The Breast Cancer and the Environment Research Centers (BCERCs) include collaborators from basic sciences, epidemiology, and the community, conducting studies to investigate whether environmental exposures are associated with the timing of puberty. A pilot study of a subset of the study participants assessed the feasibility of measuring selected biomarkers of exposure in blood and urine in girls 6–8 years of age. In the Greater Cincinnati study population, we found an elevated serum concentration of perfluorooctanoate (PFOA) among > 90% of young girls living in a small community.The research team deliberated whether and how to report the PFOA findings to our study families. We will address the issues considered in our decision, as well as the formats we used to present the findings.The results were verified as we searched for potential sources of the elevated PFOA levels. As a research team, we grappled with issues regarding the reporting of unexpected results, derived from unknown sources and with unknown clinical significance. Ultimately, we did decide to present these findings to the study families through a well-developed communication plan.Research team members came from a variety of experiences and backgrounds, which led to different interpretations about the clinical, ethical, and public health issues surrounding these findings. The ethical debates centered around the precautionary principle, the right to know, and do no harm.Given advances in environmental biomarker technologies and greater use of the transdisciplinary research model, a communication plan must be developed for those involved as study participants. Recent articles have discussed the obligations researchers have to inform study participants about their individual research results . DecidinThe University of Cincinnati (UC), in conjunction with the Cincinnati Children’s Hospital Medical Center (CCHMC) and local breast cancer advocates, forms one of four Breast Cancer and the Environment Research Centers (BCERCs) established in September 2003 with funding from the National Institute of Environmental Health Sciences and the National Cancer Institute. The BCERCs include projects in biology, epidemiology, and community outreach and education. The unifying research theme is based on the hypothesis that chemical, physical, and social factors in the environment interact with genetic factors to affect the mammary gland during peripubertal development and across the life span in ways that may alter breast cancer risk in later life. This transdisciplinary research paradigm involves biologists, epidemiologists, clinicians, and breast cancer advocates .The specific aims of the epidemiology research are to understand more fully the impact of environmental factors on pubertal maturation in young girls and how puberty may serve as a window of susceptibility for breast cancer later in life. These objectives are predicated on the established association between age at menarche and breast cancer risk . ExaminaThe Greater Cincinnati epidemiology project, known as Growing Up Female (GUF), recruited 6- and 7-year-old girls and their families from school districts in southwest Ohio and across the Ohio River in northern Kentucky. Recruitment began in Spring 2004 in the two school districts. This research study was conducted with the oversight of the CCHMC Institutional Review Board (IRB), and participation of the subjects did not occur until after written consent was obtained. These early recruits were seen every 6 months at the district schools during school hours. Anthropometric measures, including height, weight, and maturation assessment, were conducted at each visit. Data collected by questionnaire included family demographics, medical histories of the child and mother, use of personal products, residential history, drinking water source, and physical activity . A fastiThe GUF research team consisted of university-based researchers and community partners who were co-investigators actively engaged in the research as well as study staff. All members of the research team completed human subject research training as required by the CCHMC IRB.The epidemiology study protocol was first approved by the CCHMC IRB in July 2004 and annually thereafter. The consent form specified that elevated blood pressure, blood sugar, insulin, and cholesterol would be reported to the parents of the study participants. The consent form did not specify the exposure biomarkers to be analyzed, include specific language about reporting these results to the study families, or include the option to decline receipt of test results. However, the consent form did state that “The investigators will tell you about significant new findings developed during the course of the research and new information that may affect your health, welfare or willingness to stay in this study.” No Certificate of Confidentiality (COC) was in place in the early years of the study. Recently, a COC was received that retroactively covers the data collected since the inception of the study.A pilot study was conducted in winter 2006 to determine whether biomarkers of exposure could be detected in the study girls. Samples obtained in the first year from 30 girls recruited from each of the three BCERC sites were included in the pilot study. The other sites included Mount Sinai School of Medicine  and Kaiser Permanente of northern California . The urine and serum analyses were conducted by the Environmental Health Laboratory at the National Center for Environmental Health at the CDC. Classes of compounds were selected