Redesigning Pharmacy to Improve Public Health Outcomes: Expanding Retail Spaces for Digital Therapeutics to Replace Consumer Products That Increase Mortality and Morbidity Risks.

United States healthcare outcomes, including avoidable mortality rates, are among the worst of high-income countries despite the highest healthcare spending per capita. While community pharmacies contribute to chronic disease management and preventive medicine, they also offer consumer products that increase mortality risks and the prevalence of cardiovascular diseases, diabetes, cancer, and depression. To resolve these contradictions, our perspective article describes opportunities for major pharmacy chains (e.g., CVS Pharmacy and Walgreens) to introduce digital health aisles dedicated to prescription and over-the-counter digital therapeutics (DTx), together with mobile apps and wearables that support disease self-management, wellness, and well-being. We provide an evidence-based rationale for digital health aisles to replace spaces devoted to sugar-sweetened beverages and other unhealthy commodities (alcohol, tobacco) that may increase risks for premature death. We discuss how digital health aisles can serve as marketing and patient education resources, informing customers about commercially available DTx and other technologies that support healthy lifestyles. Since pharmacy practice requires symbiotic balancing between profit margins and patient-centered, value-based care, replacing health-harming products with health-promoting technologies could positively impact prevention of chronic diseases, as well as the physical and mental health of patients and caregivers who visit neighborhood pharmacies in order to pick up medicines.

The legislative position of the Osteopath in Italy after the Decree of the Ministry of Universities and Research of 29 November 2023, in agreement with the Minister of Health: implications in terms of professional responsibility and current shortcomings.

Background: At the end of a long definition and legislative process (Law No.3 of 11 January 2018 and DPR No 131 of 2021), started under the thrust of the European directives, with the Decree of the Ministry of Universities and Research of 29 November 2023, in agreement with the Minister of Health, osteopathy in Italy has become a healthcare profession in all respects. Materials and Methods: In order to understand the current legislative and professional position of the Osteopath, research of the original definitions and the history of the profession has been carried out, assessing an overview of the current situations among EU countries. Therefore, an analysis of the current Italian legislation has been carried out in a medical-legal key, with a critical eye aimed above all at assessing the current shortcomings. Conclusions: The inclusion of osteopathy as a healthcare profession in Italy is a significant step towards the regulation and recognition of this practice, implying considerable innovations both in terms of access to the profession, both in the field of the professional health responsibility. Even if with the Decree of 29 November 2023, a significant step forward has been made, further regulatory and control measures are needed to ensure the quality, safety, and effectiveness of osteopathic treatments, as well as the protection of patients and the professionalism of operators.

Analysis of the contentious relating to medical liability for healthcare-associated infections (HAI) in a Sicilian hospital.

Background: Since 2012, the Sicilian regional government, in view of the increase in malpractice claims, has adopted a "self-insurance system" The claims management activities have been delegated to the Claims Management Committees (CMCs), the importance of which was also emphasized by Law No. 24/2017. This study aims to describe the experience of Sicilian Hospital CMC and analyze the claims' features, especially for contentious HAIs. Healthcare-associated infections (HAIs) continue to be a major public health concern. The contraction of infection during hospitalization generally results in a significant worsening of the patient's quality of life and prolongation of his or her stay. Still, it is also responsible for an increase in costs that burden the hospital and the entire Health System. Material and Methods: The study investigates the analysis of claims received by a Messina Hospital Company between January 2015 and December 2023 even though for events that occurred in earlier years. From the database, cases in which the Company was sued for HAIs were extrapolated and analyzed, distinguishing them by year and by Department. The data collected were statistically processed with the Epi Info 7.1.5 program (CDC - Atlanta - USA). Conclusion: The CMC experience highlighted a statistically significant increase in complaints especially for those relating to HAI, without differences by Department. In most cases, the CMC admitted the hospital's liability, and an attempt at conciliation was promoted and moreover risk management initiatives were adopted. This is important when considering the recent ruling 6386/2023 of March 3, 2023.

Telemanagement and Radiology: current structure, opportunities and new horizons.

