scholarly journals Update to the study protocol for an implementation-effectiveness trial comparing two education strategies for improving the uptake of noninvasive ventilation in patients with severe COPD exacerbation

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Mihaela S. Stefan ◽  
Penelope S. Pekow ◽  
Christopher M. Shea ◽  
Ashley M. Hughes ◽  
Nicholas S. Hill ◽  
...  
Keyword(s):  
Study Design ◽  
Noninvasive Ventilation ◽  
Implementation Strategies ◽  
Inpatient Setting ◽  
Effectiveness Trial ◽  
Copd Exacerbation ◽  
Implementation Effectiveness ◽  
Link Type ◽  
The Impact ◽  
Severe Copd

Abstract Background There is strong evidence that noninvasive ventilation (NIV) improves the outcomes of patients hospitalized with severe COPD exacerbation, and NIV is recommended as the first-line therapy for these patients. Yet, several studies have demonstrated substantial variation in NIV use across hospitals, leading to preventable morbidity and mortality. In addition, prior studies suggested that efforts to increase NIV use in COPD need to account for the complex and interdisciplinary nature of NIV delivery and the need for team coordination. Therefore, our initial project aimed to compare two educational strategies: online education (OLE) and interprofessional education (IPE), which targets complex team-based care in NIV delivery. Due to the impact of the COVID-19 pandemic on recruitment and planned intervention, we had made several changes in the study design, statistical analysis, and implementation strategies delivery as outlined in the methods. Methods We originally proposed a two-arm, pragmatic, cluster, randomized hybrid implementation-effectiveness trial comparing two education strategies to improve NIV uptake in patients with severe COPD exacerbation in 20 hospitals with a low baseline rate of NIV use. Due to logistical constrains and slow recruitment, we changed the study design to an opened cohort stepped-wedge design with three steps which will allow the institutions to enroll when they are ready to participate. Only the IPE strategy will be implemented, and the education will be provided in an online virtual format. Our primary outcome will be the hospital-level risk-standardized NIV proportion for the period post-IPE training, along with the change in rate from the period prior to training. Aim 1 will compare the change over time of NIV use among patients with COPD in the step-wedged design. Aim 2 will explore the mediators’ role (respiratory therapist autonomy and team functionality) on the relationship between the implementation strategies and effectiveness. Finally, in Aim 3, through interviews with providers, we will assess the acceptability and feasibility of the educational training. Conclusion The changes in study design will result in several limitation. Most importantly, the hospitals in the three cohorts are not randomized as they enroll based on their readiness. Second, the delivery of the IPE is virtual, and it is not known if remote education is conducive to team building. However, this study will be among the first to test the impact of IPE in the inpatient setting carefully and may generalize to other interventions directed to seriously ill patients. Trial registration ClinicalTrials.govNCT04206735. Registered on December 20, 2019;

scholarly journals Measuring the effects of a personalized music intervention on agitated behaviors among nursing home residents with dementia: design features for cluster-randomized adaptive trial

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Ellen M. McCreedy ◽  
Roee Gutman ◽  
Rosa Baier ◽  
James L. Rudolph ◽  
Kali S. Thomas ◽  
...  
Keyword(s):  
Nursing Home ◽  
Real World ◽  
Implementation Strategies ◽  
Trial Registration ◽  
World Health ◽  
Secondary Outcome ◽  
Link Type ◽  
Cluster Randomized ◽  
The Impact ◽  
Adaptive Trial

Abstract Background Agitated and aggressive behaviors (behaviors) are common in nursing home (NH) residents with dementia. Medications commonly used to manage behaviors have dangerous side effects. NHs are adopting non-pharmacological interventions to manage behaviors, despite a lack of effectiveness evidence and an understanding of optimal implementation strategies. We are conducting an adaptive trial to evaluate the effects of personalized music on behaviors. Adaptive trials may increase efficiency and reduce costs associated with traditional RCTs by learning and making modifications to the trial while it is ongoing. Methods We are conducting two consecutive parallel cluster-randomized trials with 54 NHs in each trial (27 treatment, 27 control). Participating NHs were recruited from 4 corporations which differ in size, ownership structure, geography, and residents’ racial composition. After randomization, there were no significant differences between the NHs randomized to each trial with respect to baseline behaviors, number of eligible residents, degree of cognitive impairment, or antipsychotic use. Agitated behavior frequency is assessed via staff interviews (primary outcome), required nursing staff conducted resident assessments (secondary outcome), and direct observations of residents (secondary outcome). Between the two parallel trials, the adaptive design will be used to test alternative implementation strategies, increasingly enroll residents who are likely to benefit from the intervention, and seamlessly conduct a stage III/IV trial. Discussion This adaptive trial allows investigators to estimate the impact of a popular non-pharmaceutical intervention (personalized music) on residents’ behaviors, under pragmatic, real-world conditions testing two implementation strategies. This design has the potential to reduce the research timeline by improving the likelihood of powered results, increasingly enrolling residents most likely to benefit from intervention, sequentially assessing the effectiveness of implementation strategies in the same trial, and creating a statistical model to reduce the future need for onsite data collection. The design may also increase research equity by enrolling and tailoring the intervention to populations otherwise excluded from research. Our design will inform pragmatic testing of other interventions with limited efficacy evidence but widespread stakeholder adoption because of the real-world need for non-pharmaceutical approaches. {2a} Trial registration ClinicalTrials.govNCT03821844. Registered on January 30, 2019. This trial registration meets the World Health Organization (WHO) minimum standard.

