Pathway map development for medical device event reporting in operating theatres: a human factors approach to improving the existing system

OBJECTIVES: This study aimed to develop the actual pathway to reporting and information transfer in operating theatres in relation to medical technology malfunction/failure. This with the aim of understanding the differences with the pathway published by NHS Improvement and identification of points for improvement. DESIGN: This is a qualitative study involving stakeholder interviews with doctors, nurses, manufacturers, medical device safety officer and Medicines and Healthcare products Regulatory Agency. SETTING: Data were collected on reporting pathway used in operating theatres. Clinical staff who took part worked in different trusts throughout UK while manufacturers provided devices in UK and EU/USA. PARTICIPANTS: Semistructured interviews were completed with 15 clinicians and 13 manufacturers. Surveys were completed by 38 clinicians and 5 manufacturers. Recognised methods of pathway development were used. The Lean Six Sigma principles adapted to healthcare were used to develop suggestions for improvement. MAIN OUTCOME MEASURES: To identify the differences between the set pathway to reporting and information transfer to what is occurring on a day-to-day basis as reported by staff. Identify points in the pathway where improvements could be applied. RESULTS: The developed pathway demonstrated great complexity of the current reporting system for medical devices. It identified numerous areas that give rise to problems and multiple biases in decision making. This highlighted the core issues leading to under-reporting and lack of knowledge on device performance and patient risk. Suggestions for improvement were deduced based on end user requirements and identified problems. CONCLUSIONS: This study has provided a detailed understanding of the key problem areas that exist within the current reporting system for medical devices and technology. The developed pathway sets to address the key problems to improve reporting outcomes. The identification of pathway differences between 'work as done' and 'work as imagined' can lead to development of quality improvements that could be systematically applied

Usability challenges in the use of medical devices in the home environment: a systematic review of literature

Background Home care medical devices are the fastest-growing segment of the medical device industry with associated safety and usability challenges. Human factor studies in the home environment present many difficulties resulting in limited knowledge of device use in this setting. This systematic review aims to identify usability challenges reported directly by end-users in the home environment. Methods A systematic review of the literature was conducted concentrating on studies involving end user reporting. Reported challenges were grouped into a) device-user, b) device use environment and c) device-user interface challenges. Results 3471 studies were screened and 202 underwent full-text review. Only twelve studies had direct involvement of end users. Multiple challenges were identified, with device-user interface problems being the most common. No effective, standardised method was found to collect patient/user feedback on usability challenges in the post-market stage, leading to a knowledge gap. Conclusions This study brought together multiple usability challenges reported by individual studies. Involvement of medical device end-users in usability studies is essential and their experiences must be effectively utilised in device design

Cloning and functional analysis of a fructosyltransferase cDNA for synthesis of highly polymerized levans in timothy (Phleum pratense L.)

Variation in the structures of plant fructans and their degree of polymerization (DP) can be explained as the result of diverse combinations of fructosyltransferases (FTs) with different properties. Although FT genes have been isolated in a range of plant species, sucrose:fructan 6-fructosyltransferase (6-SFT) cDNAs have only been functionally characterized in a few species such as wheat. A novel FT cDNA possessing 6-SFT activity has been identified and characterized from the temperate forage grass, timothy (Phleum pratense L.). The cDNA of an FT homolog, PpFT1, was isolated from cold-acclimated timothy. A recombinant PpFT1 protein expressed in Pichia pastoris showed 6-SFT/sucrose:sucrose 1-fructosyltransferase (1-SST) activity and produced linear β(2,6)-linked levans from sucrose with higher DPs than present in graminans formed in vitro by wheat 6-SFT (Wft1). PpFT1 and Wft1 showed remarkably different acceptor substrate specificities: PpFT1 had high affinity for 6-kestotriose to produce levans and low affinity for 1-kestotriose, whereas Wft1 preferentially used 1-kestotriose as an acceptor. The affinity of the PpFT1 recombinant enzyme for sucrose as a substrate was lower than that of the Wft1 recombinant enzyme. It is also confirmed that timothy seedlings had elevated levels of PpFT1 transcripts during the accumulation of fructans under high sucrose and cold conditions. Our results suggest that PpFT1 is a novel cDNA with unique enzymatic properties that differ from those of previously cloned plant 6-SFTs, and is involved in the synthesis of highly polymerized levans in timothy