Background: Telemedicine is a method of providing remote services in compliance with data security, with a significant positive impact on healthcare, in which Teleradiology means the electronic transmission of radiographic images from one geographical area to another. In this context, the term "telemanagement" shows a real remote management of a diagnostic examination, concluded by the production of telereport and telediagnosis. Materials and Methods: On the basis of Italian position papers, National guidelines and current Laws, a careful analysis of multiple aspects was carried out, in order to understand the current obligations and application limits. Discussion and Conclusion.: Proper radiotelemanagement requires a shared operating protocol within the structure, which integrates verification and safety procedures, periodic checks and adequate resources. In addition, practical interface between the involved figures must be properly established. Then, guidelines highlight the "standard" radiological procedures that can be performed in the absence of the specialist: in ordinary hospitalization, it is allowed to perform Telemanagement procedures only within "standard" procedures; in emergency setting, the only limit is placed in case of administration of contrast agent. No provisions have been approved for teleradiological work in private settings. Finally, inter-company procedures are only provided for screening programs. In this context; potential negative implications are the risk of substitution of health professionals, as well as ethical issues related to data security, patient's consent and quality of the doctor-patient relationship. In an effort of optimism aimed at the future, we want to express our propensity towards a universe with lots of potential that, over time, will emerge in its concreteness.

A denigration curve to delineate the spread of communication about obstetric staff errors in Italy and its practical application.

Background: Mistrust of doctors and the desire for compensation are driving a rise in malpractice litigation worldwide. Aim: To estimate the extent to which Italians view birth complications as malpractice in obstetric care, and how widespread this perception is. Method: WhatsApp® and Facebook® contacts of one of the authors were invited to respond to an online questionnaire. The answers of 265 Italian respondents were used to estimate how common the perception of obstetric staff errors is and how this perception spreads over time: the denigration curve. To test if the denigration curve is reliable, the curve has been plotted along with the trend of the rate of litigation in Italy. Results: Almost a 50% of respondents deemed that birth complications are due to obstetric staff errors. The likelihood of the percep-tion that one has experienced a birth complication was 64.5%. The communication of obstetric staff error seemed low overall among the respondents. The denigration curve shape is almost coincident with the curve of claim rates in Italy, proving that it would be reliable. Conclusion: The respondents provided an estimate of the rate of birth complications that was higher than the real occurrence rate, and attributed these complications to obstetric staff errors. The denigration curve could predict whether and when there might be litigation related to any birth complications (both error related and non-error related).

Converting estimated breeding values from the observed to probability scale for health traits.

Dairy cattle health traits are paramount from a welfare and economic viewpoint; therefore, modern breeding programs prioritize the genetic improvement of these traits. Estimated breeding values for health traits are published as the probability of animals staying healthy. They are obtained using threshold models, which assume that the observed binary phenotype (i.e., healthy or sick) is dictated by an underlying normally distributed liability exceeding or not a threshold. This methodology requires significant computing time and faces convergence challenges as it implies a nonlinear system of equations. Linear models have more straightforward computations and provide a robust approximation to threshold models; thus, they could be used to overcome the mentioned challenges. However, linear models yield estimated breeding values on the observed scale, requiring an approximation to the liability scale analogous to that from threshold models to later obtain the estimated breeding values on the probability scale. In addition, the robustness of the approximation of linear to threshold models depends on the amount of information and the incidence of the trait, with extreme incidence (i.e., ≤ 5%) deviating from optimal approximation. Our objective was to test a transformation from the observed to the liability and then to the probability scale in the genetic evaluation of health traits with moderate and very low (extreme) incidence. Data comprised displaced abomasum (5.1M), ketosis (3.6M), lameness (5M), and mastitis (6.3M) records from a Holstein population with a pedigree of 6M animals, of which 1.7M were genotyped. Univariate threshold and linear models were performed to predict breeding values. The agreement between estimated breeding values on the probability scale derived from threshold and linear models was assessed using Spearman rank correlations and comparison of estimated breeding values distributions. Correlations were at least 0.95, and estimated breeding value distributions almost entirely overlapped for all the traits but displaced abomasum, the trait with the lowest incidence (2%). Computing time was ∼3x longer for threshold than for linear models. In this Holstein population, the approximation was suboptimal for a trait with extreme incidence (2%). However, when the incidence was ≥6%, the approximation was robust, and its use is recommended along with linear models for analyzing categorical traits in large populations to ease the computational burden.

