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1.
Med Sci Law ; : 258024241259327, 2024 Jun 11.
Article in English | MEDLINE | ID: mdl-38863277

ABSTRACT

A new Medical Examiner system was introduced in England and Wales in 2019 to scrutinise all non-coronial deaths. The three key roles of independent Medical Examiner scrutiny are to establish accurate causes of death, determine whether coronial referral is required and identify any care concerns. This is the first published service evaluation exploring the views of doctors and next of kin with whom Medical Examiner Services interact. The aims were to understand whether the Medical Examiner Service was achieving its three main roles. Surveys were sent electronically to the qualified attending practitioners, and by post to the next of kin, of a consecutive series of deceased patients reviewed by an acute NHS hospital Medical Examiner Service in the East of England. Recruitment took place over a five month period in 2023. Results are based on 100 returned surveys from doctors (response rate 35%) and 179 completed by next of kin (response rate 65%). Findings suggest the Medical Examiner Service was successfully achieving its three key roles and well received by both doctors and next of kin. Service user feedback is clearly important as Medical Examiner Services continue to develop into the statutory phase during 2024, when they are anticipated to review approximately 400,000 deaths per annum in England and Wales. This study demonstrates such feedback is not only useful for service development, but also eminently possible.

2.
Med Sci Law ; : 258024241260573, 2024 Jun 11.
Article in English | MEDLINE | ID: mdl-38860324

ABSTRACT

A medical examiner (ME) system was introduced to England and Wales in 2019 intended to ensure appropriate notification of cases to HM Coroner (HMC). The aim of the study is to determine and compare: (a) the nature of notifications to HMC for Norfolk from the Norfolk and Norwich University Hospital (NNUH) in 2018 compared with 2022; (b) to determine the outcome of those notifications and (c) to establish patterns of change in the number and nature of such notifications. HMC and ME datasets were interrogated to determine differences between notifications to HMC and outcomes in 2018 compared with 2022. From deaths at NNUH (2018 - n = 2605; 2022 - n = 2969), there were significantly fewer HMC notifications in 2022 compared with 2018 (25.3% vs. 17.6%). A decrease in notifications was noted for persons undergoing any 'treatment or procedure of a medical or similar nature' (24.0% vs. 16.2%) p < 0.0014. An increase in notifications was noted for neglect, including self-neglect (3.3% vs. 12.2%) p < 0.001. Of the coronial outcomes, there were significant increases in the numbers of post-mortem (PM) examinations (29.3% vs. 35.5%) p = 0.0276 and inquests (26.0% vs. 31.4%) p = 0.0485). There was a significant decrease in no further action by HMC (5.7 vs. 2.3) p = 0.0485. The study shows that the introduction of the medical examiner service has resulted in significant change in the nature of HMC notification categories. The notifications appear to be more appropriate, with an increased proportion of inquests and PM examinations and with a reduction in 100 A or 'no further action' outcomes.

3.
Sci Rep ; 14(1): 10007, 2024 05 01.
Article in English | MEDLINE | ID: mdl-38693157

ABSTRACT

Brazil's Atlantic Forest (BAF) is a highly fragmented, strategic environmental and socio-economic region that represents the fourth biodiversity hotspot while also producing many commodities that are exported globally. Human disturbance plays a pivotal role as a driver of BAF's soil dynamics and behaviors. The soils under Late Primary and Secondary Semideciduous Seasonal Forests (LPSF and LSSF) were characterized by high to moderate resilience, with improved chemical properties as human disturbance decreased. The Transitional Forest to Cerrado (TFC) had the worst soil conditions. Disturbed Primary and Secondary Semideciduous Seasonal Forests (DPSF and DSSF) represent a transitional stage between LPSF/LSSF and TFC. Accordingly, SOCs stocks increased from TFC << DPSF, DSSF < LPSF, LSSF. In BAF soils, to avoid unreliable data, SOCs measurements should be (i) conducted to at least 1 m soil depth and (ii) quantified with a CHN analyzer. Human disturbance strongly affected the positive feedback between vegetation succession, SOCs, and soil nutrition. Soil development decreased as human disturbance increased, thus negatively affecting SOCs. Soils in the BAF require a long time to recover after the end of human disturbance, thus suggesting that preservation strategies should be prioritized in remnant BAF fragments.