Religación. Revista de Ciencias Sociales y Humanidades (Vol. 1 no. 3 jul-sep 2016)

Religación. Revista de Ciencias Sociales y Humanidades, es una revista académica de periodicidad trimestral, editada por el Centro de Investigaciones en Ciencias Sociales y Humanidades desde América Latina, centro asociado a CLACSO. Revista Religación, pretende ser un espacio abierto para el debate y construcción del pensamiento latinoamericano en el campo de las Ciencias Sociales y Humanidades, destinado a profesionales, investigadores, estudiantes y académicos que tengan interés en el estudio de la realidad de nuestra Abya Yala con un enfoque decolonizador. Se encarga de difundir trabajos científicos de investigación producidos por los diferentes grupos de trabajo del Centro de Investigaciones, así como trabajos de investigadores nacionales e internacionales externos. Tiene su sede en Quito, Ecuador, maneja áreas que tienen relación con la: Ciencia Política, Educación, Religión, Filosofía, Antropología, Sociología, Historia y otras afines.Presentación Roberto Simbaña Q Epistemologías feministas latinoamericanas: un cruce en el camino junto-a-otras, pero no-junta-a-todas. Cura para un continente enfermo: unidad latinoamericana y la fraternidad ibero/latina en los escritos de César Zumeta. Evolución del discurso anti-resistencia en la dictadura militar chilena. El caso de Osorno, 1973-1994. Aculturación en la narrativa histórica portuguesa: aportaciones y limitaciones de Gilberto Freyre. Ciencias sociales y terapias humanistas: acercamientos para el trabajo interdisciplinario en contextos de sufrimiento social Seguimiento de la inclusión financiera a través de análisis de Déficit presupuestario en Nagaland, India Fotoensayo: Cuerpo Perdido Reseña de José Saramago Democracia e Universidade. Normas para autore

A vivência da amamentação em “mães de primeira viagem”

