success depends on how participants interact with it in local settings. Process evaluation examines these interactions, indicating why an intervention was or was not effective, and how it (and similar interventions) can be improved for better contextual fit. This is particularly important for innovative trials like Supporting Policy In health with Research: an Intervention Trial (SPIRIT), where causal mechanisms are poorly understood. SPIRIT was testing a multi-component intervention designed to increase the capacity of health policymakers to use research. Methods: Our mixed-methods process evaluation sought to explain variation in observed process effects across the six agencies that participated in SPIRIT. Data collection included observations of intervention workshops (n = 59), purposively sampled interviews (n = 76) and participant feedback forms (n = 553). Using a realist approach, data was coded for context-mechanism-process effect configurations (retroductive analysis) by two authors. Results: Intervention workshops were very well received. There was greater variation of views regarding other aspects of SPIRIT such as data collection, communication and the intervention’s overall value. We identified nine inter-related mechanisms that were crucial for engaging participants in these policy settings: (1) Accepting the premise (agreeing with the study’s assumptions); (2) Self-determination (participative choice); (3) The Value Proposition (seeing potential gain); (4) ‘Getting good stuff’ (identifying useful ideas, resources or connections); (5) Self-efficacy (believing ‘we can do this!’); (6) Respect (feeling that SPIRIT understands and values one’s work); (7) Confidence (believing in the study’s integrity and validity); (8) Persuasive leadership (authentic and compelling advocacy from leaders); and (9) Strategic insider facilitation (local translation and mediation). These findings were used to develop tentative explanatory propositions and to revise the programme theory. Conclusion: This paper describes how SPIRIT functioned in six policy agencies, including why strategies that worked well in one site were less effective in others. Findings indicate a complex interaction between participants’ perception of the intervention, shifting contextual factors, and the form that the intervention took in each site. Our propositions provide transferable lessons about contextualised areas of strength and weakness that may be useful in the development and implementation of similar studies

Proceedings of Patient Reported Outcome Measure’s (PROMs) Conference Oxford 2017: Advances in Patient Reported Outcomes Research

A33-Effects of Out-of-Pocket (OOP) Payments and Financial Distress on Quality of Life (QoL) of People with Parkinson’s (PwP) and their Carer

An overview of realist evaluation for simulation-based education

This article describes the key features of realist (realistic) evaluation and illustrates their application using, as an example, a simulation-based course for final year medical students. The use of simulation-based education (SBE) is increasing and so too is the evidence supporting its value as a powerful technique which can lead to substantial educational benefits. Accompanying these changes is a call for research into its use to be more theory-driven and to investigate both 'Did it work?' and as importantly 'Why did it work (or not)?' An evaluation methodology that is capable of answering both questions is realist evaluation. Realist evaluation is an emerging methodology that is suited to evaluating complex interventions such as SBE. The realist philosophy positions itself between positivist and constructivist paradigms and seeks to answer the question 'What works for whom, in what circumstances and why?' In seeking to answer this question, realist evaluation sets out to identify three fundamental components of an intervention, namely context, mechanism and outcome. Educational programmes work (successful outcomes) when theory-driven interventions (mechanisms) are applied to groups under appropriate conditions (context). Realist research uses a mixed methods (qualitative and quantitative) approach to gathering data in order to test the proposed context-mechanism-outcome (CMO) configurations of the intervention under investigation. Realist evaluation offers a valuable methodology for researchers investigating interventions utilising simulation-based education. By investigating and understanding the context, mechanisms and outcomes of SBE interventions, realist evaluation can provide the deeper level of understanding being called for

Stress responses in alfalfa (Medicago sativa L.) XIX. Transcriptional activation of oxidative pentose phosphate pathway genes at the onset of the isoflavonoid phytoalexin response

Article on stress responses in alfalfa (Medicago sativa L.) XIX and transcriptional activation of oxidative pentose phosphate pathway genes at the onset of the isoflavonoid phytoalexin response

Uncovering the mechanisms of research capacity development in health and social care: a realist synthesis

BACKGROUND: Research capacity development (RCD) is considered fundamental to closing the evidence-practice gap, thereby contributing to health, wealth and knowledge for practice. Numerous frameworks and models have been proposed for RCD, but there is little evidence of what works for whom and under what circumstances. There is a need to identify mechanisms by which candidate interventions or clusters of interventions might achieve RCD and contribute to societal impact, thereby proving meaningful to stakeholders. METHODS: A realist synthesis was used to develop programme theories for RCD. Structured database searches were conducted across seven databases to identify papers examining RCD in a health or social care context (1998-2013). In addition, citation searches for 10 key articles (citation pearls) were conducted across Google Scholar and Web of Science. Of 214 included articles, 116 reported on specific interventions or initiatives or their evaluation. The remaining 98 articles were discussion papers or explicitly sought to make a theoretical contribution. A core set of 36 RCD theoretical and conceptual papers were selected and analysed to generate mechanisms that map across macro contexts (individual, team, organisational, network). Data were extracted by means of 'If-Then' statements into an Excel spreadsheet. Models and frameworks were deconstructed into their original elements. RESULTS: Eight overarching programme theories were identified featuring mechanisms that were triggered across multiple contexts. Three of these fulfilled a symbolic role in signalling the importance of RCD (e.g. positive role models, signal importance, make a difference), whilst the remainder were more functional (e.g. liberate talents, release resource, exceed sum of parts, learning by doing and co-production of knowledge). Outcomes from one mechanism produced changes in context to stimulate mechanisms in other activities. The eight programme theories were validated with findings from 10 systematic reviews (2014-2017). CONCLUSIONS: This realist synthesis is the starting point for constructing an RCD framework shaped by these programme theories. Future work is required to further test and refine these findings against empirical data from intervention studies