Clinical trials research involving human participants has led to numerous medical advances. Historically, however, clinical trials research was the source of major concerns for the safety and welfare of the human participants taking part in these studies. The ethical principles of autonomy, beneficence, and justice came about in response to medical atrocities, and regulations were ultimately put in place to protect the rights and welfare of human participants and to maintain the public trust in the research enterprise. Today, clinical trials are one of the most heavily regulated practices in the world, and yet still not all people are provided the same oversights and protections, with improprieties disproportionately affecting poor-resource nations and vulnerable populations. As Africa approaches the post–communicable disease era, cancer is set to take the lead as the most burdensome disease, making the need for oncology clinical trials in Africa greater than ever before. Africa represents a heterogeneous market with 55 countries, most with their own National Regulatory Agency (NRA) and each with varying levels of regulatory maturity. This diversity creates a highly complex regulatory environment and causes challenges when bringing drugs to market. There is a large need for harmonization and increased collaboration between the African nations’ NRAs. In addition, many African countries need to be better equipped to handle research ethics committees and/or learn how to rely on neighboring countries with more established ethics committees. Well-run clinical trials offer solutions to national health care problems, and all people deserve equal access to their benefits. Still, the concepts of the importance of justice and morality have ancient roots. The ancient Egyptians believed in Ma’at, which refers to their notions of truth, balance, order, harmony, law, morality, and justice.2a Ma’at was also the goddess who manifested these concepts.2a The ancient Hippocratic Oath states that it is a physician’s duty to avoid harming the patient, but the oath was not subscribed to by the majority of doctors until the late postmodern era. Ultimately, measures for the protection of human participants have mostly come in response  to reported abuses and scandals. Society has endured significant harm as a result of research misconduct that lacked in basic concepts of morality, justice, law, and balance. As a result, our society has learned how to ensure the ethical conduct of research while continuing in the pursuit of scientific advancement for the benefit of humanity. The ethical principles and regulations that have been developed over the years were designed to protect the rights and welfare of human participants in research and maintain the public trust in the research enterprise.Through the centuries, human participants research has led to numerous breakthroughs in medicine, which were often accelerated with technologic advances. However, concerns about the ethics of research involving human participants have a long history. In the past half century, the level of oversight on human participants research has exploded from almost none to what is now an exhaustive system of protections. Still, these oversights and protections are not uniform throughout the world, and many nations, especially poor-resource nations, remain at risk for ethical improprieties. The Pure Food and Drug Act was passed in 1906 in the United States. This was the first of a series of protections for consumers before which there were no governmental or institutional regulations governing the ethical use of human participants research.Key ObjectiveWhat were the circumstances that led to modern-day research ethics boards? Do patients with cancer in Africa have access to clinical trials? What are the existing oversights to protect the welfare of clinical trial participants in countries with limited resources?Knowledge GeneratedThe ethical principles of autonomy, beneficence, and justice evolved in response to medical abuses on human participants. Regulations were put in place to protect the rights and welfare of human participants and are governed by research ethics boards; as a result, clinical trials are now heavily regulated. Approximately 10% of clinical trials occur in developing countries. Unlike in the United States or European Union, sub-Saharan Africa has a diverse and complex regulatory environment. This presents challenges that hinder oversights and protections and lead to improprieties that disproportionately affect poor-resource nations in Africa and vulnerable populations.RelevanceWell-run clinical trials provide solutions to national health care problems. There is a need to continue to develop clinical trial best practices across Africa. Everyone deserves equal access to clinical trials, and we must strive to achieve that access.16 According to the federal policy known as the Common Rule, as defined in 45 CFR 46, a human participant is “a living individual about whom an investigator  conducting research obtains information or biospecimens through intervention or interaction with the individual, and uses, studies, or analyzes the information or biospecimens; or obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens.”3In essence, human participant research, as defined by the National Institutes of Health (NIH) of the Department of Health and Human Services (DHHS) is “systematic, scientific investigation that can be either interventional  or observational (no ‘test article’) and involves human beings as research subjects.”4 Prospective assignment refers to a predefined process specified in an approved protocol that stipulates the assignment of research participants to one or more arms of a clinical trial, and intervention is defined as a manipulation of the participant’s environment for the purpose of modifying one or more health-related biomedical or behavioral processes and/or end points.4 The last component, a “health-related biomedical or behavioral outcome,” is defined as the prespecified goal(s) or condition(s) that reflect the effect of one or more interventions on human participants’ biomedical or behavioral status or quality of life.4 All 3 conditions must be met for the research study to be considered a clinical trial by the NIH, and therefore, all human participants research does not fall under the clinical trials category. For example, collecting samples from patients either at a single time point or over time without intervention or the measuring of an outcome would qualify as an observational study and not as a clinical trial. One can use the decision tool on the NIH Web site to determine whether the human participants research meets the NIH definition of a clinical trial.5Specifically, clinical trials are wide ranging in their scope and include prevention, screening, diagnostic, treatment, behavioral, and quality-of-life trials. According to the NIH, a clinical trial is a “research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes.”6 published the article “Ethics and Clinical Research” in The New England Journal of Medicine. Beecher, a senior member of the anesthesiology faculty at Harvard Medical School, examined the ethical practices of 22 studies conducted by respected investigators and published in prestigious medical journals.7 He discovered in each of these studies ethical improprieties, including but not limited to lack of informed consent and increased risk to human participants.7 Among the most horrific examples of ethical abuses in our modern history is the case of the Tuskegee Study of Untreated Syphilis in the Negro Male (commonly known as the Tuskegee Syphilis Study).9 This was a medical research project conducted by the US Department of Health from 1932 to 1972 that examined the natural course of untreated syphilis in 400 African American men. According to the Centers for Disease Control and Prevention, the participants, all impoverished sharecroppers from Macon County, Alabama, did not know they were being studied and were not told that they had syphilis. Researchers withheld treatment even when it became available in the late 1940s with the availability of penicillin. Most participants who attended the Tuskegee clinic thought they were getting treatment for “bad blood.” The study concluded in 1972, and when stories about the study leaked to the public, it caused an outcry. This and other cases of abuse, including extensive medical research conducted on prisoners in correction facilities; the Willowbrook studies (1956-1970), in which children with intellectual disabilities were deliberately infected with the hepatitis virus10; and the Jewish Chronic Disease Hospital Study (1963), in which live cancer cells were injected into 22 cognitively impaired patients, contributed to the public’s concern over medical research.10In 1966, Beecher7 On November 19, 1945, the International Military Tribunal was decreed by the Allied powers. This tribunal was a series of trials held against major war criminals and Nazi sympathizers. The Doctors’ Trial of 1947 became the first trial conducted under the Nuremberg Military Tribunals. In this trial, 23 physicians from the Nazi Party were tried for atrocious experiments they carried out on helpless and unwilling prisoners of war and for crimes against humanity. Many of the unfathomable medical experiments took place at the Auschwitz concentration camp, where demeaning numbers were tattooed onto the arms of prisoners to identify their bodies after death.11However, laws regarding the ethics of research involving human participants first developed as the result of the Nazi regime’s atrocities during World War II.12 The trials also led to the Council for International Organizations of Medical Sciences (CIOMS), which was established jointly by the WHO and the United Nations Educational, Scientific, and Cultural Organization in 1949 as an international, nongovernmental, nonprofit organization with the mission to advance public health through guidance on health research, including ethics, medical product development, and safety. The development of the CIOMS Guidelines, known as the International Ethics Guidelines for Biomedical Research Involving Human Subjects of 1982, has especially influenced research ethics in poor-resource nations such as those in Africa.13As part of the verdict, the court ordered rules for “Permissible Medical Experiments,” known as the Nuremberg Code, published in 1947. The 3 basic elements of the Nuremberg Code state that research requires voluntary informed consent, that the benefits of meritorious research outweigh the risks, and that the participants have the right and ability to terminate participation at any time without consequences to the quality of their care. The Nuremberg Code became the foundation for subsequent ethical codes and research regulations. In 1964, the World Medical Association released the Declaration of Helsinki, which built on the principles of the Nuremberg Code.15 Autonomy, beneficence, and justice provide the framework of the Belmont Report and provide the bioethical precepts of conducting human participants research. The Belmont Report identified the following 3 basic principles relevant to the ethical conduct of research involving human participants: respect for persons—all individuals should be treated as autonomous agents, and persons with diminished autonomy are entitled to protection; beneficence—researchers should maximize possible benefits and minimize possible harm; and justice—all persons should be treated equally, and the selection of research participants should be scrutinized so that no one is systematically selected on the basis of race, ethnicity, class, or other factors.16Astonishingly, the research improprieties in the United States and abroad did not prompt US congressional deliberations about human participants research oversight until 1974, which came even after the adoption of the Animal Welfare Act in 1966 . Congress’s first legislation to