Improving the normalization of complex interventions: part 1 - development of the NoMAD instrument for assessing implementation work based on normalization process theory (NPT)

Background Understanding and measuring implementation processes is a key challenge for implementation researchers. This study draws on Normalization Process Theory (NPT) to develop an instrument that can be applied to assess, monitor or measure factors likely to affect normalization from the perspective of implementation participants. Methods An iterative process of instrument development was undertaken using the following methods: theoretical elaboration, item generation and item reduction (team workshops); item appraisal (QAS-99); cognitive testing with complex intervention teams; theory re-validation with NPT experts; and pilot testing of instrument. Results We initially generated 112 potential questionnaire items; these were then reduced to 47 through team workshops and item appraisal. No concerns about item wording and construction were raised through the item appraisal process. We undertook three rounds of cognitive interviews with professionals (n = 30) involved in the development, evaluation, delivery or reception of complex interventions. We identified minor issues around wording of some items; universal issues around how to engage with people at different time points in an intervention; and conceptual issues around the types of people for whom the instrument should be designed. We managed these by adding extra items (n = 6) and including a new set of option responses: ‘not relevant at this stage’, ‘not relevant to my role’ and ‘not relevant to this intervention’ and decided to design an instrument explicitly for those people either delivering or receiving an intervention. This version of the instrument had 53 items. Twenty-three people with a good working knowledge of NPT reviewed the items for theoretical drift. Items that displayed a poor alignment with NPT sub-constructs were removed (n = 8) and others revised or combined (n = 6). The final instrument, with 43 items, was successfully piloted with five people, with a 100% completion rate of items. Conclusion The process of moving through cycles of theoretical translation, item generation, cognitive testing, and theoretical (re)validation was essential for maintaining a balance between the theoretical integrity of the NPT concepts and the ease with which intended respondents could answer the questions. The final instrument could be easily understood and completed, while retaining theoretical validity. NoMAD represents a measure that can be used to understand implementation participants’ experiences. It is intended as a measure that can be used alongside instruments that measure other dimensions of implementation activity, such as implementation fidelity, adoption, and readiness

Improving the normalization of complex interventions: measure development based on normalization process theory (NoMAD): study protocol

<b>Background</b> Understanding implementation processes is key to ensuring that complex interventions in healthcare are taken up in practice and thus maximize intended benefits for service provision and (ultimately) care to patients. Normalization Process Theory (NPT) provides a framework for understanding how a new intervention becomes part of normal practice. This study aims to develop and validate simple generic tools derived from NPT, to be used to improve the implementation of complex healthcare interventions.<p></p> <b>Objectives</b> The objectives of this study are to: develop a set of NPT-based measures and formatively evaluate their use for identifying implementation problems and monitoring progress; conduct preliminary evaluation of these measures across a range of interventions and contexts, and identify factors that affect this process; explore the utility of these measures for predicting outcomes; and develop an online users’ manual for the measures.<p></p> <b>Methods</b> A combination of qualitative (workshops, item development, user feedback, cognitive interviews) and quantitative (survey) methods will be used to develop NPT measures, and test the utility of the measures in six healthcare intervention settings.<p></p> <b>Discussion</b> The measures developed in the study will be available for use by those involved in planning, implementing, and evaluating complex interventions in healthcare and have the potential to enhance the chances of their implementation, leading to sustained changes in working practices

Quality Improvement: origins, purpose and the future for veterinary practice

Providing the highest quality veterinary care can often be a delicate balancing act: the client/owner’s wishes, financial parameters and emotional needs have to be considered, whilst also meeting the animal’s clinical needs. But what actually defines quality care? It is a term frequently used in both the human and veterinary healthcare literature, but often has little explanation or definition attached to it. ‘Quality’ in relation to care delivered is not a static concept and will hold different meanings to different individuals within a healthcare service. John Ruskin, a Victorian writer and critic of art and society observed: ‘Quality is never an accident; it is always the result of high intention, sincere effort, intelligent direction and skilful execution’

Turning round the telescope. Centre-right parties and immigration and integration policy in Europe

This is an Author's Original Manuscript of 'Turning round the telescope. Centre-right parties and immigration and integration policy in Europe', whose final and definitive form, the Version of Record, has been published in the Journal of European Public Policy 15(3):315-330, 2008 [copyright Taylor & Francis], available online at: http://www.tandfonline.com/doi.org/10.1080/13501760701847341

Translational framework for implementation evaluation and research: Protocol for a qualitative systematic review of studies informed by Normalization Process Theory (NPT)