Subject(s)
Carbon , Forests , Soil , Brazil , Soil/chemistry , Carbon/analysis , Biodiversity , Humans , Seasons , Ecosystem , Conservation of Natural Resources/methods
4.
Int J Legal Med ; 2024 Apr 17.
Article in English | MEDLINE | ID: mdl-38630276

ABSTRACT

The European Council of Legal Medicine (ECLM) is the body established in 1992 to represent practitioners forensic & legal medicine and is composed of delegates of the countries of the European Union (EU) and from other countries which form part of Europe to a current total of 34 member countries. The aims of this study were to determine the current status of undergraduate forensic & legal medicine teaching in the curriculum of medical studies in ECLM countries and to use the results of this study to determine whether it would be appropriate to develop new guidelines and standards for harmonising the content of undergraduate forensic medicine training across ECLM member countries. A detailed questionnaire was sent to all individuals or organisations listed on the ECLM contact database. Responses were received from 21 of 33 countries on the database. These responses showed considerable emphasis on undergraduate teaching of forensic medicine in all countries with the exception of Belgium and the United Kingdom. There was great general consistency in the subjects taught. The data from this survey provide a baseline which should assist in developing a strategy to harmonise forensic & legal medicine undergraduate training in member countries of the ECLM. The ECLM is now in a good position to establish a pan-European working group to coordinate a consensus document identifying an appropriate and modern core undergraduate forensic medicine curriculum that can be presented to the medical education authorities in each country, and which can be adapted for local requirements, based on available personnel, the forensic medicine structure in the country, and most importantly, the needs of the local population.

5.
Glob Ecol Biogeogr ; 33(1): 141-150, 2024 Jan.
Article in English | MEDLINE | ID: mdl-38516344

ABSTRACT

Aim: Forest disturbances are increasing around the globe due to changes in climate and management, deteriorating forests' carbon sink strength. Estimates of global forest carbon budgets account for losses of plant biomass but often neglect the effects of disturbances on soil organic carbon (SOC). Here, we aimed to quantify and conceptualize SOC losses in response to different disturbance agents on a global scale. Location: Global. Time Period: 1983-2022. Major Taxa Studied: Forest soils. Methods: We conducted a comprehensive global analysis of the effects of harvesting, wildfires, windstorms and insect infestations on forest SOC stocks in the surface organic layer and top mineral soil, synthesizing 927 paired observations from 151 existing field studies worldwide. We further used global mapping to assess potential SOC losses upon disturbance. Results: We found that both natural and anthropogenic forest disturbances can cause large SOC losses up to 60 Mg ha-1. On average, the largest SOC losses were found after wildfires, followed by disturbances from windstorms, harvests and insects. However, initial carbon stock size, rather than disturbance agent, had the strongest influence on the magnitude of SOC losses. SOC losses were greatest in cold-climate forests (boreal and mountainous regions) with large accumulations of organic matter on or near the soil surface. Negative effects are present for at least four decades post-disturbance. In contrast, forests with small initial SOC stocks experienced quantitatively lower carbon losses, and their stocks returned to pre-disturbance levels more quickly. Main Conclusions: Our results indicate that the more carbon is stored in the forest's organic layers and top mineral soils, the more carbon will be lost after disturbance. Robust estimates of forest carbon budgets must therefore consider disturbance-induced SOC losses, which strongly depend on site-specific stocks. Particularly in cold-climate forests, these disturbance-related losses may challenge forest management efforts to sequester CO2.