scholarly journals Predictors of outcome of noninvasive ventilation in severe COPD exacerbation

2019 ◽  
Vol 19 (1) ◽  
Author(s):  
Alexandru T. Steriade ◽  
Shirin Johari ◽  
Nicoleta Sargarovschi ◽  
Daniela Necula ◽  
Cornelia E. Tudose ◽  
...  
Keyword(s):  
Noninvasive Ventilation ◽  
Copd Exacerbation ◽  
Predictors Of Outcome ◽  
Severe Copd

scholarly journals How to foster successful implementation of a patient reported experience measurement in the disability sector: an example of developing strategies in co-creation

2021 ◽  
Vol 7 (1) ◽  
Author(s):  
Marjolein van Rooijen ◽  
Anneke van Dijk-de Vries ◽  
Stephanie Lenzen ◽  
Ruth Dalemans ◽  
Albine Moser ◽  
...  
Keyword(s):  
Implementation Strategies ◽  
Implementation Process ◽  
Successful Implementation ◽  
Participatory Action ◽  
Policy And Practice ◽  
Link Type ◽  
Tailored Implementation ◽  
Patient Reported ◽  
Strategy Changes ◽  
The Impact

Abstract Background The integrated uptake of patient-reported experience measures, using outcomes for the micro, meso and macro level, calls for a successful implementation process which depends on how stakeholders are involved in this process. Currently, the impact of stakeholders on strategies to improve the integrated use is rarely reported, and information about how stakeholders can be engaged, including care-users who are communication vulnerable, is limited. This study illustrates the impact of all stakeholders on developing tailored implementation strategies and provides insights into supportive conditions to involve care-users who are communication vulnerable. Methods With the use of participatory action research, implementation strategies were co-created by care-users who are communication vulnerable (n = 8), professionals (n = 12), management (n = 6) and researchers (n = 5) over 9 months. Data collection consisted of audiotapes, reports, and researchers’ notes. Conventional content analysis was performed. Results The impact of care-users concerned the strategies’ look and feel, understandability and relevance. Professionals influenced impact on how to use strategies and terminology. The impact of management was on showing the gap between policy and practice, and learning from previous improvement failures. Researchers showed impact on analysis, direction of strategy changes and translating academic and development experience into practice. The engagement of care-users who are communication vulnerable was supported, taking into account organisational issues and the presentation of information. Conclusions The impact of all engaged stakeholders was identified over the different levels strategies focused on. Care-users who are communication vulnerable were valuable engaged in co-creation implementation strategies by equipping them to their needs and routines, which requires adaptation in communication, delimited meetings and a safe group environment. Trial registration Reviewed by the Medical Ethics Committee of Zuyderland-Zuyd (METCZ20190006). NL7594 registred at https://www.trialregister.nl/.

Predictors of duration of noninvasive ventilation in severe COPD exacerbation

2018 ◽  
Author(s):  
Alexandru Tudor Steriade ◽  
Shirin Johari ◽  
Nicoleta Filip ◽  
Cornelia Tudose ◽  
Miron Alexandru Bogdan ◽  
...  
Keyword(s):  
Noninvasive Ventilation ◽  
Copd Exacerbation ◽  
Severe Copd

Exploring power in response inhibition tasks using the bootstrap: The impact of number of participants, number of trials, effect magnitude, and study design

2019 ◽  
Author(s):  
Curtis David Von Gunten ◽  
Bruce D Bartholow
Keyword(s):  
Study Design ◽  
Effect Size ◽  
Statistical Power ◽  
Bootstrap Sampling ◽  
Reliable Measure ◽  
Internal Reliability ◽  
The Impact ◽  
Power Analyses ◽  
Effect Magnitude

