Objective evaluation of acute adverse events and image quality of gadolinium-based contrast agents (gadobutrol and gadobenate dimeglumine) by blinded evaluation. Pilot study

2013 ◽  
Vol 31 (1) ◽  
pp. 96-101 ◽  
Author(s):  
Richard C. Semelka ◽  
Mateus de A. Hernandes ◽  
Clifton G. Stallings ◽  
Mauricio Castillo
2018 ◽  
Vol 9 (3) ◽  
pp. 40
Author(s):  
Teresa Vinagre ◽  
Rita Marques

The notification of errors/adverse events is one of the central aspects for the quality of care and patient safety. The purpose of this pilot study is to analyse the safety culture of the operating room in relation to the errors/adverse events and their notification, in the nurses’ perception. It is a quantitative, descriptive-exploratory pilot study. A survey “Nurses’ Perception regarding Notification of Errors/Adverse Events” was applied, consisting of 8 closed questions to an intentional non-probabilistic sample consisting of 43 nurses working in the operating room of a private hospital in Lisbon. The results showed that only 51.2% of the adverse events that caused damage to patients were always notified by the nurses. Of the various adverse events occurred, 60.5% were not reported, justified by “lack of time”. There was also a negative correlation between professional experience and the frequency of error notification (p < .05). The factors referred as those that contributed most to the occurrence of errors were, pressure to work quickly (100.0%), lack of human resources (86.0%), demotivation (86.0%), professional inexperience and hourly overload (83.7%), lack of knowledge (74.4%) and communication failures (65.1%). The perception of Patient Safety was assessed by the majority of participants as “acceptable”. In conclusion, it was evident the reduced notification of adverse events in the operation room so it becomes crucial to focus on the continuous training of health professionals, as well as work on the error, to increase a safety culture with quality.


2020 ◽  
Vol 08 (05) ◽  
pp. E591-E595 ◽  
Author(s):  
Yasuaki Nagami ◽  
Masaki Ominami ◽  
Taishi Sakai ◽  
Shusei Fukunaga ◽  
Fumio Tanaka ◽  
...  

Abstract Background and study aims Esophageal fistulas after esophagectomy are associated with high mortality and poor quality of life. They are sometimes intractable to conservative management and surgery that increases mortality. Few studies have assessed use of polyglycolic acid (PGA) sheets with fibrin glue for esophageal fistulas. We investigated the safety of using PGA sheets with fibrin glue for esophageal fistulas after esophagectomy. Patients and methods This was a single-center prospective pilot study. Patients who had refractory esophageal fistulas after esophagectomy were included. PGA sheets were filled in the fistula using biopsy forceps. Fibrin glue was applied to the PGA sheets. We repeated the procedure 1 week later. The outcome measures were the incidence of adverse events (AEs) and closure of the fistula. Results Five patients were assessed. No adverse events were observed. The esophageal fistula was closed with the application of PGA sheets four times in 40 % (2/5) of the cases. Conclusions PGA sheets with fibrin glue were safe for esophageal fistula closure after esophagectomy and do not involve the risk of AEs.


2021 ◽  
Author(s):  
Jacqueline Stone ◽  
Tak S. Fung ◽  
Matthew Machan ◽  
Christina Campbell ◽  
Rodney Li Pi Shan ◽  
...  

Abstract Background: Post-traumatic headaches (PTH) are a common sequalae of TBI and greatly impact patient function and quality of life. Post-traumatic greater occipital neuralgia (GON) is a type of post-traumatic headache. Conventional treatment includes steroid/anesthetic injections which typically alleviate pain but have a short duration of effect. Platelet rich plasma (PRP) is an emerging biological treatment for numerous degenerative disorders, including peripheral nerve disorders. The primary aim of this pilot study is to evaluate whether a randomized control trial of PRP for the treatment of GON in patients with post-traumatic headaches is feasible in regard to recruitment, adherence, retention, and adherence and adverse events. Exploratory aims includes improvement in pain, function and quality of life in patients with post-traumatic GON receiving PRP compared to steroid/anesthetic and normal saline injections. Methods: Thirty adults (over 18 years of age) with post-traumatic GON will be randomized into one of three groups: 1) autologous PRP injection 2) steroid/anesthetic injection (standard care) or 3) placebo injection with normal saline. Injections will be performed to the greater occipital nerve under ultrasound guidance by a trained physician. Daily headache intensity and frequency data will be collected pre-injection and for the duration of the study period. Feasibility will be defined as greater than 30% recruitment, 70% completion of intervention, 70% retention and less than 2 minor adverse events. Exploratory outcomes will be explored using the (HIT-6; a valid and reliable 6-item questionnaire for assessment of the impact of headaches across different diagnostic groups of headaches (42, 43)) and the quality of life in following brain injury questionnaire (QOILIBRI). Discussion: This pilot study will be the first to evaluate the feasibility of PRP as a potential treatment of GON in patients with post-traumatic headache. Trial Registration: ClinicalTrials.gov - NCT04051203 (registered August 9, 2019), available at https://clinicaltrials.gov/ct2/show/NCT04051203?cond=greater+occipital+neuralgia&draw=2&rank=1


2019 ◽  
pp. bmjspcare-2018-001542 ◽  
Author(s):  
Eduardo Guilherme D’Alessandro ◽  
Daniela Ribeiro Nebuloni Nagy ◽  
Christina May Moran de Brito ◽  
Elisangela Pinto Marinho Almeida ◽  
Linamara Rizzo Battistella ◽  
...  