protect the rights and welfare of human participants was the National Research Act of 1974. This led to the creation of the National Commission for Protection of Human Subjects of Biomedical and Behavioral Research, which issued the Belmont Report in 1976 and led to the modern-day IRB.17 Research findings causing group harm or stigma can lead to genetic determinism and economic, political, social, educational, and cultural harms. These can be difficult to measure, predict, and reverse. Conditions that are still stigmatized and vulnerable populations need to be studied to develop interventions to reduce stigma and harm to these groups. A report by Millum et al17 concluded that overprotecting vulnerable populations, whether by excluding them altogether, by instituting excessive protections, or by refusing to engage with controversial questions, should be avoided. Rather, investigators and ethics committees need to be more attentive to the problems and associated risks.Although the Belmont Report emphasizes individual autonomy, it also recognizes that when individuals who belong to vulnerable populations are involved in research, harm may come not necessarily to the individual participants but to the group as a whole, including those who did not actually take part in the research. Most formal policies and regulations on the protection of human participants research include this risk as an adjunct to the Belmont Report’s 3 core principles and attribute group harms to the misuse and misinterpretation of research findings. Groups at increased risk include minority populations, such as African Americans, Hispanics, American Indians, and other racial and ethnic minorities both in the United States and abroad that have historically faced racism and oppression; groups that are socioeconomically disadvantaged and have less access to education, social services, and health care; and groups with behaviors outside of societal norms such as sex workers and drug users. Similarly, conditions such as HIV/AIDS, leprosy, lung cancer, epilepsy, or schizophrenia, which lead to stigma, make research operationally and ethically challenging.16:Therefore, research oversight capacity is critical for the protection of human research participants, as well as to prevent exploitation of populations, communities, institutions, and countries. The IRB, also known as an independent ethics committee, ethical review board, or research ethics board, or research ethics committee (REC) outside of the United States, is an administrative body established to protect the rights and welfare of human research participants recruited to participate in research activities conducted under the auspices of the institution with which it is affiliated. The IRB, as with other ethics committees, is required to review all biomedical and behavioral research (whether funded or not) involving human participants before study initiation. The IRB has the authority to approve, disapprove, monitor, and require modifications of all research activities. In 1991, 16 federal agencies also formally adopted the core of the Belmont Report’s regulations in a common Federal Policy for the Protection of Human Subjects. More commonly known as the Common Rule, this set of ethics involving the protection of human participants is codified under Title 45, Part 46 of the Federal Regulations. These DHHS regulations are divided into 4 subparts and were revised to modernize and strengthen the Common Rule in July of 2015Subpart A: The Federal Policy, or Common RuleSubpart B: Additional protections for pregnant women, human fetuses, and neonatesSubpart C: Additional protections for prisonersSubpart D: Additional protections for children19 He conducted a study on 500 mostly black patients to test new drugs and anesthetics without the approval of the National Drug Authority. In 1996, Pfizer  sent a team of US doctors to Kano, Nigeria, to compare trovafloxacin (Trovan), an experimental drug to treat bacterial meningitis, with ceftriaxone.20 Eleven children died, and others endured brain damage in the control arm allegedly as a result of receiving a suboptimal dose of ceftriaxone. Pfizer was sued through the US courts and settled out of court. In addition to these and many other documented reports of research abuses in Africa and poor-resource nations in other parts of the world, the majority of incidences related to breaches in ethical conduct most likely go unreported. This may be a result of weak regulatory systems and mostly litigation-free environments. There is also a tendency to underreport adverse events, and volunteer participants are generally happy to participate in what they regard as innovative medical breakthrough research and treatment.19The non-Western world has certainly not been immune to research and ethics abuses, with numerous reports documenting unethical research and clinical trials in Africa and elsewhere. The 1990s were especially trying times for medical research in Africa. For example, a British anesthetist by the name of Dr Richard Gladwell McGown, working in Zimbabwe, was charged with murder for the death of 6 patients.21 The elders of the community usually preside at this forum, and all viewpoints are shared.21 For meaningful informed consent, researchers have to appreciate and respect the cultures and beliefs of the groups they recruit for research studies.19 Questions have also been raised about whether participants in vulnerable situations truly consented or whether they were paid to participate or misled to believe that the new treatment is a medical breakthrough and will cure them.Autonomy, beneficence, and justice provide the framework of the Belmont Report and provide the bioethical precepts of conducting human participants research in the United States and other Western countries. Interpreting and applying these principles in another cultural setting may be challenging. Controversies have erupted concerning the ethics of biomedical research sponsored by wealthy nations and conducted in resource-poor countries. In developing countries characterized by such factors as poverty, low literacy levels, and limited access to health care, informed consent becomes especially complex. Often there is a language and/or cultural barrier between the researcher and the participant. Beliefs about disease causation may also differ. Cultural perceptions of individuality also influence the decision-making process. In Western cultures, decisions are made independently. However, in an African context, decision making is often communitarian and semiotic, involving consultations with family and/or community members where issues at stake are discussed in a forum (imbizo).24 Another important consideration to the implementation of the Belmont Report in low-resource nations is the distribution of benefits and burdens inherent in the research design. For example, it was always the intent of the manufacturer to market the drug lucinactant in the United States and other developed countries.25 Thus, the benefits would go to infants in the United States and perhaps other more developed countries, while the burdens (risks) of the research would be borne by infants in Latin America, where the study was conducted but the drug unaffordable by its population. This distinction between the population asked to test the drug and the population in which the drug would be marketed violates the principle of distributive justice . Redesigning the study might have improved its ethical foundation. For example, the drug might have been provided to the Latin American country free for a period of time or at a discounted price.26 Thus, it is essential that local ethics committees have the knowledge, expertise, competence, and authority to review and both approve and reject, when appropriate, clinical trials.Clinical trials in poor-resource nations have also generated considerable debate about whether the use of a placebo  is ethically just, especially when there is a course of effective treatment used elsewhere in the world but that is unavailable in the countries in which the study was conducted.19 Countries that do not have review boards have the option to request assistance from neighboring countries. For example, in Guinea-Bissau, once a research proposal is disclosed to the government and deemed appropriate, it can be sent to the National Ethics Committee in The Gambia for review and approval.19 It is critical for researchers to have a clear understanding of relevant cultural issues of host countries, especially those of developing nations, to conduct studies that truly embody the essence of autonomy, beneficence, and justice and are free of group harms.The Regional Committee for Africa of the WHO conducted a survey study to determine the existence and utility of RECs across Africa.28 The study findings were that 36% of member countries had no RECs. In the countries that did have RECs, most RECs met monthly, 5 met quarterly, and 1 never met. Milford et al29 studied the resource needs of African RECs regarding HIV vaccine trial preparedness and found that 97% of African RECs felt they did not have adequate training in ethics and HIV vaccine trials and 80% felt they did not have adequate training in health research ethics.28 Hyder et al30 reported similar findings, while also demonstrating that the majority of researchers were middle-aged males who were physicians used by academic institutions, carrying out research on a part-time basis. The study by Hyder et al30 also indicated the need for local language consent forms and approval letters. Concerns for confidentiality protection of participants were raised by US IRBs in significantly higher proportions than by host country IRBs. In 2007, the Bill and Melinda Gates Foundation supported the African Malaria Network Trust to conduct a broad survey of 31 RECs in Africa to identify institutional needs.19 The results of the survey demonstrated that committees lacked guidelines and standard operating procedures, training, and electronic data management and archiving systems. Fast forwarding to 2019, many issues and inefficiencies such as obtaining timely approvals still exist in poor-resource nations, risking the ethical and data integrity of clinical trials.For these reasons, US regulations mandate a study to be reviewed and approved by an IRB in both the United States and the host country. US regulations also require that researchers adhere to the national guidelines or regulations of the host country.31 With disease burden on the rise in Africa and disproportionately affecting the developing world at large, 10% of the nearly 100,000 clinical trials conducted annually worldwide are occurring in developing countries.32 Well-run clinical trials can provide national health care solutions to national problems, build local health care capacity, provide employment and access to new health care services and treatments,19 improve the quality of care, and build confidence in health care practices.Before a clinical trial can begin, it needs to be reviewed and authorized by a regulatory agency to ensure that human participants are protected and to provide assurance that the data generated are accurate and credible. In the United States, an Investigational New Drug application must be filed with the FDA to obtain permission to start human clinical trials. In Europe, a Clinical Trial Application is filed with the European Medicines Agency. Detailed documentation about the Investigational Medicinal Product, which should include preclinical data, safety evaluation, manufacturing process, toxicology, and safety pharmacology, is required to be submitted as part of regulatory documents for obtaining clinical trial authorization. Unlike the United States or European Union, sub-Saharan Africa is not a single unified market. Rather, it is made up of 46 different markets each with its own National Regulatory Agency (NRA) and each having varying levels of regulatory maturity. This diverse regulatory environment leads