scholarly journals Seizing Opportunity at the Limits of Medicine: An Enhanced Definition of Innovative Practice

2019 ◽  
Author(s):  
Ignacio Mastroleo ◽  
Felicitas Holzer
Keyword(s):  
Best Interests ◽  
Level Of Evidence ◽  
Conceptual Tool ◽  
Innovative Practice ◽  
Traditional Research ◽  
Investigational Drugs ◽  
Core Elements ◽  
Specific Meaning ◽  
Definition Of ◽  
Right To Try Laws

The activity of innovative practice relates to seizing opportunities now for patients in desperate situations and the ethical dilemmas around it. Sadly, the term innovation has multiple meanings, adding confusion and misunderstanding to an already difficult debate. This paper aims to enhance the definition of innovative practice in two ways. Fist, we propose to curb ambiguity by replacing the term "innovative practice" with the more precise of "new non-validated practice" and by distinguishing the specific meaning of innovation at stake. To identify this meaning, we analyse the traditional research ethics’ distinction between research, validated practice, and innovation. Second, we propose the following unified definition of "new non-validated practice", that is, the first or recent use of diagnostic, therapeutic or preventive interventions that introduce a significant change (new); with an insufficient level of evidence of safety or efficacy for regular healthcare (non-validated); and with the main aim to benefit patients (practice). To avoid objections to our definition, we analyse its three core elements (significant novelty, insufficient validation for, and patients' best interests) and we present a 2D classification of medical practice that follows from our definition. If sound, our enhanced definition of "new non-validated practice" allows comparing exceptional activities in different fields of medicine that previously have been considered unconnected (e.g. compassionate use of investigational drugs, humanitarian uses of devices, novel off-label uses, etc.).  In turn, it also provides a promising conceptual tool to inform empirical research, discuss responsible access to innovative care and evaluate the regulation of innovative practice (e.g. right-to-try laws).

scholarly journals New Non-Validated Practice: An Enhanced Definition of Innovative Practice for Medicine

2019 ◽  
Author(s):  
Ignacio Mastroleo ◽  
Felicitas Holzer
Keyword(s):  
Research Ethics ◽  
Preventive Interventions ◽  
Level Of Evidence ◽  
Conceptual Tool ◽  
Current Definition ◽  
Innovative Practice ◽  
Traditional Research ◽  
Multiple Meanings ◽  
Definition Of ◽  
Right To Try Laws

A significant part of the literature on innovative practice in medicine relates to seizing opportunities and curbing harms for patients in desperate situations. Unfortunately, the term innovation has multiple meanings and a rich rhetorical flourish that adds confusion and misunderstanding to an already difficult debate. This paper aims to enhance the current definition of innovative practice for medicine. First, we replace the term innovation with the more literal of new non-validated practice. To identify this meaning, we analyse the traditional research ethics’ distinction between research, validated practice, and innovation in the Belmont Report. Second, we propose the following explicit definition of new non-validated practice: the first or recent use of diagnostic, therapeutic or preventive interventions that introduce a significant change, with an insufficient level of evidence of safety or efficacy for regular healthcare, and with the main aim to benefit individual patients. This definition is a promising conceptual tool to inform empirical research, ethicists, and the harmonization of its regulation and legislation (e.g. right-to-try laws).

The Uniform Status of Children of Assisted Conception Act: Does It Protect the Best Interests of the Child in a Surrogate Arrangement?

1990 ◽  
Vol 16 (4) ◽  
pp. 525-553
Author(s):  
Mimi Yoon
Keyword(s):  
Artificial Insemination ◽  
Medical Technology ◽  
Well Being ◽  
Best Interests ◽  
Medical Procedures ◽  
Assisted Conception ◽  
Regulatory Scheme ◽  
Infertile Couples ◽  
Definition Of

Medical technology is easing the plight of many infertile couples by offering such reproductive alternatives as in vitro fertilization, artificial insemination and surrogacy. In response to the changes in our society's definition of family, wrought by scientific advances, the National Conference of Commissioners on Uniform States Laws promulgated the Uniform Status of Children of Assisted Conception Act. The purpose of this Act is to protect the interests of children born through extraordinary medical procedures. This Note analyzes the Act's provisions regarding surrogacy and focuses on how the Commission's regulatory scheme fails to protect the child's interests. The Act's alternative of voiding the surrogacy contract also does not protect the child's interests. A more complete regulatory scheme which protects the adult parties’ interests, as well as the child's, should be devised, as the adequacy of the adult parties’ protection ultimately affects the child's well-being.

