scholarly journals N-of-1 Trials: Evidence-Based Clinical Care or Medical Research that Requires IRB Approval? A Practical Flowchart Based on an Ethical Framework

Healthcare ◽  
2020 ◽  
Vol 8 (1) ◽  
pp. 49 ◽  
Author(s):  
Bas C. Stunnenberg ◽  
Jaap Deinum ◽  
Tom Nijenhuis ◽  
Frans Huysmans ◽  
Gert Jan van der Wilt ◽  
...  
Keyword(s):  
Medical Research ◽  
Treatment Effectiveness ◽  
Clinical Care ◽  
Ethical Framework ◽  
Evidence Based ◽  
Individual Patient Level ◽  
The Past ◽  
Institutional Review ◽  
Recent Developments ◽  
The Individual

N-of-1 trials can provide high-class evidence on drug treatment effectiveness at the individual patient level and have been given renewed interest over the past decade due to improvements of the initial single patient design. Despite these recent developments, there is still no consensus under what circumstances N-of-1 trials should be considered as part of evidence-based clinical care and when they represent medical research with need for institutional review board (IRB) approval. This lack of consensus forms an obstacle for a more widespread implementation of N-of-1 trials. Based upon the existing literature, we as a group of researchers involved in N-of-1 trials and members of the IRB of a tertiary academic referral center, designed a practical flowchart based on an ethical framework to help make this distinction. The ethical framework together with a practical flowchart are presented in this communication.

Application of research evidence in clinical practice

2020 ◽  
pp. 73-79
Author(s):  
Andrea Cipriani ◽  
Stefan Leucht ◽  
John R. Geddes
Keyword(s):  
Health Care ◽  
Evidence Based Medicine ◽  
Research Evidence ◽  
Clinical Decision Making ◽  
Evidence Based ◽  
Individual Patient Level ◽  
Patient Values ◽  
The Individual ◽  
Theory Of Evidence ◽  
Based Medicine

The aim of evidence-based medicine is to integrate current best evidence from research with clinical expertise and patient values. However, it is known that one of the major challenges for clinicians is to move from the theory of evidence-based medicine to the practice of it. Evidence-based practice requires new skills of the clinician, including framing a clear question based on a clinical problem, searching and critically appraising the relevant literature, and applying the findings to routine clinical decision-making, ideally at the individual patient level. Scientific evidence is increasingly accessible through journals and information services that should combine high-quality evidence with information technology. However, the process is not straightforward, as there are several barriers to the successful application of research evidence to health care. This chapter discusses both the prospects for harnessing evidence to improve health care and the problems that clinicians will need to overcome to practise ‘evidence-based-ly’.

scholarly journals Response to Miles and Mezzich

2014 ◽  
Vol 2 (1) ◽  
pp. 83
Author(s):  
Andrew Turner ◽  
John Blakey ◽  
Roger Kerry
Keyword(s):  
Evidence Based Medicine ◽  
Evidence Based ◽  
Patient Centred Care ◽  
The Past ◽  
Comprehensive Account ◽  
Practice Models ◽  
Recent Developments ◽  
Based Medicine

Miles and Mezzich offer a welcome and comprehensive account of historical recent developments in healthcare and the role of its practice models. They identify a ‘crisis’ in medicine, which seems to have occurred in part because the science of medicine has been over-emphasised and the importance of compassion and care de-emphasised.  As they point out, this crisis has been perceived to have evolved over the past one hundred years. Evidence Based Medicine (EBM) is suggested to be inadequate to solve the crisis and it may be the case that EBM, in fact, has precipitated it because it ignores patients qua persons. It is also suggested that Patient Centred Care (PCC) seeks to address the imbalance, but that this is inadequate, too. Between these existing views it is claimed that Person Centred Medicine (PCM) solves the crisis by giving persons and evidence their proper roles and relative importances

Reflecting on Evidence Based Medicine, Person Centered Medicine and Small Area Variations: how contemporary frameworks for medicine address (or not) the needs of the individual patient

2018 ◽  
Vol 6 (3) ◽  
pp. 454 ◽  
Author(s):  
Mathew Mercuri ◽  
Amiram Gafni
Keyword(s):  
Evidence Based Medicine ◽  
Small Area ◽  
Population Level ◽  
Evidence Based ◽  
Patient Needs ◽  
Correct Treatment ◽  
The Past ◽  
Unwarranted Variation ◽  
The Individual ◽  
Based Medicine

Over the past few decades the medical literature has given much attention to three movements: Evidence Based Medicine (EBM), Person Centered Medicine (PCM) and Small Area Variations (SAV).  Each claims to provide a framework for improving the care of individual patients. This paper examines why attention to the individual patient is important in the provision and delivery of healthcare and how each of these movements seek to address individual patient needs. We suggest that EBM, PCM and SAV all suffer from a number of issues that render their use as a framework to address individual patient needs inadequate. In the case of EBM, it is a reliance on (at best) population level study (e.g., clinical trials) that do not necessarily translate to individual patients. PCM appears to recognize the information requirements to care for individual patients, but is unclear on how that information can be obtained. Likewise, SAV is limited in that its methods do not discriminate between warranted and unwarranted variation and its reliance on the EBM approach in assessing what is the correct treatment for patients. This paper concludes that EBM, PCM and SAV are not solving the problem of how to provide care for individual patients. While we do not offer a solution here, it is only when we admit we do not have the answers to this problem that we can begin to look for a solution.

