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Biosimilars represent a significant cost savings opportunity for the entire healthcare system. Despite efforts from the United States Food and Drug Administration, adoption has not been as successful as originally hoped. Perceived barriers to adoption of biosimilars have been described previously, but more knowledge is needed. Further, increased understanding is needed surrounding commercial payer preferences of biosimilars. A survey to assess perceived barriers to biosimilar adoption was dispersed to healthcare leaders who work in health-systems, physician practices, and the pharmaceutical industry. Policies from the top 15 commercial payers, by covered lives, were reviewed to collect information surrounding coverage and preferred products to assess if perceptions from healthcare leaders align with payer policies. The largest number of responses (n = 76) came from health-systems (n = 56), followed by pharmaceutical manufacturers (n = 12), and physician practices (n = 8). Responses from each cohort aligned very closely with the composite results of the group. Responses surrounding safety and efficacy were high amongst all groups, while rebate increases to payers for reference products were of highest concern for adoption. United Healthcare had the most policies preferring biosimilars (6/7, 86%). Filgrastim-sndz (Zarxio), had the most preferred statuses for a biosimilar (10/15, 67%). The infliximab reference product had the most preferred statuses for a reference product (9/15, 60%). Findings from this study outline the greatest perceived barriers to adoption of biosimilars from a variety of different stakeholders. Rebates from reference product manufacturers to payers was the main deterrent for biosimilar use.

Objective To assess physicians' attitudes toward integrative medicine (IM), including prophetic medicine (PM), combining the best of modern medicine with the best of alternative and complementary medicine. Most physicians are unfamiliar with IM and PM and may thus be against them and it may communicate that to the public. Methods Taibah University (Saudi Arabia) is the sole university in the Arab world with an educational medical course in IM and PM. We assessed IM scientific knowledge and students’ feedback regarding course contents, course design, and teaching methods. A questionnaire was administered to medical students who attended the course. Results A total 650 students (264 men, 386 women) participated in the study; 83% considered the IM (including PM) education beneficial. Among them, 49.6% (range, 60% to 100%) reported that they gained medical benefit from studying IM, and 74% expressed strong positive attitudes toward studying IM. Among participants, 65.8% agreed with the current course topics, without the need to add or delete any topics; 95% of students were satisfied with IM and PM education. Students' interest in the branches of IM included all IM subspecialties. Conclusion IM and PM education should be globally generalized to all medical students, physicians, and health practitioners, particularly in Arabic universities.

The basis of biomedical products regulation is the determination and comparison between the benefits and risks, or side effects, of the product examined in the context of medical need. High benefit, low-risk drugs such as anti-inflammatories are available over the counter and at the discretion of patients for minor aches and pains. The horrible side effects of platinum-based chemotherapies used intravenously to treat certain cancers are reserved for more dire medical circumstances and are only administered under strict medical supervision. The knowledge behind these practices and the controlling regulations have been developed via rigorous clinical trials and decades of clinician experiences. But how to assess the benefits and risks of rapidly emerging digital health tools and capabilities, most of which defy current regulatory categorization? Clearly, new qualitative and quantitative models of medical benefits and risks are needed.

Objective: Despite little survival benefit and potential for harm, contralateral prophylactic mastectomy (CPM) rates are increasing amongst early-stage breast cancer patients at low contralateral breast cancer risk. We developed a CPM decision aid (DA) and conducted a pilot implementation. Methods: Surgeons and oncologists recruited eligible patients considering CPM. Consenting patients re-ceived the DA, completed a questionnaire and participated in a semi-structured interview. Clinicians were interviewed at study close. Results: Eleven clinicians and 31 patients participated. Three themes emerged: perceived utility and impact of the DA, disagreement regarding timing of delivery and target population, and implementation strategies. Both women and clinicians found the DA valuable, indicating it confirmed rather than changed preferences. Women (all of whom raised CPM themselves), preferred offering the DA early in treatment discussions whilst clinicians favoured targeting women who enquired about CPM. Conclusion: A DA about CPM is feasible and acceptable, but questions remain about the role of DAs in these types of decisions where one option has limited medical benefit. Practice implications: Some women have a high need to make an informed choice about CPM. Tools to support this could include a DA with a clear recommendation against CPM and an explanation why. (c) 2021 Published by Elsevier B.V.

Since its first introduction in clinical practice in 2008, the concept of mobile stroke unit enabling prehospital stroke treatment has rapidly expanded worldwide. This review summarises current knowledge in this young field of stroke research, discussing topics such as benefits in reduction of delay before treatment, vascular imaging-based triage of patients with large-vessel occlusion in the field, differential blood pressure management or prehospital antagonisation of anticoagulants. However, before mobile stroke units can become routine, several questions remain to be answered. Current research, therefore, focuses on safety, long-term medical benefit, best setting and cost-efficiency as crucial determinants for the sustainability of this novel strategy of acute stroke management.