Autonomy, identity and health: defining quality of life in older age

2021 ◽  
pp. medethics-2020-107185
Author(s):  
Sara Kate Heide
Keyword(s):  
Quality Of Life ◽  
Healthcare Providers ◽  
Life Quality ◽  
The Elderly ◽  
Best Interests ◽  
Healthcare Team ◽  
Personal Experiences ◽  
Definition Of ◽  
Made In

Defining quality of life is a difficult task as it is a subjective and personal experience. However, for the elderly, this definition is necessary for making complicated healthcare-related decisions. Commonly these decisions compare independence against safety or longevity against comfort. These choices are often not made in isolation, but with the help of a healthcare team. When the patient’s concept of quality of life is miscommunicated, there is a risk of harm to the patient whose best interests are not well understood. In order to bridge this gap in understanding and unite seniors with their caretakers as a cohesive team, we need to establish a definition of quality of life. In this paper, my personal experiences with the elderly will be analysed along with five essays on the topic of ageing. These sources provide clear evidence that quality of life for seniors is majorly determined by the ability to preserve one’s lifelong identity. When making difficult decisions in geriatric healthcare, this greater understanding of the determinants of life quality will allow treatments to best serve the elderly. Defining quality of life allows healthcare providers to shift the focus from minimising disability toward maximising ability. I believe this shift would provide seniors with better health outcomes and properly enhance the quality of their years.

How We Do Race

On Inhumanity ◽  
2020 ◽  
pp. 34-42
Author(s):  
David Livingstone Smith
Keyword(s):  
Human Beings ◽  
The Road ◽  
The Core ◽  
The Everyday ◽  
Core Elements ◽  
On The Road ◽  
Definition Of

This chapter teases out the core elements of the ordinary conception of “race.” This does not include a scientific or philosophical definition of race. Rather, the chapter talks about the view of race that most people just slip into when going about the everyday business of life. It is a conception that has been taken so thoroughly for granted that many do not even question it. The chapter argues that understanding the conception of race is key to understanding dehumanization, because beliefs about race lie at the heart of the dehumanizing process. It shows that dividing human beings into races—into “our kind” and “their kind”—is the first step on the road to dehumanizing them.

Adults Who Lack Capacity to Consent and Deprivation of Liberty

2020 ◽  
pp. 93-110
Author(s):  
Daniele Bryden
Keyword(s):  
Intensive Care ◽  
Best Interests ◽  
Care Practice ◽  
Intensive Care Treatment ◽  
The Us ◽  
Life Threatening ◽  
Substituted Judgement ◽  
Sound Mind ◽  
Definition Of ◽  
Mental Capacity Act

The basic presumption of the Mental Capacity Act that an individual has capacity to make decisions regarding treatment is frequently challenged within intensive care practice where individuals are often incapacitated due to the nature of their condition or treatment for it. Because many conditions are life-threatening, treatment is frequently administered on the basis of an assumption that it provides an overall benefit to the person and that their interests are best served by preservation of life. There is now a statutory definition of best interests although factors in its determination can at times be opaque, which suggests a gradual move towards the US-based ‘substituted judgement’ test. An individual can be lawfully prevented from leaving the intensive care unit while receiving intensive care treatment provided that treatment is given in good faith and is materially the same as would be given to a person of sound mind with the same physical illness.