L'allaitement dépasse la limite du biologique, en nous insérant aussi de contextes social et psychologique. Cette étude, réalisée à la Clinique Obstétrique de ICHC-FMUSP, a utilisé la méthodologie qualitative pour interviewer en profondeur dix « mères de premier voyage », afin de comprendre des aspects psychologiques impliqués dans l'allaitement, dans la première semaine de vie du bébé, et comme ces mères traitent avec les orientations des arrivées de l'équipe de santé. Des entrevues individuelles et de l'analyse qualitative des données ont été réalisées. L'allaitement est apparu comme une expérience ambivalente, avec des sentiments de pouvoir et complétude, de féminité, mais aussi une expérience pénible. La moitié des interviewées a reçu des orientations de l'équipe de santé, senties comme une aide et une sécurité émotionnelle. Ainsi, l'allaitement, quand il n'est pas imposé, peut favoriser la rencontre de la mère avec son bébé et le contact avec elle-même. L'équipe de santé peut agir comme une facilitation, en utilisant des connaissances techniques mais en se maintenant ouverte à l'écoute de ces femmes.A amamentação ultrapassa o limite do biológico, inserindo-se também nos âmbitos social e psicológico. Esse estudo, realizado na Clínica Obstétrica do ICHC-FMUSP, utilizou a metodologia qualitativa para entrevistar em profundidade dez "mães de primeira viagem", a fim de compreender aspectos psicológicos envolvidos na amamentação, na primeira semana de vida do bebê, e como essas mães lidam com as orientações vindas da equipe de saúde. Foram realizadas entrevistas individuais e análise qualitativa dos dados. A amamentação apareceu como uma vivência ambivalente, com sentimentos de poder e completude, feminilidade, mas também uma experiência dolorosa. Metade das entrevistadas recebeu orientações da equipe de saúde, sentidas como um apoio e segurança emocional. Assim, a amamentação, quando não é imposta, pode favorecer o encontro da mãe com seu bebê e o contato com ela mesma. A equipe de saúde pode atuar como facilitadora, utilizando conhecimentos técnicos, mas mantendo-se aberta à escuta dessas mulheres.El amamantamiento sobrepasa el límite biológico, haciendo parte también de los ámbitos social y psicológico. Este estudio, realizado en la Clínica Obstétrica del ICHC-FMUSP, utilizó la metodología cualitativa para entrevistar con detenimiento a diez "madres de primer viaje", con la finalidad de comprender aspectos psicológicos vinculados al amamantamiento en la primera semana de vida del bebé, y cómo esas madres manejan las orientaciones recibidas del equipo de salud. Fueron realizadas entrevistas individuales y análisis cualitativo de los datos. El amamantamiento apareció como una experiencia ambivalente, con sentimientos de poder y sensación de plenitud, femineidad, pero también una experiencia dolorosa. La mitad de las entrevistadas recibió orientaciones del equipo de salud, las cuales fueron evaluadas como un apoyo y seguridad emocional. Así, el amamantamiento, cuando no es impuesto, puede favorecer el encuentro de la madre con su bebé y el contacto con ella misma. El equipo de salud puede actuar como facilitador, utilizando conocimientos técnicos pero manteniéndose de oídos abiertos hacia esas mujeres.Breast-feeding exceeds the boundaries of biology, inserting itself also in the social and psychological scopes. This study, taken place in the Obstetric Clinic of the ICHC-FMUSP, used the qualitative methodology to interview in depth ten "first-time mothers", in order to understand the psychological aspects involved in breast-feeding, during the baby’s first week of life, and how these mothers dealt with the guidance given by the health team. Individual interviews and qualitative analysis of the data has been carried through. Breast-feeding appeared as an ambivalent experience, with feelings of power and completeness, femininity, but also appeared as a painful experience. Half of the interviewed mothers received guidance from the health team, and felt it as an emotional support and security. Thus, breast-feeding, when it is not imposed, may favor the meeting of mother and child, as well as the contact of the mother with herself. The health team can act as a facilitator, using technical knowledge, but always keeping themselves opened to listening to these women

Clinical outcome and risk factors for recurrence in borderline ovarian tumours

We investigated the long-term prognosis of borderline ovarian tumours and determined risk factors for recurrence. One hundred and twenty-one borderline ovarian tumours treated between 1994 and 2003 at the participating institutions in the Tohoku Gynecologic Cancer Unit were retrospectively investigated for clinical stage, histopathological subtype, surgical technique, postoperative chemotherapy, the presence or absence of recurrence, and prognosis. The median follow-up period was 57 months (1–126 months). One hundred and nine cases (90.6%) were at clinical stage I. The histopathological subtypes consisted of 91 cases of mucinous tumour (75.2%), 27 cases of serous tumour (22.3%), and three cases of endometrioid tumour. Conservative surgery was used in 53 cases (43.8%), radical surgery in 68 cases (56.2%), a staging laparotomy in 43 cases (35.5%), and postoperative adjuvant therapy in 30 cases (24.8%). Recurrence was found in eight cases, but no tumour-related deaths were reported. Although no significant difference in disease-free survival rate was seen between different clinical stages, the difference in disease-free survival rate between serous and nonserous (mucinous and endometrioid) types was significant (P<0.05). The 10-year disease-free survival rate was 89.1% for the radical surgery group and 57.4% for the conservative surgery group – this difference was significant (P<0.05). In the conservative surgery group, cystectomy and serous tumour were independent risk factors for recurrence. Although recurrence was observed, the long-term prognosis of borderline ovarian tumour was favourable, without tumour-related deaths. Considering the favourable prognosis, conservative surgery can be chosen as far as the patient has a nonserous tumour and receive adnexectomy. However, in cases of serous type and/or receiving cystectomy special care should be given as relative risk rates of recurrence elevate by 2–4-folds

