Towards Greater Safety in Acupuncture Practice - a Systems Approach

2004 ◽  
Vol 22 (1) ◽  
pp. 34-39 ◽  
Author(s):  
Adrian White
Keyword(s):  
Adverse Events ◽  
Systems Approach ◽  
Traditional Approach ◽  
Check List ◽  
Alternative Culture ◽  
The Individual

Everyone wants safe medicine. The traditional approach to adverse events has developed within a culture of blaming the individual practitioner. Such an approach is likely to be damaging to individuals and possibly counterproductive by creating an atmosphere of defensiveness and denial. Industries such as airlines have developed an alternative culture using a systems approach. This approach concentrates on assessing and improving the systems of working rather than blaming an individual's performance. Frameworks have been developed for applying this approach to investigating and avoiding medical accidents. These form the basis of a check-list for acupuncture practice that is presented here, and may be useful for individuals and organisations who are concerned to reduce the risk of adverse events.

Is it Worth CANVASing for CREDENCE? A Benefit-risk Analysis

2020 ◽  
Vol 16 (5) ◽  
pp. 509-514
Author(s):  
Binayak Sinha ◽  
Samit Ghosal
Keyword(s):  
Adverse Events ◽  
Fungal Infections ◽  
Absolute Risk ◽  
Pooled Analysis ◽  
Major Adverse Cardiovascular Events ◽  
Number Needed To Treat ◽  
Pooled Data ◽  
The Individual ◽  
Fracture Risks ◽  
Number Needed To Harm

Background and Aims: A number of significant positive and negative signals emerged from the CANVAS Program and CREDENCE trial with the use of canagliflozin. These signals are confusing. A Likelihood of being Helped of Harmed (LHH) analysis was conducted to determine the risk, benefit ratio associated with canagliflozin use and address the signals as a continuum. Materials &Methods: LHH was calculated from the number needed to treat (NNT) and number needed to harm (NNH) available from the absolute risk reductions reported with the outcomes of interest, in these two trials. Results: In the CANVAS Program, LHH for major adverse cardiovascular events (MACE) points at a significant benefit with canagliflozin use in comparison to amputation (1.65), fractures (1.65) and euglycaemic diabetic ketoacidosis (euDKA) (16.67) risks. Only genital fungal infections were significant more in both sexes (0.21-M and 0.1-F) when LHH was matched against the positive outcomes. In contrast, the hHF benefits were outweighed by amputation (0.95) and fracture risks (0.95). : In CREDENCE trial, the LHH for Primary composite, Renal composite and MACE, all supported the benefits in comparison to any adverse events encountered in the trial. : The LHH from pooled data (CANVAS Program and CREDENCE trial) was in favour of all the benefits (hHF and renal composites) except for MACE matched against amputation (0.66). Conclusion: The outcome benefits were in favour of canagliflozin in comparison to all reported adverse events, when hHF and renal composite were under consideration, in both the individual and pooled LHH analysis. However, the MACE benefits were overwhelmed by amputation risk in the pooled analysis.

scholarly journals Feasibility of onchocerciasis elimination using a “test-and-not-treat” strategy in Loa loa co-endemic areas

2020 ◽  
Author(s):  
David J Blok ◽  
Joseph Kamgno ◽  
Sebastien D Pion ◽  
Hugues C Nana-Djeunga ◽  
Yannick Niamsi-Emalio ◽  
...  
Keyword(s):  
Adverse Events ◽  
Drug Administration ◽  
Mass Drug Administration ◽  
Treatment Duration ◽  
Loa Loa ◽  
Serious Adverse Events ◽  
Endemic Areas ◽  
The Individual ◽  
The Impact ◽  
Main Strategy