The logistical management of tertiary urethral disease in the United Kingdom: Implications from an online audit of male reconstructive urethral surgery

2020 ◽  
Vol 13 (4) ◽  
pp. 288-294
Author(s):  
Stephen R Payne ◽  
Sarah Fowler ◽  
Anthony R Mundy ◽  
A. Alhasso ◽  
Y. Almallah ◽  
...  
Keyword(s):  
High Volume ◽  
Risk Groups ◽  
Outcome Data ◽  
Urethral Reconstruction ◽  
Level Of Evidence ◽  
The United Kingdom ◽  
Surgical Complexity ◽  
Volume Outcome ◽  
Definition Of ◽  
The Uk

Objective: To determine those patient groupings, based on volume and risk, whose optimal urethral reconstructive management might be provided by a reorganisation of UK reconstructive surgeons. Methods: Between 2010 and 2017, ~689 men/year were enrolled onto an online audit platform collecting data about urethral reconstruction in the UK; this accrual was compared against hospital episode statistics (HES). The available workforce, and where this was based, was collected. Individual and institutional incumbent patient volumes, pathology, surgical complexity and outcomes from treatment were collated to stratify volume/risk groups. Results: More than 90% of all HES-recorded data were accrued, being provided by 50 surgeons at 39 operative sites. Most reconstructive surgery was provided at 10 centres performing >20 procedures/year. More than 50% of all interventions were of a high-volume low-risk type. Of activity, 32.3% was intermediate volume or moderate risk, and 12.5% of men presented for lower-volume or higher-risk procedures. Conclusion: Correlation of detailed volume/outcome data allows the definition of patient populations presenting for urethral reconstruction. Stratification of each group’s management, to optimise the surgical outcome, may be applied to a hierarchical service delivery model based on the complexity of the patient’s presenting urethral pathology. Level of evidence: Level IV

ETHNICITY AND GREEK HISTORY: RE‐EXAMINING OUR ASSUMPTIONS

2015 ◽  
Vol 58 (2) ◽  
pp. 1-13 ◽  
Author(s):  
KOSTAS VLASSOPOULOS
Keyword(s):  
Conceptual Tool ◽  
Alternative Framework ◽  
Greek History ◽  
Similarities And Differences ◽  
Definition Of ◽  
Blind Spots ◽  
Essentialist Definition

Abstract The study of ethnicity has become particularly popular over the last twenty years. This article explores certain unexamined assumptions concerning ancient ethnicity and points out certain important blind spots of modern research, focusing in particular on Jonathan Hall's contributions to the debate. Greek historians have devoted little time to thinking about the groups to which the concept of ethnicity is applicable: by exploring together the similarities and differences between poleis, regional, trans-regional, and Panhellenic ethnicities, some startling conclusions emerge. Furthermore, Greek historians have devoted little time to explaining why the concept of ethnicity is a better conceptual tool than that of nationality. But the concept of ethnicity tends to elide the question of an organised community and its shared activities in the formation of identity, with major resulting consequences. Instead of an essentialist definition of ethnicity, like that of Hall, I sketch an alternative framework that approaches ethnicity not as a static entity but as an open-endedprocess, in which the diverse Greek ethnicities moved variously within a spectrum, ranging between a collective and a communal pole.

Challenges in multiple sclerosis diagnosis: Misunderstanding and misapplication of the McDonald criteria

2020 ◽  
pp. 135245852091049 ◽  
Author(s):  
Andrew J Solomon ◽  
Roman Pettigrew ◽  
Robert T Naismith ◽  
Salim Chahin ◽  
Stephen Krieger ◽  
...  
Keyword(s):  
Multiple Sclerosis ◽  
Optic Neuritis ◽  
Subcortical White Matter ◽  
Web Based ◽  
Mcdonald Criteria ◽  
Correct Definition ◽  
Objective Evidence ◽  
Core Elements ◽  
Magnetic Resonance Imaging Mri ◽  
Definition Of

