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Abstract Background Clinical trials comprise multiple processes at various stages of the trial lifecycle. These processes often involve complex behaviours such as recruiting vulnerable patient populations and clinicians having to deliver complex trial interventions successfully. Few studies have utilised a behavioural framework to assess challenges and develop strategies for effective trial recruitment and delivery of trial interventions. This study reports the application of an innovative methodological approach to understand core trial processes, namely recruitment and intervention delivery, using a behavioural science approach to develop strategies designed to mitigate trial process problems. Methods The UK-REBOA trial aims to evaluate the clinical and cost-effectiveness of resuscitative endovascular balloon occlusion of the aorta (a novel intervention) in injured patients with exsanguinating haemorrhage. A behavioural investigation (‘diagnosis’) was conducted using theory-informed (Theoretical Domains Framework, TDF) semi-structured interviews with site staff from the UK-REBOA trial to examine trial processes which could be improved in relation to trial recruitment and delivery of the intervention. Interviews were analysed using the TDF to identify influences on behaviour, which were then mapped to techniques for behaviour change and developed into potential solutions. Results The behavioural diagnosis of the challenges experienced during trial processes highlighted factors relevant to a range of TDF domains: Skills, Environmental context and resources, Beliefs about capabilities, Beliefs about consequences, Social influences, and Memory, attention, and decision-making processes. Within the solution development phase, we identified 24 suitable behaviour change techniques that were developed into proposed solutions to target reported process problems with the aim of changing behaviour to improve recruitment and/or intervention delivery. Proposed solutions included targeted changes to trial training content, suggestions to restructure the environment (e.g. reinforced the purpose of the trial with information about the social and environmental consequences) and other strategies to reduce barriers to recruitment and intervention delivery. Conclusions This study demonstrates the feasibility of applying a behavioural approach to investigate (‘diagnose’) behavioural trial process problems and subsequently develop and implement targeted solutions (‘treatment’) in an active trauma trial. Understanding the factors that affected behaviour, attitudes and beliefs in this trauma trial allowed us to implement theoretically informed, evidence-based solutions designed to enhance trial practices. Trial registration ISRCTN 16,184,981

Background: Clinical trials comprise multiple processes at various stages of the trial lifecycle. These processes often involve complex behaviours such as recruiting vulnerable patient populations and clinicians having to deliver complex trial interventions successfully. Few studies have utilised a behavioural framework to assess challenges and develop strategies for effective trial recruitment and delivery of trial interventions. This study reports the application of an innovative methodological approach to understand core trial processes, namely recruitment and intervention delivery, using a behavioural science approach to develop strategies designed to mitigate trial process problems.Methods: The UK-REBOA trial aims to evaluate the clinical and cost-effectiveness of resuscitative endovascular balloon occlusion of the aorta (a novel intervention) in injured patients with exsanguinating haemorrhage. A behavioural investigation ('diagnosis') was conducted using theory-informed (Theoretical Domains Framework, TDF) semi-structured interviews with site staff from the UK-REBOA trial to examine trial processes which could be improved in relation to trial recruitment and delivery of the intervention. Interviews were analysed using the TDF to identify influences on behaviour, which were then mapped to techniques for behaviour change and developed into potential solutions.Results: The behavioural diagnosis of the challenges experienced during trial processes highlighted factors relevant to a range of TDF domains: Skills, Environmental context and resources, Beliefs about capabilities, Beliefs about consequences, Social influences, and Memory, attention, and decision-making processes. Within the solution development phase, we identified 24 suitable behaviour change techniques that were developed into proposed solutions to target reported process problems with the aim of changing behaviour to improve recruitment and/or intervention delivery. Proposed solutions included targeted changes to trial training content, suggestions to restructure the environment (e.g. reinforced the purpose of the trial with information about the social and environmental consequences) and other strategies to reduce barriers to recruitment and intervention delivery.Conclusions: This study demonstrates the feasibility of applying a behavioural approach to investigate ('diagnose') behavioural trial process problems and subsequently develop and implement targeted solutions ('treatment') in an active trauma trial. Understanding the factors that affected behaviour, attitudes and beliefs in this trauma trial allowed us to implement theoretically informed, evidence-based solutions designed to enhance trial practices.Trial Registration: ISRCTN 16,184,981. [ABSTRACT FROM AUTHOR]