Abstract Background Mass drug administration (MDA) with ivermectin is the main strategy for onchocerciasis elimination. Ivermectin is generally safe but associated with serious adverse events in individuals with high Loa loa microfilarial densities (MFD). Therefore, ivermectin MDA is not recommended in areas where onchocerciasis is hypo-endemic and L. loa is co-endemic. To eliminate onchocerciasis in those areas, a test-and-not-treat (TaNT) strategy has been proposed. We investigated whether onchocerciasis elimination can be achieved using TaNT and the required duration. Methods We used the individual-based model ONCHOSIM to predict the impact of TaNT on onchocerciasis microfilarial (mf) prevalence. We simulated pre-control mf prevalence levels from 2-40%. The impact of TaNT was simulated under varying levels of participation, systematic non-participation and exclusion from ivermectin due to high L. loa MFD. For each scenario, we assessed the time to elimination, defined as bringing onchocerciasis mf prevalence below 1.4%. Results In areas with 30-40% pre-control mf prevalence, the model predicted that it would take between 14 and 16 years to bring the mf prevalence below 1.4% using conventional MDA, assuming 65% participation. TaNT would increase the time to elimination by up to 1.5 years, depending on the level of systematic non-participation and the exclusion rate. At lower exclusion rates (≤2.5%), the delay would be less than six months. Conclusions Our model predicts that onchocerciasis can be eliminated using TaNT in L. loa co-endemic areas. The required treatment duration using TaNT would be only slightly longer than in areas with conventional MDA, provided that participation is good.

Comparison of efficacy and tolerability of oral desloratadine, rupatadine and ketotifen in seasonal allergic rhinitis

2021 ◽  
Vol 4 (3) ◽  
pp. 106-114
Author(s):  
Syed Khadeer ◽  
B Jagannath
Keyword(s):  
Allergic Rhinitis ◽  
Adverse Events ◽  
Nasal Congestion ◽  
Primary Outcome Measure ◽  
Nasal Symptom ◽  
Secondary Outcome ◽  
Open Label ◽  
Non Allergic Rhinitis ◽  
The Individual ◽  
Change In Mean

Rhinitis is inflammation of nasal mucosa which characteristically presents as running nose, blocked nose, itching on nose or sneezing. Allergic rhinitis is more common than non-allergic rhinitis. Anti-histamines are the mainstay of SAR treatment. Desloratadine, rupatadine and ketotifen are the commonly prescribed anti histamines in our region. In this study, we have compared efficacy and tolerability of desloratadine, rupatadine and ketotifen in SAR. This was a prospective, randomized, three arm, open label comparative study of desloratadine, rupatadine and ketotifen in SAR, conducted at Department of ENT, Kempegowda Institute of Medical Sciences, Bangalore; between January 2014 and December 2014. Patients’ severity of SAR symptoms were assessed by TNSS, QoL was measured using Medical Outcomes Study questionnaire (SF-12). SF-12 was administered at the start of study and then at the end of study. Adverse effects were monitored during clinical examination at each visit. Study subjects were systemically randomized into three groups – desloratadine (DES), rupatadine (RUP) and ketotifen (KET). Based on the assigned group; desloratadine was given orally in dose of 10mg OD, rupatadine orally 10 mg OD and ketotifen orally 1mg BD. All medications were given for 4 weeks. Follow up was done for all patients every week during treatment period of 4 weeks. The primary outcome measure was change in mean TNSS from baseline; secondary outcome measures were changes in the individual nasal symptom scores, change in the quality of life and tolerability to the study medications. Total 150 patients were recruited for this study, divided into 3 groups. DES and RUP were equally effective but significantly better than KET in improving rhinorrhea, nasal congestion, TNSS and AEC. (p=0.05). All the drugs were equally effective with no statistically significant intergroup difference in improving sneezing, nasal itching and QoL. RUP appeared to have better tolerability as the total number of adverse events were marginally less. DES and RUP are comparatively more effective and faster acting than KET. All the study medications were well tolerated with few mild, self-limiting, transient adverse events requiring no intervention.

scholarly journals Psychological factors underpinning vaccine willingness in Israel, Japan and Hungary

2021 ◽  
Author(s):  
Robin Goodwin ◽  
Menachem Ben-Ezra ◽  
Masahito Takahashi ◽  
Lan Anh Nguyen Luu ◽  
Krisztina Borsfay ◽  
...  
Keyword(s):  
Latent Class ◽  
Systems Approach ◽  
Vaccine Hesitancy ◽  
Effective Vaccine ◽  
Anticipated Regret ◽  
Nationally Representative ◽  
The Government ◽  
Using Data ◽  
The Individual ◽  
Representative Samples