Case of tracheal rupture after endotracheal intubation: clinical risk management and medico-legal considerations.

Background: Tracheal injury may be a rare complication of the endotracheal intubation procedure. Incidence and determinant factors are not well known, nevertheless a greater incidence have been recognized with a difficult maneuver or the use of nitrogen peroxide. The therapeutic approach can be conservative or surgical, depending on the characteristics of the lesion and of the patient and therefore the outcomes of medico-legal interest can be different. Case description: It is a case of alleged medical liability regarding a 70-year-old woman, that during the intubation procedure was pouncing on the right. Furthermore, nitrous oxide was used as an anaesthetic. A few hours after the operation the patient showed swelling on the right half of the face and on the right lateral region of the neck. The emergency chest CT scan highlighted subcutaneous emphysema and pneumomediastinum. In the operating room, fibrobronchoscopy was performed with a double-lumen bronchial tube which confirmed the hypotheses lesion; then, right posterolateral thoracotomy was perfor-med followed by suturing of the tracheal lesion. Subsequently, the patient was discharged in good clinical conditions but with a scar in the region of the right hemithorax. Conclusions: Iatrogenic tracheal injury is a rare and fearful complication of the orotracheal intubation procedure. Although risk factors that increase the probability of its onset have been recognized, in most cases it is not possible to identify the cause. From a medico-legal point of view, tracheal injury after intubation is unpredictable and inevitable, so in the case reported it was decided to proceed with a conciliatory solution.

Forensic psychiatric assessment in autism spectrum disorder: Experience of a forensic psychiatry inpatient clinic from Türkiye.

Autism spectrum disorder (ASD) is a neurodevelopmental condition characterized by marked differences in communication patterns, reciprocal social interactions, and restricted, stereotyped, and repetitive interests and activities. Various behavioral problems in ASD, more so when accompanied by coexisting psychopathology, can sometimes lead to legal problems. In this study, the cases in which an opinion was requested in terms of criminal responsibility with the diagnosis of ASD in the 5-year period between 2018 and 2022 in the expertise department of psychiatric observation, where psychiatric cases were hospitalized and observed in the Council of Forensic Medicine (CFM), which is the official expert institution in Türkiye, were retrospectively evaluated. The mean age of the group whose criminal responsibility was reduced or removed was 22.9 years (±7.52) and the mean IQ score was 76.63 ± 18.94. The most common crime in this group was intentional injury (5/11), and it is noteworthy that the victims of these crimes were usually relatives of people with ASD (5/6). The criminal acts of people with ASD are usually single-movement, spontaneous, unplanned, impulsive acts. In addition, although there is no problem in cognitive perception in people with high functioning ASD (HF-ASD), various forensic situations may arise due to defects in emotional awareness. When we look at the practices of the CFM in Türkiye, it is seen that in cases where the diagnosis of ASD is clear and can be associated with the crime, criminal responsibility is usually completely eliminated. In HF-ASD types, although it is important to be associated with the crime, it is seen that criminal responsibility is generally reduced.

Analysis of the characteristics, efficiency, and influencing factors of third-party mediation mechanisms for resolving medical disputes in public hospitals in China.