Background: Process evaluations of randomised controlled trials (RCTs) can provide insight and inform us on the intervention implementation, the causal mechanisms and the contextual factors. This will inform about interventions' success or failure due to their implementation or the interventions themselves. We aim to consolidate the methodology from previous process evaluations of complex interventions upon their findings on facilitators and barriers to address the prevention of type 2 diabetes mellitus among women with gestational diabetes mellitus (GDM). Methods: Comprehensive search will be conducted on electronic databases and reference lists of recent reviews for RCTs of complex interventions which address process evaluations of diabetes prevention intervention (DPI) for women with GDM in healthcare settings. There is no restriction on the language of the papers and year of publication until December 2020. Data from each study will be extracted by two reviewers independently using standardised forms. Data extracted include descriptive items on the study design and the outcomes of process evaluations from the three dimensions: (1) implementation; (2) mechanism of impact and (3) context. The quality of the studies will be assessed using mixed methods appraisal tool which is designed for the appraisal of mixed studies in systematic reviews. A narrative and framework analysis of the findings will be presented to inform the contents of a new DPI for women with GDM. Discussion: The findings from this process evaluation findings are valuable in determining whether a complex intervention should be scaled up or modified for other contexts in future plan. It will give deeper understanding of potential challenges and solutions to aid in the implementation of effective DPIs for GDM in Malaysia. [ABSTRACT FROM AUTHOR]

Background Although proven feasible, rapid response services (RRSs) to support urgent decision and policymaking are still a fairly new and innovative strategy in several health systems, more especially in low-income countries. There are several information gaps about these RRSs that exist including the factors that make them work in different contexts and in addition what affects their uptake by potential end users. Methods We used a case study employing process evaluation methods to determine what contextual factors affect the utilization of a RRS in Uganda. We held in-depth interviews with researchers, knowledge translation (KT) specialists and policy-makers from several research and policy-making institutions in Uganda’s health sector. We analyzed the data using thematic analysis to develop categories and themes about activities and structures under given program components that affected uptake of the service. Results We identified several factors under three themes that have both overlapping relations and also reinforcing loops amplifying each other: Internal factors (those factors that were identified as over which the RRS had full [or almost full] control); external factors (factors over which the service had only partial influence, a second party holds part of this influence); and environmental factors (factors over which the service had no or only remote control if at all). Internal factors were the design of the service and resources available for it, while the external factors were the service’s visibility, integrity and relationships. Environmental factors were political will and health system policy and decision-making infrastructure. Conclusion For health systems practitioners considering RRSs, knowing what factors will affect uptake and therefore modifying them within their contexts is important to ensure efficient use and successful utilization of the mechanisms.

Background In Ontario, an online audit and feedback tool that provides primary care physicians with detailed information about patients who are overdue for cancer screening is underused. In the present study, we aimed to examine the effect of messages operationalizing 3 behaviour change techniques on access to the audit and feedback tool and on cancer screening rates. Methods During May-September 2017, a pragmatic 2×2×2 factorial experiment tested 3 behaviour change techniques: anticipated regret, material incentive, and problem-solving. Outcomes were assessed using routinely collected administrative data. A qualitative process evaluation explored how and why the e-mail messages did or did not support Screening Activity Report access. Results Of 5449 primary care physicians randomly allocated to 1 of 8 e-mail messages, fewer than half opened the messages and fewer than 1 in 10 clicked through the messages. Messages with problem-solving content were associated with a 12.9% relative reduction in access to the tool (risk ratio: 0.871; 95% confidence interval: 0.791 to 0.958; p = 0.005), but a 0.3% increase in cervical cancer screening (rate ratio: 1.003; 95% confidence interval: 1.001 to 1.006; p = 0.003). If true, that association would represent 7568 more patients being screened. No other significant effects were observed. Conclusions For audit and feedback to work, recipients must engage with the data; for e-mail messages to prompt activity, recipients must open and review the message content. This large factorial experiment demonstrated that small changes in the content of such e-mail messages might influence clinical behaviour. Future research should focus on strategies to make cancer screening more user-centred. [ABSTRACT FROM AUTHOR]

Background: Although proven feasible, rapid response services (RRSs) to support urgent decision and policymaking are still a fairly new and innovative strategy in several health systems, more especially in low-income countries. There are several information gaps about these RRSs that exist including the factors that make them work in different contexts and in addition what affects their uptake by potential end users. Methods: We used a case study employing process evaluation methods to determine what contextual factors affect the utilization of a RRS in Uganda. We held in-depth interviews with researchers, knowledge translation (KT) specialists and policy-makers from several research and policy-making institutions in Uganda's health sector. We analyzed the data using thematic analysis to develop categories and themes about activities and structures under given program components that affected uptake of the service. Results: We identified several factors under three themes that have both overlapping relations and also reinforcing loops amplifying each other: Internal factors (those factors that were identified as over which the RRS had full [or almost full] control); external factors (factors over which the service had only partial influence, a second party holds part of this influence); and environmental factors (factors over which the service had no or only remote control if at all). Internal factors were the design of the service and resources available for it, while the external factors were the service's visibility, integrity and relationships. Environmental factors were political will and health system policy and decision-making infrastructure. Conclusion: For health systems practitioners considering RRSs, knowing what factors will affect uptake and therefore modifying them within their contexts is important to ensure efficient use and successful utilization of the mechanisms. [ABSTRACT FROM AUTHOR]

The article describes what evaluation studies have to offer to legal research. Several cases and types of evaluations are presented, in relation to legal or semi-legal questions. Also, a short overview of the contemporary history of evaluation studies is presented. Finally, it will address the question of how to ensure that in legal research and in legal training attention is paid to theories, designs and methods of evaluation studies.