to challenges when bringing a drug to market. In June 2016, during a meeting of the African Vaccine Regulatory Forum, heads of NRAs and national ethics committees across Africa agreed to harmonize their practices to strengthen regulatory oversight of clinical trials across the continent.33 There are differing clinical trial authorization time lines depending on the phase of the clinical trial. For instance, first-in-human studies tend to have shorter review and approval time lines than phase II and III studies. During the development of anticancer drugs, clinical trials usually involve patients with cancer whose disease condition is progressive and fatal. In addition, the dose levels in these clinical trials are often close to the adverse effect dose levels.Clinical trials are usually carried out in different stages, called phases. In the preclinical stage of anticancer drugs, there are specific nonclinical guidelines that must be adhered to and that regulatory authorities will look out for when the regulatory dossier is submitted for authorization. There are 4 main phases of clinical trials—phases I to IV—although some trials may be categorized as phase 0 trials. Phase 0 trials involve a small number of patients with cancer (approximately 10-20 patients) and test a small drug dose. These trials aim to determine whether the study drug targets the cancer cells and whether there are early signs of efficacy. Phase I trials enroll 20-80 patients. The main aim of phase I clinical trials is to determine the safety of a new drug and the maximum-tolerated dose. If a drug is proven to be safe, it advances to phase II. Phase II trials enroll 100-300 patients and aim to determine therapeutic efficacy as well as to continue to monitor drug safety and the adverse effect profile. Phase III trials enroll hundreds of patients and aim to compare the new treatment to standard-of-care treatment, which serves as the control arm. Safety continues to be monitored. Patients are randomly assigned to a treatment arm to minimize bias, and the study is double-blinded, meaning neither the patient nor the doctor knows which treatment has been assigned to the participant until the study is over. Phase IV trials test a drug after it has been approved. They are conducted in thousands of patients, and the goals is to learn more about the drug’s short-lived and long-lasting adverse effects, long-term benefits, and cost-benefit analysis.28 Researchers need to enhance their cultural competency to adjust their mindset to the specific needs of the patients who are participants in their research and also need to gain a clear understanding of the ethical guidelines of both the sponsoring and host countries. Finally, the scientific community needs to continue to debate best practices in low-resource nations. After all, everyone deserves equal access to clinical trials, and we must strive to achieve that.In conclusion, the purpose of ethics and regulations is to protect the rights and welfare of patients, ensuring autonomy, beneficence, and fairness. However, all people are not provided the same oversights and protections, with improprieties disproportionately affecting poor-resource nations and vulnerable populations. As we approach the post–communicable disease era in Africa, cancer will take the lead as the most burdensome ailment on the continent. As a result, the need for oncology clinical trials in Africa is greater than ever before. However, this must be tackled in concert with improving ethical standards, compliance, and reporting. In addition, many African countries need to be better equipped to handle RECs or learn how to rely on neighboring countries with more established ethics committees. Additional information on how African RECs function, including their staffing, operating procedures, strengths, and challenges, would be useful for African and international researchers working within Africa and for growing efforts to enhance ethics capacity across the continent.


The coronavirus disease 2019 has not hit Nepal as hard as it has the rest of the world (as of 4th April 2020). Countries are reporting a saturation in healthcare facilities and facing a rise in demand for human resources for health. It is difficult to predict the extent of the disease transmission in Nepal in the absence of epidemiologic and statistical analysis in our context. But based on calculations made by epidemiologists in other countries, there seems to be a significant possibility of an outbreak in our communities too. Medical students can be a valuable human resource in a variety of ways to aid in the country's response to a possible outbreak. However, their involvement in the pandemic comes with its own challenges. Thorough planning and preparation must be done before allowing medical students to take part in the battle against the pandemic. In such a context, the future will present substantial challenges.The World Health Organization (WHO) reports that as of April 11, 2020, the coronavirus disease 2019 (COVID-19) has spread throughout the world with 1,610,909 confirmed cases and 99,690 mortalities globally.1 As of April 11, 2020, there are 15 patients in isolation in different hospitals, and 9 confirmed cases of COVID-19 out of 4426 tests done in Nepal.3 Although this data is from the time when a lockdown was not put into place in China, it shows how easily the spread could go out of hand.Countries that have been affected the most have reported a significant scarcity of health resources resulting in a depleted and overworked human resource for health (HRH). From a public health perspective, mitigation measures  that have been put into place in Nepal aim to flatten the epidemic curve so that those who are infected can be managed without saturating available health resources. Though we can hope for a future where the number of COVID-19 positive cases that require health services at any given time remains in proportion with the available resources, globally a much scarier picture is being seen. COVID-19 had a doubling time of 4-5 days, in its early stages in China.Preparations must factor in the possibility of a lack of human resources during an outbreak. Utilizing doctors, nurses, paramedics, and all auxiliary healthcare providers might not be enough if such a situation arises. With an eminent risk of the frontline workers themselves being infected and having to be isolated until recovery present, it would be unwise to falter in deciding how to maintain an adequate human resource. Thus, the country might have to deploy medical students in response. As a matter of fact, the Ministry of Health and Population (MoHP) has asked state governments to deploy medical students studying with a government scholarship if necessary.4Several governments have alluded the possible use of medical students in health systems affected by COVID-19.5There are medical schools that are allowing students to graduate early or return to the clinical environment to help address impending staff shortages.6A group of Harvard medical students have prepared a faculty reviewed COVID-19 curriculum.7 Similar initiatives have been taken in other countries too.Hundreds of medical students in the United States (US) have contributed to collect and distribute surgical and N95 masks, deployed to call-centers, provided child-care services and used technology and innovation to help in different ways.Medical students can take inspiration from peers in other countries. Simply, medical students can help spread authentic information on COVID-19 and aid in risk communication and community engagement (RCCE). They can explain their families and community members the relevance of social distancing and handwashing practices, give them knowledge on mitigation and containment and their effectiveness in controlling the disease spread, and explain the ways in which the disease transmits and the methods of preventing it. Teaching people the proper ways of handwashing could contribute in putting a stop to the transmission. Many people might be having seasonal flu, whose symptoms are like those exhibited by patients with mild cases of COVID-19, causing unnecessary stress and anxiety in them. Although the diagnosis should be made by a licensed practitioner, a medical student, based on sound scientific evidence can counsel them about the prognosis and possible outcomes, and warn them about the danger signs following which they should ought for medical care immediately.6Creative students can help spread credible information via social media and digital platforms through infographics made in an understandable language. A further step would be to translate such information in a local language, which can increase the reach of the information and engage more people. For example, I have collaborated with the COVID-19 student response team of the Harvard Medical School to translate graphical summaries of their COVID-19 curriculum into Nepali.On a larger scale, the government can deploy medical students to trace undiagnosed cases of COVID-19. They can assist the case investigation and contact tracing teams in screening large groups of people for the disease via rapid diagnostic tests or in sample collection for the polymerase chain reaction test. This could be valuable training for medical students; which they wouldn’t get through the usual curriculum. They can also assist in distributing humanitarian aid, like food and necessities to the needy.Without the risk of an exposure, medical students can be placed in call-centers to offer guidance to concerned individuals about their symptoms, and provide information on infection control measures, when to visit a doctor, where to get tested, what hospitals have been assigned to treat COVID-19 cases, etc.Although deploying medical students alongside physicians seems like a great idea, it does come with its challenges. Firstly, the ethical issue of whether or not to expose unlicensed students to the direct risks of transmission has to be given much thought. Due to a limited experience, putting the safety of students, other healthcare providers and patients in danger by deploying them would depend on the extent and severity of the outbreak and the demand of the situation. Training medical students before deployment would be one way to come around this challenge. However, in case of an already stretched-out and overworked human resource during the outbreak, it would be difficult to organize such training.Guidelines and standard operating procedures (SOP) for medical students must be prepared beforehand to provide a clear description of what roles are to be played. Since, students are not licensed practitioners, they are not bound by the same governing legal and ethical provisions as are health professionals. For example, there are ethical codes, guidelines, Nepal Medical Council (NMC) act and regulation for medical practitioners. However, the same could also not be used to govern medical students. So, a description of their roles and responsibilities, ethical and legal guidelines, and terms of reference describing what to do and what not to do when faced with a difficult situation must be provided to students.Putting students in the frontline would mean that they are exposed not just to the infection, but also to the immense physical and mental stress the situation brings. Watching patients in distress, and debilitated patients lose their lives might leave a severe psychological impact on them.Medical students are a trained cohort of people with knowledge of the disease, epidemiology, and principles of infection transmission and control. Technical information and concepts can be simpler to grasp for the students in comparison to others. Thus, it would be effective, time-efficient, and would require fewer efforts to train them for certain roles in the battle against the outbreak. However, it would require thorough planning and proper guidelines and a collaboration with multiple sectors before bringing it into practice.None.


