Pottawattamie County Farm to Fork (Phase III)

This continuation of a previous project showed the value of hiring a local food coordinator to aid in advancing local food systems in southwest Iowa

Clinical trialist perspectives on the ethics of adaptive clinical trials: a mixed-methods analysis

Abstract Background In an adaptive clinical trial (ACT), key trial characteristics may be altered during the course of the trial according to predefined rules in response to information that accumulates within the trial itself. In addition to having distinguishing scientific features, adaptive trials also may involve ethical considerations that differ from more traditional randomized trials. Better understanding of clinical trial experts’ views about the ethical aspects of adaptive designs could assist those planning ACTs. Our aim was to elucidate the opinions of clinical trial experts regarding their beliefs about ethical aspects of ACTs. Methods We used a convergent, mixed-methods design employing a 22-item ACTs beliefs survey with visual analog scales and open-ended questions and mini-focus groups. We developed a coding scheme to conduct thematic searches of textual data, depicted responses to visual analog scales on box-plot diagrams, and integrated findings thematically. Fifty-three clinical trial experts from four constituent groups participated: academic biostatisticians (n = 5); consultant biostatisticians (n = 6); academic clinicians (n = 22); and other stakeholders including patient advocacy, National Institutes of Health, and U.S. Food and Drug Administration representatives (n = 20). Results The respondents recognized potential ethical benefits of ACTs, including a higher probability of receiving an effective intervention for participants, optimizing resource utilization, and accelerating treatment discovery. Ethical challenges voiced include developing procedures so trial participants can make informed decisions about taking part in ACTs and plausible, though unlikely risks of research personnel altering enrollment patterns. Conclusions Clinical trial experts recognize ethical advantages but also pose potential ethical challenges of ACTs. The four constituencies differ in their weighing of ACT ethical considerations based on their professional vantage points. These data suggest further discussion about the ethics of ACTs is needed to facilitate ACT planning, design and conduct, and ultimately better allow planners to weigh ethical implications of competing trial designs.http://deepblue.lib.umich.edu/bitstream/2027.42/111302/1/12910_2015_Article_22.pd

Lack of association between hyperglycaemia at arrival and clinical outcomes in acute stroke patients treated with tissue plasminogen activator

Hyperglycaemia is associated with adverse outcomes in some studies of acute ischaemic stroke.We hypothesised that in thrombolytic-treated stroke patients, hyperglycaemia would be independently associated with haemorrhagic transformation and unfavourable outcome.Consecutive rt-PA-treated acute ischaemic stroke patients presenting to four emergency departments were analysed. Associations of initial blood glucose and survival to hospital discharge, symptomatic intracerebral haemorrhage, any form of intracerebral haemorrhage, and disability at hospital discharge were determined. Potentially confounding factors of age, National Institutes of Health Stroke Scale, and smoking were analysed by univariate logistic regression and those with P <0·3 included in the multivariate model.In 268 patients, initial glucose values ranged from 62 to 507 mg/dl (mean 131). Elevated glucose at arrival was not significantly associated with any adverse clinical outcomes. A trend towards higher mortality in hyperglycaemic patients (odds ratio 1·71 per 100 mg/dl increase in glucose, 95% confidence interval 0·92–3·13, P =0·08) was seen, but is of unclear significance, and was not corroborated by effects on discharge disability, symptomatic intracerebral haemorrhage or intracerebral haemorrhage.Thrombolytic-treated stroke patients with hyperglycaemia at presentation did not have significantly worse outcomes than others in this cohort. These data fail to confirm previously described associations seen in similarly sized studies. Further study of these associations and their magnitude are necessary to better define the relationship between serum glucose and outcome in thrombolytic-treated acute ischaemic stroke.Peer Reviewedhttp://deepblue.lib.umich.edu/bitstream/2027.42/79242/1/j.1747-4949.2010.00425.x.pd

