scholarly journals The Treatment of Brain AVMs Study (TOBAS): an all-inclusive framework to integrate clinical care and research

2018 ◽  
Vol 128 (6) ◽  
pp. 1823-1829 ◽  
Author(s):  
Elsa Magro ◽  
Jean-Christophe Gentric ◽  
André Lima Batista ◽  
Marc Kotowski ◽  
Chiraz Chaalala ◽  
...  

OBJECTIVEThe management of brain arteriovenous malformations (bAVMs) remains controversial. The Treatment of Brain AVMs Study (TOBAS) was designed to manage patients with bAVMs within a clinical research framework. The objective of this study was to study trial feasibility, recruitment rates, patient allocation to the various management groups, and compliance with treatment allocation.METHODSTOBAS combines two randomized care trials (RCTs) and a registry. Designed to be all-inclusive, the study offers randomized allocation of interventional versus conservative management to patients eligible for both options (first RCT), a second RCT testing the role of preembolization as an adjunct to surgery or radiotherapy, and a registry of patients managed using clinical judgment alone. The primary outcome of the first RCT is death from any cause or disabling stroke (modified Rankin Scale score > 2) at 10 years. A pilot phase was initiated at one center to test study feasibility, record the number and characteristics of patients enrolled in the RCTs, and estimate the frequency of crossovers.RESULTSAll patients discussed at the multidisciplinary bAVM committee between June 2014 and June 2016 (n = 107) were recruited into the study; 46 in the randomized trials (23 in the first RCT with 21 unruptured bAVMs, 40 in the second RCT with 17 unruptured bAVMs, and 17 in both RCTs), and 61 patients in the registry. Three patients crossed over from surgery to observation (first RCT).CONCLUSIONSClinical research was successfully integrated with normal practice using TOBAS. Recruitment rates in a single center are encouraging. Whether the trial will provide meaningful results depends on the recruitment of a sufficient number of participating centers.Clinical trial registration no.: NCT02098252 (clinicaltrials.gov)

2020 ◽  
pp. 019394592096313
Author(s):  
Jeana M. Holt ◽  
Aaron Winn ◽  
Rachel Cusatis ◽  
AkkeNeel Talsma ◽  
Bradley H. Crotty

The Patient Activation Measure (PAM) assesses a person’s level of knowledge, skills, and confidence to self-manage their day-to-day health. We conducted a mediation analysis to examine potential direct effects of race on significantly lower baseline PAM scores in Black than in White participants (p<0.001) who were a subset of 184 adults who participated in a randomized controlled trial. In the mediation analysis, using natural indirect effects, the continuous outcome was the PAM score. The mediators were income, education, ability to pay bills, and health literacy; race (Black or White) was the “exposure.” The results indicate that income (p=0.025) and difficulty paying monthly bills (p=0.04) mediated the relationship between race and baseline PAM score, whereas health literacy (p=0.301) and education (p=0.436) did not. Researchers must further investigate the role of economic diversity as an underlying mechanism of patient activation and differences in outcomes. Clinical Trial Registration: Avoiding Health Disparities When Collecting Patient Contextual Data for Clinical Care and Pragmatic Research: NCT03766841 https://clinicaltrials.gov/ct2/show/NCT03766841?term=crotty&draw=2&rank=1


2003 ◽  
Vol 348 (14) ◽  
pp. 1386-1388 ◽  
Author(s):  
Steven M. Grunberg ◽  
William T. Cefalu

2020 ◽  
pp. OP.20.00020
Author(s):  
Lowell Anthony ◽  
George Atweh ◽  
Ravi Bhatia ◽  
Lisa A. Carey ◽  
Jenny C. Chang ◽  
...  

The role of clinical researchers is vital to cancer progress. The teaching, research, and leadership roles that academic oncologists hold need to be accounted for and appropriately compensated. National metrics are currently inexistent, but are necessary to move the oncology research field forward. Clinical research and routine clinical care must be harmoniously integrated without competing. This article reviews the national landscape of clinical cancer research and proposes a call for action.


2018 ◽  
Vol 68 (suppl 1) ◽  
pp. bjgp18X696713
Author(s):  
David Seamark ◽  
Deborah Davidson ◽  
Helen Tucker ◽  
Angela Ellis-Paine ◽  
Jon Glasby

BackgroundIn 2000 20% of UK GPs had admitting rights to community hospitals. In subsequent years the number of GPs engaged in community hospital clinical care has decreased.AimWhat models of medical care exist in English community hospitals today and what factors are driving changes?MethodInterviews with community hospital clinical staff conducted as part of a multimethod study of the community value of community hospitals.ResultsSeventeen interviews were conducted and two different models of medical care observed: GP led and Trust employed doctors. Factors driving changes were GP workload and recruitment challenges; increased medical acuity of patients admitted; fewer local patients being admitted; frustration over the move from ‘step-up’ care from the local community to ‘step-down’ care from acute hospitals; increased burden of GP medical support; inadequate remuneration; and GP admission rights removed due to bed closures or GP practices withdrawing from community hospital work.ConclusionMultiple factors have driven changes in the role of GP community hospital clinicians with a consequent loss of GP generalist skills in the community hospital setting. The NHS needs to develop a focused strategy if GPs are to remain engaged with community hospital care.