The increasing commercialization of oocyte donation is a source of concern. This evolution is expressed in the fact that oocyte donors’ interests are not a priority. For decades now, people mention that oocyte donation holds serious health risks for donors, as if this is an unavoidable given. However, most of the harm is caused by high hormonal stimulation. The risk/benefit balance of high stimulation compared to the risk/benefit balance of mild stimulation does not justify causing greater harm to donors, especially given the fact that donors submit to the procedure without any medical benefit for themselves and to help others.

Decisions about whether to admit patients with covid-19 to critical care should consider the medical benefit including the patient’s likelihood of recovery, the National Institute for Health and Care Excellence (NICE) has recommended. The advice is among a raft of recommendations included in three new rapid guidelines from NICE advising doctors on caring for people with suspected or confirmed covid-19. The guidelines, published on 21 March, cover critical care, delivery of systemic anticancer treatments, and dialysis service delivery. They are the swiftest NICE has ever published and were produced in collaboration with NHS England and NHS Improvement with support from specialist societies and royal colleges. The guideline on critical care1 says that “irrespective of covid-19 status” all patients on admission to hospital should continue to be assessed for frailty. For patients with confirmed covid-19, …

Purpose: Children with Ewing sarcoma (ES) routinely undergo surveillance imaging after completion of therapy; however, the medical benefit of this imaging remains unclear. We aimed to determine whe...

Pectus excavatum (PEx) is one of the most common congenital chest wall deformities. Depending on the severity, presentation of PEx may range from minor cosmetic issues to disabling cardiopulmonary symptoms. The effect of PEx on adult patients has not been extensively studied. Symptoms may not occur until the patient ages, and they may worsen over the years. More recent publications have implied that PEx may have significant cardiopulmonary implications and repair is of medical benefit. Adults presenting for PEx repair can undergo a successful repair with a minimally invasive "Nuss" approach. Resolution of symptoms, improved quality of life, and satisfying results are reported.

Introduction: Botulinum toxin, primarily known for its use in cosmetic surgery, is also used for therapeutic purposes in many medical fields. It works as a muscle relaxant and inhibits glandular secretions. In the orofacial sphere, the use of this toxin is proposed in particular for disabling myofascial pain and aberrant salivary disorders. Methodology: A critical analysis of the literature, based on PUBMED data, concerning the orofacial indications of botulinum toxin was carried out. Results: The literature is abundant regarding the therapeutic interest of this toxin for several oral pathologies, but scientific merits vary markedly from one indication to another. Discussion: The musculorelaxant and antisecretory action of this toxin appears to be demonstrated in the case of bruxism, limitation of the mouth opening and in hypersialorrhea. On the other hand, its medical benefit is still not supported by scientific evidence for masseter hypertrophy, tonicity of the levator labii superioris muscles, sialocele fistulae and Frey's syndrome. Conclusion: Additional high-level studies, unbiased, randomized controlled trials, are required to eliminate the uncertainties that persist about the clinical impact of botulinum toxin and to justify the development of recommendations for good practice valid and credible.

The paper presents a novel methodology based on machine learning to optimize medical benefits in healthcare settings, i.e., corporate, private, public or statutory. The optimization is applied to design healthcare insurance packages based on the employee healthcare record. Moreover, with the advancement in the insurance industry, it is rapidly adapting mathematical and machine learning models to enhance insurance services like funds prediction, customer management and get better revenue from their businesses. However, conventional computing insurance packages and premium methods are time-consuming, designation specific, and not cost-effective. During the design of insurance packages, an employee’s needs should be given more importance than his/her designation or position in an organization. The design of insurance packages in healthcare is a non-trivial task due to the employees’ changing healthcare needs, therefore, using the proposed technique employees can be moved from their existing package to another depending upon his/her need. This provides the motivation to propose a methodology in which we applied machine learning concepts for designing need-based health insurance packages rather than professional tagging. By the design of need-based packages, medical benefit optimization which is the core goal of our proposed methodology is effectively achieved. Our proposed methodology derives insurance packages that are need-based and optimal based on our defined criteria. We achieved this by first applying the clustering technique to historical medical records. Subsequently, medical benefit optimization is achieved from these packages by applying a probability distribution model on five years employees’ insurance records. The designed technique is validated on real employees’ insurance records from a large enterprise.The proposed design provides 25% optimization on medical benefit amount compared to current medical benefits amount therefore, gives better healthcare to all the employees.