Chemotherapy-induced peripheral neuropathy (CIPN) can cause loss of independence and poor quality of life (QoL) due to severe disabilities, but in spite of its importance there is still a lack of data for the management of CIPN. Acupuncture has showed promising results and may be a cost-effective option for the treatment.ObjectivesTo evaluate the effect of acupuncture treatment on neurological symptoms of CIPN and QoL of oncological patients.MethodsWe performed a clinical, single-centre, randomised and controlled pilot study that involved 33 adult patients with cancer and CIPN randomised into two groups (control and acupuncture treated with 10 sessions, two times per week). Both groups were subjected to a complete physical examination and clinical assessment with National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Scale V.2.0, FIM Scale, European Organisation for the Research and Treatment of Cancer Quality of Life Questionnaire Core (EORTC QLQ-C30) Scale and Visual Analogue Scale for pain before and 5 weeks after treatment.ResultsThere were no adverse events, and we found statistical differences in groups in physical (p=0.03) and function (p=0.04) domains of EORTC QLQ-C30 when comparing control and acupuncture groups. About NCI CTCAE Scale and neuropathy sensory symptoms, we found better results in acupuncture group, comparing pretreatment and post-treatment analyses (p=0.01). In control group, we have no differences after 5 weeks (p=0.11).ConclusionAlthough these results suggest an interesting effect of acupuncture on this patient population, the clinical significance has remained unclear. Given the tendency towards benefit and the lack of adverse effects, the authors recommend a follow-up acupuncture trial using higher follow-up time and better sample size.Trial registration numberNCT02309164.


2019 ◽  
Vol 61 (1) ◽  
pp. 101-109
Author(s):  
Jihang Sun ◽  
Qifeng Zhang ◽  
Zuofu Zhou ◽  
Chenguang Jia ◽  
Wei Yang ◽  
...  

Background The use of weight-adapted pediatric computed tomography (CT) tube voltage protocols has been suggested, but a consensus standard has not been established and clinical available studies are not sufficient. Purpose To determine the best tube voltage for low dose abdominal CT imaging in children. Material and Methods Eighty-seven cases who needed three CT exams in a 1–3-month interval between scans were enrolled (mean age = 4.69 ± 3.20 years). The three scans were performed with three different tube voltages at 80 kV, 100 kV, and 120 kV, keeping the same radiation dose and same contrast injection protocol. Patients were divided into five groups for analysis based on their body weight. The subjective image quality of the three exams were evaluated using a 4-point scale (4 being the best) for image noise and image quality. The objective evaluation in terms of CT values and standard deviation in aorta, liver, spleen, pancreas, and kidney were measured to calculate the degree of enhancement and contrast-to-noise ratio (CNR) of organs. One-way ANOVA was used to compare the subjective and objective image quality with respect to different tube voltages and different patient weights. Result The 80-kV tube voltage provided the highest overall enhancement and CNR for the entire patient population and the best objective image quality for the 6.1–28.0 kg subgroup. Conclusion Patient weight-dependent tube voltage selection maximizes image quality for abdominal enhanced CT in children. The optimal tube voltage for children with weight <28 kg is 80 kV; higher voltages should be selected for children weighing 28.1–50.0 kg.


2021 ◽  
Vol 36 (Supplement_1) ◽  
Author(s):  
Severin Schricker ◽  
Moritz Schanz ◽  
Tina Oberacker ◽  
Silke Merz ◽  
Martin Kimmel ◽  
...  

