You will be presented with a collection of medical randomized controlled trial (RCT) reports addressing a shared clinical question -- for instance, the efficacy of a medical intervention on a disease or condition. Given the titles and abstracts of these reports, your task is to generate the conclusion of the systematic review article synthesizing the key findings. Your conclusion should be a few sentences long. In your response, include only the conclusion and no other text. The RCT reports are below.



Title 1:
Exploring implementation and sustainability of models of care: can theory help?
Abstract 1:
Objective Research on new models of care in health service provision is complex , as is the introduction and embedding of such models , and positive research findings are only one factor in whether a new model of care will be implemented . In order to underst and why this is the case , research design must not only take account of proposed changes in the clinical encounter , but the organisational context that must sustain and normalise any changed practice s. We use two case studies where  new models of maternity care were implemented and evaluated via  r  and omised controlled trials ( RCTs ) to discuss how ( or whether ) the use of theory might inform implementation and sustainability strategies . The Normalisation Process Model is proposed as a suitable theoretical framework , and a comparison made using the two case studies – one where a theoretical framework was used , the other where it was not . Context and approachIn the maternity sector there is considerable debate about which model of care provides the best outcomes for women , while being sustainable in the organisational setting . We explore why a model of maternity care – team midwifery ( where women have a small group of midwives providing their care ) – that was implemented and tested in an RCT was not continued after the RCT ’s conclusion , despite showing the same or better outcomes for women in the intervention group compared with women allocated to usual care . We then discuss the conceptualisation and rationale leading to the use of the ‘ Normalisation Process Model ' as an aid to exploring aspects of implementation of a caseload midwifery model ( where women are allocated a primary midwife for their care ) that has recently been evaluated by RCT . Discussion We demonstrate how the Normalisation Process Model was applied in planning of the evaluation phases of the RCT as a means of exploring the implementation of the caseload model of care . We argue that a theoretical underst and ing of issues related to implementation and sustainability can make a valuable contribution when research ing complex interventions in complex setting s such as hospitals . Conclusion and implication sApplication of a theoretical model in the research of a complex intervention enables a greater underst and ing of the organisational context into which new models of care are introduced and identification of factors that promote or challenge implementation of these models of care


Title 2:
Drawbacks and benefits associated with inter-organizational collaboration along the discovery-development-delivery continuum: a cancer research network case study
Abstract 2:
Background The scientific process around cancer research begins with scientific discovery , followed by development of interventions , and finally delivery of needed interventions to people with cancer . Numerous studies have identified substantial gaps between discovery and delivery in health research . Team science has been identified as a possible solution for closing the discovery to delivery gap ; however , little is known about effective ways of collaborating within teams and across organizations . The purpose of this study was to determine benefits and drawbacks associated with organizational collaboration across the discovery-development-delivery research continuum . Methods Representatives of organizations working on cancer research across a state answered a survey about how they collaborated with other cancer research organizations in the state and what benefits and drawbacks they experienced while collaborating . We used exponential r and om graph modeling to determine the association between these benefits and drawbacks and the presence of a collaboration tie between any two network members . Results Different drawbacks and benefits were associated with discovery , development , and delivery collaborations . The only consistent association across all three was with the drawback of difficulty due to geographic differences , which was negatively associated with collaboration , indicating that those organizations that had collaborated were less likely to perceive a barrier related to geography . The benefit , enhanced access to other knowledge , was positive and significant in the development and delivery networks , indicating that collaborating organizations viewed improved knowledge exchange as a benefit of collaboration . ‘ Acquisition of additional funding or other re sources ’ and ‘ development of new tools and methods ’ were negatively significantly related to collaboration in these networks . So , although improved knowledge access was an outcome of collaboration , more tangible outcomes were not being realized . In the development network , those who collaborated were less likely to see ‘ enhanced influence on treatment and policy ’ and ‘ greater quality or frequency of publications ’ as benefits of collaboration . Conclusion With the exception of the positive association between knowledge transfer and collaboration and the negative association between geography and collaboration , the significant relationships identified in this study all reflected challenges associated with inter-organizational collaboration . Underst and ing network structures and the perceived drawbacks and benefits associated with collaboration will allow research ers to build and funders to support successful collaborative teams and perhaps aid in closing the discovery to delivery gap


Title 3:
A critical synthesis of literature on the promoting action on research implementation in health services (PARIHS) framework
Abstract 3:
Background The Promoting Action on Research Implementation in  Health Services framework  , or PARIHS , is a conceptual framework that posits key , interacting elements that influence successful implementation of evidence -based practice s. It has been widely cited and used as the basis for empirical work ; however , there has not yet been a literature review to examine how the framework has been used in implementation projects and research . The purpose of the present article was to critically review and synthesize the literature on PARIHS to underst and how it has been used and operationalized , and to highlight its strengths and limitations . Methods We conducted a qualitative , critical synthesis of peer- review ed PARIHS literature published through March 2009 . We synthesized findings through a three-step process using semi-structured data abstract ion tools and group consensus . Results Twenty-four articles met our inclusion criteria : six core concept articles from original PARIHS authors , and eighteen empirical articles ranging from case reports to quantitative studies . Empirical articles generally used PARIHS as an organizing framework for analyses . No studies used PARIHS prospect ively to design implementation strategies , and there was generally a lack of detail about how variables were measured or mapped , or how conclusions were derived . Several studies used findings to comment on the framework in ways that could help refine or vali date it . The primary issue identified with the framework was a need for greater conceptual clarity regarding the definition of sub-elements and the nature of dynamic relationships . Strengths identified included its flexibility , intuitive appeal , explicit acknowledgement of the outcome of ' successful implementation , ' and a more expansive view of what can and should constitute ' evidence . ' Conclusions While we found studies reporting empirical support for PARIHS , the single greatest need for this and other implementation models is rigorous , prospect i ve use of the framework to guide implementation projects . There is also need to better explain derived findings and how interventions or measures are mapped to specific PARIHS elements ; greater conceptual discrimination among sub-elements may be necessary first . In general , it may be time for the implementation science community to develop consensus guidelines for reporting the use and usefulness of theoretical frameworks within implementation studies