6.
Med Sci Law ; 63(1): 6-13, 2023 Jan.
Article in English | MEDLINE | ID: mdl-35289209

ABSTRACT

The COVID-19 pandemic commenced in March 2020. In May 2019, a new Medical Examiner system was introduced to scrutinise deaths of patients dying within acute National Health Service Trusts. The Coronavirus Act 2020 which came into force in March 2020 modified certification of death requirements. Newly formed Medical Examiner Services were advised they could suspend scrutiny during the pandemic. The Norfolk & Norwich University Hospital Medical Examiner Service (NNUH MES) continued to scrutinise patient deaths throughout. This study summarises the workload of the NNUH MES from 1st June 2020 to 31st May 2021 over which period 2856 deaths were recorded and 2687 scrutinised by the Medical Examiners.


Subject(s)
COVID-19 , Humans , State Medicine , Coroners and Medical Examiners , Pandemics , Workload , Hospitals
7.
J Environ Manage ; 325(Pt B): 116521, 2023 Jan 01.
Article in English | MEDLINE | ID: mdl-36283166

ABSTRACT

Forests provides major ecosystem services worldwide. The Brazilian Atlantic Forest (BAF) has been dramatically devastated, with fragmentation processes jeopardizing its long-term sustainability. This study investigated the structure and successional dynamics in BAF natural regeneration along an anthroposequence characterized by increasing human disturbance histories as: secondary (SF) > disturbed (DF) > late forest (LF). We aimed to understand how and the degree to which BAF fragmentation and human disturbance affected plants, soils, and the whole soil-plant relationships and feedbacks. We investigated the natural regeneration conditions of plants (using plant classification and quali-quantitative analyses) and soil chemistry (including pH-CaCl2, H + Al, C, N, Pt, cation-exchange capacity (CEC), exchangeable cations, Al, B, Cu, Fe, K, Mn, and Zn) at twelve permanent, 2000 m2 plots, distributed across LF, DF, and SF forests. Significant differences were determined by ANOVA. Correlation matrix (CM) and factor analysis (FA) were used for understanding correlations and feedbacks/variability among investigated parameters, respectively. Most of investigated plant and soil parameters showed significant differences (p < 0.05) between more developed plant formations (LF) vs less developed ones (SF), with differences mainly due to soil's development stage. All investigated forest formations are featured by a great influence of the soil-plant relationships and feedbacks, with a decreasing magnitude as LF → DF → SF. Thus, there is a direct, statistically recognizable impact of both "recent" as well as "ancient" human disturbance on investigated soil-plant formations. The anthropogenic influence clearly affected not only plant and soil as "separate" systems but the whole complex of interactions and feedbacks among ecosystem components. A decreasing quality in soil and plant parameters was observed as human disturbance increased. We demonstrated that BAF plant and soil require decades for their recovery after human disturbances, with complex mechanisms and behaviors in the relationships among ecosystem components. The results can be useful for managing future recovery in an ecosystem of worldwide strategic importance.


Subject(s)
Ecosystem , Rainforest , Humans , Forests , Soil/chemistry , Plants , Trees
8.
Diabetes Obes Metab ; 24(7): 1255-1266, 2022 07.
Article in English | MEDLINE | ID: mdl-35293666