based on their biologic activity, relevance to pubertal development, and feasibility. Urine samples from all three cohorts were analyzed for compounds such as phenols, phthalates, phytoestrogens, and cotinine . Blood sIn late winter 2006, the CDC alerted our lead epidemiologist that there were elevated serum perfluorooctanoate (PFOA) levels among girls in the Greater Cincinnati cohort compared with the national median for older children (12–19 years of age) in the 1999–2000 National Health and Nutrition Examination Survey (NHANES), as measured by the same CDC laboratory.PFOA is a common PFC, a class of man-made compounds extremely resistant to environmental degradation. Recent publications had reported its detection in the blood of humans . On closIn spring–summer 2006, we focused our attention on the PFOA findings to determine what additional studies and follow-up should be conducted. Efforts to identify potential sources of exposure were inconclusive. We presented our preliminary findings to our BCERC colleagues and shared with them our concern about how to proceed.In summer 2006, the research team convened two “biomarker summits.” Attendees included members of the research team as well as experts in exposure assessment and toxicology. The objectives included presentation of the pilot study results and environmental samples collected at the schools; identification of the IRB of record for the pilot study; establishing priorities for verifying the pilot study results; and developing the components of a communication strategy. We discussed possible target audiences, what results might be reported, and how we might report those results.In fall 2006, serum samples from 15 of the original community B pilot study girls and from 30 additional girls from the same community were sent to the CDC. We wanted to determine whether the elevated PFOA concentrations persisted and whether other study girls in community B were affected. Although the repeated PFOA concentrations decreased between 2005 and 2006 in community B, serum levels of 88% of the girls were above the NHANES 95th percentile.We continued to review the scientific literature for PFOA studies as well as lay media sources for information about PFOA contamination. The “Community Exposure to C8 [PFOA] in the Little Hocking Water Service Area Study,” taking place 250 miles up the Ohio River from Cincinnati, was particularly compelling , as drinAs the decision to report the findings to the pilot study families evolved, the need for a communication plan became apparent. The plan needed to be responsive to all the target audiences, including study families, school administrators, health officials, and the media. The information needed to be factual, understandable, and consistent. It was important to use trusted individuals and institutions to communicate that plan . The plaThe communication plan consisted of:PowerPoint presentation(s) tailored to different audiencesInformation packet with fact sheets from government web sitesGraphs depicting the range of results for a sample analyte for each chemical classGraphs depicting the range of PFOA results from the pilot study and other referencesA one-page summary of preliminary GUF study findingsGlossary of termsFrequently Asked Questions (FAQs) with answersA dedicated phone line for questions from study familiesA press release.The CCHMC IRB was notified of all components of the communication plan. Members of the research team developed the FAQs to ensure that we were prepared to address questions likely to arise and that our responses were consistent no matter the respondent, setting, or target audience.In May 2007, three family meetings were held in the two pilot study communities and at CCHMC. In community B, study families received a written invitation, and the study principal investigator (PI) phoned each family to encourage attendance. The study PI, an adolescent medicine physician known to all of the study families, presented a study update and the biomarker results using PowerPoint slides carefully developed by the research team. A template was designed that depicted the study data points for an analyte for each chemical class. For example, brominated diphenyl ether–100 served as the sample analyte for the brominated flames retardants. The 50th and 95th percentiles based on NHANES data recently reported by the CDC  were incThe PFOA findings were presented in a graphic that compared the results for communities A and B with data from the 1999–2000 NHANES national data set, a Parkersburg, West Virginia, cohort, and the San Francisco Bay area BCERC cohort. These additional data points were intended to provide context for the study families to interpret and compare the local data and their child’s results, as shown in Each study family whose child participated in the pilot study received a report of the serum and urine biomarker results of their child. A sample analyte for each chemical class of biomarker was presented; the chemical classes included phenols, phthalates, cotinine, metals, phytoestrogens, brominated flame retardants, polychlorinated biphenyls, and persistent pesticides. Perfluorooctane sulfonate and PFOA were reported for the PFCs. The median for Greater Cincinnati (based on the 30 participants in communities A and B), national references , and theThe handout packet included a list of references, a glossary of > 70 terms, and copies of web site materials about the different biomarkers. These materials were downloaded from web sites maintained by federal agencies, state health agencies, and National