BACKGROUND: Medical disputes, which are prevalent in China, are a growing global public health problem. The Chinese government has proposed third-party mediation (TPM) to resolve this issue. However, the characteristics, efficiency, and influencing factors of TPM in resolving medical disputes in public hospitals in China have yet to be determined. METHODS: We conducted a systematic study using TPM records from medical disputes in Gansu Province in China from 2014 to 2019. A χ2 test was used to compare differences between groups, and binary logistic analysis was performed to determine the factors influencing the choice of TPM for resolving medical disputes. RESULTS: We analyzed 5,948 TPM records of medical disputes in Gansu Province in China. The number of medical disputes and the amount of compensation awarded in public hospitals in the Gansu Province increased annually from 2014 to 2019, with most of the disputes occurring in secondary and tertiary hospitals. Approximately 89.01% of the medical disputes were handled by TPM; the average compensation amount with TPM was Chinese Yuan (CNY) 48,688.73, significantly less than that awarded via court judgment and judicial mediation. TPM was more likely to succeed in settling medical disputes in the < CNY10,000 compensation group than in the no-compensation group (odds ratio [OR] = 3.14, 95% confidence interval [CI] 1.53-6.45). However, as the compensation amount increased, the likelihood of choosing TPM decreased significantly. Moreover, TPM was less likely to be chosen when medical disputes did not involve death (OR = 0.49, 95% CI 0.36-0.45) or when no-fault liability was determined (vs. medical accidents; OR = 0.37, 95% CI 0.20-0.67). CONCLUSION: Our findings demonstrate that TPM mechanisms play a positive role in efficiently reducing compensation amounts and increasing medical dispute resolution rates which was the main settlement method in resolving medical disputes in public hospitals of Gansu Province in China. TPM could help greatly reduce conflicts between doctors and patients, avoid litigation, and save time and costs for both parties. Moreover, compensation amounts, non-fatal outcomes, and no-fault liability determinations influence the choice of TPM for settling medical disputes.

Weight of Evidence: Is an Animal Study Warranted? Assessments for Carcinogenicity, Drug Abuse Liability, and Pediatric Safety.

Nonclinical safety studies are typically conducted to establish a toxicity profile of a new pharmaceutical in clinical development. Such a profile may encompass multiple differing types of animal studies, or not! Some types of animal studies may not be warranted for a specific program or may only require a limited evaluation if scientifically justified. The goal of this course was to provide a practical perspective on regulatory writing of a dossier(s) using the weight of evidence (WOE) approach for carcinogenicity, drug abuse liability and pediatric safety assessments. These assessments are typically done after some clinical data are available and are highly bespoke to the pharmaceutical being developed. This manuscript will discuss key data elements to consider and strategy options with some case studies and examples. Additionally, US FDA experience with dossier(s) including WOE arguments is discussed.

AI in Radiology: Navigating Medical Responsibility.

The application of Artificial Intelligence (AI) facilitates medical activities by automating routine tasks for healthcare professionals. AI augments but does not replace human decision-making, thus complicating the process of addressing legal responsibility. This study investigates the legal challenges associated with the medical use of AI in radiology, analyzing relevant case law and literature, with a specific focus on professional liability attribution. In the case of an error, the primary responsibility remains with the physician, with possible shared liability with developers according to the framework of medical device liability. If there is disagreement with the AI's findings, the physician must not only pursue but also justify their choices according to prevailing professional standards. Regulations must balance the autonomy of AI systems with the need for responsible clinical practice. Effective use of AI-generated evaluations requires knowledge of data dynamics and metrics like sensitivity and specificity, even without a clear understanding of the underlying algorithms: the opacity (referred to as the "black box phenomenon") of certain systems raises concerns about the interpretation and actual usability of results for both physicians and patients. AI is redefining healthcare, underscoring the imperative for robust liability frameworks, meticulous updates of systems, and transparent patient communication regarding AI involvement.

Nicotine flux and pharmacokinetics-based considerations for early assessment of nicotine delivery systems.

In the past few years, technological advancements enabled the development of novel electronic nicotine delivery systems (ENDS). Several empirical measures such as "nicotine flux" are being proposed to evaluate the abuse liability potential of these products. We explored the applicability of nicotine flux for clinical nicotine pharmacokinetics (PK) and 52-week quit success from cigarettes for a wide range of existing nicotine delivery systems. We found that the differences in nicotine flux for various nicotine delivery systems are not related to changes in PK, as nicotine flux does not capture key physiological properties such as nicotine absorption rate. Further, the 52-week quit success and abuse liability potential of nicotine nasal sprays (high nicotine flux product), and nicotine inhalers (nicotine flux similar to ENDS) are low, suggesting that nicotine flux is a poor metric for the assessment of nicotine delivery systems. PK indices are more dependable for characterizing nicotine delivery systems, and a nicotine plasma C max T max > 1 could improve 52-week quit success from cigarettes. However, a single metric may be inadequate to fully assess the abuse liability potential of nicotine delivery systems and needs to be further studied. A combination of in vitro and in silico approaches could potentially address the factors influencing the inhaled aerosol dosimetry and resulting PK of nicotine to provide early insights for ENDS assessments. Further research is required to understand nicotine dosimetry and PK for ad libitum product use, and abuse liability indicators of nicotine delivery systems. This commentary is intended to (1) highlight the need to think beyond a single empirical metric such as nicotine flux, (2) suggest potential PK-based metrics, (3) suggest the use of in vitro and in silico tools to obtain early insights into inhaled aerosol dosimetry for ENDS, and (4) emphasize the importance of considering comprehensive clinical pharmacology outcomes to evaluate nicotine delivery systems.