Background: Normalization Process Theory (NPT) identifies mechanisms that have been demonstrated to play an important role in implementation processes. It is now widely used to inform feasibility, process evaluation, and implementation studies in healthcare and other areas of work. This qualitative synthesis of NPT studies aims to better understand how NPT explains observed and reported implementation processes, and to explore the ways in which its constructs explain the implementability, enacting and sustainment of complex healthcare interventions. Methods: We will systematically search Scopus, PubMed and Web of Science databases and use the Google Scholar search engine for citations of key papers in which NPT was developed.  This will identify English language peer-reviewed articles in scientific journals reporting (a) primary qualitative or mixed methods studies; or, (b) qualitative or mixed methods evidence syntheses in which NPT was the primary analytic framework. Studies may be conducted in any healthcare setting, published between June 2006 and 31 December 2021. We will perform a qualitative synthesis of included studies using two parallel methods: (i) directed content analysis based on an already developed coding manual; and (ii) unsupervised textual analysis using Leximancer® topic modelling software. Other: We will disseminate results of the review using peer reviewed publications, conference and seminar presentations, and social media (Facebook and Twitter) channels. The primary source of funding is the National Institute for Health Research ARC North Thames. No human subjects or personal data are involved and no ethical issues are anticipated

Improving the normalization of complex interventions : part 2 - validation of the NoMAD instrument for assessing implementation work based on normalization process theory (NPT)

Funding This study is funded by the Economic and Social Research Council Study [Grant Number RES-062-23-3274] which is gratefully acknowledged. This work was also partially supported by funding from the European Union’s Horizon 2020 research and innovation programme under grant agreement No 733025, ImpleMentAll project. This content reflects only the author’s view and the European Commission is not responsible for any use that may be made of the information it contains.The Health Services Research Unit, University of Aberdeen, receives core funding from the Chief Scientist Office of the Scottish Government Health Directorates. CRV was funded by a Clinician Scientist award supported by the National Institute for Health Research during this independent research. Availability of data and materials The datasets generated and/or analysed during the current study are deposited on UK Datashare (record 852,387). Further information is available from the corresponding author on reasonable request.Peer reviewedPublisher PD

Indicators of ‘critical’ outcomes in 941 horses seen ‘out-of-hours’ for colic

Background: This study aimed to describe the presentation and outcomes of horses with signs of colic (abdominal pain) seen ‘out-of-hours’ in equine practice. Methods: This was a retrospective study of horses seen ‘out-of-hours’ with colic by two equine veterinary practices between 2011-2013. Case outcomes were categorised as ‘critical’ or ‘not critical’. A critical outcome was defined as requiring medical or surgical hospital treatment, or resulting in euthanasia or death. A non-critical outcome was defined as resolving with simple medical treatment. A hierarchical generalised linear model was used to identify ‘red flag’ parameters (aspects of signalment, history and presenting clinical signs) associated with critical outcomes.Results: Data were retrieved from 941 cases that presented with colic; 23.9% (n=225/941) were critical. Variables significantly associated with the likelihood of a critical outcome in the final multivariable mode were: increased heart rate (p [less than] 0.001), age of the horse (p=0.013) and abnormal mucous membrane colour (p [less than] 0.001). Overall 18% of cases (n=168/941) were euthanased.Conclusions: This study highlights the mortality associated with colic. The ‘red flag’ parameters identified should be considered an essential component of the primary assessment of horses with colic

Using Normalization Process Theory in feasibility studies and process evaluations of complex healthcare interventions: a systematic review.

BACKGROUND: Normalization Process Theory (NPT) identifies, characterises and explains key mechanisms that promote and inhibit the implementation, embedding and integration of new health techniques, technologies and other complex interventions. A large body of literature that employs NPT to inform feasibility studies and process evaluations of complex healthcare interventions has now emerged. The aims of this review were to review this literature; to identify and characterise the uses and limits of NPT in research on the implementation and integration of healthcare interventions; and to explore NPT's contribution to understanding the dynamics of these processes. METHODS: A qualitative systematic review was conducted. We searched Web of Science, Scopus and Google Scholar for articles with empirical data in peer-reviewed journals that cited either key papers presenting and developing NPT, or the NPT Online Toolkit ( www.normalizationprocess.org ). We included in the review only articles that used NPT as the primary approach to collection, analysis or reporting of data in studies of the implementation of healthcare techniques, technologies or other interventions. A structured data extraction instrument was used, and data were analysed qualitatively. RESULTS: Searches revealed 3322 citations. We show that after eliminating 2337 duplicates and broken or junk URLs, 985 were screened as titles and abstracts. Of these, 101 were excluded because they did not fit the inclusion criteria for the review. This left 884 articles for full-text screening. Of these, 754 did not fit the inclusion criteria for the review. This left 130 papers presenting results from 108 identifiable studies to be included in the review. NPT appears to provide researchers and practitioners with a conceptual vocabulary for rigorous studies of implementation processes. It identifies, characterises and explains empirically identifiable mechanisms that motivate and shape implementation processes. Taken together, these mean that analyses using NPT can effectively assist in the explanation of the success or failure of specific implementation projects. Ten percent of papers included critiques of some aspect of NPT, with those that did mainly focusing on its terminology. However, two studies critiqued NPT emphasis on agency, and one study critiqued NPT for its normative focus. CONCLUSIONS: This review demonstrates that researchers found NPT useful and applied it across a wide range of interventions. It has been effectively used to aid intervention development and implementation planning as well as evaluating and understanding implementation processes themselves. In particular, NPT appears to have offered a valuable set of conceptual tools to aid understanding of implementation as a dynamic process