Author(s):  
Sourav Bhattacharjee

In this second Expert Perspective video with Sourav Bhattacharjee of the University College Dublin, Sourav discusses how nanomedicine is being used in clinical research, with particular emphasis on the role of nanomedicine and nanotechnology in cancer treatment.


Author(s):  
Marian Tanofsky-Kraff ◽  
Denise E. Wilfley

Interpersonal psychotherapy (IPT) is a focused, time-limited treatment that targets interpersonal problem(s) associated with the onset and/or maintenance of EDs. IPT is supported by substantial empirical evidence documenting the role of interpersonal factors in the onset and maintenance of EDs. IPT is a viable alternative to cognitive behavior therapy for the treatment of bulimia nervosa and binge eating disorder. The effectiveness of IPT for the treatment of anorexia nervosa requires further investigation. The utility of IPT for the prevention of obesity is currently being explored. Future research directions include enhancing the delivery of IPT for EDs, increasing the availability of IPT in routine clinical care settings, exploring IPT adolescent and parent–child adaptations, and developing IPT for the prevention of eating and weight-related problems that may promote full-syndrome EDs or obesity.


2019 ◽  
Vol 8 (4) ◽  
pp. 555 ◽  
Author(s):  
Cátia Caneiras ◽  
Cristina Jácome ◽  
Sagrario Mayoralas-Alises ◽  
José Ramon Calvo ◽  
João Almeida Fonseca ◽  
...  

The increasing number of patients receiving home respiratory therapy (HRT) is imposing a major impact on routine clinical care and healthcare system sustainability. The current challenge is to continue to guarantee access to HRT while maintaining the quality of care. The patient experience is a cornerstone of high-quality healthcare and an emergent area of clinical research. This review approaches the assessment of the patient experience in the context of HRT while highlighting the European contribution to this body of knowledge. This review demonstrates that research in this area is still limited, with no example of a prescription model that incorporates the patient experience as an outcome and no specific patient-reported experience measures (PREMs) available. This work also shows that Europe is leading the research on HRT provision. The development of a specific PREM and the integration of PREMs into the assessment of prescription models should be clinical research priorities in the next several years.


Author(s):  
Elizabeth Biswell R ◽  
Michael Clark ◽  
Michela Tinelli ◽  
Gillian Manthorpe ◽  
Joanne Neale ◽  
...  

2020 ◽  
Vol 7 (Supplement_1) ◽  
pp. S435-S436
Author(s):  
Sarath G Nath ◽  
Francesca Lee ◽  
Anjali Bararia ◽  
Ank E Nijhawan

Abstract Background C.difficile Toxin Polymerase Chain Reaction (C.diff PCR) and C.difficile Toxin Enzyme Immunoassays (toxin EIA) are commonly used tests to diagnose Clostridoides difficile infection (CDI). C.diff PCR cannot differentiate between colonization and infection, leading to a higher false-positive diagnosis of CDI. Toxin EIA has low sensitivity leading to a missed diagnosis of CDI. In patients with C.diff PCR positive(+) and Toxin EIA negative(-), clinical judgment is often needed regarding the decision to treat or not to treat. C.diff cytotoxic assay (CCA), is a more sensitive method to detect the toxin but is time-consuming and not readily available. Methods Between 6/2019 and 12/2019, 83 patients who were admitted to the hospital, met our inclusion criteria (C.diff PCR+/EIA-). Clinicians who cared for these patients were contacted and surveyed with a predesigned questionnaire evaluating the rationale of treatment. Also, a simultaneous medical records review was done to ensure consistency. Along with this C.diff PCR+/EIA- stool samples were sent to ARUP laboratories for CCA. The CCA results were not available for clinicians and did not impact clinical care. Average cost for a CCA assay was $29 Results Demographics of the clinicians were variable (Table 1). Several parameters were considered when making decisions regarding treatment and GI/ID were frequently involved (figure 1). Among the 83 patients, 41(49%) were CCA (+) and 42(51%) were CCA (-). 48 of 83 (58%) patients received treatment for CDI. 25 of 48 (52%) patients who were treated were CCA positive while 23 of 48 (48%) patients were CCA negative. Among the untreated patients, 16/35 (46%) were CCA+ while 19/35(54%) were CCA-. There was no statistically significant correlation between clinical judgment and CCA assay results (p: 0.56 on the Chi test). Demographics of the clinicians Clinician survey responses CDI Treatment and by CCA positivity Conclusion Clinicians regardless of their background and training face challenges with the treatment of C.diff PCR+/EIA- patients. Patient outcomes based on the incorporation of CCA assay into an algorithm for C.diff PCR+/EIA- patients, need to be evaluated. But it has a potential role in stopping unnecessary CDI treatment as well as avoidance of missed treatment opportunities while possibly also being cost-effective. Disclosures Ank E. Nijhawan, MD, MPH, Gilead (Grant/Research Support, Scientific Research Study Investigator, Research Grant or Support)


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