scholarly journals Planning for success: overcoming challenges to recruitment and conduct of an open-label emergency department–led paediatric trial

2020 ◽  
pp. emermed-2020-209487
Author(s):  
Louise Roper ◽  
Mark D Lyttle ◽  
Carrol Gamble ◽  
Amy Humphreys ◽  
Shrouk Messahel ◽  
...  

BackgroundKey challenges to the successful conduct of The Emergency treatment with Levetiracetam or Phenytoin in Status Epilepticus in children (EcLiPSE) trial were identified at the pre-trial stage. These included practitioner anxieties about conducting research without prior consent (RWPC), inexperience in conducting an ED-led trial and use of a medication that was not usual ED practice. As part of an embedded study, we explored parent and practitioner experiences of recruitment, RWPC and conduct of the trial to inform the design and conduct of future ED-led trials.MethodsA mixed-methods study within a trial involving (1) questionnaires and interviews with parents of randomised children, (2) interviews and focus groups with EcLiPSE practitioners and (3) audio-recorded trial discussions. We analysed data using thematic analysis and descriptive statistics as appropriate.ResultsA total of 143 parents (93 mothers, 39 fathers, 11 missing information) of randomised children completed a questionnaire and 30 (25 mothers, 5 fathers) were interviewed. We analysed 76 recorded trial recruitment discussions. Ten practitioners (4 medical, 6 nursing) were interviewed, 36 (16 medical, 20 nursing) participated in one of six focus groups. Challenges to the success of the trial were addressed by having a clinically relevant research question, pragmatic trial design, parent and practitioner support for EcLiPSE recruitment and research without prior consent processes, and practitioner motivation and strong leadership. Lack of leadership negatively affected practitioner engagement and recruitment. EcLiPSE completed on time, achieving its required sample size target.ConclusionsSuccessful trial recruitment and conduct in a challenging ED-led trial was driven by trial design, recruitment experience, teamwork and leadership. Our study provides valuable insight from parents and practitioners to inform the design and conduct of future trials in this setting.

2021 ◽  
Vol 4 (Supplement_1) ◽  
pp. 41-42
Author(s):  
E Johnson ◽  
M Carbonneau ◽  
D Campbell-Scherer ◽  
P Tandon ◽  
A Hyde

Abstract Background Cirrhosis is the leading cause of mortality and morbidity in individuals with gastrointestinal disease. Multiple care gaps exist for hospitalized patients with cirrhosis, resulting in high rates of re-hospitalization (e.g. 44% at 90 days in Alberta). The Cirrhosis Care Alberta (CCAB) is a 4-year multi-component pragmatic trial with an aim to reduce acute-care utilization by implementing an electronic order set and supporting education across eight hospital sites in Alberta. Aims As part of the pre-implementation evaluation, this qualitative study analyzed data from provider focus groups to identify barriers and facilitators to implementation. Methods We conducted focus groups at eight hospital sites with a total of 54 healthcare providers (3–12 per site). A semi-structured interview guide based upon constructs of the Consolidated Framework for Implementation Research (CFIR) and Normalization Process Theory (NPT) frameworks was used to guide the focus groups. Focus groups were recorded and transcribed verbatim. Data was analyzed thematically and inductively. Results Five major themes emerged across all eight sites: (i) understanding past implementation experiences, (ii) resource challenges, (iii) competing priorities among healthcare providers, (iv) system challenges, and (v) urban versus rural differences. Site-specific barriers included perceived lack of patient flow, time restraints, and concerns about the quality and quantity of past implementation interventions. Facilitators included passionate project champions, and an ample feedback process. Conclusions Focus groups were useful for identifying pre-implementation barriers and facilitators of an electronic orders set. Findings from this study are being refined to address the influence of COVID-19, and the data will be used to inform the intervention roll-out at each of the sites. Funding Agencies Alberta Innovates


2021 ◽  
pp. 1-10
Author(s):  
Ronald C. Kessler ◽  
Toshi A. Furukawa ◽  
Tadashi Kato ◽  
Alex Luedtke ◽  
Maria Petukhova ◽  
...  