Background: Group-based early parenting interventions delivered through community-based services may be a potentially effective means of promoting infant and family health and wellbeing. Process evaluations of these complex interventions provide vital information on how they work, as well as the conditions which shape and influence outcomes. This information is critical to decision makers and service providers who wish to embed prevention and early interventions in usual care settings. In this paper, a process evaluation protocol for an early years parenting intervention, the Parent and Infant (PIN) program, is described. This program combines a range of developmentally-appropriate supports, delivered in a single intervention process, for parents and infants (0-2 years) and aimed at enhancing parental competence, strengthening parent-infant relationships and improving infant wellbeing and adjustment.Methods: The process evaluation is embedded within a controlled trial and accompanying cost-effectiveness evaluation. Building from extant frameworks and evaluation methods, this paper presents a systematic approach to the process evaluation of the PIN program and its underlying change principles, the implementation of the program, the context of implementation and the change mechanisms which influence and shape parent and infant outcomes. We will use a multi-method strategy, including semi-structured interviews and group discussions with key stakeholders, documentary analysis and survey methodology.Discussion: The integration of innovations into existing early years systems and services is a challenging multifaceted undertaking. This process evaluation will make an important contribution to knowledge about the implementation of such programs, while also providing an example of how theory-based research can be embedded within the evaluation of community-based interventions. We discuss the strengths of the research, such as the adoption of a collaborative approach to data collection, while we also identify potential challenges, including capturing and assessing complex aspects of the intervention.Trial Registration: ISRCTN17488830 (Date of registration: 27/11/15). This trial was retrospectively registered. [ABSTRACT FROM AUTHOR]

Background: Randomised controlled trials (RCTs) of complex interventions in primary health care (PHC) are needed to provide evidence-based programmes to achieve the Declaration of Alma Ata goal of making PHC equitable, accessible and universal and to effectively address the rising burden from chronic disease. Process evaluations of these RCTs can provide insight into the causal mechanisms of complex interventions, the contextual factors, and inform as to whether an intervention is ineffective due to implementation failure or failure of the intervention itself. To build on this emerging body of work, we aim to consolidate the methodology and methods from process evaluations of complex interventions in PHC and their findings of facilitators and barriers to intervention implementation in this important area of health service delivery. Methods: Systematic review of process evaluations of randomised controlled trials of complex interventions which address prevalent major chronic diseases in PHC settings. Published process evaluations of RCTs will be identified through database and clinical trial registry searches and contact with authors. Data from each study will be extracted by two reviewers using standardised forms. Data extracted include descriptive items about (1) the RCT, (2) about the process evaluations (such as methods, theories, risk of bias, analysis of process and outcome data, strengths and limitations) and (3) any stated barriers and facilitators to conducting complex interventions. A narrative synthesis of the findings will be presented. Discussion: Process evaluation findings are valuable in determining whether a complex intervention should be scaled up or modified for other contexts. Publishing this protocol serves to encourage transparency in the reporting of our synthesis of current literature on how process evaluations have been conducted thus far and a deeper understanding of potential challenges and solutions to aid in the implementation of effective interventions in PHC beyond the research setting. [ABSTRACT FROM AUTHOR]

Background: Although care pathways are often said to promote teamwork, high-level evidence that supports this statement is lacking. Furthermore, knowledge on conditions and facilitators for successful pathway implementation is scarce. The objective of the European Quality of Care Pathway (EQCP) study is therefore to study the impact of care pathways on interprofessional teamwork and to build up understanding on the implementation process. Methods/design: An international post-test-only cluster Randomised Controlled Trial (cRCT), combined with process evaluations, will be performed in Belgium, Ireland, Italy, and Portugal. Teams caring for proximal femur fracture (PFF) patients and patients hospitalized with an exacerbation of chronic obstructive pulmonary disease (COPD) will be randomised into an intervention and control group. The intervention group will implement a care pathway for PFF or COPD containing three active components: a formative evaluation of the actual teams' performance, a set of evidence-based key interventions, and a training in care pathway-development. The control group will provide usual care. A set of team input, process and output indicators will be used as effect measures. The main outcome indicator will be relational coordination. Next to these, process measures during and after pathway development will be used to evaluate the implementation processes. In total, 132 teams have agreed to participate, of which 68 were randomly assigned to the intervention group and 64 to the control group. Based on power analysis, a sample of 475 team members per arm is required. To analyze results, multilevel analysis will be performed. Discussion: Results from our study will enhance understanding on the active components of care pathways. Through this, preferred implementation strategies can be defined. [ABSTRACT FROM AUTHOR]