scholarly journals Informing the Gestalt: An Ethical Framework for Allocating Scarce Federal Public Health and Medical Resources to States During Disasters

2014 ◽  
Vol 8 (1) ◽  
pp. 79-88 ◽  
Author(s):  
Ann R. Knebel ◽  
Virginia A. Sharpe ◽  
Marion Danis ◽  
Lauren M. Toomey ◽  
Deborah K. Knickerbocker
Keyword(s):  
Public Health ◽  
Decision Making ◽  
Logic Model ◽  
Ethical Framework ◽  
Decision Making Process ◽  
State Governments ◽  
Medical Resources ◽  
Individual Patient Level ◽  
Federal Leaders ◽  
The Individual

AbstractDuring catastrophic disasters, government leaders must decide how to efficiently and effectively allocate scarce public health and medical resources. The literature about triage decision making at the individual patient level is substantial, and the National Response Framework provides guidance about the distribution of responsibilities between federal and state governments. However, little has been written about the decision-making process of federal leaders in disaster situations when resources are not sufficient to meet the needs of several states simultaneously. We offer an ethical framework and logic model for decision making in such circumstances. We adapted medical triage and the federalism principle to the decision-making process for allocating scarce federal public health and medical resources. We believe that the logic model provides a values-based framework that can inform the gestalt during the iterative decision process used by federal leaders as they allocate scarce resources to states during catastrophic disasters. (Disaster Med Public Health Preparedness. 2014;0:1–10)

scholarly journals Some Recent Developments of Microstrip Antenna

2012 ◽  
Vol 2012 ◽  
pp. 1-10 ◽  
Author(s):  
Yong Liu ◽  
Li-Ming Si ◽  
Meng Wei ◽  
Pixian Yan ◽  
Pengfei Yang ◽  
...  
Keyword(s):  
Microstrip Antenna ◽  
High Gain ◽  
Planar Antennas ◽  
Wave Regime ◽  
High Frequencies ◽  
The Past ◽  
Recent Developments ◽  
Advanced Machining ◽  
Points Of View ◽  
The Individual

Although the microstrip antenna has been extensively studied in the past few decades as one of the standard planar antennas, it still has a huge potential for further developments. The paper suggests three areas for further research based on our previous works on microstrip antenna elements and arrays. One is exploring the variety of microstrip antenna topologies to meet the desired requirement such as ultrawide band (UWB), high gain, miniaturization, circular polarization, multipolarized, and so on. Another is to apply microstrip antenna to form composite antenna which is more potent than the individual antenna. The last is growing towards highly integration of antenna/array and feeding network or operating at relatively high frequencies, like sub-millimeter wave or terahertz (THz) wave regime, by using the advanced machining techniques. To support our points of view, some examples of antennas developed in our group are presented and discussed.

Staying True to Our PBS Roots in a Changing World

2017 ◽  
Vol 20 (1) ◽  
pp. 15-18 ◽  
Author(s):  
Don Kincaid
Keyword(s):  
Problem Behaviors ◽  
Well Being ◽  
Evidence Based ◽  
Behavior Support ◽  
The Past ◽  
Service Programs ◽  
Critical Components ◽  
Definition Of ◽  
The Individual ◽  
Social Service Programs

The field of Positive Behavior Support (PBS) has grown and changed significantly in the past 25 years and should be expected to continue that trend for the next 25 years. These changes cannot always be predicted, but they can be managed by considering some current changes to the definition of PBS (Kincaid et al., 2016). This paper discussed how PBS can remain close to its empirical and philosophical roots by attending to five key features that include (a) research-based assessment, intervention, and data-based decision making; (b) building social and other functional competencies, creating supportive contexts, and preventing the occurrence of problem behaviors; (c) being respectful of a person’s (or group’s) dignity and overall well-being; (d) being open to data from a variety of fields and evidence-based procedures; and (e) application within a multi-tiered framework at the level of the individual and the level of the larger systems (e.g., families, classrooms, schools, social service programs, and facilities). The paper also considers some strategies for keeping the critical components of PBS in the minds of researchers and readers.

The Need to Refocus on the Group as the Site of Radicalization

2019 ◽  
Vol 15 (2) ◽  
pp. 327-352 ◽  
Author(s):  
Laura G. E. Smith ◽  
Leda Blackwood ◽  
Emma F. Thomas
Keyword(s):  
Social Interactions ◽  
Group Processes ◽  
Social Psychological ◽  
Socialization Process ◽  
The Past ◽  
The Social ◽  
Violent Extremism ◽  
Recent Developments ◽  
The Individual

The past decade has witnessed burgeoning efforts among governments to prevent people from developing a commitment to violent extremism (conceived of as a process of radicalization). These interventions acknowledge the importance of group processes yet in practice primarily focus on the idiosyncratic personal vulnerabilities that lead people to engage in violence. This conceptualization is problematic because it disconnects the individual from the group and fails to adequately address the role of group processes in radicalization. To address this shortcoming, we propose a genuinely social psychological account of radicalization as an alternative. We draw on recent developments in theory and research in psychological science to suggest that radicalization is fundamentally a group socialization process through which people develop identification with a set of norms—that may be violent or nonviolent—through situated social interactions that leverage their shared perceptions and experiences. Our alternative provides a way of understanding shifts toward violent extremism that are caused by both the content (focal topics) and process of social interactions. This means that people’s radicalization to violence is inseparable from the social context in which their social interactions take place.