The rapid international spread of the SARS-CoV-2 virus 19 led to unprecedented attempts to develop and administer an effective vaccine. However, there is evidence of considerable vaccine hesitancy in some countries and sub-populations. We investigated willingness to vaccinate in three nations with historically different levels of vaccine willingness and attitudes to the COVID-19 vaccine rollout: Israel, Japan and Hungary. Employing an ecological-systems approach we analysed associations between demographic factors and health status, individual cognitions, normative pressures, trust in government, belief in COVID-19 myths and willingness to be vaccinated, using data from three nationally representative samples (Israel, N=1011 (Jan 2021); Japan, N= 997 (Feb 2021); Hungary, N=1131 (Apr 2021)). In Israel 74% indicated a willingness to vaccinate, but only 51% in Japan and 31% in Hungary. Results from multigroup regression analyses indicated greater vaccine willingness amongst those who perceived benefits to vaccination, anticipated regret if not vaccinated and trusted the government. Multi-group latent class analysis of ten COVID-19 (mis)beliefs identified three classes of myths, with concerns about the alteration of DNA (Israel), allergies (Hungary) and catching COVID-19 from the vaccine (Japan) specific to vaccine willingness for each culture. Rather than focusing primarily on disease threats, intervention campaigns should focus on increasing trust and addressing culturally specific myths while emphasising the individual and social group benefits of vaccination.

Internal-External Control Orientation, Self-Description, and Bridge Playing Expertise

1972 ◽  
Vol 31 (3) ◽  
pp. 683-689 ◽  
Author(s):  
Marvin Reznikoff ◽  
Carolyn Bridges ◽  
Tannah Hirsch
Keyword(s):  
Risk Taking ◽  
Self Concept ◽  
External Control ◽  
Check List ◽  
Life Orientation ◽  
Adjective Check List ◽  
Control Orientation ◽  
The Individual ◽  
The Relationship

This study investigated the relationship between expertise in bridge playing, the degree to which the individual believes that luck or fate determine his success and self-description. Ss, 46 males and 24 females participating in a national bridge tournament, were administered Rotter's I-E scale and the Adjective Check List (ACL). Correlations of I-E scores and degree of expertness showed that the more expert males were significantly less external, indicating that they perceive bridge as much more a game of skill rather than chance. No significant correlation was found for the group of female bridge players, perhaps due to the smaller number of Ss and the greater degree of homogeneity in the group. On the ACL male experts perceived themselves as more controlled and optimistic toward life and their ability to cope with it. Female experts seemed to regard themselves as more assertive and self-confident than their less expert confreres and as having a more risk-taking life orientation. Correlations of the ACL and I-E scores indicated in general that the more internally oriented person had a more positive self-concept.

Ego Involvement in the Systems Design Process

1970 ◽  
Vol 12 (1) ◽  
pp. 7-12 ◽  
Author(s):  
John H. Burgess
Keyword(s):  
Design Process ◽  
Interpersonal Relations ◽  
Systems Approach ◽  
Systems Design ◽  
Corporate Management ◽  
Total System ◽  
Design Team ◽  
System Perspective ◽  
Professional Goals ◽  
The Individual

Psychological interactions among members of a systems design team are frequently of major importance in the design process. Problems arise from specialized design interests as well as failure in systems discipline. Such problems can be resolved only by understanding the nature of the individual and his involvement in interpersonal design conflicts. Several areas may be considered for improving interpersonal relations in the systems design effort. Through increasing emphasis on significance of systems design, greater personal and professional involvement in the systems approach may be possible. Attention is required at the corporate-management organization level to orient individual engineering professional goals in terms of total system perspective. Indoctrination and discipline in systems philosophy and practices also require increased emphasis. Comprehensive design-team training might be considered as a means for improving the systems design process. Further study is suggested.