Objective: Process evaluations (PEs) alongside randomised controlled trials of complex interventions are valuable because they address questions of for whom, how and why interventions had an impact. We synthesised the methods used in PEs of primary care interventions, and their main findings on implementation barriers and facilitators., Design: Systematic review using the UK Medical Research Council guidance for PE as a guide., Data Sources: Academic databases (MEDLINE, SCOPUS, PsycINFO, Cumulative Index to Nursing and Allied Health Literature, EMBASE and Global Health) were searched from 1998 until June 2018., Eligibility Criteria: We included PE alongside randomised controlled trials of primary care interventions which aimed to improve outcomes for patients with non-communicable diseases., Data Extraction and Synthesis: Two independent reviewers screened and conducted the data extraction and synthesis, with a third reviewer checking a sample for quality assurance., Results: 69 studies were included. There was an overall lack of consistency in how PEs were conducted and reported. The main weakness is that only 30 studies were underpinned by a clear intervention theory often facilitated by the use of existing theoretical frameworks. The main strengths were robust sampling strategies, and the triangulation of qualitative and quantitative data to understand an intervention's mechanisms. Findings were synthesised into three key themes: (1) a fundamental mismatch between what the intervention was designed to achieve and local needs; (2) the required roles and responsibilities of key actors were often not clearly understood; and (3) the health system context-factors such as governance, financing structures and workforce-if unanticipated could adversely impact implementation., Conclusion: Greater consistency is needed in the reporting and the methods of PEs, in particular greater use of theoretical frameworks to inform intervention theory. More emphasis on formative research in designing interventions is needed to align the intervention with the needs of local stakeholders, and to minimise unanticipated consequences due to context-specific barriers., Prospero Registration Number: CRD42016035572., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

The Cochrane Qualitative and Implementation Methods Group develops and publishes guidance on the synthesis of qualitative and mixed-method evidence from process evaluations. Despite a proliferation of methods for the synthesis of qualitative research, less attention has focused on how to integrate these syntheses within intervention effectiveness reviews. In this article, we report updated guidance from the group on approaches, methods, and tools, which can be used to integrate the findings from quantitative studies evaluating intervention effectiveness with those from qualitative studies and process evaluations. We draw on conceptual analyses of mixed methods systematic review designs and the range of methods and tools that have been used in published reviews that have successfully integrated different types of evidence. We outline five key methods and tools as devices for integration which vary in terms of the levels at which integration takes place; the specialist skills and expertise required within the review team; and their appropriateness in the context of limited evidence. In situations where the requirement is the integration of qualitative and process evidence within intervention effectiveness reviews, we recommend the use of a sequential approach. Here, evidence from each tradition is synthesized separately using methods consistent with each tradition before integration takes place using a common framework. Reviews which integrate qualitative and process evaluation evidence alongside quantitative evidence on intervention effectiveness in a systematic way are rare. This guidance aims to support review teams to achieve integration and we encourage further development through reflection and formal testing., (Copyright © 2017 Elsevier Inc. All rights reserved.)

Background: Randomised controlled trials (RCTs) of complex interventions in primary health care (PHC) are needed to provide evidence-based programmes to achieve the Declaration of Alma Ata goal of making PHC equitable, accessible and universal and to effectively address the rising burden from chronic disease. Process evaluations of these RCTs can provide insight into the causal mechanisms of complex interventions, the contextual factors, and inform as to whether an intervention is ineffective due to implementation failure or failure of the intervention itself. To build on this emerging body of work, we aim to consolidate the methodology and methods from process evaluations of complex interventions in PHC and their findings of facilitators and barriers to intervention implementation in this important area of health service delivery., Methods: Systematic review of process evaluations of randomised controlled trials of complex interventions which address prevalent major chronic diseases in PHC settings. Published process evaluations of RCTs will be identified through database and clinical trial registry searches and contact with authors. Data from each study will be extracted by two reviewers using standardised forms. Data extracted include descriptive items about (1) the RCT, (2) about the process evaluations (such as methods, theories, risk of bias, analysis of process and outcome data, strengths and limitations) and (3) any stated barriers and facilitators to conducting complex interventions. A narrative synthesis of the findings will be presented., Discussion: Process evaluation findings are valuable in determining whether a complex intervention should be scaled up or modified for other contexts. Publishing this protocol serves to encourage transparency in the reporting of our synthesis of current literature on how process evaluations have been conducted thus far and a deeper understanding of potential challenges and solutions to aid in the implementation of effective interventions in PHC beyond the research setting., Systematic Review Registration: PROSPERO CRD42016035572.