ABSTRACT

AIM: To establish if alpha-7 nicotinic acetylcholine receptor (α7nAChR) agonist GTS-21 exerts a blood glucose-lowering action in db/db mice, and to test if this action requires coordinate α7nAChR and GLP-1 receptor (GLP-1R) stimulation by GTS-21 and endogenous GLP-1, respectively. MATERIALS AND METHODS: Blood glucose levels were measured during an oral glucose tolerance test (OGTT) using db/db mice administered intraperitoneal GTS-21. Plasma GLP-1, peptide tyrosine tyrosine 1-36 (PYY1-36), glucose-dependent insulinotropic peptide (GIP), glucagon, and insulin levels were measured by ELISA. A GLP-1R-mediated action of GTS-21 that is secondary to α7nAChR stimulation was evaluated using α7nAChR and GLP-1R knockout (KO) mice, or by co-administration of GTS-21 with the dipeptidyl peptidase-4 inhibitor, sitagliptin, or the GLP-1R antagonist, exendin (9-39). Insulin sensitivity was assessed in an insulin tolerance test. RESULTS: Single or multiple dose GTS-21 (0.5-8.0 mg/kg) acted in a dose-dependent manner to lower levels of blood glucose in the OGTT using 10-14 week-old male and female db/db mice. This action of GTS-21 was reproduced by the α7nAChR agonist, PNU-282987, was enhanced by sitagliptin, was counteracted by exendin (9-39), and was absent in α7nAChR and GLP-1R KO mice. Plasma GLP-1, PYY1-36, GIP, glucagon, and insulin levels increased in response to GTS-21, but insulin sensitivity, body weight, and food intake were unchanged. CONCLUSIONS: α7nAChR agonists improve oral glucose tolerance in db/db mice. This action is contingent to coordinate α7nAChR and GLP-1R stimulation. Thus α7nAChR agonists administered in combination with sitagliptin might serve as a new treatment for type 2 diabetes.


Subject(s)
Benzylidene Compounds , Blood Glucose , Insulin Resistance , Nicotinic Agonists , Pyridines , alpha7 Nicotinic Acetylcholine Receptor , Animals , Benzylidene Compounds/pharmacology , Blood Glucose/analysis , Blood Glucose/drug effects , Diabetes Mellitus, Type 2/drug therapy , Female , Gastric Inhibitory Polypeptide/metabolism , Glucagon/metabolism , Glucagon-Like Peptide 1 , Glucagon-Like Peptide-1 Receptor/genetics , Glucagon-Like Peptide-1 Receptor/metabolism , Glucose Tolerance Test , Humans , Incretins/therapeutic use , Insulin/therapeutic use , Male , Mice , Mice, Knockout , Nicotinic Agonists/pharmacology , Pyridines/pharmacology , Sitagliptin Phosphate/therapeutic use , Tyrosine/therapeutic use , alpha7 Nicotinic Acetylcholine Receptor/agonists , alpha7 Nicotinic Acetylcholine Receptor/metabolism
9.
J Environ Manage ; 274: 111116, 2020 Nov 15.
Article in English | MEDLINE | ID: mdl-32823085

ABSTRACT

The increasing production of biosolids in urban areas has been led to a search for alternative disposal avenues of this residue, which is rich in organic matter and nutrients. Agricultural land application of biosolids, motivated by its fertilizing power, is a widespread practice in many countries, but there are safety and regulatory concerns regarding the presence of pathogens in Class B biosolids. In addition, the scarcity of studies under tropical climate conditions raises questions that impede the agricultural use of this residue in some regions. The objective of this study was to evaluate the survival of thermotolerant coliforms over 12 months (52 weeks) after biosolids application on the surface of a Quartzipsamment neosol cultivated with Eucalyptus. Two different biosolids were studied: those generated by a biological treatment system with complete mixing aeration ponds followed by decantation ponds (Treatment A) and biosolids from a biological treatment system with conventional activated biosolids reactors (Treatment B), both delineated in randomized blocks with four replicates. After application on the forest soil, we estimated an average survival time of 54 weeks for thermotolerant coliforms present in Treatment A biosolids and 93 weeks in Treatment B biosolids. Thermotolerant coliforms persist much longer under tropical climate conditions in Brazil than in comparable studies under temperate climate conditions. This reaffirms the need to carry out studies covering the full range of moisture and temperature regimes in which biosolids are applied as fertilizer.