The American College of Veterinary Behaviorists is a specialty group within the American Veterinary Medical Association. It was formed by eight veterinarians and has grown ten-fold in the following decades. The specialty ensures that those who are its diplomates have taken the training, seen hundreds of cases, published research on animal behavior, and successfully passed an examination so the public can be assured that their animal will get the best treatment for its behavior problem.The American College of Veterinary Behavior has grown in number and in expertise over the past quarter century. There are now 86 diplomates, at least three textbooks on treating behavior problems, and a text on veterinary psychopharmacology. Although veterinary behavior began in veterinary colleges, the majority of residents are now trained in non-conforming programs. Many more diplomates practice privately in specialty clinics or as separate businesses. Progress has been made in both diagnosis and treatment with polypharmacy, resulting in successful outcomes for many dogs and cats suffering from separation anxiety, fear, or aggression. While the study of basic animal behavior had been around for decades, the study of pet animals and the behaviors they exhibit that their owners do not want was a relatively unexplored discipline. The discussion of Veterinary Behavioral Medicine as a discipline to add to veterinary medicine began in the early 1980s. In the US there were several veterinarians employed at veterinary schools teaching animal behavior. They were at Texas A&M, University of California at Davis, University of Pennsylvania, Georgia, and Cornell. By then, cats and dogs had become “family members” and shared the home with the family. What followed were behavior issues that needed resolving. What the students wanted to learn was not the neurohumoral basis of feeding behavior, for example, but what kinds of behavior problems they would see in practice. We began to see cases as soon as the clinicians realized that there was someone who could help dog and cat owners with their pets’ behavior problems. The problems were unruly behaviors, aggression toward family and unfamiliar people, house soiling in dogs and mainly house soiling in cats.Because this was a new field, we wanted to get together to share experiences and learn from each other, so we began to meet annually. One of the big decisions was whether to include non-veterinarians in the group, many of whom were seeing (and curing) behavior problems. The American Society of Veterinary Ethology (ASVE) was founded in 1976 and in 1986 was renamed the American Veterinary Society of Animal Behavior (AVSAB), and is still in existence today. Any veterinarian can join and others with advanced degrees can become adjunct members. In Europe, The Society for Veterinary Ethology was created in Edinburgh on 4 June 1966. It rapidly expanded to cover all applied aspects of ethology and other behavioral sciences relevant to human-animal interactions, such as farming, wildlife management, the keeping of companion and laboratory animals, and the control of pests. The Society also quickly became increasingly international: it now has an international federal structure as well as regional representatives around the world. In 1991, on the 25th anniversary of the SVE, the society was re-named the International Society for Applied Ethology (ISAE).AVSAB was an interest group and forming an interest group is easy. Find a number of people with a common interest, write a constitution, hold meetings, charge dues, and you are a Society. AVSAB continues to this day, but before long veterinary behaviorists knew that a more formal and disciplined structure was needed, as we grew both in knowledge and size.Number of potential candidates in the near future;Plans for existing training programs, both conventional (university residencies) and non-conforming (private practice residencies), and what a resident will need to do in each;Plans for incorporation as 501 c organizations;Credentialing and examination process and plans.The process of becoming a veterinary specialty takes determination and a devoted group of likeminded individuals. In the United States within veterinary medicine, the American Veterinary Medical Association controls the creation and recognition of specialty colleges. To begin, you must gather a small nucleus, the founders or charter members, create a document that describes what you are and what you will do, and then you have to convince the American Board of Veterinary Specialists that Behavior is a legitimate specialty. The American Board of Veterinary Specialists consists of about a dozen veterinarians from other already approved specialties such as surgery and internal medicine. We had to provide the following information: The American College of Veterinary Behaviorists was approved as an official specialty of the American Veterinary Medical Association in 1993. The European College of Animal Welfare and Behavioural Medicine received provisional recognition from the European Board of Veterinary Specialisation (EBVS) in 2002 and full recognition in 2012There were only eight people on the founding committee: Bonnie Beaver from Texas A&M, Katherine Houpt from Cornell, Benjamin Hart from University of California Davis, Victoria Voith from the University of Pennsylvania, Sharon Crowell-Davis from the University of Georgia, and several veterinarians chosen for their expertise in fields other than behavior. Tom Wolfle was a laboratory animal specialist, board-certified by the American College of Laboratory Animal Medicine, Elizabeth Schull was board-certified in Neurology, and R.K. Anderson was board-certified in Public Health.As a new college we had many tasks and only eight people to do them. We had already determined that in order to be board-certified a veterinarian must have at least one year of clinical medical experience after veterinary school and then a two- to three-year residency, during which the major portion of time is devoted to treating animals with behavior problems, augmented with course work in various aspects of behavior, such as ethology, learning, and neuroscience. In addition to the residency, the veterinarian must publish a paper in a refereed journal, submit three acceptable case reports and take a two-day written examination. See Pankratz et al. 2017) and Albright et al. (2015) for examples of scientific papers that meet the criteria [7 and AlbInitially, we had three residency programs, each taking one individual. Training was usually three years or more if a MS and/or PhD were also pursued. We were the first board certifying organization for behavior, and initially the growth of the college was slow. We always had a “non-conforming” track for those whose training pre-dated the formation of the college and those not in a university residency program. Over time we have refined and expanded our non-conforming training programs to meet the growing desire and need to have more veterinary behaviorists. At the present time most of the residents are in training programs not situated within the university setting. This has allowed our college to grow from 16 in 1996 to 86 today. The growth of non-traditional programs has allowed the American College of Veterinary Behaviorists to expand and broaden our reach across North America and even into foreign countries.Initially, diagnostic terminology utilized broad terms and even borrowed some terms utilized in other animal behavior disciplines based on observations of many species, including chickens, wolves, and horses. The issues that arise in canine behavioral consultations are generally related to the interactions between the caregiver and the pet; therefore, the early focus was an attempt to understand and reorganize the human-canine relationship. Dogs communicate with each other using a system of assertive and subordinate postures to establish who prevails in a social conflict, generally over resources. In animal behavior literature, the term “dominance hierarchy” is used to denote a social ranking within a group in which some individuals give way to others in a social encounter or access to scarce resources . This leThe dog is not trying to dominate, but is trying to communicate using the only language they know—facial expressions, body postures, and vocalizations. Because anxiety and fearful postures were recognized in the situation, many terms have evolved, but none are standard across behavioral organizations. Some terms utilized recently include “conflict aggression” , a descrAnother change in diagnosis was the realization that many dogs and cats are living in environments that do not meet their needs, resulting in anxiety and frustration. When veterinarians began to see behavior cases many dogs and cats were allowed free access to the outdoors, allowing them to engage in many of their species appropriate behaviors and meet many of their mental and physical needs. Often the dogs and cats were not alone all day. However, over the last 10–15 years that has changed. Most dogs are alone at home all day, perhaps without another dog to interact with. Many cats are no longer allowed outside, depriving them of hunting and play activities that are vital to their welfare. This has led to an increase in diagnoses related to anxiety , and frustration with the inability to engage in normal species behaviors and forced social interactions within their living situations, which the pet did not choose.Another change in veterinary behavioral medicine within the USA is the realization that many pets relinquished to shelters and rescue situations could find homes with proper placement and training. However, due to vigorous spay/neuter program, a lack of dogs in one area of the country compared to another has led to dogs sourced from other places. Often, they have not received proper socialization/training or veterinary care and are placed in homes with inexperienced pet owners without the needed support to create a strong and lasting bond. Ongoing research is taking place to optimize placement of these pets and increase their chances of finding life-long homes. Improving the welfare of shelter dogs has long been the goal of diplomates of the American College of Veterinary Behaviorists ,8.Treatment of almost all behavior problems in dogs requires behavior modification with or without the addition of psychoactive medication. It is very helpful to have an assistant who can help the owner with behavior modification. Dog trainers can be hired, but the formation of the veterinary technician specialty in behavior, the Academy of Veterinary Behavior Technicians, has led to a pool of individuals who are not only experts in handling dogs, but have also demonstrated a thorough knowledge of learning principles. Use of those skilled in positive reinforcement and other non-aversive techniques allow the veterinary behaviorist time to determine the most likely diagnosis and most promising medication for the patient, while the technicians help the owner with behavior modification.