Hintergrund Der Gemeinsame Bundesausschuss (G-BA) fuhrt fur alle neu zugelassenen Arzneimittel eine (Zusatz)Nutzenbewertung durch (vgl. § 35a SGB V). Fur Arzneimittel zur Behandlung seltener Erkrankungen (sogenannte Orphan Drugs [OD]) gelten einige Sonderregeln. Methodik Anhand offentlich zuganglicher Dokumente auf der Homepage des G-BA sowie der Fachinformationen erfolgte eine deskriptive Analyse der von September 2011 bis Juni 2016 abgeschlossenen OD Verfahren. Die Datenextraktion umfasste dabei u. a. den Studientyp der zulassungsbegrundenden Studie, den primaren Endpunkt und die Einschatzung dessen Patientenrelevanz, die in der Nutzenbewertung festgestellte Nutzenkategorie (nicht quantifizierbar, gering, betrachtlich, erheblich) sowie die Erfassung der Lebensqualitat. Ergebnisse Insgesamt wurden 36 Verfahren (47 Anwendungsgebiete [AWG]) analysiert. Auf Verfahrensebene dienten 16 der bewerteten ODs der Behandlung von onkologischen Erkrankungen, 11 der Therapie von Stoffwechselkrankheiten, und 9 der Behandlung von sonstigen Erkrankungen. Bei ca. 83% der Verfahren (70% der AWG) lag mind. eine randomisiert kontrollierte Studie vor. Bei 26 Verfahren (29 AWG) bewertete der G-BA den primaren Endpunkt der Zulassungsstudie als nicht patientenrelevant. 64% der OD Zulassungsstudien enthielten Ergebnisse zur Lebensqualitat. Daten zu diesen Endpunkten lagen haufig jedoch eingeschrankt vor. Bei 19 OD Verfahren wurde das Ausmas des Zusatznutzen vom G-BA als nicht quantifizierbar, bei 14 Verfahren als gering und bei einem Verfahren als betrachtlich eingestuft. Bei 2 weiteren Verfahren wurden jeweils 2 Subgruppen unterschieden. In dem ersten Verfahren wurden jeweils ein geringer und ein betrachtlicher Zusatznutzen und in dem zweiten Verfahren wurden ein geringer und ein nicht quantifizierbarer Zusatznutzen festgestellt. Schlussfolgerung Nach den bisherigen Erfahrungen mit der wertung von OD im G-BA zeigt sich, dass fur 70% der zugelassenen Anwendungsgebiete Daten aus RCTs vorliegen, d. h. dass ein randomisiertes Studiendesign auch bei seltenen Erkrankungen moglich ist. Bei unzureichender Evidenzlage, v. a. wenn keine RCTs durchgefuhrt wurden, resultiert oftmals eine Befristung des Beschlusses. Unterschiedliche Auffassungen bestehen derzeit noch bei der Einschatzung der Patientenrelevanz einer Reihe von primaren Endpunkten. Daten zu Lebensqualitats-Endpunkten mussen besser berichtet werden, damit ein Einbezug zur Bestimmung des Zusatznutzens moglich wird. Background The Federal Joint Committee (G-BA) performs an (additional) benefit assessment (see § 35a SGB V) of all newly approved drugs. For drugs treating rare diseases (so-called orphan drugs [OD]), some special rules apply. The legislature has specified that an additional medical benefit is already considered proven upon approval of the drug [and the G-BA only evaluates its extent]. Methodology We conducted an analysis of all OD assessments completed between 09/2011 and 06/2016 using publicly available documents from the G-BA website as well as Summary of Product Characteristics documents. Data extracted included study type of the pivotal studies, the primary endpoint and an assessment of its relevance to patients, the extent of additional benefit as given by the benefit assessment category (non-quantifiable, minor, considerable, major), and the assessment of patient quality of life. Results A total of 36 assessments (47 therapeutic indications) were analyzed. 16 ODs were for treatment of oncological diseases, 11 for metabolic diseases, and 9 for treatment of other diseases. In 83% of the procedures (70% of the therapeutic indications), there was at least one randomized controlled trial. In 26 procedures (29 therapeutic indications), the G-BA assessed the primary endpoint of the pivotal trial as not patient relevant. Almost all OD pivotal studies reported results on quality of life. However, data on these endpoints were often limited. For 19 OD procedures, the extent of the additional benefit as determined by the G-BA was non-quantifiable, 14 procedures had a minor additional benefit and one procedure had a considerable additional benefit. In 2 other procedures, 2 subgroups were distinguished, one with a minor and a considerable additional benefit and the other with a minor and non-quantifiable additional benefit. Conclusion The experience with the evaluation of OD in G-BA shows that about 70% of the approved therapeutic indications have data from RCTs. Thus, a randomized study design is also possible for rare diseases. In case of insufficient evidence, especially when no RCTs were carried out, the decision is often a limited. Pharmaceutical entrepreneurs and the G-BA disagree over the assessment of the relevance to patients of a number of primary endpoints. Data on quality of life endpoints must be better reported in order to enable their inclusion in the benefit assessments.