Subject(s)
Eucalyptus , Soil Pollutants/analysis , Biosolids , Brazil , Sewage , Soil
10.
Torture ; 30(1): 66-78, 2020.
Article in English | MEDLINE | ID: mdl-32657772

ABSTRACT

Conversion therapy is a set of practices that aim to change or alter an individual's sexual orientation or gender identity. It is premised on a belief that an individual's sexual orientation or gender identity can be changed and that doing so is a desirable outcome for the individual, family, or community. Other terms used to describe this practice include sexual orientation change effort (SOCE), reparative therapy, reintegrative therapy, reorientation therapy, ex-gay therapy, and gay cure. Conversion therapy is practiced in every region of the world. We have identified sources confirming or indicating that conversion therapy is performed in over 60 countries. In those countries where it is performed, a wide and variable range of practices are believed to create change in an individual's sexual orientation or gender identity. Some examples of these include: talk therapy or psychotherapy (e.g., exploring life events to identify the cause); group therapy; medication (including anti-psychotics, anti- depressants, anti-anxiety, and psychoactive drugs, and hormone injections); Eye Movement Desensitization and Reprocessing (where an individual focuses on a traumatic memory while simultaneously experiencing bilateral stimulation); electroshock or electroconvulsive therapy (ECT) (where electrodes are attached to the head and electric current is passed between them to induce seizure); aversive treatments (including electric shock to the hands and/or genitals or nausea-inducing medication administered with presentation of homoerotic stimuli); exorcism or ritual cleansing (e.g., beating the individual with a broomstick while reading holy verses or burning the individual's head, back, and palms); force-feeding or food deprivation; forced nudity; behavioural conditioning (e.g., being forced to dress or walk in a particular way); isolation (sometimes for long periods of time, which may include solitary confinement or being kept from interacting with the outside world); verbal abuse; humiliation; hypnosis; hospital confinement; beatings; and "corrective" rape. Conversion therapy appears to be performed widely by health professionals, including medical doctors, psychiatrists, psychologists, sexologists, and therapists. It is also conducted by spiritual leaders, religious practitioners, traditional healers, and community or family members. Conversion therapy is undertaken both in contexts under state control, e.g., hospitals, schools, and juvenile detention facilities, as well as in private settings like homes, religious institutions, or youth camps and retreats. In some countries, conversion therapy is imposed by the order or instructions of public officials, judges, or the police. The practice is undertaken with both adults and minors who may be lesbian, gay, bisexual, trans, or gender diverse. Parents are also known to send their children back to their country of origin to receive it. The practice supports the belief that non-heterosexual orientations are deviations from the norm, reflecting a disease, disorder, or sin. The practitioner conveys the message that heterosexuality is the normal and healthy sexual orientation and gender identity. The purpose of this medico-legal statement is to provide legal experts, adjudicators, health care professionals, and policy makers, among others, with an understanding of: 1) the lack of medical and scientific validity of conversion therapy; 2) the likely physical and psychological consequences of undergoing conversion therapy; and 3) whether, based on these effects, conversion therapy constitutes cruel, inhuman, or degrading treatment or torture when individuals are subjected to it forcibly2 or without their consent. This medico-legal statement also addresses the responsibility of states in regulating this practice, the ethical implications of offering or performing it, and the role that health professionals and medical and mental health organisations should play with regards to this practice. Definitions of conversion therapy vary. Some include any attempt to change, suppress, or divert an individual's sexual orientation, gender identity, or gender expression. This medico-legal statement only addresses those practices that practitioners believe can effect a genuine change in an individual's sexual orientation or gender identity. Acts of physical and psychological violence or discrimination that aim solely to inflict pain and suffering or punish individuals due to their sexual orientation or gender identity, are not addressed, but are wholly condemned. This medico-legal statement follows along the lines of our previous publications on Anal Examinations in Cases of Alleged Homosexuality1 and on Forced Virginity Testing.2 In those statements, we opposed attempts to minimise the severity of physical and psychological pain and suffering caused by these examinations by qualifying them as medical in nature. There is no medical justification for inflicting on individuals torture or other cruel, inhuman, or degrading treatment or punishment. In addition, these statements reaffirmed that health professionals should take no role in attempting to control sexuality and knowingly or unknowingly supporting state-sponsored policing and punishing of individuals based on their sexual orientation or gender identity.