Institutes of Health–sponsored research programs. The CCHMC IRB was notified of all materials provided to the study families.a) sources, pathways, and duration of exposure(s); b) possibility of follow-up studies that would include family members; c) likelihood of bioaccumulation; d) factors likely associated with higher concentrations, such as length of residence; e) recommendations for preventing future exposures; and f) implications for the puberty study. Given the dearth of specific information about exposure sources and pathways as well as health impacts, attendees asked why the information was being emphasized and should study families be concerned. Responses to these questions sought to allay concerns, emphasizing the absence of relevant data, the lack of standards, and the multiplicity of consumer products containing this compound.At the meetings, time was allocated for questions and answers as well as one-on-one and small group discussions facilitated by the study PI and co-investigators. PFOA-related questions pertained to In community B, the superintendent of the school district attended the meeting, having been alerted to the results by the study PI. The superintendent and several attendees commented that the findings might have implications beyond the study families and perhaps the county. The superintendent remarked that CCHMC is a trustworthy institution, inferring that there would be follow-up if health concerns came to light.Three percent of the study families from community A and 41% of the study families from community B attended the meetings in their respective neighborhood school. Seventy-eight percent of the families attending the meetings completed a one-page evaluation of the program. Respondents generally felt the program met their expectations, that the information was presented in a manner they could understand, and that questions from the audience were answered satisfactorily. Respondents expressed interest in learning more about the study findings, both individual and aggregate results, especially from the psychosocial questionnaires as well as the exposure biomarkers, hormone analyses, and maturation assessments. As with the topics addressed in the question-and-answer period, respondents wanted more information about PFOA and ongoing updates. We mailed meeting-specific information packets to those study families who could not attend the meetings.The UC Department of Public Relations and Communications had been alerted in advance about the family meetings. A press release was drafted should the need arise for a more public statement concerning the findings. Soon after the family meetings, members of the research team met with relevant water district personnel in Greater Cincinnati to notify them of the biomarker findings and to inquire about the availability of local water sample analyses for PFCs. Officials assisted us with information about their water intake sites along the Ohio River, purification technologies at each treatment facility, quality control standards, and the geographic distribution boundaries of each facility.The research team grappled with the decision to communicate the unexpected PFOA findings to the study families. A number of competing and complementary perspectives were considered until consensus was reached.Transdisciplinary science is best described as the interactive work of scientists from multiple disciplines on a common problem with a common conceptual frame work, resulting in novel insights and approaches . The traThe researchers from the UC Department of Environmental Health had years of experience in reporting individual results to study participants from pediatric lead exposure studies, medical monitoring programs , and comA clinical perspective reflected the Hippocratic Oath, “Do No Harm,” and some team members feared unnecessarily stressing the parents in this nonintervention study. These team members argued that it was not right for us to give parents information about a contaminant where the possible health effects of the source(s) or solution(s) to limiting exposure were unknown. At that time, there was no formalized communication plan to report back study results except elevated lipids, high blood pressure, and at-risk psychosocial indicators.The epidemiology members of the research team experienced in population-based studies had long ago adopted the terminology of study participants versus study subjects. The term “participant” reinforces individuality and argues against the notion that the terms are interchangeable. “Study participant” implies an active role in which individuals are engaged in an exchange of information, whereas “study subject” implies a passive role in which information is transferred in a single direction. This perspective reinforced the viewpoint that full disclosure to the study families was appropriate.The scientists at the CDC Environmental Health Laboratory where the analyses had been performed supported informing the families about these findings. Likewise, colleagues within the BCERC network encouraged us to discuss these high PFOA levels in community B.Ultimately, it was the breast cancer advocates who were a key factor influencing the decision of when and how to report results back. The advocate members of the research team spoke out on behalf of the study families. They espoused the concept of a partnership with the study parents and reasoned that individuals respect honesty. This perspective as a stand-in or proxy parent of the girls argued for full disclosure of available information, even if the source(s) of