Title 4:
What work has to be done to implement collaborative care for depression? Process evaluation of a trial utilizing the Normalization Process Model
Abstract 4:
Background There is a considerable evidence base for ' collaborative care ' as a method to improve quality of care for depression , but an acknowledged gap between efficacy and implementation . This study utilises the Normalisation Process Model ( NPM ) to inform the process of implementation of collaborative care in both a future full-scale trial , and the wider health economy . Methods Application of the NPM to qualitative data collected in both focus groups and one-to-one interviews before and after an exploratory r and omised controlled trial of a collaborative model of care for depression . Results Findings are presented as they relate to the four factors of the NPM ( interactional workability , relational integration , skill-set workability , and context ual integration ) and a number of necessary tasks are identified . Using the model , it was possible to observe that predictions about necessary work to implement collaborative care that could be made from analysis of the pre-trial data relating to the four different factors of the NPM were indeed borne out in the post-trial data . However , additional insights were gained from the post-trial interview participants who , unlike those interviewed before the trial , had direct experience of a novel intervention . The professional freedom enjoyed by more senior mental health workers may work both for and against normalisation of collaborative care as those who wish to adopt new ways of working have the freedom to change their practice but are not obliged to do so . Conclusions The NPM provides a useful structure for both guiding and analysing the process by which an intervention is optimized for testing in a larger scale trial or for subsequent full-scale implementation


Title 5:
Understanding the implementation of complex interventions in health care: the normalization process model
Abstract 5:
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


Title 6:
REsearch into implementation STrategies to support patients of different ORigins and language background in a variety of European primary care settings (RESTORE): study protocol
Abstract 6:
Background The implementation of guidelines and training initiatives to support communication in cross-cultural primary care consultations is ad hoc across a range of international setting s with negative consequences particularly for migrants . This situation reflects a well-documented translational gap between evidence and practice and is part of the wider problem of implementing guidelines and the broader range of professional educational and quality interventions in routine practice . In this paper , we describe our use of a contemporary social theory , Normalization Process Theory and participatory research methodology —Participatory Learning and Action — to investigate and support implementation of such guidelines and training initiatives in routine practice . Methods This is a qualitative case study , using multiple primary care sites across Europe . Purposive and maximum variation sampling approaches will be used to identify and recruit stakeholders — migrant service users , general practitioners , primary care nurses , practice managers and administrative staff , interpreters , cultural mediators , service planners , and policy makers . We are conducting a mapping exercise to identify relevant guidelines and training initiatives . We will then initiate a PLA-brokered dialogue with stakeholders around Normalization Process Theory ’s four constructs — coherence , cognitive participation , collective action , and reflexive monitoring . Through this , we will enable stakeholders in each setting to select a single guideline or training initiative for implementation in their local setting . We will prospect ively investigate and support the implementation journeys for the five selected interventions . Data will be generated using a Participatory Learning and Action approach to interviews and focus groups . Data analysis will follow the principles of thematic analysis , will occur in iterative cycles throughout the project and will involve participatory co- analysis with key stakeholders to enhance the authenticity and veracity of findings . Discussion This research employs a unique combination of Normalization Process Theory and Participatory Learning and Action , which will provide a novel approach to the analysis of implementation journeys . The findings will advance knowledge in the field of implementation science because we are using and testing theoretical and method ological approaches so that we can critically appraise their scope to mediate barriers and improve the implementation processes


Title 7:
Understanding factors that inhibit or promote the utilization of telecare in chronic lung disease
Abstract 7:
Objectives : To perform a process evaluation of a r and omized controlled trial ( RCT ) of home telecare for the management of acute exacerbations of chronic obstructive pulmonary disease ( COPD ) , using the normalization process model ( NPM ) as an explanatory framework . Methods : Semi-structured interviews were carried out with patients ( n = 9 ) and nurses ( n = 11 ) participating in a RCT . A framework approach to data analysis was used . Results : The telecare service did not provide an interactional advantage for the nurses providing this service and did not fit with the nurses ' views of the most appropriate or preferred use of their skills . The telecare service seemed unlikely to become normalized as part of routine healthcare delivery , because the nursing team lacked confidence that it was a safe way to provide healthcare in this context and it was not perceived as improving efficiency . Discussion : The NPM effectively mapped onto the study findings and explained those factors that inhibited the routine delivery of COPD services by telecare
Results Twenty-nine articles met the inclusion criteria ; in the main , NPT is being applied to qualitatively analyze a diverse range of complex interventions , many beyond its original field of e-health and telehealth .
The NPT constructs have high stability across setting s and , notwithst and ing challenges in applying NPT in terms of managing overlaps between constructs , there is evidence that it is a beneficial heuristic device to explain and guide implementation processes .
Conclusions NPT offers a generalizable framework that can be applied across context s with opportunities for incremental knowledge gain over time and an explicit framework for analysis , which can explain and potentially shape implementation processes .