Objective: To assess comprehension and application of the McDonald criteria. Background: Studies suggest that knowledge gaps for specific core elements of the McDonald criteria may contribute to multiple sclerosis (MS) misdiagnosis. Methods: Neurology residents (NR) and multiple sclerosis specialists (MSS) in North America completed a web-based survey. Results: A total of 160 participants were included: 72 NR and 88 MSS. Syndromes incorrectly identified as typical of MS included: complete transverse myelopathy (35% NR and 15% MSS), intractable vomiting/nausea/hiccoughs (20% NR and 5% MSS), and bilateral optic neuritis/unilateral optic neuritis with poor visual recovery (17% NR and 10% MSS). Periventricular magnetic resonance imaging (MRI) lesions were correctly identified by 39% NR and 52% MSS, and juxtacortical lesions were correctly identified by 28% NR and 53% MSS. The correct definition of “periventricular” was chosen by 38% NR and 61% MSS, and that of “juxtacortical” was chosen by 19% NR and 54% MSS. Regions incorrectly identified for MRI dissemination in space fulfillment included the optic nerve (31% NR and 26% MSS) and the subcortical white matter (11% NR and 18% MSS). The majority of participants assessed previous non-specific neurological symptoms without objective evidence of a central nervous system (CNS) lesion as sufficient for clinical dissemination in time. Conclusion: The McDonald criteria are often misunderstood and misapplied. Concerted educational efforts may prevent MS misdiagnosis.

scholarly journals Return-to-Sport Criteria After Upper Extremity Surgery in Athletes—A Scoping Review, Part 1: Rotator Cuff and Shoulder Stabilization Procedures

2021 ◽  
Vol 9 (8) ◽  
pp. 232596712110218
Author(s):  
Rebecca Griffith ◽  
Nickolas Fretes ◽  
Ioanna K. Bolia ◽  
Iain R. Murray ◽  
John Meyer ◽  
...  
Keyword(s):  
Rotator Cuff ◽  
Muscle Strength ◽  
Range Of Motion ◽  
Scoping Review ◽  
Return To Sport ◽  
Radiographic Evaluation ◽  
Shoulder Stabilization ◽  
Level Of Evidence ◽  
Specific Test ◽  
Definition Of

Background: Standardized criteria are lacking to guide patient return to sport (RTS) after rotator cuff surgery (RCS) or shoulder stabilization surgery (SSS). Purpose: To describe RTS criteria used after RCS and SSS in athletic populations. Study Design: Scoping review; Level of evidence, 4. Methods: This scoping review was based on the PRISMA-ScR (Preferred Reporting Items for Systematic Reviews and Meta-Analyses–Scoping Review) guidelines. A total of 5 electronic databases (MEDLINE, Scopus, SPORTDiscus, Embase, Google Scholar Advanced search) and the gray literature were searched for English-language studies that reported at least 1 RTS criterion in athletes after shoulder surgery. Studies were assigned to the RCS or SSS subgroup based on the primary procedure performed. Data were extracted and summarized as frequencies or arithmetic mean and standard deviation. Results: Included were 52 studies and 2706 athletes (2206 male, 500 female, with a mean age of 28.8 ± 1.8 years). The RCS group consisted of 14 studies and the SSS group consisted of 38 studies. Time from surgery was the most common RTS criterion reported overall (37/52 studies; 71%) as well as within the RCS (93%) and SSS (63%) subgroups. Muscle strength (25/52 studies; 48%) and range of motion (23/52; 44%) were used by almost half of the included articles. RTS criteria reported less often were absence of pain, successful completion of sport-specific or position-specific test, proprioception, radiographic evaluation, patient-surgeon agreement, minimum time required to participate in pain-free throwing, and satisfactory scapulothoracic mechanics. All studies used 1 to 3 of the above RTS criteria; however, the definition of each criterion differed among the included articles. Conclusion: Time from surgery was the most commonly reported RTS criterion after RCS or SSS in athletes, whereas muscle strength and range of motion were used by almost half of the articles. There was high heterogeneity in the definition of each RTS criterion used among the included studies, which also used different combinations of 1 to 3 RTS criteria. These results suggest the need to better define quantitative and qualitative RTS criteria in athletes undergoing rotator cuff and shoulder stabilization procedures in order to safely return athletes to sport.

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