Resource utilization and outcome at a university versus a community teaching hospital in tPA treated stroke patients: a retrospective cohort study

<p>Abstract</p> <p>Background</p> <p>Comparing patterns of resource utilization between hospitals is often complicated by biases in community and patient populations. Stroke patients treated with tissue plasminogen activator (tPA) provide a particularly homogenous population for comparison because of strict eligibility criteria for treatment. We tested whether resource utilization would be similar in this homogenous population between two hospitals located in a single Midwestern US community by comparing use of diagnostic testing and associated outcomes following treatment with t-PA.</p> <p>Methods</p> <p>Medical records from 206 consecutive intravenous t-PA-treated stroke patients from two teaching hospitals (one university, one community-based) were reviewed. Patient demographics, clinical characteristics and outcome were analyzed, as were the frequency of use of CT, MRI, MRA, echocardiography, angiography, and EEG.</p> <p>Results</p> <p>Seventy-nine and 127 stroke patients received t-PA at the university and community hospitals, respectively. The two patient populations were demographically similar. There were no differences in stroke severity. All outcomes were similar at both hospitals. Utilization of CT scans, and non-invasive carotid and cardiac imaging studies were similar at both hospitals; however, brain MR, TEE, and catheter angiography were used more frequently at the university hospital. EEG was obtained more often at the community hospital.</p> <p>Conclusions</p> <p>Utilization of advanced brain imaging and invasive diagnostic testing was greater at the university hospital, but was not associated with improved clinical outcomes. This could not be explained on the basis of stroke severity or patient characteristics. This variation of practice suggests substantial opportunities exist to reduce costs and improve efficiency of diagnostic resource use as well as reduce patient exposure to risk from diagnostic procedures.</p

Qualitative Data Collection and Analysis Methods: The INSTINCT Trial

Peer Reviewedhttp://deepblue.lib.umich.edu/bitstream/2027.42/71497/1/j.1553-2712.2007.tb02390.x.pd

Provider perceptions of barriers to the emergency use of tPA for Acute Ischemic Stroke: A qualitative study

Abstract Background Only 1-3% of ischemic stroke patients receive thrombolytic therapy. Provider barriers to adhering with guidelines recommending tPA delivery in acute stroke are not well known. The main objective of this study was to describe barriers to thrombolytic use in acute stroke care. Methods Twenty-four hospitals were randomly selected and matched into 12 pairs. Barrier assessment occurred at intervention sites only, and utilized focus groups and structured interviews. A pre-specified taxonomy was employed to characterize barriers. Two investigators independently assigned themes to transcribed responses. Seven facilitators (three emergency physicians, two nurses, and two study coordinators) conducted focus groups and interviews of emergency physicians (65), nurses (62), neurologists (15), radiologists (12), hospital administrators (12), and three others (hospitalists and pharmacist). Results The following themes represented the most important external barriers: environmental and patient factors. Important barriers internal to the clinician included familiarity with and motivation to adhere to the guidelines, lack of self-efficacy and outcome expectancy. The following themes were not substantial barriers: lack of awareness of the existence of acute stroke guidelines, presence of conflicting guidelines, and lack of agreement with the guidelines. Conclusions Healthcare providers perceive environmental and patient-related factors as the primary barriers to adherence with acute stroke treatment guidelines. Interventions focused on increasing physician familiarity with and motivation to follow guidelines may be of highest yield in improving adherence. Improving self-efficacy in performing guideline concordant care may also be useful. Trial Registration ClinicalTrials.gov identifier: NCT00349479</p

The Impact of Emergency Physician Turnover on Planning for Prospective Clinical Trials