the exposure and the health implications were unknown. They also considered the study participants and any pregnant family members as vulnerable populations because of their increased sensitivity to an increased body burden due to environmental exposures .At the time of our deliberations, the health consequences of PFOA were poorly understood, no health standard(s) existed, and it was unknown whether blood levels reflected past or current exposures. Our center was at a loss for recommendations as to how to remove this chemical from the body. The precautionary principle encourages policies that protect human health in the face of uncertain risks. The precautionary principle states that evidence of harm, rather than definitive proof of harm, should prompt policy action, and that the burden of proof should lie with manufacturers to demonstrate that chemicals are safe, rather than with the public to show that they cause harm . We usedThe principles of respect for persons, beneficence, and justice shape the conduct of research with human subjects . Right-tOther factors were discussed as reasons not to share the PFOA results to study families at that time:Study recruitment was ongoing, and there was concern that these unexpected results could negatively influence enrollment and/or retention of the girls already enrolled in the study.Ongoing litigation and regulatory review of manufacturing facilities along the Ohio River that had disposed of PFOA into the environment concerned the research team. Public release of the biomarker findings might lead to Freedom of Information Act requests from news media or participants involved in legal actions at PFOA contamination sites around the country. Members of the research team were concerned about the possibility of legal challenges that might compromise the anonymity and confidentiality of study families. At the time, no COC existed for this study.Accurately reporting these findings to study families was going to be an extremely time-consuming task on top of existing day-to-day study commitments. There were no extra funds or support to pay for additional items such as retesting serum samples, testing water samples, or hiring support staff.PFOA biomarkers were not part of the original BCERC protocol. Because at the initiation of the pilot study PFCs were not biomarkers of interest in relation to puberty or breast cancer, some argued that we had no obligation to become involved in something that was outside our study objectives. Because these results had not been published in a peer-reviewed journal, there was some reticence to release the data.Some team members argued that we were not obligated to remedy the situation simply because we had encountered an unexplained phenomenon .Human research protocols must adapt as scientific methods improve, research standards evolve, new collaborations with diverse stakeholders develop, and community knowledge and expectations change. Our experience offers an example of communicating an unexpected research finding to the families of study participants. Although we have not yet developed a comprehensive protocol for communicating individual results, we have learned a number of important lessons for the future.A realistic assessment of what should and can be shared needs to be addressed before recruitment begins. The consent form is a crucial document that must be developed with care, clearly stating what, when, and how aggregated and individual data will be communicated to whom. The option to opt out of receiving all or some of the study results can be included in the consent form to accommodate the preferences of individual participants. A COC should be acquired for the study, because it provides protection for study participants beyond that provided by the process of obtaining informed consent.Consider forming an advisory committee of stakeholders, including study participants. This venue can serve to inform the research team about expectations of key stakeholders vis-à-vis the study and changes in public knowledge and opinions about environmental exposures and health. It is also an opportunity for researchers to educate key stakeholders about research, its strengths, its uncertainties, and the prolonged time frame.A good transdisciplinary research team will by its very nature reflect a diversity of perspectives. Members can have strong opinions reflective of their training and experiences, leading to vigorous disagreements as to how to proceed. Resolution of issues can take many months as team members assimilate new information and perhaps revise attitudes and approaches. When members are willing to listen to these diverse opinions and are open to learning and change, the dialogue can result in a solution that is acceptable to all and benefits the research team, study participants, and the general public.With the transdisciplinary model becoming a frequent research design, all members of the research team should be able to inspect and review the data so challenging issues—such as whether, when, and how to communicate research findings—can be discussed openly and candidly among all members. Community partners, like university-based researchers and study staff, should complete all the standard training for human subject research so the breadth of experience, knowledge, and perspectives of all the members of the transdisciplinary team can be accessed. It is our experience that those community members will drive the “Right to Know” principles and encourage open and timely communication when the research involves human participants.