Abstract Background There is growing interest in using composite individualized treatment rules (ITRs) to guide depression treatment selection, but best approaches for doing this are not widely known. We develop an ITR for depression remission based on secondary analysis of a recently published trial for second-line antidepression medication selection using a cutting-edge ensemble machine learning method. Methods Data come from the SUN(^_^)D trial, an open-label, assessor blinded pragmatic trial of previously-untreated patients with major depressive disorder from 48 clinics in Japan. Initial clinic-level randomization assigned patients to 50 or 100 mg/day sertraline. We focus on the 1549 patients who failed to remit within 3 weeks and were then rerandomized at the individual-level to continuation with sertraline, switching to mirtazapine, or combining mirtazapine with sertraline. The outcome was remission 9 weeks post-baseline. Predictors included socio-demographics, clinical characteristics, baseline symptoms, changes in symptoms between baseline and week 3, and week 3 side effects. Results Optimized treatment was associated with significantly increased cross-validated week 9 remission rates in both samples [5.3% (2.4%), p = 0.016 50 mg/day sample; 5.1% (2.7%), p = 0.031 100 mg/day sample] compared to randomization (30.1–30.8%). Optimization was also associated with significantly increased remission in both samples compared to continuation [24.7% in both: 11.2% (3.8%), p = 0.002 50 mg/day sample; 11.7% (3.9%), p = 0.001 100 mg/day sample]. Non-significant gains were found for optimization compared to switching or combining. Conclusions An ITR can be developed to improve second-line antidepressant selection, but replication in a larger study with more comprehensive baseline predictors might produce stronger and more stable results.


2021 ◽  
Vol 7 (1) ◽  
Author(s):  
Elizabeth Deja ◽  
Louise Roper ◽  
Lyvonne N. Tume ◽  
Jon Dorling ◽  
Chris Gale ◽  
...  

Abstract Background Routine measurement of gastric residual volume (GRV) to guide feeding in neonatal and paediatric intensive care is widespread. However, this practice is not evidence based and may cause harm. As part of a feasibility study, we explored parent and practitioner views on the acceptability of a trial comparing GRV measurement or no GRV measurement. Methods A mixed-methods study involving interviews and focus groups with practitioners and interviews with parents with experience of tube feeding in neonatal and/or paediatric intensive care. A voting system recorded closed question responses during practitioner data collection, enabling the collection of quantitative and qualitative data. Data were analysed using thematic analysis and descriptive statistics. Results We interviewed 31 parents and nine practitioners and ran five practitioner focus groups (n=42). Participants described how the research question was logical, and the intervention would not be invasive and potential benefits of not withholding the child’s feeds. However, both groups held concerns about the potential risk of not measuring GRV, including delayed diagnosis of infection and gut problems, increased risk of vomiting into lungs and causing discomfort or pain. Parent’s views on GRV measurement and consent decision making were influenced by their views on the importance of feeding in the ICU, their child’s prognosis and associated comorbidities or complications. Conclusions The majority of parents and practitioners viewed the proposed trial as acceptable. Potential concerns and preferences were identified that will need careful consideration to inform the development of the proposed trial protocol and staff training.


2021 ◽  
Vol 8 (1) ◽  
pp. e000949
Author(s):  
Muriel Fartoukh ◽  
Alexandre Demoule ◽  
Olivier Sanchez ◽  
Sophie Tuffet ◽  
Emmanuel Bergot ◽  
...  

BackgroundWhereas first-line bronchial artery embolisation (BAE) is considered standard of care for the management of severe haemoptysis, it is unknown whether this approach is warranted for non-severe haemoptysis.Research questionTo assess the efficacy on bleeding control and the safety of first-line BAE in non-severe haemoptysis of mild abundance.Study design and methodsThis multicentre, randomised controlled open-label trial enrolled adult patients without major comorbid condition and having mild haemoptysis (onset <72 hours, 100–200 mL estimated bleeding amount), related to a systemic arterial mechanism. Patients were randomly assigned (1:1) to BAE associated with medical therapy or to medical therapy alone.ResultsBleeding recurrence at day 30 after randomisation (primary outcome) occurred in 4 (11.8%) of 34 patients in the BAE strategy and 17 (44.7%) of 38 patients in the medical strategy (difference −33%; 95% CI −13.8% to −52.1%, p=0.002). The 90-day bleeding recurrence-free survival rates were 91.2% (95% CI 75.1% to 97.1%) and 60.2% (95% CI 42.9% to 73.8%), respectively (HR=0.19, 95% CI 0.05 to 0.67, p=0.01). No death occurred during follow-up and no bleeding recurrence needed surgery.Four adverse events (one major with systemic emboli) occurred during hospitalisation, all in the BAE strategy (11.8% vs 0%; difference 11.8%, 95% CI 0.9 to 22.6, p=0.045); all eventually resolved.ConclusionIn non-severe haemoptysis of mild abundance, BAE associated with medical therapy had a superior efficacy for preventing bleeding recurrences at 30 and 90 days, as compared with medical therapy alone. However, it was associated with a higher rate of adverse events.Trial registration numberNCT01278199


