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

Comparing the measurement equivalence of EQ-5D-5L across different modes of administration

Background: Interest in collecting Patient Reported Outcomes using electronic methods such as mobile phones has increased in recent years. However there is debate about the level of measurement equivalence between the traditional paper and newer electronic modes. Information about the acceptability of the electronic versions to respondents is also required. The aim of this study is to compare the equivalence of delivering a widely used generic measure of health status (EQ-5D-5L) across two administration modes (paper and mobile phone). Methods: Respondents from a research cohort of people in South Yorkshire were identified, and randomly allocated to one of two administration modes (paper vs. mobile phone) based on stratifications for age and gender (and across a range of self-reported health conditions). A parallel group design was used where each respondent only completed EQ-5D-5L using one of the modes. In total, 70 respondents completed the measure in the mobile phone arm, and 66 completed the standard paper version. Follow up usability questions were also included to assess the acceptability of the mobile version of EQ-5D-5L. Measurement equivalence was compared at the dimension, utility score and visual analogue scale level using chi square analysis and ANOVA, and by comparing mean differences to an estimated minimally important difference value. Results: Response rates were higher in the mobile arm. The mean EQ-5D-5L utility and VAS scores, and the frequency of respondents endorsing individual EQ-5D-5L dimension response levels did not significantly differ across the administration modes. The majority of the mobile arm agreed that the mobile version of EQ-5D-5L was easy to complete, and that the phone was easy to use, and that they would complete mobile health measures again. Conclusions: Completing health status measures such as EQ-5D using mobile phones produces equivalent results to more traditional methods, but with added benefits (for example lessening the burden of data entry). Respondents are positive towards completing questionnaires using these methods. The results provide evidence that electronic measures are valid for use to collect data in a range of settings including clinical trials, routine care, and in health diary settings

Supporting successful implementation of public health interventions: protocol for a realist synthesis

Background There is a growing emphasis in public health on the importance of evidence-based interventions to improve population health and reduce health inequities. Equally important is the need for knowledge about how to implement these interventions successfully. Yet, a gap remains between the development of evidence-based public health interventions and their successful implementation. Conventional systematic reviews have been conducted on effective implementation in health care, but few in public health, so their relevance to public health is unclear. In most reviews, stringent inclusion criteria have excluded entire bodies of evidence that may be relevant for policy makers, program planners, and practitioners to understand implementation in the unique public health context. Realist synthesis is a theory-driven methodology that draws on diverse data from different study designs to explain how and why observed outcomes occur in different contexts and thus may be more appropriate for public health. Methods This paper presents a realist review protocol to answer the research question: Why are some public health interventions successfully implemented and others not? Based on a review of implementation theories and frameworks, we developed an initial program theory, adapted for public health from the Consolidated Framework for Implementation Research, to explain the implementation outcomes of public health interventions within particular contexts. This will guide us through the review process, which comprises eight iterative steps based on established realist review guidelines and quality standards. We aim to refine this initial theory into a ‘final’ realist program theory that explains important context-mechanism-outcome configurations in the successful implementation of public health interventions. Discussion Developing new public health interventions is costly and policy windows that support their implementation can be short lived. Ineffective implementation wastes scarce resources and is neither affordable nor sustainable. Public health interventions that are not implemented will not have their intended effects on improving population health and promoting health equity. This synthesis will provide evidence to support effective implementation of public health interventions taking into account the variable context of interventions. A series of knowledge translation products specific to the needs of knowledge users will be developed to provide implementation support. Systematic review registration PROSPERO CRD4201503005

An Evidence-Based Theory About PRO Use in Kidney Care: A Realist Synthesis

Background: There is international interest on the use of patient-reported outcomes (PROs) in nephrology. Objectives: Our objectives were to develop a kidney-specific program theory about use of PROs in nephrology that may enhance person-centered care, both at individual and aggregated levels of care, and to test and refine this theory through a systematic review of the empirical literature. Together, these objectives articulate what works or does not work, for whom, and why. Methods: Realist synthesis methodology guided the electronic database and gray literature searches (in January 2017 and October 2018), screening, and extraction conducted independently by three reviewers. Sources included all nephrology patients and/or practitioners. Through a process of extraction and synthesis, each included source was examined to assess how contexts may trigger mechanisms to influence specific outcomes. Results: After screening 19,961 references, 84 theoretical and 34 empirical sources were used. PROs are proposed to be useful for providing nephrology care through three types of use. The first type is use of individual-level PRO data at point of care, receiving the majority of theoretical and empirical explorations. Clinician use to support person-centered care, and patient use to support patient engagement, are purported to improve satisfaction, health, and quality of life. Contextual factors specific to the kidney care setting that may influence the use of PRO data include the complexity of kidney disease symptom burden, symptoms that may be stigmatized, comorbidities, and time or administrative constraints in dialysis settings. Electronic collection of PROs may facilitate PRO use given these contexts. The second type is use of aggregated PRO data at point of care, including public reporting of PROs to inform decisions at point of care and improve quality of care, and use of PROs for treatment decisions. The third type is use of aggregated PRO data by organizations, including publicly available PRO data to compare centers. In single-payer systems, regular collection of PROs by dialysis centers can be achieved through economic incentives. Both the second and third types of PRO use include pressures that may trigger quality improvement processes. Conclusion: The current state of the evidence is primarily theoretical. There is pressing need for empirical research to improve the evidence-base of PRO use at individual and aggregated levels of nephrology care