Systems theory and cascades in developmental psychopathology

2010 ◽  
Vol 22 (3) ◽  
pp. 497-506 ◽  
Author(s):  
Martha J. Cox ◽  
Roger Mills-Koonce ◽  
Cathi Propper ◽  
Jean-Louis Gariépy
Keyword(s):  
Psychosocial Adjustment ◽  
Developmental Psychopathology ◽  
Systems Approach ◽  
Developmental Process ◽  
Developmental Sequence ◽  
Functional Relationships ◽  
Antecedent Conditions ◽  
Social Ecological ◽  
General Adaptation ◽  
The Individual

AbstractIn the wake of prominent theoreticians in developmental science, whose contributions we review in this article, many developmental psychologists came to endorse a systems approach to understanding how the individual, as it develops, establishes functional relationships to social ecological contexts that from birth to school entry rapidly increase in complexity. The concept of developmental cascade has been introduced in this context to describe lawful processes by which antecedent conditions may be related with varying probabilities to specified outcomes. These are understood as processes by which function at one level or in one domain of behavior affect the organization of competency in later developing domains of general adaptation. Here we propose a developmental sequence by which the developing child acquires regulative capacities that are key to adjustment to a society that demands considerable control of emotional and cognitive functions early in life. We report empirical evidence showing that the acquisition of regulative capacities may be understood as a cascade of shifts in control parameters induced by the progressive integration of biological, transactional, and socioaffective systems over development. We conclude by suggesting how the developmental process may be accessed for effective intervention in populations deemed “at risk” for later problems of psychosocial adjustment.

Improving Traffic Safety: A New Systems Approach

2003 ◽  
Vol 1830 (1) ◽  
pp. 1-9 ◽  
Author(s):  
Sany R. Zein ◽  
Francis P. D. Navin
Keyword(s):  
Traffic Safety ◽  
Systems Approach ◽  
Graphical Representation ◽  
Building Blocks ◽  
Road User ◽  
Crash Risk ◽  
Safety Issues ◽  
The Road ◽  
Starting Point ◽  
The Individual

A guiding principle of modern traffic safety professionals attempting to reduce the risks associated with traffic is to holistically address traffic safety as a multidisciplinary partnership issue. The systems approach focuses on the relationships and dependencies between the various elements of the traffic system. The C3-R3 Systems Approach to traffic safety is introduced; the building blocks of the C3-R3 approach are three entities (the road user, the vehicle, and the road environment), three pre-crash timeline phases (creation, cultivation, and conduct), and three postcrash timeline phases (response, recovery, and reflection). This approach is proposed as a framework for multidisciplinary traffic safety professionals to research traffic safety issues in an integrated, systematic manner. The C3-R3 approach provides an enhanced systematic framework that more clearly identifies the stages at which traffic safety professionals can intervene to promote road safety. The graphical representation of the C3-R3 system, as presented, emphasizes the convergence of the entities as the timeline proceeds toward a crash event and their subsequent redivergence in the postcrash timeline. Every combination of entity and timeline phase represents a cell in the C3-R3 system; the contents of each cell represent the individual elements that traffic safety professionals need to focus on and understand in order to reduce the crash risk. The C3-R3 Systems Approach represents a starting point to encapsulate the systems approach concepts in traffic safety. It is expected that as more professionals adopt systems thinking, the C3-R3 approach will continue to evolve, expand, and improve.

scholarly journals Adverse Events ‒ One of the Most Important Health Care Quality Indicators: A Case Study

2017 ◽  
Vol 13 (12) ◽  
pp. 288 ◽  
Author(s):  
Vinsas Janusonis
Keyword(s):  
Health Care ◽  
High Risk ◽  
Adverse Events ◽  
Care Quality ◽  
Individual Characteristics ◽  
Team Work ◽  
Registration System ◽  
Causal Factors ◽  
Medium Risk ◽  
The Individual