®, Parsippany, NJ, USA) selegiline), for the treatment of cognitive dysfunction in dogs [In the beginning owners were very reluctant to give psychoactive medication to dogs or cats. Their attitude was “just say no to drugs”. There seemed to be two objections to the use of medication: (1) the owners did not want to admit to others that they were using drugs to control their dogs; (2) they did not want to change the dog’s personality . Over the years, owners have become more educated about anxiety-related behaviors and are more likely to demand drugs than to refuse them. The other change was the development of three drugs with FDA approval for treating canine behavior problems. The efficacy of each of these drugs was proven by the research sponsored by the pharmaceutical companies and performed mostly by ACVB diplomates. The first was deprenyl , for separation anxiety in dogs [® Pensacola, FL, USA), for separation anxiety in dogs [The second was clomipramine  is available as a gel to be given transmucosally. That route of administration leads to a very rapid onset of action. For that reason, it is very useful for treating storm and other noise phobias in dogs.Most of the medications used for behavioral problems are given orally, but dexmedetomidine  or tricyclic antidepressant, reduced fear-based behavior problems [The next big step in treatment was combining drugs. Gruen et al. (2007) found that adding trazodone improved the behavior of dogs suffering from separation anxiety who were also receiving clomipramine . Ogata aproblems .Now, it is not uncommon to use three drugs on our referred cases to reduce anxiety . TrazodoThe veterinary psychopharmacology text by Crowell-Davis et al. 2019) has added, in the second addition, chapters on miscellaneous serotonergic agents, anti-convulsants and mood stabilizers, N-methyl-D-aspartamate receptor agonists, and drug combinations [ has addeOver the past thirty years the American College of Veterinary Behaviorists has been able to improve the outcomes of behavior problems through better diagnostic procedures and, in particular, more effective use of psychoactive medication. Our progress is reflected in the textbooks on clinical animal behavior published by diplomates of the American College of Veterinary Behavior ,21,22.We look forward to specialty groups in behavior forming in other regions of the world. Below are some guidelines for those establishing certification for veterinarians specializing in treatment of behavior problems of animals.(1) Establish flexible bylaw rules for establishing training programs that can be altered by the voting members of the specialty group;(2) Account for people whose training predates the formation of the specialty organization;How many will be grandfathered (exempt from training provisions) and why?How long will certain options exist for providing alternative training paradigms once formal establishment of the specialty occurs?(3) Make sure from the beginning to have alternate pathways to the same end, including university-based training programs and programs that take place within a private practice setting.From the very beginning these programs should have the same requirements and oversight.Update those requirements from time to time for both groups as the field changes;(4) Keep good records and document how the training and testing have evolved to avoid confusion as the specialty group grows.


Health care professionals are caught between the wish of patients to speed up health-related communication via emails and the need for protecting health information.We aimed to analyze the demographic characteristics of patients providing an email, and study the distribution of emails’ domain names.We used the information system of the European Hospital Georges Pompidou (HEGP) to identify patients who provided an email address. We used a 1:1 matching strategy to study the demographic characteristics of the patients associated with the presence of an email, and described the characteristics of the emails used .Overall, 4.22%  of the total population of patients provided an email address. The year of last contact with the patient is the strongest driver of the presence of an email address . Patients more likely to provide an email address were treated for chronic conditions and were more likely born between 1950 and 1969 . Of the 41,004 email addresses collected, 37,779 were associated with known email providers, 31,005 email addresses were associated with Google, Microsoft, Orange, and Yahoo!, 2878 with business emails addresses, and 347 email addresses with personalized domain names.Emails have been collected only recently in our institution. The importance of the year of last contact probably reflects this recent change in contact information collection policy. The demographic characteristics and especially the age distribution are likely the result of a population bias in the hospital: patients providing email are more likely to be treated for chronic diseases. A risk analysis of the use of email revealed several situations that could constitute a breach of privacy that is both likely and with major consequences. Patients treated for chronic diseases are more likely to provide an email address, and are also more at risk in case of privacy breach. Several common situations could expose their private information. We recommend a very restrictive use of the emails for health communication. Several studies illustrate this trend throughout the world -4. The a natives  among bo natives , or the  natives ).Regarding data privacy and electronic communication, the American HIPAA Compliance Guide  clearly Regardless of those guidelines, patients may use a variety of email services in their everyday life, including personal email servers (hosted directly by the patient or by a mandated third party), public email providers , and business email providers .The use of business or personal email addresses accessed from the workplace is regulated, and could lead to privacy breaches. The US -13 and EData privacy can also be weakened or even shattered by different types of security breaches such as global surveillance programs  in Paris, France. We described the demographic and minimal clinical characteristics of the patients who provided an email address in contrast to those who did not. We examined what types of email services  were used by patients, identified the main email service providers, and studied the use of business email accounts. Finally, we discussed the potential issues associated with the type of email services.In this section, we detail the data collection and wrangling process, the statistical methodology used to analyze the demographic characteristics, and describe the methodology used to explore email characteristics.The study had a cross-sectional design, and we followed the STROBE recommendation  for the Data were extracted from the clinical information system of HEGP, a 700-bed university hospital located in Paris, France, specializing in oncology, cardiovascular disease, and emergency medicine. HEGP has been using a clinical information system since its opening in 2000  and is cThe study population includes all patients with a hospital stay or an outpatient visit between January 1, 2000, and November 1, 2018, dates on which data were extracted.domain name In the remainder of the manuscript, we will refer to the part of an email address located after the character “@” as the We collected the following data from the hospital’s information system: the domain name of the patient’s email address, sex, year of birth, year of the first contact with the hospital (stay or visit), year of last contact with the hospital, and the presence of their first or last names in the domain name of their email addresses. To preserve privacy, an algorithm automatically substituted the domain name with a random string before the extraction when the domain name included the first or last names of the patient.The presence of an email address in the database may depend on the year of first contact with the hospital. In addition, the use of email address and the administrative registration procedure are time dependent. To mitigate this risk of bias, we matched cases (patients with email address) and controls (patients without email address) on the year of first contact with the hospital using a 1:1 ratio.(univariate matching). The quality of the matching was checked . In addiWhois requests when necessary. We then evaluated in the curated data the frequency of each of the providers.We mapped the most frequently used domain names to companies providing the email service . The companies were identified using prior knowledge and We defined a business email as an email provided by someone’s employer. To define business emails, we leveraged a list of free email service providers compiled by Svay , secondaPersonal emails were identified during the extraction process by the presence of the first or the last name in the domain name.U test for numerical data and chi-square test for categorical data. A logistic regression analysis was performed to determine characteristics associated with having an email address on the matched groups. All analysis were performed using R Statistical Software [Data were expressed as n (%). Characteristics were compared between groups  by Mann–Whitney Software . The souSoftware .The study was authorized by the HEGP Institutional Review Board on December 21, 2018. The HEGP Institutional Review Board  has waivBetween 2000 and August of 2018, we collected 41,004 patient email addresses . Of the total number of patients in the database , we selected a subgroup of 41,004 patients as a control group . The characteristics of the population and the control group are described in The 10 most frequent email providers and their frequency on the data set are summarized in Starting from 41,004 email addresses, we identified 37,779 email addresses associated with known email providers. We removed 347 emails likely to use personalized domain names  and identified 2878 domain names likely to be associated with business email addresses.For privacy reasons, we did not detail the nature of the companies present in the list. However, we can highlight notable findings: around 100 people used email addresses from our own institution. We also found more than 50 email addresses associated with other governmental institutions.Unsurprisingly, among the most represented companies, businesses geographically located close to the hospital are on top of the list.P<.001). The proportion of patients born between 1950 and 1969 with an email address was higher , whereas we observed the opposite for patients born after 1989 . Between 2000 and August 2018, out of 971,822 recorded patients, HEGP patients have provided 41,004 email addresses. Patients providing email addresses were mostly born between 1950 and 1989  and had their first contact  with the hospital after 2010. Among patients who provided an address, the follow-up duration was mostly less than 3 months , or more than 60 months .Among all the email addresses collected , 37,779 corresponded to known email providers. Among the top 10 email providers , 65.99%  were hosted by companies with headquarters located in the USA, versus 30.13%  hosted by companies located in Europe; 7.02%  of the patients provided business email addresses, and 0.85%  used a personalized domain name.Compared with patients who did not provide an email address, patients who provided one were older. The systematic collection of email addresses in our institution was put in place only recently, explaining the strong effect of the year of last contact .We counterintuitively observed a lower proportion of email addresses in younger patients. A selection bias in the hospital population is likely to be blamed. Indeed, our hospital is specializing in cardiovascular diseases, oncology, and emergency medicine. Younger patients mostly treated for nonchronic diseases or visiting the emergency department are less likely to provide their address than older patients with a regular follow-up for a chronic condition in specialized departments.To the best of our knowledge no institution has provided a