Introduction: Emergency physician (EP) turnover is a significant issue that can have strong economic impact on hospital systems, as well as implications on research efforts to test and improve clinical practice. This work is particularly important to researchers planning randomized trials directed toward EPs because a large degree of turnover within a physician group would attenuate the effectiveness of the desired intervention. We sought to determine the incidence and factors associated with EP workforce changes.Methods: In an attempt to determine EP turnover and workforce change, data from the INSTINCT (INcreasing Stroke Treatment through INterventional behavior Change Tactics) trial were used. The INSTINCT trial is a prospective, cluster-randomized, controlled trial evaluating a targeted behavioral intervention to increase appropriate use of tissue plasminogen activator in acute ischemic stroke. Individual EPs staffing each of the study hospitals were identified at baseline and 18 months. Surveys were sent to EPs at both intervals. Models were constructed to investigate relationships between physician/hospital characteristics and workforce change.Results: A total of 278 EPs were identified at baseline. Surveys were sent to all EPs at baseline and 18 months with a response rate of 72% and 74%, respectively. At 18 months, 37 (15.8%) had left their baseline hospital and 66 (26.3%) new EPs were working. Seven EPs switched hospitals within the sample. The total number of EPs at 18 months was 307, a 10.8% overall increase. Among the 24 hospitals, 6 had no EP departures and 5 had no new arrivals. The median proportion of EP workforce departing by hospital was 16% (interquartile range [IQR] ¼ 4%–25%; range ¼ 0%–73%), and the median proportion added was 21% (IQR ¼ 7%–41%; range ¼ 0%–120%). None of the evaluatedcovariates investigating relationships between physician/hospital characteristics and workforce change were significant.Conclusion: EP workforce changes over an 18-month period were common. This has implications for emergency department directors, researchers, and individual EPs. Those planning research involvinginterventions upon EPs should account for turnover as it may have an impact when designing clinical trials to improve performance on healthcare delivery metrics for time-sensitive medical conditions suchas stroke, acute myocardial infarction, or trauma. [West J Emerg Med. 2013;14(1):16–22.

The Impact of Emergency Physician Turnover on Planning for Prospective Clinical Trials

Introduction: Emergency physician (EP) turnover is a significant issue that can have strong economic impact on hospital systems, as well as implications on research efforts to test and improve clinical practice. This work is particularly important to researchers planning randomized trials directed toward EPs because a large degree of turnover within a physician group would attenuate the effectiveness of the desired intervention. We sought to determine the incidence and factors associated with EP workforce changes.Methods: In an attempt to determine EP turnover and workforce change, data from the INSTINCT (INcreasing Stroke Treatment through INterventional behavior Change Tactics) trial were used. The INSTINCT trial is a prospective, cluster-randomized, controlled trial evaluating a targeted behavioral intervention to increase appropriate use of tissue plasminogen activator in acute ischemic stroke. Individual EPs staffing each of the study hospitals were identified at baseline and 18 months. Surveys were sent to EPs at both intervals. Models were constructed to investigate relationships between physician/hospital characteristics and workforce change.Results: A total of 278 EPs were identified at baseline. Surveys were sent to all EPs at baseline and 18 months with a response rate of 72% and 74%, respectively. At 18 months, 37 (15.8%) had left their baseline hospital and 66 (26.3%) new EPs were working. Seven EPs switched hospitals within the sample. The total number of EPs at 18 months was 307, a 10.8% overall increase. Among the 24 hospitals, 6 had no EP departures and 5 had no new arrivals. The median proportion of EP workforce departing by hospital was 16% (interquartile range [IQR] ¼ 4%–25%; range ¼ 0%–73%), and the median proportion added was 21% (IQR ¼ 7%–41%; range ¼ 0%–120%). None of the evaluatedcovariates investigating relationships between physician/hospital characteristics and workforce change were significant.Conclusion: EP workforce changes over an 18-month period were common. This has implications for emergency department directors, researchers, and individual EPs. Those planning research involvinginterventions upon EPs should account for turnover as it may have an impact when designing clinical trials to improve performance on healthcare delivery metrics for time-sensitive medical conditions suchas stroke, acute myocardial infarction, or trauma. [West J Emerg Med. 2013;14(1):16–22.