A primary psychometric concern with laboratory-based inhibition tasks has been their reliability. However, a reliable measure may not be necessary or sufficient for reliably detecting effects (statistical power). The current study used a bootstrap sampling approach to systematically examine how the number of participants, the number of trials, the magnitude of an effect, and study design (between- vs. within-subject) jointly contribute to power in five commonly used inhibition tasks. The results demonstrate the shortcomings of relying solely on measurement reliability when determining the number of trials to use in an inhibition task: high internal reliability can be accompanied with low power and low reliability can be accompanied with high power. For instance, adding additional trials once sufficient reliability has been reached can result in large gains in power. The dissociation between reliability and power was particularly apparent in between-subject designs where the number of participants contributed greatly to power but little to reliability, and where the number of trials contributed greatly to reliability but only modestly (depending on the task) to power. For between-subject designs, the probability of detecting small-to-medium-sized effects with 150 participants (total) was generally less than 55%. However, effect size was positively associated with number of trials. Thus, researchers have some control over effect size and this needs to be considered when conducting power analyses using analytic methods that take such effect sizes as an argument. Results are discussed in the context of recent claims regarding the role of inhibition tasks in experimental and individual difference designs.

scholarly journals Sex disparities in vitamin D status and the impact on systemic inflammation and survival in rectal cancer

BMC Cancer ◽  
2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Hanna Abrahamsson ◽  
Sebastian Meltzer ◽  
Vidar Nyløkken Hagen ◽  
Christin Johansen ◽  
Paula A. Bousquet ◽  
...  
Keyword(s):  
Rectal Cancer ◽  
Vitamin D ◽  
Cancer Patients ◽  
Systemic Inflammation ◽  
Elevated Serum ◽  
Metastatic Progression ◽  
Vitamin D Status ◽  
Cancer Specific Survival ◽  
Link Type ◽  
The Impact

Abstract Background We reported previously that rectal cancer patients given curative-intent chemotherapy, radiation, and surgery for non-metastatic disease had enhanced risk of metastatic progression and death if circulating levels of 25-hydroxyvitamin D [25(OH) D] were low. Here we investigated whether the association between the vitamin D status and prognosis pertains to the general, unselected population of rectal cancer patients. Methods Serum 25(OH) D at the time of diagnosis was assessed in 129 patients, enrolled 2013–2017 and representing the entire range of rectal cancer stages, and analyzed with respect to season, sex, systemic inflammation, and survival. Results In the population-based cohort residing at latitude 60°N, 25(OH) D varied according to season in men only, who were overrepresented among the vitamin D-deficient (< 50 nmol/L) patients. Consistent with our previous findings, the individuals presenting with T4 disease had significantly reduced 25(OH) D levels. Low vitamin D was associated with systemic inflammation, albeit with distinct modes of presentation. While men with low vitamin D showed circulating markers typical for the systemic inflammatory response (e.g., elevated erythrocyte sedimentation rate), the corresponding female patients had elevated serum levels of interleukin-6 and the chemokine (C-X-C motif) ligand 7. Despite disparities in vitamin D status and the potential effects on disease attributes, significantly shortened cancer-specific survival was observed in vitamin D-deficient patients irrespective of sex. Conclusion This unselected rectal cancer cohort confirmed the interconnection of low vitamin D, more advanced disease presentation, and poor survival, and further suggested it may be conditional on disparate modes of adverse systemic inflammation in men and women. Trial registration ClinicalTrials.govNCT01816607; registration date: 22 March 2013.

scholarly journals Technology Entrepreneurship and the Performance of Enterprises in the Conditions of Covid-19 Pandemic: The Fuzzy Set Analysis of Waste to Energy Enterprises in Poland

Energies ◽  
2021 ◽  
Vol 14 (13) ◽  
pp. 3891
Author(s):  
Piotr Kordel ◽  
Radosław Wolniak
Keyword(s):  
Fuzzy Set ◽  
High Performance ◽  
Qualitative Comparative Analysis ◽  
Flexible Structures ◽  
Implementation Strategies ◽  
Waste To Energy ◽  
Energy Industry ◽  
Technology Entrepreneurship ◽  
Research Results ◽  
The Impact

This article’s aim is to explain the impact of technology entrepreneurship phenomenon on waste management enterprise performance in the conditions of COVID-19 pandemic. The concept of technology entrepreneurship according to the configuration approach and the category of high-performance organization are the theoretical bases of empirical investigation. For the implementation of empirical research, Fuzzy set Qualitative Comparative Analysis (FsQCA) was adopted. The research sample included a group of producers of Refused Derived Fuel (RDF) as a central part of the waste to energy industry located in Poland. The research results showed that the waste to energy sector is highly immune to pandemic threats. While during COVID-19, the basic economic parameters (i.e., sales, profitability and employment) of the entire industry in Poland clearly decreased, the same parameters in the case of the waste to energy industry remained at the same level. The research results allow the formulation of two high-performance models of technology entrepreneurship in the waste to energy industry under COVID-19 conditions. The first model is based on traditional technologies and hierarchical organizational structures, and the second is using innovative technologies and flexible structures. Both technology entrepreneurship models are determined by their emergence as complementary to implementation strategies and the opportunity-oriented allocation of resources within business model portfolios.