description of email providers used by their patients. Newhouse et al  have desThe comparison with related studies should be made carefully as the French and US populations are not strictly comparable; furthermore, the organization of the French and US health systems are substantially different.This study has some limitations. The first is a selection bias which may limit the generalizability of its findings. This is a cross-sectional study with a large period of inclusion but our population comes from a university hospital in Paris and is not representative of the national population.This study only reflects the official collection of email addresses. It is possible that health care professionals use direct email communication with their patients outside of the hospital information system. Therefore, the volume of email addresses collected might be underestimated. However, it is likely that the distribution of domain names remains similar.Another limitation is a bias in the measurement of chronic comorbidities from the ICD-10 according to . BetweenThe main risk lies in the interception of the email by a third party. Two main cases appear very probable: (1) breach of privacy through smartphone notifications, given that only a limited number of smartphone users are able to fine-tune the privacy settings of their smartphones and tablets; (2) breach of privacy through family members: the email address provided in the information system may be used by other members of the family. It could be a shared email address with their spouse, the address of a child for elderly patients, or that of a parent for younger patients. The shared address collected at a point in time might not reflect the patients’ aspirations for privacy at a later date.The hacking of email accounts and information accessed by employers are both likely. It is worth noting that business emails can legally be monitored. In such a case the infrastructure to read and capture the information may already be deployed. In the case of email hacking, additional steps are needed.Many health professionals now use encrypted emails to exchange information with their colleagues. In such cases, the privacy of the exchange is guaranteed by technological means. However, most of the secured email solutions in health care are designed to protect communications among health care professionals, and not with patients. The direct communication via emails may put the patients at risk of a privacy breach.In the communication between health institutions and patients, 3 strategies can be identified: a push strategy , a pull strategy , or a bidirectional strategy. The first 2 are already taken into account with the current communication protocols by most of the health care providers. However, unsolicited direct communication from the patients to their physicians can lead to privacy breaches. Health organizations increasingly rely on secured platforms to transmit health documents to their patients . HoweveNote that in the context of health care, the name of the institution can reveal sensitive information . To mitigate this risk, the use of an email address from a general care provider  might be preferable.Patients can expose their health data to harm when they use unsecured communication channels . Regulators engaged the responsibility of the institution through the GDPR and HIPAA guidance (in Europe and the United States), but cannot fully protect citizens against their own data sharing behavior.engaged citizen-patients . The education of citizens regarding data privacy and governance should be promoted and encouraged.Protection of data privacy is based on both accountable health care professionals and The demand, and legitimate need, for easier ways of communication might overlap strongly with the privacy paradox. First mentioned by Brown in 2001  and defi


There is lack of literature on international comparison of gender differences in the use of active travel modes. We used population-representative travel surveys for 19 major cities across 13 countries and 6 continents, representing a mix of cites from low-and-middle income (n = 8) and high-income countries (n = 11). In all the cities, females are more likely than males to walk and, in most cities, more likely to use public transport. This relationship reverses in cycling, with females often less likely users than males. In high cycling cities, both genders are equally likely to cycle. Active travel to access public transport contributes 30–50% of total active travel time. The gender differences in active travel metrics are age dependent. Among children (< 16 years), these metrics are often equal for girls and boys, while gender disparity increases with age. On average, active travel enables one in every four people in the population to achieve at least 30 min of physical activity in a day, though there is large variation across the cities. In general, females are more likely to achieve this level than males. The results highlight the importance of a gendered approach towards active transport policies. Such an approach necessitates reducing road traffic danger and male violence, as well as overcoming social norms that restrict women from cycling. Walking and cycling are physical activities that can be incorporated in daily lives. People who engage in active travel tend to be more physically active . PhysicaWalking and cycling can be for the whole journey or to access public transport. Studies have reported that use of public transportation is a significant contributor to physical activity . A signiDaily mobility in a population is highly gendered . AverageWhat are the gender differences across the cities in terms of use of active modes of transport for all trips and for trips to work?What are the gender differences in What are the gender differences in the proportion of the population achieving 30 min of physical activity from active travel?Given that gender inequalities vary across countries, it is likely that the gender gap, in both mobility generally and active travel specifically, varies greatly across the world. The following includes the section on method that provide details of the datasets used, as well as the analysis conducted. This is followed by a section on results. Next, we present discussion and conclusions of the paper.To answer these research questions, we used population-representative household travel surveys for 19 cities from 13 different countries in five different continents . An exceTravel survey datasets include demographic and socio-economic details of the individuals among the sampled households, and their travel diary on a given day, consisting of trips and corresponding stages. Within a trip, a stage is completed when a transfer is made from one mode to another. For example, a bus trip usually consists of three stages, with first stage of walking to bus stop, second stage of travelling by bus, and third stage of walking from bus stop to destination. Travel surveys often assign a date to the sampled households for which they report their travel activities in a diary format. In some surveys that involve face-to-face interviews of the respondents, respondents are asked to recall travel activities of the previous day. As a result, in travel surveys, there are individuals who report no travel activity, as is possible for a variety of reasons. This day for which respondents report their travel activities is referred to as ‘travel day’.For this analysis, our focus is the use of active travel modes i.e. walking and cycling, and their contribution to population-level activity levels. Active modes of transport can be used to travel the whole trip, or one or more stages of a trip, for example, walking to public transport access points or to the parking lot. The ideal travel survey dataset for our analysis is when mode of transport and travel time are reported for each stage within a trip. Among the 19 cities, the datasets differ in reporting this detail. For some cities, all the required information is reported for the stages . For some, duration of total walking, done for part(s) of the trips, is reported for each trip (Sao Paulo and Bogota). In Buenos Aires, mode of travel for each of the stages is known, but duration of those stages is not. For some, stage-level data is not reported for any trip . In total there are 10 cities with data on stage-level active travel and 9 without it see . We highAs many trips are multimodal in nature, ‘main mode’ of a trip is typically defined as the one with which a stage with the longest duration has been travelled. Some datasets reported main mode of transport for all trips. For the cities where it was not reported, we used the stage-level duration data to identify main mode. For cities, where stage-level data was reported, but no travel time (e.g. Buenos Aires), we used a hierarchyFollowing the research questions (RQ) mentioned above, we present five metrics of active travel use. These include mode share of all trips and for work trips (RQ 1), level of immobility (RQ 2) and active travel time per capita (RQ 2), percentage contribution of active travel time by main modes (RQ 2), and percentage of individuals achieving 30 min or more of daily active travel time (RQ 3). Mode share is calculated as the percentage share of trips by the main mode of travel. Level of immobility is the percentage of individuals who reported not going out of home on travel day, which could result from sickness, disability, voluntary decision to stay at home, or underreporting by survey respondents . Active Among the metrics described above, active travel time per capita, percentage share of active travel time contributed by the main modes, and percent individuals attaining ≥ 30 min of active travel time on their travel day suffer from inconsistency of stagelevel data, which presents a challenge in comparing these metrics across the settings. For cities where stage-level data is not reported, this leads to underestimation of active travel that individuals engage in as part of public transport trips. Therefore, we developed the following method to harmonise these metrics across the cities. We calculated gender-specific trip-level average active travel time for all main modes  for each of the 10 cities where stage-level data is available. The averages were calculated for the following modes—bus, metro, train, taxi, car, and motorcycle. In some cities, one or more of these modes are not available. We calculated the median of those averages from 10 cities . Next, wIn more likely to cycle than males. Cycling levels are generally the highest among the working age group followed by children, and the lowest among older adults. The gender differences vary greatly over the age groups. Among children, girls are 30% less likely to cycle than boys. Among working age groups and older adults, gender differences are equally high, with about 50% lower likelihood among women than men.Among the three modes of transport, levels of cycling show greatest variation across the cities. The lowest levels of cycling are in Accra and Cape Town, with almost no cycling among females and less than a percent among males. The highest levels are in the four German cities with an average of 14–15% for the two gender groups. The gender differences are the highest for this mode of transport, and in a direction opposite to that of walking. On average, females are half as likely as males to cycle. The notable exceptions are the German cities of Berlin, Munich, and Hamburg, where females are Highest levels of public transportation mode shares are in the Latin American cities of Bogota, Buenos Aires, Mexico