Cystic Fibrosis and the Law: The Ramifications of New Treatments.

Until the discovery of the gene for cystic fibrosis (CF) in 1989, diagnostic developments were limited, and treatment focused on symptom alleviation. However, following the genetic breakthrough, some 2,000 mutations of the gene have been identified. More recently CF transmembrane conductance regulator modulator triple therapy (CFTRm) has been introduced in the form of triple therapy with ivacaftor, lumacaftor and tezacaftor (ETI), in the United States from 2019, Europe from 2020 and then Australia from 2021. The new treatment option has revolutionised both the quality of life and life expectancy of many persons diagnosed with CF. This editorial reviews major developments in the clinical care that can now be provided to patients, and reflects on the legal and ethical ramifications of the improved situation for many patients in the contexts of medical negligence, damages assessment, family law and criminal law. It also considers the difficult issues of access and equity caused by the limited availability of the triple therapy in low- and middle-income countries.

Advancements in defensive medicine research: Based on current literature.

To investigate and comprehend the evolving research hotspots, cutting-edge trends, and frontiers associated with defensive medicine. The original data was collected from the Web of Science core collection and then subjected to a preliminary retrieval process. Following screening, a total of 654 relevant documents met the criteria and underwent subsequent statistical analysis. Software CiteSpace was employed for conducting a customized visual analysis on the number of articles, keywords, research institutions, and authors associated with defensive medicine. The defensive medicine research network was primarily established in Western countries, particularly the United States, and its findings and conceptual framework have significantly influenced defensive medicine research in other regions. Currently, quantitative methods dominated most studies while qualitative surveys remained limited. Defensive medicine research mainly focused on high-risk medical specialties such as surgery and obstetrics. Research on defensive medicine pertained to the core characteristics of its conceptual framework. An in-depth investigation into the factors that give rise to defensive medicine is required, along with the generation of more generalizable research findings to provide valuable insights for improving and intervening in defensive medicine.

A Bivariate Twin Study of Lifetime cannabis Initiation and Lifetime Regular Tobacco Smoking Across Three Different Countries.

Regular cigarette smoking and cannabis consumption are strongly positively related to each other, yet few studies explore their underlying variation and covariation. We evaluated the genetic and environmental decomposition of variance and covariance of these two traits in twin data from three countries with different social norms and legislation. Data from the Netherlands Twin Register, FinnTwin12/16, and the Minnesota Center for Twin Family Research (total N = 21,617) were analyzed in bivariate threshold models of lifetime regular smoking initiation (RSI) and lifetime cannabis initiation (CI). We ran unstratified models and models stratified by sex and country. Prevalence of RSI was lowest in the Netherlands and prevalence of CI was highest in Minnesota. In the unstratified model, genetic (A) and common environmental factors (C) contributed substantially to the liabilities of RSI (A = 0.47, C = 0.34) and CI (A = 0.28, C = 0.51). The two liabilities were significantly phenotypically (rP = 0.56), genetically (rA = 0.74), and environmentally correlated in the unstratified model (rC = 0.47and rE = 0.48, representing correlations between common and unique environmental factors). The magnitude of phenotypic correlation between liabilities varied by country but not sex (Minnesota rP ~ 0.70, Netherlands rP ~ 0.59, Finland rP ~ 0.45). Comparisons of decomposed correlations could not be reliably tested in the stratified models. The prevalence and association of RSI and CI vary by sex and country. These two behaviors are correlated because there is genetic and environmental overlap between their underlying latent liabilities. There is heterogeneity in the genetic architecture of these traits across country.