Dear Editor,The number of publications plays a major role in assessing scientific progress in different countries. To determine the status of our country in terms of the number of published papers in indexed peer-reviewed medical journals, we searched MEDLINE/PubMed. This database belongs to the National Library of Medicine, the world’s largest biomedical library located in Bethesda, Maryland, USA, which is freely accessible and contains over 18 million journal citations since 1948.The total number of indexed papers from ophthalmic institutions during the above mentioned period was 119,640. The overall number of Iranian publications rose dramatically over the recent years, especially during the last decade . There aCountries such as India, China and Turkey have demonstrated significant growth in the number of publications and reached volumes exceeding certain developed countries. Similarly, the number of Iranian ophthalmologic publications has shown a significant increase over the past 30 years. In addition to the crude number of publications, citations to a paper is of great importance and shows the impact of that paper on the scientific community.7Since PubMed mainly covers English language articles, our statistics may not reflect the exact number of ophthalmologic publications for each country. In addition, it is possible that the name of the country was not mentioned in the affiliation field. However, since these biases were similar for all included countries, one may assume our results to be an acceptable estimate of Iran’s situation in the ophthalmic community during the past decades.Although the number of Iranian ophthalmologic publications in international peer-reviewed journals has risen significantly, our nation still needs to make a greater contribution to science and to better demonstrate its capabilities. In order to gain a better ranking in the world, we need to extend and improve scientific thinking among our medical care workers which requires a great amount of effort from Iranian ophthalmologists and research centers. Main obstacles to the production of indexed papers in most developing countries include language barriers, instability and incorrect research priorities, as well as the large burden of disease prohibiting the allocation of adequate research budget.10


Online pharmacies are companies that sell pharmaceutical preparations, including prescription-only drugs, on the Internet. Very little is known about this phenomenon because many online pharmacies operate from remote countries, where legal bases and business practices are largely inaccessible to international research. The aim of the study was to perform an up-to-date and comprehensive review of the scientific literature focusing on the broader picture of online pharmacies by scanning several scientific and institutional databases, with no publication time limits.We searched 4 electronic databases up to January 2011 and the gray literature on the Internet using the Google search engine and its tool Google Scholar. We also investigated the official websites of institutional agencies . We focused specifically on online pharmacies offering prescription-only drugs. We decided to analyze and report only articles with original data, in order to review all the available data regarding online pharmacies and their usage.We selected 193 relevant articles: 76 articles with original data, and 117 articles without original data  including 5 reviews. The articles with original data cover samples of online pharmacies in 47 cases, online drug purchases in 13, consumer characteristics in 15, and case reports on adverse effects of online drugs in 12. The studies show that random samples with no specific limits to prescription requirements found that at least some websites sold drugs without a prescription and that an online questionnaire was a frequent tool to replace prescription. Data about geographical characteristics show that this information can be concealed in many websites. The analysis of drug offer showed that online a consumer can get virtually everything. Regarding quality of drugs, researchers very often found inappropriate packaging and labeling, whereas the chemical composition usually was not as expected in a minority of the studies’ samples. Regarding consumers, the majority of studies found that not more than 6% of the samples had bought drugs online.Online pharmacies are an important phenomenon that is continuing to spread, despite partial regulation, due to intrinsic difficulties linked to the impalpable and evanescent nature of the Web and its global dimension. To enhance the benefits and minimize the risks of online pharmacies, a 2-level approach could be adopted. The first level should focus on policy, with laws regulating the phenomenon at an international level. The second level needs to focus on the individual. This approach should aim to increase health literacy, required for making appropriate health choices, recognizing risks and making the most of the multitude of opportunities offered by the world of medicine 2.0. Neo, which pill would you choose? You take the blue pill—the story ends, you wake up in your bed and believe whatever you want to believe. You take the red pill—you stay in Wonderland and I show you how deep the rabbit-hole goes[1].The Matrix, but still important in terms of health care delivery, consumers nowadays can make another decision: they can choose a pill sold at their local pharmacy, as they have always done, or they can choose one from the Web, by purchasing it from a “cyberpharmacy” or “online pharmacy” [Although their choice is much less metaphysical than the question posed to Neo in the science fiction movie harmacy” . An onliThe online sale of drugs started in the late 1990s and has expanded so much that the US Food and Drug Administration (FDA) has implemented an entire section on its website dedicated to “Buying medicines over the Internet” ,4. The WIt is very difficult to estimate the number of online pharmacies and people buying online, the volume of drugs traded, and the revenue and profits generated by such a hidden business. Moreover, the geographical distribution of the phenomenon