2009 ◽  
Vol 111 (11) ◽  
pp. 2505-2534 ◽  
Author(s):  
Andy Hargreaves ◽  
Dennis Shirley

Background/Context This study draws on the voluminous research on teachers’ workplace orientations and especially on Dan Lortie's documentation of conservatism, individualism, and presentism among teachers. Purpose/Objective/Research Question/Focus of Study This study investigated a school reform network of over 300 secondary schools entitled Raising Achievement Transforming Learning (RATL) to explore the role of the network's interventions in increasing or diminishing presentism. Setting England. Population/Participants/Subjects Quantitative performance data were analyzed for all 300 schools. Site visits were made to 10 RATL schools in which educational administrators and teachers were interviewed individually and in focus groups. Additional phone interviews were conducted with administrators in 14 RATL schools. Intervention/Program/Practice RATL provided a combination of interventions and supports for schools in the network, including data analysis and capacity enhancement; partnering mentor schools with low-performing schools; regional conferences; a Web portal for schools in the project; and a menu of short-, medium-, and long-term strategies for change. Research Design Qualitative interviews and focus groups of educators in RATL schools, along with secondary analysis of pupil performance data. Conclusions/Recommendations In Dan Lortie's seminal research on teachers’ workplace orientations, he identified “presentism,” or short-term thinking, with conservatism and individualism. This research indicates that in the RATL project, individualism among teachers diminished, but this did not diminish either conservatism or presentism. The research identifies three kinds of presentism—endemic, adaptive, and addictive—that have amplified educational conservatism while altering its nature to fit the current culture and political economy of fast capitalism.


2020 ◽  
pp. 604-613
Author(s):  
Mette L. Baran ◽  
Janice E. Jones

This chapter serves as a guideline for outlining the core characteristics of mixed methods research (MMR) and the various steps researchers undertake in order to conduct a research study. The purpose is to create a worksheet assisting the researcher step by step from beginning to end following the seven steps to conducting research. While the focus is on MMR the steps are similar for any type of research methodology. It is important to note that MMR is not a limiting form of research. Researchers need a MMR question and a mixed methods purpose statement for the research project. This chapter will also help explain why mixed method research is one of the best approaches in answering a research question. Finally, the chapter includes a suggestion to the importance of adding a visual diagram of the MMR into the research project and into the final report.


Author(s):  
Mette L. Baran ◽  
Janice E. Jones

This chapter serves as a guideline for outlining the core characteristics of mixed methods research (MMR) and the various steps researchers undertake in order to conduct a research study. The purpose is to create a worksheet assisting the researcher step by step from beginning to end following the seven steps to conducting research. While the focus is on MMR the steps are similar for any type of research methodology. It is important to note that MMR is not a limiting form of research. Researchers need a MMR question and a mixed methods purpose statement for the research project. This chapter will also help explain why mixed method research is one of the best approaches in answering a research question. Finally, the chapter includes a suggestion to the importance of adding a visual diagram of the MMR into the research project and into the final report.


Author(s):  
Andrea Crowell ◽  
Patricio Riva-Posse ◽  
Helen S. Mayberg

A growing circuit-based understanding of the mechanisms underlying psychological processes and psychiatric syndromes, paired with growing technological advances in neuroimaging and neuromodulation techniques, has led to the investigational use of deep brain stimulation as a surgical treatment for a variety of psychiatric disorders. Still in its early stages, there is reason for optimism about its potential use in patients with severe and treatment-refractory illness. However, as larger, randomized trials have not yet delivered on the promise of smaller, open-label case series, we must be cautious and attentive to appropriate patient selection and trial design in order to establish scientific efficacy and protect vulnerable populations.


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