The scientific purpose of phase I trials is to determine the maximum tolerated dose and/or optimal biological dose of experimental agents. Yet most participants in phase I oncology trials enroll hoping for direct medical benefit. The most common phase I trial designs use low starting doses and escalate cautiously in a "risk-escalation" model focused on minimizing risk for each participant. This approach ensures that a proportion of subjects will likely not receive any benefit, even if the intervention proves to be successful at appropriate doses. In this article, we propose that trial designs should employ dosing strategies that increase chances of providing benefit if the investigational agent should prove to be successful while limiting risk to reasonable levels. We then describe how adaptive trial designs can facilitate refined dose optimization based on both therapeutic benefit and toxicity, which can simultaneously decrease the risk of harm while increasing the chances of benefit.

Thailand achieves universal health coverage through the introduction of three benefit schemes: the Civil Servant Medical Benefit Scheme (CSMBS), Social Security Scheme, and Universal Coverage Scheme. The primary benefit package of these schemes includes all medicines referenced in the National List of Essential Medicines. However, the CSMBS pays for nonessential drugs (NEDs) for particular conditions. The CSMBS's cost escalation prompted the Ministry of Finance to tightly control drug expenditure. In 2010, glucosamine-an NED-was prohibited from CSMBS reimbursement. Subsequently, a dispute was lodged at the Administrative Court by two CSMBS beneficiaries. The court ruled that glucosamine reimbursement should be reinstated in the CSMBS scheme based on two grounds: the Royal College of Orthopedic Surgeons of Thailand's clinical practice guidelines and an argument with reference to Article 78(8) of the 2007 Constitution mandating the state to provide appropriate benefits to government and state officials. Our comments are based on two factors: (1) the integrity of evidence that the Court applied and (2) the ruling with reference to Constitution Article 78(8) as it conflicts with Article 51, which aims to ensure equal rights to health services by all citizens. Because court cases concerning health care coverage in Thailand may expand in the future, we call upon the public to discuss the following issue: whether the court should rule on the inclusion of particular interventions or whether it should focus on the integrity of the coverage decision-making process. Similar lessons can be drawn from the experiences of countries in Latin America and Europe. In any case, all concerned parties including the court should be equipped with a good understanding of the complexity of the country's health systems in either option.

Over the past ten years, technology has been developed to the point, where it can enable continuous and efficient monitoring of blood glucose levels for patients with diabetes mellitus. The biggest step forward was demonstrated by biosensors, which, with a non-invasive approach, provide healthcare workers with the information required for good titration of insulin doses. We looked at the benefits of using biosensors in diabetes monitoring in terms of medical aspect and economic justification of replacing traditional test strips with biosensors. In this paper, we have shown potential benefits in terms of improving diabetes control, patient benefits, and how the medical benefit is collerating with the economic viability of biosensors use. On the territory of Bosnia and Herzegovina test strips for glucose control are still in use. This paper includes an analysis of the costs of traditional monitoring and monitoring using biosensors. We also reviewed the monitoring of diabetes in neighboring countries such as Croatia, Slovenia, Montenegro, and Serbia in order to compare them with the current situation in Bosnia and Herzegovina.

Background The prevalence of pulmonary embolism (PE) in patients presenting with syncope to the emergency department (ED) is largely unknown. This information, however, is necessary to balance the potential medical benefit or harm of systematic PE screening in patients presenting with syncope to the ED. Objectives This study sought to determine the prevalence of PE in patients with syncope. Methods Unselected patients presenting with syncope to the ED were prospectively enrolled in a diagnostic multicenter study. Pre-test clinical probability for PE was assessed using the 2-level Wells score and the results of D-dimer testing using age-adapted cutoffs. Presence of PE was evaluated by imaging modalities, when ordered as part of the clinical assessment by the treating ED physician or by long-term follow-up data. Results Long-term follow-up was complete in 1,380 patients (99%) at 360 days and 1,156 patients (83%) at 720 days. Among 1,397 patients presenting with syncope to the ED, PE was detected at presentation in 19 patients (1.4%; 95% confidence interval [CI]: 0.87% to 2.11%). The incidence of new PEs or cardiovascular death during 2-year follow-up was 0.9% (95% CI: 0.5% to 1.5%). In the subgroup of patients hospitalized (47%), PE was detected at presentation in 15 patients (2.3%; 95% CI: 1.4% to 3.7%). The incidence of new PEs or cardiovascular death during 2-year follow-up was 0.9% (95% CI: 0.4% to 2.0%). Conclusions PE seems to be a rather uncommon cause of syncope among patients presenting to the ED. Therefore, systematic PE-screening in all patients with syncope does not seem warranted. (BAsel Syncope EvaLuation Study [BASEL IX]; NCT01548352)

In addition to safeguarding the central nervous system (CNS) from the vast majority of pathogens and toxins, transvascular barriers impose immense challenges to the delivery of beneficial cargo. A few toxins and neurotropic viruses capable of penetrating the brain have proved to be potentially valuable for neuron targeting and enhanced transfer of restorative medicine and therapeutic genes. Here we review molecular concepts and implications of the highly neurotropic tetanus toxin (TeTx) and botulinum neurotoxins (BoNTs) and their ability to infiltrate and migrate throughout neurons. We discuss recent applications of their detoxified variants as versatile nanovehicles for retroaxonal delivery of therapeutics to motor neurons and synapses. Continued advances in research on these remarkable agents in preclinical trials might facilitate their future use for medical benefit.