seems to be very heterogeneous. With regard to the number of online pharmacies, MarkMonitor in a 2009 press release claimed to have found nearly 3000 websites selling prescription medicines, while a 2010 review by the US National Association of Boards of Pharmacy (NABP) investigated the characteristics of 5859 Internet outlets selling prescription medications . AnotherThis new market has undoubted advantages for patients: access to drugs for the disabled or housebound, access 24 hours a day, a virtually unlimited number of products available, relative privacy, which may encourage patients to ask questions about embarrassing issues, and more affordable prices -21. But To our knowledge, 2 reviews about online pharmacies in general and 3 others on specific aspects related to online pharmacies are available. With regard to general reviews, Fung et al  searchedOther reviews tackled specific issues but were unable to give an overall picture of the phenomenon. A recent review examined counterfeit phosphodiesterase type 5 inhibitors (PDE5Is) for the treatment of erectile dysfunction, similar to the 2000 review of sildenafil and the Internet ,30. The This review sought to investigate the available evidence on the phenomenon of online pharmacies. We report data on the 3 main areas on which the literature focuses: the characteristics of the websites, the quality of pharmaceutical products purchased online, and the number of consumers and their characteristics.The literature search covered the period up to January 2011. The search was performed on 3 sources: electronic databases, search engines, and institutional websites. First, we searched, without any limitations as to publication date, the following electronic databases: PubMed , ISI WebThe database search identified 18,857 records, and other sources  gave 5893 additional records. Screening of these 24,750 records led to 730 articles, excluding duplicates and nonpertinent results. It is important to point out that such a drop in numbers depends mainly on the use of multiple key words, which are often very similar, which were used in order not to miss any pertinent studies. This resulted in a notable “noise effect,” thereby decreasing the specificity and increasing the sensitivity of our search strategy. An in-depth analysis of the 730 selected articles produced 193 eligible ones that were pertinent to the study and fit the inclusion criteria. Of these, 117 where excluded from the analysis and are listed in We included all articles relevant to the subject of the research—namely, online pharmacies, their characteristics, their products, and their consumers. We selected only articles dealing with the sale of prescription-only drugs and with websites that presented themselves as pharmacies: the purpose was to stay within the sphere of substances that are supposed to involve a doctor–patient relationship. Articles regarding only over-the-counter medicines, complementary medicines, herbal remedies, supplements, and drugs of abuse were excluded. If the researchers analyzed websites selling prescription and over-the-counter drugs, we considered websites selling prescription drugs if it was possible to identify them. We decided to deal only with prescription drugs, although over-the-counter substances can also have negative effects on people’s health, despite the no-harm claims made by their producers, as several clinical cases demonstrate ,49. AlthAs an additional inclusion criterion, we selected articles in English that had the abstract or the full text available. We included only scientific articles, which means that we excluded popular articles published in daily newspapers, and in weekly and monthly magazines.We classified the articles according to whether they reported original data. We selected only the articles reporting original data, which means that we excluded articles lacking original data, which means those with only a speculative discussion about the problem or only citing data from other studies; these are, for example, editorials, letters, comments, articles about regulation issues, and reviews. However, to make this debate easily available to the reader, we have listed all articles without original data in The original data are described according to 3 main subjects: types and characteristics of online pharmacies, drugs purchased online, and online pharmacy consumer data, which included case reports on complications occurring in consumers of drugs purchased online. Some articles with original data covered more than 1 of these subjects and were consequently allocated to more than 1 group. Each of these categories is described below.If they were available, we recorded the number of online pharmacies analyzed in each study, year of data collection, willingness to dispense pharmaceuticals with or without a prescription, availability of a physician’s assistance or online medical consultation, disclosure of contact details, geographical location, delivery conditions, types of medicines available, availability of drug information, prices of online drugs and overall costs, sales-promotion strategies, how long websites were accessible, privacy and disclaimer statements, date of last website update, and presence of quality certifications .We recorded studies in which the researchers bought prescription drugs online and evaluated the actual purchase and its characteristics. We summarized data regarding the type of drug ordered, the response rate, the quality of the process, and the drugs purchased. Regarding process characteristics, we recorded prescription requirements, management of the online questionnaire, money transactions, and subsequent advertising; with regard to drug quality, we recorded data about packaging and instructions, and chemical composition.We described articles dealing with the number of people purchasing drugs online, which was estimated by means of questionnaires or interviews. Researchers attempted to list the most frequently requested drugs, the main reasons for buying pharmaceutical products online, the importance of the location of online pharmacies they bought from, and the perceived risks related to this practice. In addition, we