Improved functionalization of oleic acid-coated iron oxide nanoparticles for biomedical applications

Superparamagnetic iron oxide nanoparticles can providemultiple benefits for biomedical applications in aqueous environments such asmagnetic separation or magnetic resonance imaging. To increase the colloidal stability and allow subsequent reactions, the introduction of hydrophilic functional groups onto the particles’ surface is essential. During this process, the original coating is exchanged by preferably covalently bonded ligands such as trialkoxysilanes. The duration of the silane exchange reaction, which commonly takes more than 24 h, is an important drawback for this approach. In this paper, we present a novel method, which introduces ultrasonication as an energy source to dramatically accelerate this process, resulting in high-quality waterdispersible nanoparticles around 10 nmin size. To prove the generic character, different functional groups were introduced on the surface including polyethylene glycol chains, carboxylic acid, amine, and thiol groups. Their colloidal stability in various aqueous buffer solutions as well as human plasma and serum was investigated to allow implementation in biomedical and sensing applications.status: publishe

Impact of renal impairment on atrial fibrillation: ESC-EHRA EORP-AF Long-Term General Registry

Background: Atrial fibrillation (AF) and renal impairment share a bidirectional relationship with important pathophysiological interactions. We evaluated the impact of renal impairment in a contemporary cohort of patients with AF. Methods: We utilised the ESC-EHRA EORP-AF Long-Term General Registry. Outcomes were analysed according to renal function by CKD-EPI equation. The primary endpoint was a composite of thromboembolism, major bleeding, acute coronary syndrome and all-cause death. Secondary endpoints were each of these separately including ischaemic stroke, haemorrhagic event, intracranial haemorrhage, cardiovascular death and hospital admission. Results: A total of 9306 patients were included. The distribution of patients with no, mild, moderate and severe renal impairment at baseline were 16.9%, 49.3%, 30% and 3.8%, respectively. AF patients with impaired renal function were older, more likely to be females, had worse cardiac imaging parameters and multiple comorbidities. Among patients with an indication for anticoagulation, prescription of these agents was reduced in those with severe renal impairment, p&nbsp;&lt;.001. Over 24&nbsp;months, impaired renal function was associated with significantly greater incidence of the primary composite outcome and all secondary outcomes. Multivariable Cox regression analysis demonstrated an inverse relationship between eGFR and the primary outcome (HR 1.07 [95% CI, 1.01–1.14] per 10&nbsp;ml/min/1.73&nbsp;m2 decrease), that was most notable in patients with eGFR &lt;30&nbsp;ml/min/1.73&nbsp;m2 (HR 2.21 [95% CI, 1.23–3.99] compared to eGFR ≥90&nbsp;ml/min/1.73&nbsp;m2). Conclusion: A significant proportion of patients with AF suffer from concomitant renal impairment which impacts their overall management. Furthermore, renal impairment is an independent predictor of major adverse events including thromboembolism, major bleeding, acute coronary syndrome and all-cause death in patients with AF

Clinical complexity and impact of the ABC (Atrial fibrillation Better Care) pathway in patients with atrial fibrillation: a report from the ESC-EHRA EURObservational Research Programme in AF General Long-Term Registry