Jeremy sustained bilateral complete brachial plexus injuries in an auto collision on an icy road a month before his third birthday. The accident rendered both upper extremities completely flail and insensate: he has no motor or sensory function of his shoulders, elbows, wrists, or digits. Jeremy does, however, have normal function of the lower extremities. Physical therapists have worked with the child for over a year with no noted improvement in arm function. Jeremy falls frequently, causing injury to his face and head, and occasionally, his arms get twisted or caught in his crib and his fingers turn blue. Jeremy's mother, who carries the main responsibility for his daily care, believes that his insensate arms are too heavy and "get in his way," causing the falls. She and Jeremy's father present to the orthopedic clinic at the children's hospital with the request of having both arms amputated. The primary orthopedic surgeon and the orthopedic team disagree with the parents that bilateral upper-extremity amputation offers any medical benefit, but Jeremy's mother tells the surgeon that, if he will not perform the surgery, her family will find a doctor who will. The surgeon, who feels ethically distressed by the parental insistence on this amputation in such a young child, requests an ethics consultation.

A variety of factors, from the personal level to the social level, are associated with suicide, most previous studies have focused on individual characteristics. Of suicide attempters are related to economic factors. The experience of economic difficulties is a factor that greatly affects the life of the individual. In this study, we focus on the groups that have economic difficulties and pay attention to why they commit suicide. In order to reduce and prevent the suicide rate of the elderly, we investigate the demography and character based on elderly suicide attempters who visited the emergency room. Based on the in-depth survey data of emergency room injured patients with 20 hospitals, from January 2011 to December 2015, benefit insurance suicide in 1894 (7.09%) and other insurance suicide party for 24 821 (92.9%) people were analyzed were divided into elderly and adults. Among 26 715 eligible patients, 1894 (7.09%) patients were Medical benefit Insurance, 24 821 (92.9%) other Insurance. Medical benefits insurance was 1632 (86.2%), elderly was 262 (13.8%), young adults was 20 924 (84.3%) and elderly was 3897 (15.7%) in other Insurance. The logistic results were total deaths in hospitals were 2.75 higher in elderly, 2.86 higher in ICU hospitalization and hospital deaths and 3.73 higher in EMRISS. In the interaction model, AORs (95% CIs) of only benefit insurance elderly EMRISS than other insurance elderly was higher 3.73 (3.43–4.06). The mortality rate was not high when the medical insurance was protected.By comparing adults and suicide attempts in the elderly, we could identify the differences.

Background: Live donor nephrectomy is an operation that places the donor at risk of complications without the possibility of medical benefit. Rigorous donor selection and assessment is therefore essential to ensure minimisation of risk and for this reason robust national guidelines exist. Previous studies have demonstrated poor adherence to donor guidelines. Methods: We developed a clinical decision support system (CDSS), based upon national living donor guidelines, to facilitate the identification of contraindications, additional investigations, special considerations and the decision as to nephrectomy side in potential living donors. The CDSS was then tested with patient data from 45 potential kidney donors. Results: The CDSS comprises 17 core tasks completed by either patient or nurse, and 17 optional tasks that are triggered by certain patient demographics or conditions. Decision rules were able to identify contraindications, additional investigations, special considerations and predicted operation side in our patient cohort. 17/45 patients went on to donate a kidney, of whom 7 had major contraindications defined in the national guidelines, many of which were not identified by the clinical team. Only 43% of additional investigations recommended by national guidelines were completed, with the most frequently missed investigations being oral glucose tolerance testing and routine cancer screening. Conclusions: We have demonstrated the feasibility of turning a complex set of national guidelines into an easy-to-use machine-readable CDSS. Comparison with real-world decisions suggests that use of this CDSS may improve compliance with guidelines and informed consent tailored to individual patient risks.

Computer games become a common thing and provide many forms for different stages of age. However, today people argue that those games bring adverse effect on children by exposing hostile characters and violence. On the contrary, such games are utilized as a tool that makes the users enjoy their fun activities. Nowadays, computer games are not only for entertainment purposes. It can be observed from the rapid development of serious games that can be used for serious purposes such as education, simulation, health research, and therapy. The examples of serious games include game designed for cognitive disorders for relaxation therapy during painful medical treatments, e.g., for the cancer chemotherapy patients and games based on assessment/observation psychological scenario with some therapeutic purposes and focused on the problem of pre-school children. Those serious games are intended to help professionals as well as to enable users to enjoy themselves through straightforward, real interaction while learning how to cope with several real social situations. This paper explained and discussed the benefits of serious games based on the technology review of some related researches. It found out that serious games can be a reliable and effective tool when they are used as a method for social benefit and medical benefit.