classified in this section articles that reported clinical cases of adverse effects to active substances and drugs purchased via the Internet as an indicator of this phenomenon.We selected 193 relevant articles: 76 articles with original data (39%), and 117 articles without original data  including 5 reviews. Articles with original data concerned samples of online pharmacies in 47 cases, online drug purchase in 13, consumer characteristics in 15, and case reports of adverse effects of online drugs in 12.We selected 47 articles about online pharmacies. All of them are shown in The remaining 42 articles ,27,57-95The works were published between 1999 ,61,66 anOnline pharmacy samples varied hugely in size, from 4 ,94,95 toOne of the most controversial and widely studied features is prescription requirement. For the first time, online pharmacies are providing easy access to traditionally controlled (according to each country’s regulations) substances, such as pharmaceutical products, which in regulated systems need an original medical prescription before they can be bought. The peculiar distribution chain for prescription drugs is due to the unique nature of pharmaceutical products; the philosophy behind prescription is that consumers are not skilled enough to make their own choice, but need to be given a prescription by a health professional trained to make a risk–benefit evaluation ,24. In aDue to the different methods of sample selection, distribution varies greatly in the articles. Some online pharmacy samples were specifically selected to have only websites not asking for a prescription from the customer’s physician , 82,93. Some of the online pharmacies not asking for a prescription replaced it with an online health status evaluation, performed by means of an “online questionnaire.” Researchers reported a percentage of online pharmacies offering and/or requiring an online prescription in a range of 10% to 81% ,93. ThosContact details were revealed in the majority   found thBoth Arruanda  and BessWhat do online pharmacies have to offer? From an analysis of the literature it appears that online pharmacies have become more and more complex as time passes; whereas 10 years ago they tended to sell principally lifestyle drugs such as sildenafil, it looks today as if they offer virtually anything. Back in 1999, Bloom and Iannacone  studied Some studies focused on specific classes of drugs. They looked for Parkinson disease medications , 3 typesLittlejohn et al  and MakiIn 1999 Armstrong et al  found thHolmes et al  evaluateArruanda  evaluateA comparison of online pharmacy and retail pharmacy prices had different results. Drugs offered online were more expensive in Bloom and Iannacone’s studies ,62, in TAdditional costs have to be considered: the need to join clubs or member groups and pay a nonrefundable fee, with the risk of not finding the wanted drug after joining ,80; and Only a few articles focused on the marketing strategies of online pharmacies. Levaggi et al  and OrizThe presence of at least 1 quality certification was found to range from 12% to 13% ,70,86 toRegarding health content quality, Arruanda  found thAs regards the security of the money transaction, Arruanda  found thA special study was performed by Kuzma  about thKunz and Osborne  assessedArruanda  found thIn several of the papers analyzed we found that some websites required the consumer to relieve the companies from all liability, from 100% of websites ,66, to 6Only 1 study investigated the date of the online pharmacies’ last update, which was displayed by 4% of them  of all the studies we found with original data were published in or after 2005, which seems to indicate that the phenomenon of purchasing medications online is increasing.The main challenge in conducting this review was that the works we further analyzed and report were fairly difficult to compare owing to the widely differing methods used to select and assess samples, and often the works were written in answer to multiple research questions. In order not to miss the multiple aspects of these works we elaborated different research questions—in our opinion the only way to analyze these data. This could be seen as a limit of the study in terms of coherence, but we prefer to view it as an added value of this review, since we wanted to impress on the reader the complexity of the papers’ methods and data, mirroring the complexity of the phenomenon of online pharmacies.Despite this complexity, we made an effort to identify a common denominator in all the research questions scholars have used in tackling the issue, and we related them back to the broad issue of consumer safety in its multiple variations. Ultimately, the tangible side of this consumer safety framework is clinical reports of health damage caused by drugs purchased online, the last link in the chain, when the feared dangers have already occurred. Consumer studies have tried to estimate the number of exposed people and to identify at-risk groups. The majority of these studies focused on the general population or specific groups, and found that 6% or less of the sample had bought drugs online. As depicted in One of the major risks posed by online pharmacies is drug misuse. Prescription requirement and use of online questionnaires can be linked to avoiding the physician and hence to the possible misuse of drugs. All the random samples with no specific limits regarding prescription requirements found that at least some websites sold drugs without a prescription, and that online questionnaires could be used as a substitute for prescriptions. This issue leads to the risk of one of the most feared consequences: the possible disruption of the doctor–patient relationship, which has been widely discussed. In the context of the doctor–patient relationship, drugs purchased online can have acute effects, and even chronic and irreversible ones, and nowadays doctors should always investigate the use of nonprescribed substances in their anamnesis . Also coPrivacy issues are about the confidentiality of consumers’ data and personal data protection. The evidence suggests that online pharmacies (or ones presumed to be such) could be a tool