Background: Clinical complexity is increasingly prevalent among patients with atrial fibrillation (AF). The ‘Atrial fibrillation Better Care’ (ABC) pathway approach has been proposed to streamline a more holistic and integrated approach to AF care; however, there are limited data on its usefulness among clinically complex patients. We aim to determine the impact of ABC pathway in a contemporary cohort of clinically complex AF patients. Methods: From the ESC-EHRA EORP-AF General Long-Term Registry, we analysed clinically complex AF patients, defined as the presence of frailty, multimorbidity and/or polypharmacy. A K-medoids cluster analysis was performed to identify different groups of clinical complexity. The impact of an ABC-adherent approach on major outcomes was analysed through Cox-regression analyses and delay of event (DoE) analyses. Results: Among 9966 AF patients included, 8289 (83.1%) were clinically complex. Adherence to the ABC pathway in the clinically complex group reduced the risk of all-cause death (adjusted HR [aHR]: 0.72, 95%CI 0.58–0.91), major adverse cardiovascular events (MACEs; aHR: 0.68, 95%CI 0.52–0.87) and composite outcome (aHR: 0.70, 95%CI: 0.58–0.85). Adherence to the ABC pathway was associated with a significant reduction in the risk of death (aHR: 0.74, 95%CI 0.56–0.98) and composite outcome (aHR: 0.76, 95%CI 0.60–0.96) also in the high-complexity cluster; similar trends were observed for MACEs. In DoE analyses, an ABC-adherent approach resulted in significant gains in event-free survival for all the outcomes investigated in clinically complex patients. Based on absolute risk reduction at 1 year of follow-up, the number needed to treat for ABC pathway adherence was 24 for all-cause death, 31 for MACEs and 20 for the composite outcome. Conclusions: An ABC-adherent approach reduces the risk of major outcomes in clinically complex AF patients. Ensuring adherence to the ABC pathway is essential to improve clinical outcomes among clinically complex AF patients

Antiinflammatory Therapy with Canakinumab for Atherosclerotic Disease

Background: Experimental and clinical data suggest that reducing inflammation without affecting lipid levels may reduce the risk of cardiovascular disease. Yet, the inflammatory hypothesis of atherothrombosis has remained unproved. Methods: We conducted a randomized, double-blind trial of canakinumab, a therapeutic monoclonal antibody targeting interleukin-1β, involving 10,061 patients with previous myocardial infarction and a high-sensitivity C-reactive protein level of 2 mg or more per liter. The trial compared three doses of canakinumab (50 mg, 150 mg, and 300 mg, administered subcutaneously every 3 months) with placebo. The primary efficacy end point was nonfatal myocardial infarction, nonfatal stroke, or cardiovascular death. RESULTS: At 48 months, the median reduction from baseline in the high-sensitivity C-reactive protein level was 26 percentage points greater in the group that received the 50-mg dose of canakinumab, 37 percentage points greater in the 150-mg group, and 41 percentage points greater in the 300-mg group than in the placebo group. Canakinumab did not reduce lipid levels from baseline. At a median follow-up of 3.7 years, the incidence rate for the primary end point was 4.50 events per 100 person-years in the placebo group, 4.11 events per 100 person-years in the 50-mg group, 3.86 events per 100 person-years in the 150-mg group, and 3.90 events per 100 person-years in the 300-mg group. The hazard ratios as compared with placebo were as follows: in the 50-mg group, 0.93 (95% confidence interval [CI], 0.80 to 1.07; P = 0.30); in the 150-mg group, 0.85 (95% CI, 0.74 to 0.98; P = 0.021); and in the 300-mg group, 0.86 (95% CI, 0.75 to 0.99; P = 0.031). The 150-mg dose, but not the other doses, met the prespecified multiplicity-adjusted threshold for statistical significance for the primary end point and the secondary end point that additionally included hospitalization for unstable angina that led to urgent revascularization (hazard ratio vs. placebo, 0.83; 95% CI, 0.73 to 0.95; P = 0.005). Canakinumab was associated with a higher incidence of fatal infection than was placebo. There was no significant difference in all-cause mortality (hazard ratio for all canakinumab doses vs. placebo, 0.94; 95% CI, 0.83 to 1.06; P = 0.31). Conclusions: Antiinflammatory therapy targeting the interleukin-1β innate immunity pathway with canakinumab at a dose of 150 mg every 3 months led to a significantly lower rate of recurrent cardiovascular events than placebo, independent of lipid-level lowering. (Funded by Novartis; CANTOS ClinicalTrials.gov number, NCT01327846.