Hands are commonly injured in burned patients. Optimal outcome is predicated on prompt and comprehensive action in diagnosing the depth of the burn, decompressing compartment syndromes, early and aggressive therapy, early excision and grafting, and coordinated secondary reconstructions. Rapid closure of hand burns is associated with better functional outcomes. Hand therapy is central to outcome and sufficient staff is central to care. When contractures occur, aggressive reconstruction can improve function. The most common debilitating pathology is insufficient skin coverage to allow proper range of motion. Surgical release results in a defect that can be covered with grafts or flaps. Electrical injuries commonly affect the hands. Total care of the burned hand is predicated on aggressive management and takes years to reach maximal medical benefit. Patients should be offered the full range of acute and reconstructive options in a comprehensive burn center environment.

Healthcare professionals (HCPs) regularly face requests from parents for predictive genetic testing of children for adult-onset conditions. Little is known about how HCPs handle these test requests, given that guidelines recommend such testing is deferred to adulthood unless there is medical benefit to testing before that time. Our study explored the process of decision-making between HCPs and parents. Semi-structured interviews were conducted with 34 HCPs in 8 regional genetic services across the UK, and data were thematically analysed. We found that instead of saying ‘yes’ or ‘no’ to such requests, many HCPs framed the consultation as an opportunity to negotiate the optimal time of testing. This, they argued, facilitates parents’ considered decision-making, since parents’ eventual decisions after requesting a test was often to defer testing their child. In cases where parents’ requests remained a sustained wish, most HCPs said they would agree to test, concluding that not testing would not serve the child’s wider best interest. As a strategy for determining the child’s best interest and for facilitating shared decision-making, we recommend that HCPs re-frame requests for testing from parents as a discussion about the optimal time of testing for adult-onset disease.

This review is based on literature search to determine the risks and benefits of marijuana as a medical agent and the role for marijuana in mainstream medicine. “Marijuana" is the natural form of cannabis derived from the Cannabis sativa plant and refers specifically to the dried leaves and flowering tops or "herbal cannabis”. Other terms for marijuana are cannabis or hemp. Current clinical studies do not focus on the natural form of marijuana, but evaluate synthetical forms of THC instead. Marijuana is a schedule I substance by federal law with high potential of addiction and no medical benefit which limits research studies and forbids clinical use. However, the synthetically form THC cannot be compared with the natural form of marijuana and vice versa. Unlike most medications on the market, marijuana does not have only one or two active agents. Natural forms of marijuana are derived from the plant, Cannabis sativa, and consist of over 400 compounds including flavonoids and terpenoids and more than 60 cannabinoids other than delta-tetrahydrocannabinol (THC). Many of these compounds are not understood and their effects and adverse effects unknown.

The objectives of patient care during a periviable preterm delivery are to support patient autonomy, while balancing risks and benefits, and provide evidence-based obstetric care. In most cases of periviability, delivery by a cesarean section is not consistent with these patient care goals, given its lack of maternal or fetal medical benefit, and is therefore considered medically inappropriate. However, by expanding the definition of benefit to include potential maternal psychological and spiritual goals, there are cases in which a cesarean may be ethically justified. In this chapter we explore this concept and suggest that in the context of realistic maternal goals and adequate informed consent, a cesarean section at 22 weeks gestation may be ethically justified through an expanded definition of maternal beneficence.

The Supreme Court of Canada (SCC) ruling on Cuthbertson v. Rasouli has implications for all acute healthcare providers. This well-publicized case involved a disagreement between healthcare providers and a patient's family regarding the principles surrounding withdrawal of life support, which the physicians involved considered no longer of medical benefit and outside the standard of care, and whether consent was required for such withdrawals. Our objective in writing this article is to clarify the implications of this ruling on the care of critically ill patients.SCC ruling Cuthbertson v. Rasouli.The SCC ruled that consent must be obtained for all treatments that serve a "health-related purpose", including withdrawal of such treatments. The SCC did not fully consider what the standard of care should be. Health-related purpose is not sufficient in and of itself to mandate treatment, and clinicians must still ensure that their patients or decision-makers are aware of the possible medical benefits, risks, and expected outcomes of treatments. The provision of treatments that have no potential to provide medical benefit and carry only risks would still fall outside the standard of care. Nevertheless, due to their health-related purpose, physicians must seek consent for the discontinuation of these treatments.The SCC ruled that due to the legal definition of "health-related purpose", which is distinct from medical benefit, consent is required to withdraw life-support and outlined the steps to be taken should conflict arise. The SCC decision did not directly address the role of medical standard of care in these situations. In order to ensure optimal decision-making and communication with patients and their families, it is critical for healthcare providers to have a clear understanding of the implications of this legal ruling on medical practice.