The shift from inpatient to outpatient hysterectomy for endometrial cancer in the United States: trends, enabling factors, cost, and safety

2021 ◽  
pp. ijgc-2020-002192
Author(s):  
Serena Cappuccio ◽  
Yanli Li ◽  
Chao Song ◽  
Emeline Liu ◽  
Gretchen Glaser ◽  
...  
Keyword(s):  
Endometrial Cancer ◽  
Abdominal Hysterectomy ◽  
The United States ◽  
Inpatient Setting ◽  
Significant Shift ◽  
Robotic Hysterectomy ◽  
Post Discharge ◽  
Enabling Factors ◽  
Healthcare Database ◽  
The Impact

ObjectiveTo evaluate trends in outpatient versus inpatient hysterectomy for endometrial cancer and assess enabling factors, cost and safety.MethodsIn this retrospective cohort study, patients aged 18 years or older who underwent hysterectomy for endometrial cancer between January 2008 and September 2015 were identified in the Premier Healthcare Database. The surgical approach for hysterectomy was classified as open/abdominal, vaginal, laparoscopic or robotic assisted. We described trends in surgical setting, perioperative costs and safety. The impact of patient, provider and hospital characteristics on outpatient migration was assessed using multivariate logistic regression.ResultsWe identified 41 246 patients who met inclusion criteria. During the time period studied, we observed a 41.3% shift from inpatient to outpatient hysterectomy (p<0.0001), an increase in robotic hysterectomy, and a decrease in abdominal hysterectomy. The robotic hysterectomy approach, more recent procedure (year), and mid-sized hospital were factors that enabled outpatient hysterectomies; while abdominal hysterectomy, older age, Medicare insurance, black ethnicity, higher number of comorbidities, and concomitant procedures were associated with an inpatient setting. The shift towards outpatient hysterectomy led to a $2500 savings per case during the study period, in parallel to the increased robotic hysterectomy rates (p<0.001). The post-discharge 30-day readmission and complications rate after outpatient hysterectomy remained stable at around 2%.ConclusionsA significant shift from inpatient to outpatient setting was observed for hysterectomies performed for endometrial cancer over time. Minimally invasive surgery, particularly the robotic approach, facilitated this migration, preserving clinical outcomes and leading to reduction in costs.

scholarly journals European registry of type A aortic dissection (ERTAAD) - rationale, design and definition criteria

2021 ◽  
Vol 16 (1) ◽  
Author(s):  
Fausto Biancari ◽  
Giovanni Mariscalco ◽  
Hakeem Yusuff ◽  
Geoffrey Tsang ◽  
Suvitesh Luthra ◽  
...  
Keyword(s):  
Adverse Events ◽  
Aortic Dissection ◽  
Treatment Strategies ◽  
Kidney Injury ◽  
Type A ◽  
Salvage Procedure ◽  
Type A Aortic Dissection ◽  
Mortality And Morbidity ◽  
Link Type ◽  
The Impact

Abstract Background Acute Stanford type A aortic dissection (TAAD) is a life-threatening condition. Surgery is usually performed as a salvage procedure and is associated with significant postoperative early mortality and morbidity. Understanding the patient’s conditions and treatment strategies which are associated with these adverse events is essential for an appropriate management of acute TAAD. Methods Nineteen centers of cardiac surgery from seven European countries have collaborated to create a multicentre observational registry (ERTAAD), which will enroll consecutive patients who underwent surgery for acute TAAD from January 2005 to March 2021. Analysis of the impact of patient’s comorbidities, conditions at referral, surgical strategies and perioperative treatment on the early and late adverse events will be performed. The investigators have developed a classification of the urgency of the procedure based on the severity of preoperative hemodynamic conditions and malperfusion secondary to acute TAAD. The primary clinical outcomes will be in-hospital mortality, late mortality and reoperations on the aorta. Secondary outcomes will be stroke, acute kidney injury, surgical site infection, reoperation for bleeding, blood transfusion and length of stay in the intensive care unit. Discussion The analysis of this multicentre registry will allow conclusive results on the prognostic importance of critical preoperative conditions and the value of different treatment strategies to reduce the risk of early adverse events after surgery for acute TAAD. This registry is expected to provide insights into the long-term durability of different strategies of surgical repair for TAAD. Trial registration ClinicalTrials.gov Identifier: NCT04831073.

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