Subject(s)
Aversive Therapy/methods , Gender Identity , Punishment , Sexual Behavior , Torture , Central Nervous System Agents , Consensus , Electroconvulsive Therapy , Female , Humans , Male , Psychotherapy
11.
J Environ Qual ; 48(2): 526-530, 2019 Mar.
Article in English | MEDLINE | ID: mdl-30951106

ABSTRACT

Agricultural recycling of human Class B biosolids in sugarcane ( spp.) crop is a promising alternative to reduce the costs of biosolids disposal. However, the presence of fecal contamination indicators such as thermotolerant coliforms and pathogenic organisms such as enterovirus and spp. in biosolids impose barriers to effective and widespread use of biosolids as fertilizer. In addition, there is a scarcity of studies that investigate the persistence of these organisms in tropical soils. This study aimed to evaluate the persistence of pathogenic and fecal indicators for 258 d in a tropical clayey soil amended with human Class B biosolids and cultivated with sugarcane. Treatments were immediate incorporation of biosolids into soil after application (T1) or superficial application of biosolids followed by incorporation after 35 d (T2), emulating the typical procedure in sugarcane fields. Thermotolerant coliforms were estimated to persist for 437 d in T1 and 398 d in T2. For enterovirus, mean estimated persistence time in soil was 26 d for T1, but the sampling frequency was insufficient in T2 for persistence analysis. After 35 d, no enterovirus was detected in any sample. Mean estimated persistence time for viable spp. eggs in soil was 22 d in T1 and 41 d in T2.


Subject(s)
Agriculture/methods , Environmental Monitoring , Fertilizers , Soil Pollutants/analysis , Waste Disposal, Fluid/methods , Feces , Saccharum , Soil
12.
Otol Neurotol ; 39(9): 1184-1190, 2018 10.
Article in English | MEDLINE | ID: mdl-30106845

ABSTRACT

OBJECTIVE: Stereotactic radiation therapy is increasingly used to treat vestibular schwannomas (VSs) primarily and to treat tumor remnants following microsurgery. Little data are available regarding the effects of radiation on VS cells. Tyrosine nitrosylation is a marker of oxidative stress following radiation in malignant tumors. It is not known how long irradiated tissue remains under oxidative stress, and if such modifications occur in benign neoplasms such as VSs treated with significantly lower doses of radiation. We immunostained sections from previously radiated VSs with an antibody that recognizes nitrosylated tyrosine residues to assess for ongoing oxidative stress. STUDY DESIGN: Immunohistochemical analysis. METHODS: Four VSs, which recurred after excision, were treated with stereotactic radiation therapy. Ultimately each tumor required salvage reresection for regrowth. Histologic sections of each tumor before and after radiation were immunolabeled with a monoclonal antibody specific to nitrotyrosine and compared. Two VSs that underwent reresection of a growing tumor remnant without previous radiation therapy served as additional controls. RESULTS: Irradiated tumors enlarged in volume by 3.16 to 8.62 mL following radiation. Preradiation sections demonstrated little to no nitrotyrosine immunostaining. Three of four of irradiated VSs demonstrated increased nitrotyrosine immunostaining in the postradiation sections compared with preradiation tumor sections. Nonirradiated VSs did not label with the antinitrotyrosine antibody. CONCLUSIONS: VSs exhibit oxidative stress up to 7 years after radiotherapy, yet these VSs continued to enlarge. Thus, VSs that grow following radiation appear to possess mechanisms for cell survival and proliferation despite radiation-induced oxidative stress.