Ethical Issues in Prehospital Research

1993 ◽  
Vol 8 (S1) ◽  
pp. S11-S14 ◽  
Author(s):  
Eric A. Davis ◽  
Ronald F. Maio
Keyword(s):  
World War Ii ◽  
Medical Research ◽  
Ethical Issues ◽  
Human Subjects ◽  
Medical Science ◽  
Institutional Review Boards ◽  
Research Subjects ◽  
Institutional Review ◽  
Protection Of Human Subjects ◽  
The Individual

The atrocities committed by Nazi physicians and scientists, in the name of furthering medical science, is an appalling page of the history of medical research. In the wake of World War II, the scientific community strived to develop regulations to guard against future abuses in medical research. However, a particularly sobering thought is that the atrocities in Germany were being carried out in a country that had specific regulations for protecting human research subjects: Nazi Germany was the only European country to have such regulations. A more in-depth look at these regulations reveals institutional or department heads were held accountable, but not the individual researcher. The lesson from this analysis is clear: individual investigators must bear the responsibility of conducting ethical research. Governmental regulations and Institutional Review Boards never can replace investigators who are advocates for the protection of human subjects.The purpose of this paper is to address issues broadly regarding ethics and prehospital research, with a focus on the topic of informed consent.

scholarly journals Personalizing psychological care for chronic cancer-related fatigue: A case study on symptom dynamics.

2021 ◽  
Vol 7 (1) ◽  
pp. 1-13
Author(s):  
Melanie P. J. Schellekens ◽  
Tom I. Bootsma ◽  
Rosalie A. M. Van Woezik ◽  
Marije L. Van der Lee
Keyword(s):  
Mental Healthcare ◽  
Network Models ◽  
Evidence Based ◽  
Psychological Care ◽  
The Past ◽  
Cancer Related Fatigue ◽  
The Moment ◽  
The Individual ◽  
Insight Into

Approximately 25% of cancer patients suffer from chronic cancer-related fatigue (CCRF), which is a complex, multifactorial condition. While there are evidence-based interventions, it remains unclear what treatment works best for the individual patient. Psychological network models can offer a schematic representation of interrelations among fatigue and protective and perpetuating factors for the individual patient. We explored whether feedback based on these individual fatigue networks can help personalize psychological care for CCRF. A 34-year old woman with CCRF was referred to our mental healthcare institute for psycho-oncology. During the waitlist period, she filled out an experience sampling app for 101 days, including five daily assessments of fatigue, pain, mood, activity and fatigue coping. The interplay between items was visualized in network graphs at the moment-level and day-level, which were discussed with the patient. For example, acceptance of fatigue in the past three hours was associated with less hopelessness and less fatigue in the following moment. At the day-level, acceptance was also being associated with less fatigue, less hopelessness, a better mood, and more motivation to do things. The patient recognized these patterns and explained how unexpected waves of fatigue can make her feel hopeless. This started a dialogue on how cultivating acceptance could potentially help her handle the fatigue. The patient would discuss this with her therapist. Feedback based on individual fatigue networks can provide direct insight into how one copes with CCRF and subsequently offer directions for treatment. Further research is needed in order to implement this in clinical practice.

scholarly journals TAREKAT DAN INTELEKTUALITAS: Studi Keterlibatan Kalangan Intelektual dalam Tarekat Tijaniyah di Kota Banjarmasin

2016 ◽  
Vol 15 (1) ◽  
pp. 1
Author(s):  
Saifuddin . ◽  
Wardani . ◽  
Dzikri Nirwana
Keyword(s):  
The Other ◽  
Rural Culture ◽  
The Past ◽  
Other Hand ◽  
The People ◽  
Recent Developments ◽  
The One ◽  
The Individual

The development of tariqat in Indonesia is historically and sociologically related to the climate and culture of the people who in the past was formed by rural culture. However, in recent developments, in South Kalimantan for example, the assumption is very different. Although, this tariqat is usually described as traditional, backward, and associated with the countryside, it is not entirely true. With its tradisional nature, the tariqat become attractions for scholars. Those with rational thingkings entering this world with diverse motivations. There are two complementary sides. On the one hand, rational intellectuals/scholars enter into the tariqat and give a new baseline. On the other hand, the members of the tariqat also renew themselves. Motivations that drive the interest to this tariqat are doctrinal, rational, moral, and psychological. This motivation does not stand alone; it is intertwined and supports each other, in the internalization of the tariqat into the consciousness of the individual.

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