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

What’s in a Realist Configuration? Deciding Which Causal Configurations to Use, How, and Why

Background: Realist studies represent an increasingly popular approach for exploring complex interventions’ successes and failures. The theory-driven approach seeks to explain “what works, how, why, in which contexts, for whom, and to what extent” using context–mechanism–outcome (CMO) configurations. When the approach was first developed, CMO configurations were the method for expressing causal explanations. Increasingly, realist studies have been conducted using different variations of the heuristic such as strategy–context–mechanism–outcome (SCMO) configurations or intervention–context–actor–mechanism–outcome (ICAMO) configurations. Researchers have highlighted a lack of methodological guidance regarding which additional explanatory factors can be included in configurations (e.g., strategies, interventions, actors). This article aims to clarify and further develop the concept of configurations by discussing how explanatory factors could be robustly added to the original CMO configuration as put forward by Pawson and Tilley. Comparing the use of different types of configurations: We draw on two of our own studies, one which formulated CMO configurations and one which formulated SCMO configurations, and on an evidence scan of realist studies. We explored the effects these different configurations had on studies’ findings and highlight why researchers chose CMOs or SCMOs. Finally, we provide recommendations regarding the use of configurations. These are as follows: Using additional explanatory factors is possible but consider the research scope to select the configuration appropriate for the study; Be transparent about the choice in configuration and include examples of configurations; Further studies about the use of additional explanatory factors are needed to better understand the effects on each step in the realist evaluation cycle; and New ways of disseminating realist findings are needed to balance transparency regarding the use of configurations. Conclusions: Adding explanatory factors is possible and can be insightful depending on the study’s scope and aims; however, any configuration type must adhere to the rule of generative causation

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

On the pathogenesis of penile venous leakage: role of the tunica albuginea

<p>Abstract</p> <p>Background</p> <p>Etiology of venogenic erectile dysfunction is not exactly known. Various pathologic processes were accused but none proved entirely satisfactory. These include presence of large venous channels draining corpora cavernosa, Peyronie's disease, diabetes and structural alterations in fibroblastic components of trabeculae and cavernous smooth muscles. We investigated hypothesis that tunica albuginea atrophy with a resulting subluxation and redundancy effects venous leakage during erection.</p> <p>Methods</p> <p>18 patients (mean age 33.6 ± 2.8 SD years) with venogenic erectile dysfunction and 17 volunteers for control (mean age 31.7 ± 2.2 SD years) were studied. Intracorporal pressure was recorded in all subjects; tunica albuginea biopsies were taken from 18 patients and 9 controls and stained with hematoxylin and eosin and Masson's trichrome stains.</p> <p>Results</p> <p>In flaccid phase intracorporal pressure recorded a mean of 11.8 ± 0.8 cm H₂O for control subjects and for patients of 5.2 ± 0.6 cm, while during induced erection recorded 98.4 ± 6.2 and 5.9 ± 0.7 cmH₂O, respectively. Microscopically, tunica albuginea of controls consisted of circularly-oriented collagen impregnated with elastic fibers. Tunica albuginea of patients showed degenerative and atrophic changes of collagen fibers; elastic fibers were scarce or absent.</p> <p>Conclusion</p> <p>Study has shown that during erection intracorporal pressure of patients with venogenic erectile dysfunction was significantly lower than that of controls. Tunica albuginea collagen fibers exhibited degenerative and atrophic changes which presumably lead to tunica albuginea subluxation and floppiness. These tunica albuginea changes seem to explain cause of lowered intracorporal pressure which apparently results from loss of tunica albuginea veno-occlusive mechanism. Causes of tunica albuginea atrophic changes and subluxation need to be studied.</p

The influence of contextual factors on healthcare quality improvement initiatives:what works, for whom and in what setting? Protocol for a realist review

Background&nbsp; Context shapes the effectiveness of knowledge implementation and influences health improvement. Successful healthcare quality improvement (QI) initiatives frequently fail to transfer to different settings, with local contextual factors often cited as the cause. Understanding and overcoming contextual barriers is therefore crucial to implementing effective improvement; yet context is still poorly understood. There is a paucity of information on the mechanisms underlyinghowandwhyQI projects succeed or fail in given settings. A realist review of empirical studies of healthcare QI initiatives will be undertaken to examine the influence and impact of contextual factors on quality improvement in healthcare settings and explore whether QI initiatives can work in all contexts.&nbsp; Methods&nbsp; The review will explore which contextual factors are important, and how, why, when and for whom they are important, within varied settings. The dynamic nature of context and change over time will be explored by examining which aspects of context impact at key points in the improvement trajectory. The review will also consider the influence of context on improvement outcomes (provider- and patient-level), spread and sustainability. The review process will follow five iterative steps: (1) clarify scope, (2) search for evidence, (3) appraise primary studies and extract data, (4) synthesise evidence and draw conclusions and (5) disseminate findings. The reviewers will consult with experts and stakeholders in the early stages to focus the review and develop a programme theory consisting of explanatory &lsquo;context&ndash;mechanism&ndash;outcome&rsquo; configurations. Searches for primary evidence will be conducted iteratively. Data will be extracted and tested against the programme theory. A review advisory group will oversee the review process. Review findings will follow RAMESES guidelines and will be disseminated via a report, presentations and peer-reviewed publications.&nbsp; Discussion&nbsp; The review will update and consolidate evidence on the contextual conditions for effective improvement and distil new knowledge to inform the design and development of context-sensitive QI initiatives. This review ties in with the study of improvement programmes as vehicles of change and the development of an evidence base around healthcare improvement by addressing whether QI initiatives can work in all contexts.&nbsp; Systematic review registration&nbsp; PROSPERO&nbsp;CRD4201706213

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

Longitudinal realist evaluation of the dementia PersonAlised care team (D-PACT) intervention: protocol

Background Different dementia support roles exist but evidence is lacking on which aspects are best, for whom and in what circumstance, and on their associated costs and benefits. Phase 1 of the Dementia PersonAlised Care Team programme (D-PACT), developed a post-diagnostic primary care-based intervention for people with dementia and their carers and assessed the feasibility of a trial. AimPhase 2 of the programme aims to 1) refine our programme theory on how, when and for whom the intervention works and 2) evaluate its value and impact. Design & setting A realist longitudinal mixed-methods evaluation will be conducted in urban, rural, and coastal areas across Southwest and Northwest England where low-income groups or ethnic minorities (eg, South Asian) are represented. Design was informed by patient, public and professional stakeholder input and Phase one findings. Method High volume qualitative and quantitative data will be collected longitudinally from people with dementia, carers and practitioners. Analyses will comprise: 1) realist longitudinal case studies; 2) conversation analysis of recorded interactions; 3) statistical analyses of outcome and experience questionnaires; 4 a) health economic analysis examining costs of delivery; 4b) realist economic analysis of high-cost events and ‘near misses’. All findings will be synthesised using a joint display table, evidence appraisal tool, triangulation and stakeholder co-analysis. Conclusion Our realist evaluation will describe how, why and for whom the intervention leads (or not) to change over time; it also demonstrates how a non-randomised design can be more appropriate for complex interventions with similar questions or populations