Living donor kidney transplant is the preferred treatment for end-stage renal disease; however, the shortage of kidney donors remains a big problem. One of the major reasons for the shortage of living donors is the risk of potentially serious surgical complications of a procedure in which the donor has no personal medical benefit. Therefore it is important to understand the risk factors for perioperative complications associated with donor nephrectomy. Hand-assisted laparoscopic donor nephrectomy is the preferred approach for kidney procurement in many medical centers. This review gives an overview of the risk factors in donor nephrectomy and more specifically in hand-assisted laparoscopic donor nephrectomy. (C) 2014 NATCO, The Organization for Transplant Professionals

Developers of drugs, biologicals, and medical devices must ensure product safety, demonstrate medical benefit in people, and mass produce the product. Preclinical development starts before clinical trials and the main goals are to determine safety and effectiveness of the intervention. If preclinical studies show that the therapy is safe and effective, clinical trials are started. Clinical trial phases are steps in the research to determine if an intervention would be beneficial or detrimental to humans and include Phases 0, I, II, III, IV, and V clinical studies. Understanding the basis of clinical trial phases will help researchers plan and implement clinical study protocols and, by doing so, improve the number of therapies coming to market for patients.

A legal guardian's consent is needed to give a medical benefit to a juvenile patient. In some measure this consent substitutes the juvenile's consent. Such rule has the usage towards juveniles till they reach 16. After reaching this age both legal guardian and juvenile consent is required. In this subject in the progress of diagnostic-therapeutic treatment many problems may be found, for instance those concerning a definition of the way of the doctor's behavior when parents do not give consent for suggested medical treatment. In some situations the juvenile is allowed to make an objection by himself. There are also many cases when the matter has to be solved by the guardianship court. But when a delay could cause life threat or severe health disorder – is the doctor allowed to perform a treatment without the court's consent? This article is an attempt to solve such legal intricacies concerning treatment of the juvenile.

Although living donor transplantation is considered an ethically acceptable undertaking for the purpose of saving another's life, its safety remains under investigation.Although living donors undertake considerable medical risks for no direct medical benefit, the question remains whether the risks are acceptable and should be tolerated by providers and patients or whether additional interventions and safeguards are needed to reduce and/or prevent complications. By reviewing complication risk statistics and synthesizing empirical research regarding risk-taking thresholds and attitudes, this paper examines the possibilities for determining an acceptable level of complication risk for living donors. This paper also delineates the ethical tensions surrounding protecting donors from unnecessary risk versus respecting donor autonomy to accept risks, and concludes by discussing the importance of donor follow-up and the value of donor registries.In the absence of information on long-term donor outcomes, transplant centers should take special precautions to protect prospective donors given increasing pressures to reduce the organ shortage and concerns that donors often disregard risks to themselves to save the lives of others.

Female genital mutilation (FGM) refers to alteration of the external genitalia of girls without medical benefit. It is estimated by United Nations agencies that 200 million living girls and women have been subjected to different forms of FGM worldwide. Despite the criminalization of the procedure in the vast majority of countries where it is practiced, the decline in the incidence of this ritual is far from satisfactory. Immediate and long-term ill effects are well documented. Most publications of relevance originate from countries outside the map of FGM. In addition, there are major gaps in research related to this issue, considering the magnitude of the problem. International medical organizations and societies should assume their responsibility by providing a platform to professionals engaged in the prevention and treatment of the consequences of FGM, especially those living in the communities where the practice is endemic.

Female genital mutilation (FGM) is a traditional practice that has no medical benefit and severe health consequences for girls and women. This article discusses the risks to patients who are pregnant and have had FGM. It will describe urinary tract infections caused by FGM, and how this condition increases the risk of preterm labour and delivery. It will also address the difficulty in vaginal examinations that can be caused by FGM and instances when this can delay diagnosis and treatment. In addition, it will explore a number of intrapartum risks caused by FGM and the role of deinfibulation in pregnancy. Finally, it will look at the link between maternal and fetal morbidity and mortality, and FGM.

Purpose of review Despite its continued increase in prevalence in minorities, data regarding hypertension (HTN) control among such ethnic groups remains limited. This review highlights the most recent literature on the epidemiology, prevalence, and treatment strategies of HTN among four racial groups (non-Hispanic Whites (NHW), Blacks, Hispanics, and Asians). Recent findings Overall awareness and treatment of HTN were found to be higher in blacks when compared with NHWs. Access to health insurance is associated with successful HTN control, particularly among the Hispanic populations. Recent data from SBP Intervention Trial suggests the blood pressure control and adherence rates in blacks were highest among men, with a higher number of comorbidities, and on diuretic therapy. Additionally, the initiation of thiazide-type diuretics and calcium channel blocker was superior to badrenergic blockers and angiotensin converting enzyme inhibitor/angiotensin receptor blockers in blood pressure lowering among blacks. However, no specific treatment recommendations exist for Hispanics or Asians. Finally, recent guidelines from the Joint National Commission recommend initial treatment with a thiazide-type diuretic regardless of race. Summary Despite recent progress, racial disparities in awareness and treatment of HTN continue to exist. To reduce this important gap, future research should focus on epidemiologic, genetic, and sociologic factors as well as specific therapies to achieve maximum medical benefit in these subgroups.

