Project description:Organizational readiness for change in healthcare settings is an important factor in successful implementation of new policies, programs, and practices. However, research on the topic is hindered by the absence of a brief, reliable, and valid measure. Until such a measure is developed, we cannot advance scientific knowledge about readiness or provide evidence-based guidance to organizational leaders about how to increase readiness. This article presents results of a psychometric assessment of a new measure called Organizational Readiness for Implementing Change (ORIC), which we developed based on Weiner's theory of organizational readiness for change.We conducted four studies to assess the psychometric properties of ORIC. In study one, we assessed the content adequacy of the new measure using quantitative methods. In study two, we examined the measure's factor structure and reliability in a laboratory simulation. In study three, we assessed the reliability and validity of an organization-level measure of readiness based on aggregated individual-level data from study two. In study four, we conducted a small field study utilizing the same analytic methods as in study three.Content adequacy assessment indicated that the items developed to measure change commitment and change efficacy reflected the theoretical content of these two facets of organizational readiness and distinguished the facets from hypothesized determinants of readiness. Exploratory and confirmatory factor analysis in the lab and field studies revealed two correlated factors, as expected, with good model fit and high item loadings. Reliability analysis in the lab and field studies showed high inter-item consistency for the resulting individual-level scales for change commitment and change efficacy. Inter-rater reliability and inter-rater agreement statistics supported the aggregation of individual level readiness perceptions to the organizational level of analysis.This article provides evidence in support of the ORIC measure. We believe this measure will enable testing of theories about determinants and consequences of organizational readiness and, ultimately, assist healthcare leaders to reduce the number of health organization change efforts that do not achieve desired benefits. Although ORIC shows promise, further assessment is needed to test for convergent, discriminant, and predictive validity.

Project description:BackgroundNormalisation process theory (NPT) provides researchers with a set of tools to support the understanding of the implementation, normalisation and sustainment of an intervention in practice. Previous reviews of published research have explored NPT's use in the implementation processes of healthcare interventions. However, its utility in intervention research, specifically in orthopaedic and musculoskeletal interventions, remains unclear. The aim of this review is to explore how NPT (including extended NPT, ENPT) has been used in orthopaedic/musculoskeletal intervention research.MethodsA qualitative systematic review was conducted. Two bibliographic databases (Scopus and Web of Science) and a search engine (Google Scholar) were searched for peer-reviewed journal articles citing key papers outlining the development of NPT, related methods, tools or the web-based toolkit. We included studies of any method, including protocols, and did not exclude based on published language. A data extraction tool was developed, and data were analysed using a framework approach.ResultsCitation searches, of the 12 key studies, revealed 10,420 citations. Following duplicate removal, title, abstract and full-text screening, 14 papers from 12 studies were included. There were 8 key findings assessed against GRADE-CERQual (Confidence in Evidence from Reviews of Qualitative research). Five were of high confidence supporting NPT/ENPT's use in the implementation process for interventions targeting a range of MSK/orthopaedic conditions. NPT/ENPT offers a useful analytical lens to focus attention and consider implementation factors robustly. There is limited evidence for the selection of NPT/ENPT and for the use of the Normalisation Measure Development instrument. Three findings of moderate confidence suggest that coherence is seen as a fundamental initial step in implementation, there is limited evidence that study population limits NPT's utility and the application of ENPT may pose a challenge to researchers.ConclusionThis review demonstrates NPT's utility in supporting intervention implementation for orthopaedic and musculoskeletal conditions. We have theorised the benefits ENPT offers to intervention development and refinement and recommend future researchers consider its use. We also encourage future researchers to offer clear justification for NPT's use in their methodology.Trial registrationThe review protocol is registered with PROSPERO (CRD42022358558).

Project description:There is a need to move from binary hazard assessment to more quantitative assessment of genotoxicity to better inform human health risk assessment and understand the relevance of positive in vitro genotoxicity findings. New approach methodologies (NAMs), including transcriptomic biomarkers combined with high-throughput technologies, enable the testing of a broad concentration range, which allows quantitative assessment of in vitro results. Initial work with the transcriptomic GENOMARK and TGx-DDI biomarkers demonstrate their potential use for hazard identification and chemical prioritization; however, no study has evaluated the concordance and complementarity of GENOMARK and TGx-DDI. The overall aim of this study is to examine if a combined approach of integrating both transcriptomic biomarkers for genotoxicity in human relevant HepaRGTM cells increases the certainty in hazard calls and potency rankings of chemicals. A sub-aim is to investigate whether GENOMARK is applicable to the TempO-Seq® high-throughput sequencing technology, to collect concentration-response data to rapidly perform hazard classification and potency ranking. Therefore, HepaRGTM cells were exposed to 10 chemicals (i.e. eight known in vivo genotoxicants and two in vivo non-genotoxicants) in increasing concentrations over 72h. TempO-Seq® was used to obtain concentration-response data for both biomarkers. Benchmark concentration (BMC) modelling of chemicals that were classified positive was conducted to obtain BMCs and transcriptomic points of departure (tPODs) for potency ranking. The results confirm that GENOMARK is applicable to TempO-Seq® since it achieved 100% predictive accuracy. In addition, a high concordance was observed in the hazard classifications and potency rankings between both biomarkers. Overall, our findings show that in vitro transcriptomic data can be used to rapidly and effectively identify genotoxic hazards while simultaneously providing additional insights on potency that is more informative in a modern hazard assessment paradigm. The results of this case study support the high value of integrating these NAMs in a weight of evidence evaluation of genotoxicity using the important human-liver cell line.

Dataset Information

How to Measure the Intervention Process? An Assessment of Qualitative and Quantitative Approaches to Data Collection in the Process Evaluation of Organizational Interventions.

Publications

How to Measure the Intervention Process? An Assessment of Qualitative and Quantitative Approaches to Data Collection in the Process Evaluation of Organizational Interventions.

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