Subject(s)
Neoplasm Recurrence, Local/metabolism , Neoplasm Recurrence, Local/radiotherapy , Neuroma, Acoustic/metabolism , Neuroma, Acoustic/radiotherapy , Oxidative Stress/radiation effects , Radiosurgery , Humans , Middle Aged
13.
J Forensic Leg Med ; 57: 58-65, 2018 Jul.
Article in English | MEDLINE | ID: mdl-29801954

ABSTRACT

Death and harm is well-recognised in detainees in police custody worldwide. Based on the results of previous global surveys and the CPT (European Committee for the Prevention of Torture) recommendations a questionnaire was developed to summarise the current medical aspects of police custody in European countries. The survey was distributed to named contacts in all European countries. Data from 25 European countries was obtained. The results reveal significant differences in the regulations among the different countries, with nothing close to a harmonised European standard in place at present. This study has identified interesting variations in the methods and standards of healthcare and forensic medical services to detainees in police custody (e.g. quantitative mode of monitoring, qualification of the doctors, maximum time allowed for holding a detainee in police custody, body or an organisation that investigates complaints against the police). There are both very detailed legal regulations in some countries while in others there are only generally observed provisions that sometimes are only given in the form of recommendations. A multinational, multiprofessional expert group is required to identify best practices, recommend basic standards of care and identify qualifications which would be appropriate for healthcare professionals working in this field.


Subject(s)
Delivery of Health Care/statistics & numerical data , Prisoners , Delivery of Health Care/standards , Europe , Humans , Police , Surveys and Questionnaires
14.
J Forensic Leg Med ; 57: 66-72, 2018 Jul.
Article in English | MEDLINE | ID: mdl-29801955

ABSTRACT

The care of detainees (prisoners) in police custody has had much focus in recent years. The nature of the role of the doctor or other healthcare professionals within the police custodial setting may often be subject to conflicts, but their respective duties as healthcare professionals should generally overide any police or forensic issue that may be relevant. The laws or rules or statute that govern doctor, nurse or paramedic practice may vary from country to country, but the broad principles of healthcare ethics are universal and have been formulated not only by national healthcare regulatory bodies but by international organizations such as the World Medical Association. This article discusses in particular the duties of consent and confidentiality within the police custodial setting, giving examples of where conflicts may arise, and how they should be dealt with.


Subject(s)
Confidentiality , Informed Consent , Police , Prisoners , Codes of Ethics , Confidentiality/legislation & jurisprudence , Disclosure/legislation & jurisprudence , Duty to Warn/legislation & jurisprudence , Europe , Humans , Informed Consent/legislation & jurisprudence , Mandatory Reporting , Mental Competency/legislation & jurisprudence , Physical Examination
15.
Ther Innov Regul Sci ; 52(5): 537-545, 2018 09.
Article in English | MEDLINE | ID: mdl-29714582

ABSTRACT

BACKGROUND: Current clinical trial labels are designed primarily to meet regulatory requirements. These labels have low patient and site utility, few are opened, and they have limited space and small fonts. As our world transitions from paper to electronic, an opportunity exists to provide patients with information about their investigational clinical trial product in a way that is more easily accessible, meets Health Authority requirements, and provides valuable additional information for the patient and caregiver. METHODS: A TransCelerate initiative was launched to understand the current regulatory and technology landscape for the potential use an electronic label (eLabel) for investigational medicinal products (IMPs). Concepts and an example proof of concept were developed intended to show the "art of the possible" for a foundational eLabel and a "universal printed label." In addition, possible patient-centric enhancements were captured in the eLabel proof of concept. These concepts were shared with Health Authorities as well as patient and site advisory groups to gather feedback and subsequently enhance the concepts. RESULTS: Feedback indicated that the concept of an eLabel provides value and concepts should continue to be pursued. While the Health Authorities engaged with did not express issues with the use of an eLabel per se, the reduction in the content on the paper label is not possible in some geographic locations due to existing regulations. CONCLUSIONS: There is nothing that prevents transmitting the label electronically in conjunction with current conventional labeling. While there are still some regulatory barriers that need to be addressed for reducing what is on the paper label, advancement toward a more patient-centric approach benefits stakeholders and will enable a fully connected patient-centric experience. The industry must start now to build the foundation.