City, Santiago, and Sao Paulo, with an average of 39% among females, and 37% among males. These levels are many times greater than in Chicago, Los Angeles, and Melbourne, which have the lowest levels of public transport use (average of 7% for the two gender groups). In all the cities, except Delhi and Mexico City, females are more likely to use public transport. On an average, likelihood to use public transport among females is about 6% higher than among males. The use of public transport is lowest among the children, highest among the working age, and slightly lower among the older adults than the working age. Gender difference in the use of public transportation is highest among older adults. In this age group, women are, on average, 26% more likely to use public transportation than men. Among children and working age group, females are only 5–6% more likely, on average.In The levels of public transportation among women are the highest in Bogota, Buenos Aires, Mexico City, New York City, and Santiago, ranging from 57 to 68%, while among men, these levels range from 37 to 54% in those cities. In contrast, in Chicago and Los Angeles, use of public transportation among women is 8–12%, and among men, less than 10%. Women are on average 21% more likely than men to use public transport to travel to work, and this gender gap is much higher than in all trips combined. The gender differences in the use of public transport are the highest in the Latin American cities.Similar to the finding in the previous section, the four German cities have the highest levels of cycling to work, and these levels are even higher than their corresponding values in all trips combined, presented in lower levels of activity than males, and in the latter, females have 15% higher levels of activity than males.lower active travel time per capita than males. This gender difference among older adults is in an opposite direction to the other two age groups— among children and working age groups, females have higher levels of activity than males. In Delhi and Buenos Aires, which have the highest gender difference for all age groups combined, activity levels are equal among children. It is in the higher age groups that the gender gap widens for the two cities, except in Buenos Aires, two gender groups are again equal among older adults. Using the alternate method for harmonisation, we found that the average results of most cities are within 4 percent of the estimates obtained using the main approach . Older women have the lowest levels among all gender and age sub-groups, and the gender difference within this age group is also the highest— women have on average 16% oach see . Thus, oIn Cycling contributes an average of 8% of total active travel time among females across the cities, while it contributes about twice as much (15%) among males. The four German cities have the highest contribution of cycling to active travel time, with an average of 24% among females and 29% among males. The average contribution of public transport to total active travel time is 28–29% for the two gender groups, and the gender gap is the lowest among the three modes of transport. The three cities with the highest contribution of public transport to active travel time for females are Buenos Aires, New York City and Santiago (43–51%), and for males are Buenos Aires, Mexico City and Santiago (46–55%). Delhi has the lowest contribution by public transport for females (8%) and Zurich for males (14%).Among the three age groups, walking has the highest contribution to active travel time among children, and the lowest among working age group. Public transport and cycling have the highest contribution among the working age group. The lowest share of public transport is among children, and the lowest share of cycling is among older adults. The gender differences are the lowest among children for all the three modes. The highest gender gap for walking is among working age adults, and the highest gender gap for cycling is among working age and older adults. For these two age groups, the share of cycling to active travel time among females is half that of males.In Among the three age groups, working age adults are most likely to achieve at least 30 min of active travel and older adults have the lowest, with children in the middle. Children are most gender equal among the three age groups. In Delhi, where overall gender gap is the highest, there is no gender gap among the children. In Mexico City and Bogota also, the gender gap among children is much smaller than the other age groups. Working age group has similar gender gap  as all age groups combined, and among older adults, the gender gap is in an opposite direction, and females are 8% less likely than males to achieve 30 min of active travel.In most cities, females have greater level of immobility than males. In some cities of low-and-middle income countries , this gender gap is much wider. Females in all cities are more likely to walk for all trips combined and, in most cases, more likely to use public transport compared to males. This relationship reverses in cycling and females are always less likely users than males, except in German cities. For commuting to work, women’s use of public transportation is significantly greater than men. Per capita active travel time is highest in Accra and New York City, followed by the German cities. About one-third of total active travel time across the cities is from active travel related to public transport. In some of the Latin American cities, this proportion is as high as 50 percent. On average, daily travel results in one in every four people in the population to achieve at least 30 min of active travel, though there is large variation across the cities. In general, females are more likely to achieve this level than males. The gender differences of active travel metrics are often age dependent. Children (< 16 years) are often gender equal and gender disparity increases with age.An interesting finding is that despite large gender differences in the use of modes of transport, as expressed by mode shares, overall levels of active travel time are remarkably similar. We also found regional differences in the sources of active travel. In Latin America, public transport is most dominant, in Germany, cycling, and in Africa and Asia, walking. German cities are clear outliers with their high levels of cycling as well as gender equality in its use. This is in line with a global comparison of cycling in the cities  that repOur study results highlight the levels of physical activity that can be achieved from daily travel as well as the modes of transport that contribute to this activity. While the former is a determinant of health, the latter determines the access to the city. In Bogota, for example, females and males have almost the same levels of active travel time (24 and 23 min per capita). However, males gain a much greater proportion of active travel time by cycling than females (28% and 7%), and therefore the former can achieve far greater spatial access. Similarly, in Delhi, females gain almost no active travel from cycling, while men gain up to 20% of all active travel time. Thus a focus on active travel time alone underestimates gender differences in travel behaviour and its impact on access. Gender inequality often results in lower access to vehicles for women, which increases their dependence on active travel and public transport . Within and has safe infrastructure for cycling. As a result, the city has high levels of gender equality in both active travel time as well as the modes of transport used. Similar results were reported by  and high-income countries (n = 11). We found that in many cities there are large gender differences in the modes of transport that individuals use to attain travel physical activity even if the levels of activity are almost the same. We argue that these gender differences stem in part from social norms that restrict women to certain modes of transport combined with lack of safe infrastructure for active travel, most notably cycling. Evaluations of transport policies in general, and active travel policies in particular, should focus on the pathways that result in reduced risk of traffic danger, harassment, and assault while using active travel modes and normalise cycling amongst women.https://doi.org/10.1007/s11116-021-10259-4.The online version contains supplementary material available at Supplementary Material


Nowadays, the classic perception of the pharmaceutical profession in community pharmacies is facing worldwide extinction due to many factors. Among the numerous factors, online pharmacies are increasingly gaining ground thanks to their ability to facilitate customer demand. Nevertheless, they are endangering “face-to-face” contact, affecting the building of customer loyalty based on direct “human” interaction, and consequently reducing pharmacists to mere commercial figures. Patient-centered care communication is emphasized as the essential element to build a solid and appropriate interpersonal relationship with the patient, to make the consultancy process effective, and to strengthen the pharmacist’s professionalism in community pharmacy. This paper presents a narrative review of existing literature with the first aim of pinpointing the factors affecting pharmacy professional practice, and secondly, of how to improve patient-centered communication skills. A more widespread introduction of in-depth study and practice of behavioral, communication, educational, and sociological methodologies and techniques would allow for the development of more effective skills used for providing an efficient consultancy service, improving the capacity of future professionals to approach public relations. The progress of scientific and technological knowledge, the socio-economic and political changes, the demographic growth and the development of National Health Systems, and the birth of clinical pharmacy and pharmaceutical care have all contributed to the evolution of the pharmaceutical profession, which began to expand into other sectors: community pharmacy, hospital pharmacy, pharmaceutical industry, regulatory control, drug management, and academic activity ,3,4,5,6.The pharmacist acts as an intermediary between the doctor and the patient by providing both medicines and free medical advice without the need for an appointment. Although pharmacists can be the first point of contact for some healthcare consumers, they are a relatively underutilized resource and almost “invisible” in recent health care policies ,14,15.In order to enhance their profession, pharmacists have begun to reinvent themselves by finding solutions to extend their role in community pharmacy. In general, they focused on establishing a closer relationship with the patient and enhancing their professionalism by self-assuming the great responsibility of providing appropriate advice (decision-making power) .With the aim of preventing, protecting, and promoting the patient’s health, the pharmacist has to give clear and easily understandable information about the correct use of a drug and its possible contraindications so that the patient gets the maximum benefit from it  . For exaDespite all of these attempts to strengthen the profession through a new vision more inclined to customer care, today the perception of the pharmaceutical profession is increasingly at risk. It is mainly undermined by health policies, by the growing presence of drugs in supermarkets, by the increase in multiple-shop pharmacies, and by the impact of Information Technology on society. The growing use of