***TASK*** the task is to summarize an input biomedical literature in six sentences 
    ***INPUT*** the input is a biomedical literature 
    ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences 
    ***DOCUMENTATION*** 
    ***EXAMPLES*** 
    Input: Background The Normalization Process Model is a theoretical model that assists in explaining the processes by which complex interventions become routinely embedded in health care practice . It offers a framework for process evaluation and also for comparative studies of complex interventions . It focuses on the factors that promote or inhibit the routine embedding of complex interventions in health care practice . Methods A formal theory structure is used to define the model , and its internal causal relations and mechanisms . The model is broken down to show that it is consistent and adequate in generating accurate description , systematic explanation , and the production of rational knowledge cl aims about the workability and integration of complex interventions . Results The model explains the normalization of complex interventions by reference to four factors demonstrated to promote or inhibit the operationalization and embedding of complex interventions ( interactional workability , relational integration , skill-set workability , and context ual integration ) . Conclusion The model is consistent and adequate . Repeated calls for theoretically sound process evaluations in r and omized controlled trials of complex interventions , and policy-makers who call for a proper underst and ing of implementation processes , emphasize the value of conceptual tools like the Normalization Process Model Background A number of single case reports have suggested that the context within which intervention studies take place may challenge the assumptions that underpin r and omised controlled trials ( RCTs ) . However , the diverse ways in which context may challenge the central tenets of the RCT , and the degree to which this information is known to research ers or subsequently reported , has received much less attention . In this paper , we explore these issues by focusing on seven RCTs of interventions varying in type and degree of complexity , and across diverse context s. Methods This in-depth multiple case study using interviews , focus groups and documentary analysis was conducted in two phases . In phase one , a RCT of a nurse-led intervention  provided a single exploratory case and informed the design , sampling and data collection within the main study . Phase two consisted of a multiple explanatory case study covering a spectrum of trials of different types of complex intervention . A total of eighty-four data sources across the seven trials were accessed . Results We present consistent empirical evidence across all trials to indicate that four key elements of context ( personal , organisational , trial and problem context ) are crucial to underst and ing how a complex intervention works and to enable both assessment s of internal validity and likely generalisability to other setting s. The ways in which context challenged trial operation was often complex , idiosyncratic , and subtle ; often falling outside of current trial reporting formats . However , information on such issues appeared to be available via first h and ‘ insider accounts ’ of each trial suggesting that improved reporting on the role of context is possible . Conclusions Sufficient detail about context needs to be understood and reported in RCTs of complex interventions , in order for the transferability of complex interventions to be assessed . Improved reporting formats that require and encourage the clarification of both general and project-specific threats to the likely internal and external validity need to be developed . In addition , a cultural change is required in which the open and honest reporting of such issues is seen as an indicator of study strength and research er integrity , rather than a symbol of a poor quality study or investigator ability Background Process evaluations are recommended to open the ‘ black box ’ of complex interventions evaluated in trials , but there is limited guidance to help research ers design process evaluations . Much current literature on process evaluations of complex interventions focuses on qualitative methods , with less attention paid to quantitative methods . This discrepancy led us to develop our own framework for design ing process evaluations of cluster-r and omised controlled trials . Methods We review ed recent theoretical and method ological literature and selected published process evaluations ; these publications identified a need for structure to help design process evaluations . We drew upon this literature to develop a framework through iterative exchanges , and tested this against published evaluations . Results The developed framework presents a range of c and i date approaches to underst and ing trial delivery , intervention implementation and the responses of targeted participants . We believe this framework will be useful to others design ing process evaluations of complex intervention trials . We also propose key information that  process evaluations could report to facilitate their identification and enhance their usefulness . Conclusion There is no single best way to design and carry out a process evaluation . Research ers will be faced with choices about what questions to focus on and which methods to use . The most appropriate design depends on the purpose of the process evaluation ; the framework aims to help research ers make explicit their choices of research questions and methods .Trial registration Clinical trials.gov Background Based on a critical synthesis of literature on use of the Promoting Action on Research Implementation in Health Services ( PARIHS ) framework , revisions and a companion Guide were developed by a group of research ers independent of the original PARIHS team . The purpose of the Guide is to enhance and optimize efforts of research ers using PARIHS in implementation trials and evaluations . Methods Authors used a planned , structured process to organize and synthesize critiques , discussion s , and potential recommendations for refinements of the PARIHS framework arising from a systematic review . Using a templated form , each author independently recorded key components for each review ed paper ; that is , study definitions , perceived strengths/ limitations of PARIHS , other observations regarding key issues and recommendations regarding needed refinements . After reaching consensus on these key components , the authors summarized the information and developed the Guide . Results A number of revisions , perceived as consistent with the PARIHS framework 's general nature and intent , are proposed . The related Guide is composed of a set of reference tools , provided in Additional files . Its core content is built upon the basic elements of PARIHS and current implementation science . Conclusions We invite research ers using PARIHS for targeted evidence -based practice ( EBP ) implementations with a strong task-orientation to use this Guide as a companion and to apply the revised framework prospect ively and comprehensively . Research ers also are encouraged to evaluate its use relative to perceived strengths and issues . Such evaluations and critical reflections regarding PARIHS and our Guide could thereby promote the framework 's continued evolution Background The case has been made for more and better theory-informed process evaluations within trials in an effort to facilitate insightful underst and ings of how interventions work . In this paper , we provide an explanation of implementation processes from one of the first national implementation research r and omized controlled trials with embedded process evaluation conducted within acute care , and a proposed extension to the Promoting Action on Research Implementation in Health Services ( PARIHS ) framework . Methods The PARIHS framework was prospect ively applied to guide decisions about intervention design , data collection , and analysis processes in a trial focussed on reducing peri-operative fasting times . In order to capture a holistic picture of implementation processes , the same data were collected across 19 participating hospitals irrespective of allocation to intervention . This paper reports on findings from data collected from a purposive sample of 151 staff and patients pre- and post-intervention . Data were analysed using content analysis within , and then across data sets . Results A robust and uncontested evidence base was a necessary , but not sufficient condition for practice change , in that individual staff and patient responses such as caution influenced decision making . The implementation context was challenging , in which individuals and teams were bounded by professional issues , communication challenges , power and a lack of clarity for the authority and responsibility for practice change . Progress was made in sites where processes were aligned with existing initiatives . Additionally , facilitators reported engaging in many intervention implementation activities , some of which result in practice changes , but not significant improvements to outcomes . Conclusions This study provided an opportunity for reflection on the comprehensiveness of the PARIHS framework . Consistent with the underlying tenant of PARIHS , a multi-faceted and dynamic story of implementation was evident . However , the prominent role that individuals played as part of the interaction between evidence and context is not currently explicit within the framework . We propose that successful implementation of evidence into practice is a planned facilitated process involving an interplay between individuals , evidence , and context to promote evidence -informed practice . This proposal will enhance the potential of the PARIHS framework for explanation , and ensure theoretical development both informs and responds to the evidence base for implementation . Trial registration IS RCT N18046709 - Peri-operative Implementation Study Evaluation ( PoISE ) OBJECTIVES Despite recognition that implementation of evidence -based clinical practice s ( EBPs ) usually depends on the structure and processes of the larger health care organizational context , the dynamics of implementation are not well understood . This project 's aim was to deepen that underst and ing by implementing and evaluating an organizational model hypothesized to strengthen the ability of health care organizations to facilitate EBPs . CONCEPTUAL MODEL : The model posits that implementation of EBPs will be enhanced through the presence of three interacting components : active leadership commitment to quality , robust clinical process re design incorporating EBPs into routine operations , and use of management structures and processes to support and align re design . STUDY DESIGN In a mixed- methods longitudinal comparative case study design , seven medical centers in one network in the Department of Veterans Affairs participated in an intervention to implement the organizational model over 3 years . The network was selected r and omly from three interested in using the model . The target EBP was h and -hygiene compliance . Measures included ratings of implementation fidelity , observed h and -hygiene compliance , and factors affecting model implementation drawn from interviews . FINDINGS Analyses support the hypothesis that greater fidelity to the organizational model was associated with higher compliance with h and -hygiene guidelines . High-fidelity sites showed larger effect sizes for improvement in h and -hygiene compliance than lower-fidelity sites . Adherence to the organizational model was in turn affected by factors in three categories : urgency to improve , organizational environment , and improvement climate . IMPLICATION S Implementation of EBPs , particularly those that cut across multiple processes of care , is a complex process with many possibilities for failure . The results provide the basis for a refined underst and ing of relationships among components of the organizational model and factors in the organizational context affecting them . This underst and ing suggests practical lessons for future implementation efforts and contributes to theoretical underst and ing of the dynamics of the implementation of EBPs 
    Output:
    
The concept of implementation presents largely consensual definitions and relatively well-defined boundaries , while distinguishing features , preconditions and outcomes are not yet fully articulated .