Subject(s)
Drug Labeling , Internet , Clinical Trials as Topic , Humans
16.
J Environ Qual ; 46(3): 522-527, 2017 May.
Article in English | MEDLINE | ID: mdl-28724093

ABSTRACT

In many countries, the main reason for severely restricting or outright banning the land application of class B biosolids is the lack of risk assessment for adverse human health impacts. Among pathogens that are not often studied are helminth ova, including that of the spp. Almost all of the knowledge about the persistence of spp. ova in soils fertilized with biosolids is based on studies developed in North America, Europe, and Asia. These studies have almost always been conducted under temperate climate conditions, which may cause erroneous interpretations when the conclusions are extrapolated to tropical regions such as those found in Brazil. This team evaluated the persistence of viable spp. ova in a sandy Quartzipsamment tropical soil, previously planted with × hybrid () and fertilized with biosolids, over a 52-wk period. During the reporting period, the average temperature of soil and biosolids fluctuated between 15 and 30°C, and the average moisture of biosolids fluctuated between 60 and 90%. The estimated persistence time of viable spp. ova after land application was estimated at close to 7 wk, indicating that ova may not be viable for as long as it has been shown to be in studies of more temperate areas. The relationship of temperature with persistence of viable spp. ova in a tropical soil was stronger than moisture content, suggesting that temperature substantially contributed to their nonviability over the course of the experiment.


Subject(s)
Ascaris , Eucalyptus , Ovum , Refuse Disposal , Animals , Fertilizers , Soil , Soil Microbiology , Soil Pollutants
19.
J Vis Commun Med ; 37(1-2): 3-12, 2014 May.
Article in English | MEDLINE | ID: mdl-24848573

ABSTRACT

Investigators assessing the likelihood of physical abuse, must make a decision as to whether the injury seen matches the explanation given. In some instances the pattern of these injuries can give the investigator a possible link to the cause of the injury. Thus, matching an injury pattern to an implement or weapon used has forensic implications. The current method of capturing patterned injuries together with poor scale placement often result in some form of distortion that causes a change to the shape of the patterned injury. The aim of this guideline is to assist individuals dealing with the capture of photographic evidence for the investigation of suspected non-accidental patterned cutaneous injuries (PCI), and to ensure high standards of image quality are met for both evidential records and for forensic analysis. The technical equipment specified within these guidelines are recommended by the authors as a basic requirement for imaging best practice, due to their ability to capture detailed and critical data. For precise pattern matching analysis, it is vital that both the injury and the suspected implement are photographed in accordance with this guidance.


Subject(s)
Domestic Violence , Guidelines as Topic , Photography/methods , Photography/standards , Skin/injuries , Forensic Medicine/methods , Humans
20.
J Forensic Leg Med ; 24: 7-11, 2014 May.
Article in English | MEDLINE | ID: mdl-24794842

ABSTRACT

An investigator who is involved in assessing the likelihood of physical abuse must make a decision as to whether the injury seen matches the explanation given. In some instances the pattern of these injuries can give the investigator a possible link to the cause of the injury. Photographic imaging is used to record the patterned cutaneous injuries (PCI) and to facilitate forensic interpretation. The current method of capturing PCI often results in some form of distortion that causes a change to the shape of the patterned injury. The Dermatological Patterned Injury Capture and Analysis (DePICA) research group was formed to assess current image capture methods and practices. An online survey was set up to assess the value of localised imaging protocols and training specific to imaging PCI and was made available to law enforcement professionals, forensic investigators and hospital staff. 80 participants responded to the survey. The majority of the survey participants have had training in medical or forensic photography, however 66 (83%) have not had specific training in how to photograph PCI. 41 (51%) of the participants responded that they always use a rigid scale and 34 (43%) position the camera so that it is perpendicular to the scale and injury. Comments made about the quality of images obtained and produced raises concerns about how much knowledge those initiating such images have about image relevance in criminal cases. It is evident that a clear and comprehensive guide to photographing PCIs is required to improve the quality of the photographic evidence that is collected.


Subject(s)
Photography/methods , Skin/injuries , Skin/pathology , Attitude of Health Personnel , Forensic Medicine , Humans , Personnel, Hospital , Photography/education , Police , Surveys and Questionnaires
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