The aim of study: to evaluate inpatients, experienced adverse events (AE) in Klaipeda university hospital (KUH) contingent, healthcare profiles, location and causal factors, the degree of risk, possibility to avoide its, and to compare assessment of doctors and experts, and estimate their changes in different analyzed periods. Material and methods. The study carried out by analyzing the AE reporting forms in KUH at 2000-2014time period. Exploring and comparing 1690 patients, experienced AE data by age, gender, health care profile, the reasons. Results. The survey showed that AE was 0.3 % of hospitalized patients, most of them (54.9 %) ‒ associated with surgery. The largest group of AE ‒ repeated operations (44.8 %), related to childbirth AE (26.2 %) and related to infection ‒ (13.1 %). Almost half (43.2 %) AE were medium risk, one-third (33.8 %) ‒ minimal and one-fifth (21.6 %) ‒ high risk. Doctors (nurses) and experts opinions on the major causative factors of AE ‒ the individual characteristics of the patients (88.5 % and 90.3 %) basically was similar. However, due to the individual characteristics of doctors (nurses) ‒ experts often (14.2 %) could see them as causal factor than doctors or nurses (9.8 %). Due possibility of AE avoidance ‒ doctors (nurses) and experts opinion that almost half of them (44.7 % and 48.8 %) were avoidable was the same, but stood for full possibility of avoidance (11.2 % doctors (nurses) and 16.9 % experts) and complete inevitability (44.1 % doctor (nurses) and 34.3 % experts) of AE. Conclusions: Long-term operating adverse events reporting and registration system and analysis showed that adverse events in KUH is much less than in comparable large multiprofile hospitals of other countries. The structure of AE have advantages with structure in other countries ‒ the most adverse events related to surgery, infections, nursing, but there are significant differences ‒ reported little adverse events related to drugs, diagnostics, and a small number of falls compared with many births related AE. The majority ‒ almost four fifths of the AE was minimal or medium risk, one-fifths ‒ high-risk. The AE related with deaths were few. The main causal factors of AE ‒ individual characteristics of the patients and the doctors, and team work failure. A twothirds of AE could be fully or partially prevented.

scholarly journals Suspected Cardiovascular Side Effects of two Covid-19 Vaccines

2021 ◽  
Author(s):  
Karla Johanna Lehmann
Keyword(s):  
Side Effects ◽  
Adverse Events ◽  
European Medicines Agency ◽  
Vein Thrombosis ◽  
Cardiovascular Side Effects ◽  
Life Threatening ◽  
The Individual ◽  
A Current ◽  
Circulatory Disturbances ◽  
Cardiovascular Reactions

Fatalities or cardiovascular side effects of vaccines were rather uncommon in the past. So far, numerous reports of side effects and deaths associated with Covid-19 vaccination have been accepted behind the background of the pandemic situation. Cardiac and heart circulatory disturbances resp. cardiovascular side effects associated with the application of Covid-19 vaccines have not been recognized up to now with the exception of thrombotic/embolic side effects and cases of myocarditis. But the mechanism of action suggests that downregulation of ACE2 by non-neutralised spike proteins may have cardiovascular effects.The objective of this analysis was to determine the total number of reported adverse events and fatalities and to record suspected cardiovascular adverse events up to the cut-off date in European countries. Therefore, a current review/analysis of spontaneously reported fatalities as well as of adverse events after application of Covid-19 vaccines has been performed. Data were retrieved from the EudraVigilance web reports of the European Medicines Agency (EMA), partly also from the safety reports of the German PEI. Covid-19 vaccine-associated suspected side effects and related deaths are alarming. Surprisingly, numerous cardiovascular reactions were reported, many of which were life-threatening. Cardiac and heart circulatory caused fatalities alone accounted for about 33% of all ComirnatyR vaccine-related deaths. The second most important side effects were vascular thrombotic/embolic side effects, often also associated with serious consequences. Based on their quality and quantity, these side effects seem to be characteristic for spike-producing vaccines and do not appear to be substance-specific. Further investigations are needed to clarify the approximately 3.5 times more frequent cases of sinus vein thrombosis and the some different frequent cases of thrombotic/embolic events after VaxzevriaR. The hypothesis could be confirmed. Because of their importance and their sometimes life-threatening consequences, cardiovascular side effects need to be better communicated.Limitations of the investigation result from the individual reporting and recording procedure, the lack of detailed individual information and the lack of an appropriate comparison population.

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