Artificial intelligence in healthcare: an Italian perspective on ethical and medico-legal implications.

Artificial intelligence (AI) is a multidisciplinary field intersecting computer science, cognitive science, and other disciplines, able to address the creation of systems that perform tasks generally requiring human intelligence. It consists of algorithms and computational methods that allow machines to learn from data, make decisions, and perform complex tasks, aiming to develop an intelligent system that can work independently or collaboratively with humans. Since AI technologies may help physicians in life-threatening disease prevention and diagnosis and make treatment smart and more targeted, they are spreading in health services. Indeed, humans and machines have unique strengths and weaknesses and can complement each other in providing and optimizing healthcare. However, the healthcare implementation of these technologies is related to emerging ethical and deontological issues regarding the fearsome reduction of doctors' decision-making autonomy and acting discretion, generally strongly conditioned by cognitive elements concerning the specific clinical case. Moreover, this new operational dimension also modifies the usual allocation system of responsibilities in case of adverse events due to healthcare malpractice, thus probably imposing a redefinition of the established medico-legal assessment criteria of medical professional liability. This article outlines the new challenges arising from AI healthcare integration and the possible ways to overcome them, with a focus on Italian legal framework. In this evolving and transitional context emerges the need to balance the human dimension with the artificial one, without mutual exclusion, for a new concept of medicine "with" machines and not "of" machines.

South Tyrol Healthcare Company: A Look at a Peculiar Model of Claims Management in Italy and Analysis of Its Last 11 Years.

BACKGROUND: Alternative Disputes Resolution (ADR) systems are becoming increasingly important tools in recent years for the management and resolution of health responsibility cases, but their dissemination and efficiency are still poorly described. The purpose of this paper is to present an ADR system in the autonomous province of Bolzano: the Conciliation Commission. METHODS: systematic collection of all claims of the South Tyrol Sanitary Service that were dealt with in the Conciliation Commission from 1 January 2012 to 31 December 2022. RESULTS: closing times of the applications received turn out to be less than a year in 63.8% of the cases, with a number of cases managed rather stably in the time, even if minimal if compared to the number of complaints received to the South Tirol Health Service. Only 5.3% of the application continued the legal process before a civil court. CONCLUSIONS: the Conciliation Commission of South Tirol appears to be an excellent instrument for the resolution of disputes in the healthcare field, with rapid resolution times and little to zero costs for the healthcare company, a public health institution. Despite its effectiveness, it seems to be a tool that is still little-known in South Tyrol.

Effects of the Synthetic Cathinone α-Pyrrolidinobutiothiophenone (α-PBT) on Discriminative Stimulus Effects and Intracranial Self-Stimulation Thresholds in Male Rats.

Recently, the abuse of synthetic cathinones is increasing among young people. α-Pyrrolidinobutiothiophenone (α-PBT), a synthetic cathinone, is a designer drug that is freely traded online with no legal restrictions. Moreover, there is currently no scientific basis for legal regulation. Here, we examined the addictive properties of α-PBT using a drug discrimination (DD) task. We also investigated the role of α-PBT in brain stimulation reward (BSR) using an intracranial self-stimulation (ICSS) paradigm in rats. Initially, the rats were trained to discriminate between cocaine and saline. After the discrimination training criteria were met, we determined the dose-effect curves of cocaine and conducted generalization tests with α-PBT and α-pyrrolidinopentiothiophenone (α-PVT) using a cumulative dosing protocol. In a separate set of studies, we examined the dopaminergic mechanisms underlying the function of α-PBT as an interoceptive stimulus (17.8 mg/kg) by intraperitoneally injecting either the dopamine (DA) D1 antagonist SCH23390 (0.06 and 0.12 mg/kg) or the D2 antagonist eticlopride (0.05 and 0.1 mg/kg) 15 min before DD testing. Brain reward function was measured using an ICSS procedure to examine the effects of α-PBT on ICSS threshold under the frequency-rate procedure. Our results showed that α-PBT functioned as a discriminative cue similar to cocaine in rats. More importantly, SCH23390 abolished the effects of α-PBT as an interoceptive stimulus in a dose-dependent manner in rats trained to press a lever to receive cocaine. Similarly, eticlopride dose-dependently attenuated the effect of α-PBT used as a discriminative cue. Additionally, cumulative α-PBT administration dose-dependently lowered ICSS thresholds compared with those in saline-treated rats. Furthermore, α-PBT-induced potentiation of BSR was abolished by pretreatment with both SCH23390 and eticlopride. Taken together, our results suggest that α-PBT can function as a cocaine-like discriminative cue via the activation of D1 and D2 receptors. α-PBT also appears to influence BSR by reducing the brain reward threshold via changes in D1 and D2 receptors. The present study suggests that α-PBT could have addictive properties through DA D1 and D2 receptors and thus poses a threat to humans.