Abstract Background and Aims Telemedicine is advancing. However, studies that examine the integration into home dialysis care are still scarce. This multicenter, Germany-wide prospective observational pilot-study investigated the effects, acceptance and usability of an app as a new care concept compared to conventionally cared-for patients. Method Here, we employed the “DiaApp”, a tablet based documentation, communication, information and supply ordering system developed by the PHV – a non-profit dialysis network in Germany with around 7,000 patients. During a pilot rollout phase of the app between 2018 and 2019, 25 patients participated in four dialysis practices. Participants were free to choose between app use (app) and the previous paper-based documentation (control). We collected prospective data on demographics, adverse events as well as questionnaires regarding quality of life (KDQL v1.3), affinity for technology (TA-EG), satisfaction with the app (UTAUT), and self-confidence in dealing with chronic illness (SES6G). Furthermore, 5 app users were interviewed in a qualitative interview over 90 min about their attitude towards technology, illness and the app. Results Of the 25 participants, 13 used the app (52%). App users tended to be younger, more likely to be male (60.0%) and on peritoneal dialysis (n=15, 60.0%). Median age and dialysis vintage for app users and controls were 51 (38-60; 0) vs. 59 (37-64; 1) years and 51.5 (34-68; 3) vs. 38 (28-66; 5) months, respectively. Mean follow-up durations were 6.5 months and 12 months. All participants continued to use the app. One exit site infection (app), 3 hospitalizations (peritonitis and shunt revision, controls; inguinal hernia, app) and no serious app-related adverse event occurred. App users exhibited small trends (n.s.) towards lower quality of life (median SF-12 physical composite app: 43, IQR 40-48 controls: 47, IQR 38-50; SF-12 mental composite median app: 53, IQR 35-55; controls: 56, IQR 42-59;) greater self-confidence in managing chronic illness (SESG6 Score app: 7.33, IQR: 6-8.83; controls:7.17, IQR 6-7.83) and higher affinity for technology (in all four TA-EG dimensions). App users were more likely to have completed a master’s degree, while non-users mostly had a bachelor's degrees (Chi-square 14.183, df 6, p=0.028). Overall, the educational level of participants was high. There was a tendency (n.s.) for actual app users to have slightly lower performance expectations (median control arm 5.5 vs. app arm 5.88 on a Likert scale 1-7), a slightly higher assessment of their own and other available resources (supportive conditions median control arm 6 vs. app arm 6.67 on a Likert scale 1-7). In the qualitative interviews, all app users surveyed stated that they regularly used digital offerings in all areas of their lives. Therefore, expectations were similar to other apps to be more efficient in terms of time, material and effort than paper-based documentation. The attitude towards the app was that towards an auxiliary tool, “it should simply work”, and found it to be useful. Patients disliked the necessity of a dedicated (in this case a tablet) device for running the app. Information about the disease was more likely to be outside of the app in e.g. the internet. Conclusion In this study, we found no significant differences between app users and controls. No adverse events occurred. Via trends and interviews, the picture emerges that an upcoming, younger generation of dialysis patients appreciates the advantages of flexible home dialysis procedures and, as in other areas of life, expects simple, digital and thus resource-saving options for self-management and communication. At the same time, such applications are also subject to the expectations of digital user experiences from other areas of life. This poses enormous challenges for the often-costly development of such applications by non-commercial providers and limited number of target audiences.


2001 ◽  
Author(s):  
F. Avraham Dilmanian ◽  
Hanns-Joachim Weinmann ◽  
Zhong Zhong ◽  
Tigran Bacarian ◽  
Luigi Rigon ◽  
...  

Nutrients ◽  
2019 ◽  
Vol 11 (7) ◽  
pp. 1500 ◽  
Author(s):  
Stephen D. Anton ◽  
Stephanie A. Lee ◽  
William T. Donahoo ◽  
Christian McLaren ◽  
Todd Manini ◽  
...  

A growing body of evidence indicates that time restricted feeding (TRF), a popular form of intermittent fasting, can activate similar biological pathways as caloric restriction, the only intervention consistently found to extend healthy lifespan in a variety of species. Thus, TRF may have the potential to also improve function in older adults. Given the challenges many individuals have in following calorie restriction regimens over long-time periods, evaluation of alternative approaches that may produce weight loss and improve function in overweight, older adults is important. Ten overweight, sedentary older adults (≥65 years) at risk for, or with mobility impairments, defined by slow gait speed (<1.0 m/s) participated in this trial. All participants received the intervention and were instructed to fast for approximately 16 h per day over the entire four-week intervention. Outcomes included changes in body weight, waist circumference, cognitive and physical function, health-related quality of life, and adverse events. Adherence levels were high (mean = 84%) based on days goal was met, and mean weight loss was 2.6 kg (p < 0.01). Since body composition was not measured in this study, it is unclear if the observed weight loss was due to loss of fat mass, muscle mass, or the combination of fat and muscle mass. There were no significant changes in other outcomes; however, there were clinically meaningful changes in walking speed and improvements in quality of life, with few reported adverse events. The findings of this pilot study suggest that time restricted feeding is an acceptable and feasible eating pattern for overweight, sedentary older adults to follow.


2013 ◽  
Vol 37 (5) ◽  
pp. 930-933 ◽  
Author(s):  
Kai Deng ◽  
Wei Li ◽  
Jun-jun Wang ◽  
Guang-li Wang ◽  
Hao Shi ◽  
...  

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