While there are ongoing debates with regard to the level of risk, if any, associated with medical imaging, the benefits from medical imaging exams are well documented. This forum article looks at outcome-based medical studies and guidance from expert panels in an effort to bring the benefits of medical imaging, specifically CT imaging, into focus. The position is taken that imaging, medical, and safety communities must not continue to discuss small hypothetical risks from ionizing radiation without emphasizing the large well-documented benefits from medical imaging exams that use ionizing radiation.

Researchers and ethicists have long been concerned about the expectations for direct medical benefit expressed by participants in early phase clinical trials. Early work on the issue considered the possibility that participants misunderstand the purpose of clinical research or that they are misinformed about the prospects for medical benefit from these trials. Recently, however, attention has turned to the possibility that research participants are simply expressing optimism or hope about their participation in these trials. The ethical significance of this therapeutic optimism remains unclear. This paper argues that there are two distinct phenomena that can be associated with the term 'therapeutic optimism'-one is ethically benign and the other is potentially worrisome. Distinguishing these two phenomena is crucial for understanding the nature and ethical significance of therapeutic optimism. The failure to draw a distinction between these phenomena also helps to explain why different writers on the topic often speak past one another.

Evaluation of the potential kidney donor is a complex activity that differs substantially from other types of preoperative assessments. The well being of the donor, who derives no medical benefit from this surgery, must be assured in both the short term and long term, and the potential adverse consequences to the recipient must be determined as well. The criteria that must be met for a person to donate a kidney are rigorous and include medical, social, psychosocial, ethical, and legal issues. Donor evaluation can be divided into assessments to protect the health and safety of the donor and assessments to protect the health and safety of the recipient. This article provides an approach to evaluating a donor, focusing on the complex issues that an evaluator is faced with. A careful assessment of risks and benefits to both the donor and recipient can lead to favorable outcomes.

Nanotechnology involves the creation and use of materials and devices at the size scale of intracellular structures and molecules, and involves systems and constructs in the order of

This paper discusses three crucial factors for the adoption of pervasive computing in healthcare: proof of medical benefit, user participation, and financial clarification. This system could also differentiate healthy from unhealthy people by measuring the participants step amplitude and velocity.

Frequently, in data packages submitted for Marketing Approval to the CHMP, there is a lack of relevant head-to- head comparisons of medicinal products that could enable national authorities responsible for the approval of reimbursement to assess the Added Therapeutic Value (ASMR) of new clinical entities or line extensions of existing therapies. Indirect or mixed treatment comparisons (MTC) are methods stemming from the field of meta-analysis that have been designed to tackle this problem. Adjusted indirect comparisons, meta-regressions, mixed models, Bayesian network analyses pool results of randomised controlled trials (RCTs), enabling a quantitative synthesis. The REAL procedure, recently developed by the HAS (French National Authority for Health), is a mixture of an MTC and effect model based on expert opinions. It is intended to translate the efficacy observed in the trials into effectiveness expected in day-to-day clinical practice in France.

Because of the unique features of specialty pharmaceuticals and insurance plans, specialty pharmaceutical products can be paid through the pharmacy benefit or the medical benefit. While most pharmacists are very comfortable with the conventions of reimbursement in the pharmacy benefit, they are less familiar with the processes for payment in the medical benefit.To review the 2 parallel processes for payment of specialty pharmaceuticals, the pharmacy benefit and the medical benefit, and to compare and contrast these 2 processes.The medical benefit and pharmacy benefit processes for payment of specialty pharmaceuticals use different claim forms, product coding systems, pricing conventions, and contracts. Even though the services delivered can be identical, the financial aspects of paying for these services are quite different.Pharmacists who are interested in entering the specialty pharmacy arena, either as a provider or manager of providers, need to understand the payment processes for specialty pharmaceuticals through both the pharmacy and medical benefits.

Gastroenterological treatment is often comprised of a series of multiple interventions, each one associated with a potential benefit, as well as harm. The analysis addresses the question of when to stop a series of consecutive interventions and maximize medical benefit. The benefit and harm associated with gastroenterological interventions are modeled as 'continuous' influences on patient health or as a 'discrete' sequence of random events. The analysis suggests that the benefit of a sequence of gastroenterological interventions is likely to accumulate following few interventions at the beginning of therapy and that any prolonged sequence is likely to inflict as much harm as benefit. It is impossible to reach a state of perfect health with inherently imperfect interventions. Health cannot be raised above a level that equals the ratio of expected benefit/(expected benefit+expected harm). As the achievement of perfect health constitutes an unattainable goal, a sequence of gastroenterological interventions should not be continued much further beyond its initial success.