Evaluation of insurance policies in the Saudi Arabian construction contracts.

The construction sector is more complicated and prone to risk than many other industries due to the size of the projects and the financial capital involved. Arranging insurance is the prudent course of action for risk management in the construction sector. There is a lack of clarity in insurance policies for public construction projects in the Kingdom of Saudi Arabia (KSA), which poses additional risks to all involved contracting parties. The aim of this research is to evaluate insurance policies in the KSA's public construction projects to identify the key deficiencies and obstacles and provide a road map for improvement in the insurance sector concerning insurance against financial losses, professional liability, defects' liability, hidden defects, and others. Forty-two contractors and forty-two owners in Saudi Arabia were surveyed, using a questionnaire to gather information for the study about their knowledge of and attitudes regarding risk transfer through insurance (professional liability, defects liability, and hidden defects). The study also covers the selection criteria for insurance policies for projects that potentially shift risk to the construction sector. Ten criteria were also examined as potential sources of liability issues and suggested as potential remedies in KSA. The findings indicate that the duty and liability of engineers and those participating in these projects can be offset by engineers' insurance against professional errors and hidden flaws, and by the construction industry's clear liability policy. Additionally, the research is envisaged to contribute to construction projects' overall quality and safety, ensuring that robust legal and financial safeguards protect all stakeholders.

The "Gateway" hypothesis: evaluation of evidence and alternative explanations.

BACKGROUND: Electronic nicotine delivery systems (ENDS) offer a substantial harm reduction opportunity for adults who smoke and are unlikely to quit. However, a major concern about ENDS is their use by non-smoking youth, and particularly whether ENDS are acting as a "gateway" that leads youth to later start smoking cigarettes. However, evidence for the gateway hypothesis can be interpreted in alternative ways, e.g. that youth who have certain characteristics were already predisposed to use both ENDS and cigarettes ("common liability" explanation). AIMS: This commentary provides an evaluation of the gateway hypothesis that is accessible by a lay audience. This paper first reviews and evaluates the evidence interpreted as supporting the gateway hypothesis. Important alternative explanations (i.e., common liability) are discussed, as are different types of evidence (i.e., population-level trends) that can help differentiate between these competing explanations. OVERVIEW: Evidence for the gateway hypothesis is based on the finding that youth who use ENDS are more likely to also smoke cigarettes. However, this evidence suffers from an important flaw: these studies fail to fully account for some youths' pre-existing tendency to use products containing nicotine, and inappropriately interpret the results as ENDS use causing some youth to smoke. Common liability studies suggest that ENDS use does not, in and of itself, directly cause youth to later smoke cigarettes, beyond their pre-existing tendency to use products containing nicotine. Population-level trends show that youth cigarette smoking declined faster after ENDS use became common, which contradicts the central prediction of the gateway hypothesis (i.e. that youth smoking would be more common following ENDS uptake, than otherwise be expected). CONCLUSION: Evidence offered in support of the gateway hypothesis does not establish that ENDS use causes youth to also smoke cigarettes. Instead, this evidence is better interpreted as resulting from a common liability to use both ENDS and cigarettes. Population-level trends are inconsistent with the gateway hypothesis, and instead are consistent with (but do not prove) ENDS displacing cigarettes. Policies based on misinterpreting a causal gateway effect may be ineffective at best, and risk the negative unintended consequence of increased cigarette smoking.