online and mail-order pharmacies has certainly facilitated the customers but has also deprived them of the physical encounter with professionals in pharmacy. Thus, by resorting to these means, personal communication between the pharmacist and the patient has been reduced or has even disappeared ,3,21,22.As Cipolle et al. state, “Care means communication. Quality care means quality communication” . Since oGiven that the use of effective communication skills is considered essential to providing adequate assistance and advice to patients, the study and practical application of behavioral methods and communication techniques would permit pharmacists to establish a productive dialogue with the patient and thus increase social relations with the public.This paper presents a narrative review of existing literature with the aim of giving an analytical and reflective reading on the pharmacist’s role in modern society. The research was performed by pinpointing factors affecting the pharmacy professional practice and by identifying studies focused on how to improve patient-centered communication skills and health literacy. On the basis of the literature consulted and the practical cases analyzed, we underline the importance of the quality and the impact of patient-pharmacist communication. This was done with the specific purpose of exploring the possibility of translating it into a more widespread introduction of in-depth academic study and professional training of behavioral, communication, educational, and sociological methodologies and techniques. These would potentially allow a common improvement in the pharmacy practice through the development of specific and effective communication skills in order to provide an even more efficient consultancy service and to enhance the future community pharmacists’ capacity to approach public relations.In general, as Hughes  and FrieEven if they are often underestimated, the pharmacist, far from being a mere “trader,” is a health professional with a specialized knowledge in science who provides the public with services aiming to protect patients’ health and to ensure a correct, effective, and rational use of drugs ,33,34. IThis professional frame is endangered first and foremost by incongruent public intervention when policymakers, instead of considering pharmacy as a branch of the health sector and the pharmacist as a health professional, tend to regulate it as a business company like any other commercial enterprise, thus ignoring its specific role in society ,24. An eConsequently, also because of the misinterpretation of internet information, the greatest risk is that most people often operate a risk-benefit assessment with the high probability of incurring serious side effects. In particular, the elderly are at a higher risk because they are frequently not well informed about the appropriate dosing of Over the Counter OTC medications and/or their interaction with other drugs. Moreover, frequently health providers do not know which OTC drugs their patients are taking . All thiAs mentioned above, another factor negatively affecting community pharmacies, is, with few exceptions , the progressive loss of monopoly in drug dispensing . LiberalNonetheless, pharmacists are in competition with other market players who implement drug distribution based on mere economic purposes  ,39. As pAnother category of services endangering the profession, differing mostly in terms of delivery method, is represented by the entry  of oFirst and foremost, the inability of immediate response to requests of urgent advice could lead to serious health problems for the patient, hence, for instance, the prohibition in Austria of long-distance drug sale where only physical pharmacy outlets are allowed to dispense medicines . SecondlConsidering what has been said up until now and leaving aside the objective advantages that these alternative pharmacy structures and services offer, these new trends are seen by many pharmacists and some patients as a threat to effective health care. They consider internet and mail order pharmacies as impersonal and distant “factories of prescriptions,” where an interpersonal, loyalty-based patient-pharmacist relationship is impossible. The pharmacist suffers a loss in the face-to-face dialogue with the patient, a reduction of what is his/her professional role in community pharmacy, and is penalized in his/her ability to offer efficient public services ,23,24. MIn the light of what is considered in this section, it is possible to identify and highlight the factors that are undermining the professional status of the pharmacist, and they are condensed in Preparing the Pharmacist of the Future: Curricular Development, the pharmacist, in order to be defined as an effective communicator, must focus on building an open exchange of information and on involving patients in the treatment decision-making process . In. InmakinWhat seems of fundamental significance is the systematic consequence of a widespread high level of health literacy, which clearly exceeds the boundary of mere cultural aspect. As Veenker and Paans report, it is important to stress how “there is an association between the levels of health literacy and the self-assessed health status in the population: higher levels of health literacy go hand in hand with higher self-assessed health status, while low health literacy is associated with lower perceived health status”. A high (or just adequate) level of health literacy generates a higher self-awareness regarding one’s own health status. This increased awareness leads to better and more effective self-medication and self-management. Ultimately, this greater autonomy will lead to a lowered impact of household drug expenses and of the “weight” that each individual (in particular elderly people) exercise on national health systems .The above-mentioned necessity of simplifying the medical terminology into a more confidential and accessible language can be quite complicated for the pharmacist. In order to guarantee students have the right skills necessary to conduct a clear and comprehensive dialogue with the patient, tutors should include educational methods which stimulate students to carefully reflect on the “language register” used and, if necessary, lead them to learn new and more appropriate terminology. This should be then integrated into the practice of counseling sessions, giving students the opportunity to learn how to put into practice the acquired theoretical communication skills. Students need training to evolve into health care professionals with their own communication styles that could be then effective for counseling and in all the other phases characterizing the pharmacist-patient interaction  in patient-centered care services . In thisIn 2007 the US Accreditation Council for Pharmacy Education (ACPE) created guidelines (revised in 2016)  setting In the EU context, in Denmark the study of social pharmacy is a compulsory subject within the academic curriculum, while in Finland, the bachelor’s degree in pharmacy includes in its curriculum the study of how to set up proper communication, from counseling to patient education to health. This path also includes communication techniques  and the study of foreign languages ,78.There is a lack of literature on pharmacy patient-centered communication and the few existing examples applied to pharmacy practice are derived from those developed for physicians ,79,80, sApplying the CCG (an evidence-based model) enables pharmacists to tailor medical consultation through the improvement of 71 communication skills and behaviors . The FHMwww.consultationskillsforpharmacy.com) where pharmacists can self-assess their own level of communication skills. In general, the program balances theoretical and practical tools for pharmacists to enhance their communication skills by providing six thematic “routes” that the professionals can undertake to perfect his/her skills and which are related to: 1. medicines optimization and adherence; 2. effective communication fundamentals and patient history; 3. history and background to consultation models, and theory and consultation styles affecting practice; 4. effective consultation skills, shared decision-making, and tools supporting practice; 5. health coaching and motivational interviewing to support behavioral change; 6. action planning to move your practice forward [An interesting example is the development of a set of practice standards for communication skills within the actions implemented in 2012 by the UK National Modernizing Pharmacy Careers (MPC) program. The main purpose was to individuate “the standard of knowledge, skills and behaviours expected of all pharmacy professionals in order for them to carry out effective patient-centred consultations”. The initiative was integrated by the national Consultation Skills for Pharmacy Practice Programme  and by the possibility of consulting an online national learning portal , community pharmacists, the regulatory setting, and the undergraduate academic education have responded to the shift in the pharmacist’s role towards the increased focus on the communicative interrelations with the patient. The pharmacy practice is essential in developing and training communication skills for the patient encounter. In spite of that, an experiential training method is not provided in all schools, it is often concentrated approximately in the last part of the five years of academic education curricula, and it consists of a number of hours that varies from six to 92. Therefore, the regulations are not supporting the pharmacist role as they should. Among the goals of the course developed by leaders in the Nordic pharmacy, the context is to outline and improve communication skills in order to both enhance the community pharmacist training and strengthen his/her professional role .Considering all of the above, universities should offer even more specifically tailored pre- and post-graduate training for those students willing to work in community pharmacies. By doing so, the new graduates would be allowed to achieve a specialization specifically taught for the practice of the profession in the community pharmacy, including appropriate training on communication and social skills . MoreoveNowadays, the pharmacist’s profession in the community pharmacy is not highly regarded since the commercial vision of the profession created for pharmacists includes the image of the shopkeeper. Some pharmacists in some countries are no longer involved in dispensing, but only in providing the drug and giving advice . In spitSince one of the key roles of the pharmacist in the community pharmacy is focused on counseling, communication is essential for the pharmacist in order to fulfill his primary ethical duty. Communication is also indispensable for the patient in order to receive all of the necessary information on the use of a given medicine in an interactive, direct, clear, and detailed manner, and to acquire the knowledge to obtain the maximum benefit from the therapy to be performed. Communication is therefore the key and essential element in order to build a solid interpersonal relationship with the patient in order to retain him/her, to make the consultancy process effective, and to strengthen the future of the pharmacist profession in the community pharmacy.In a future perspective, to revitalize the community pharmacist role and to improve his/her specific patient-centered communication skills and health literacy, it is essential to implement adequate and common changes in the academic curricula, which need to be regularly monitored and up-to-date ,88. A mo