for data fishing or fraud when they do not deliver the products (sometimes charging the consumer anyway) or send something different from what was ordered. It is not just a matter of privacy; it becomes a matter of security. This could even mean that stealing money from vulnerable consumers could lead to them not being able to afford the drug or having to wait to obtain it elsewhere, thus posing problems of denial of care and delay of care.In terms of drug quality, when the researchers bought drugs online, they very frequently found inappropriate packaging and labeling, whereas the chemical composition was not as expected in a minority of the samples of studies, except for one .Drug accessibility is a core issue regarding online pharmacies. Worldwide delivery eliminates national barriers for consumers; but the place of dispatch can be indicative of the place of production, and therefore it could be linked to drug quality. The analysis of the drugs on offer showed that an online consumer can get virtually anything, which is a matter of risk as well as accessibility, since some drugs are more intrinsically dangerous than others. Lastly, prices can modify drug accessibility and could be linked to drug quality.Another important area associated with consumer safety is transparency in giving consumers details of the company they are buying from; this aspect can be assessed by analyzing the contact details, geographical location, time websites were accessible, quality certifications, and last website update. Geographical characteristics showed that this information is concealed on many websites, and that US-based websites tend to behave better than others. Studies that investigated the presence of quality certification found it in a minority of the websites.From a policy point of view, online pharmacies are only partially regulated due to intrinsic difficulties linked to the impalpable and evanescent nature of the Web and its global dimension, with no national barriers. The legal implications are really challenging, since the virtual “brave new world” created by the Internet poses issues never faced before. The fragmentary picture of online drug trading regulations is a recognized issue, and a noteworthy attempt to regulate the phenomenon is the “Implementation of the Ryan Haight Online Pharmacy Consumer Protection Act” by the US Department of Justice in 2009 -132. LiaGiven the technical difficulty of reducing the risks from an enforcement point of view, the role of the consumer becomes essential. The role of the patient as an active partner in health care, and not just a passive object of diagnostic testing and medical treatment, is widely accepted. As this view is accepted, providing information to patients becomes a very crucial issue. Attempts to create some sort of labeling to distinguish trustworthy from rogue websites are valuable, but they cannot be very effective as long as people are not aware of these tools and of the risks involved in buying medication online. As described by Eysenbach , medicinIn conclusion, online pharmacies are a case where major conflicts occur between the concept of individuals being able to decide their purchases in their own interests on the one hand, and on the other the demand that the state must prevent people from harming themselves and must use public resources fairly and efficiently, as well as the value of social solidarity . In ordeAcknowledgments                                    The authors wish to thank the anonymous reviewers for their valuable comments and insightful suggestions to improve the quality of the paper.Authors’ Contributions                                    GO participated in the conception and the design of the study, checked the collected data, analyzed and interpreted the data, and drafted the article; AM collected and assembled the data; PJS participated in the conception and the design of the study and made a critical revision of the article; UG participated in the conception and the design of the study and collection and interpretation of data, and continuously revised the article during drafting. All authors approved the final article.


Traditional medicine (TM) occupies a special place in the management of diseases in Uganda. Not with standing the many people relying on TM, indigenous knowledge (IK) related to TM is getting steadily eroded. To slow down this loss it is necessary to document and conserve as much of the knowledge as possible. This study was conducted to document the IK relevant to traditional medicine in the districts of Mukono, Nakapiripirit, Kanungu and Pallisa, in Uganda.An ethnobotanical survey was conducted between October 2008 and February 2009 using techniques of key informant interviews and household interviews.The common diseases and conditions in the four districts include malaria, cough, headache, diarrhea, abdominal pain, flu, backache and eye diseases. Respondents stated that when they fall sick they self medicate using plant medicines or consult western-trained medicine practitioners. Self medication using herbal medicines was reported mostly by respondents of Nakapiripirit and Mukono. Respondents have knowledge to treat 78 ailments using herbal medicines. 44 species, mentioned by three or more respondents have been prioritized. The most frequently used part in herbal medicines is the leaf, followed by the stem and root. People sometime use animal parts, soil, salt and water from a grass roof, in traditional medicines. Herbal medicines are stored for short periods of time in bottles. The knowledge to treat ailments is acquired from parents and grandparents. Respondents’ age and tribe appears to have a significant influence on knowledge of herbal medicine, while gender does not.This survey has indicated that IK associated with TM stills exists and that TM is still important in Uganda because many people use it as a first line of health care when they fall sick. Age and tribe influence the level of IK associated with herbal medicine, but gender does not. Traditional medicine (TM) has been used by humans for thousands of years. The World Health Organization 2002), defines traditional medicine, in part, as a medicine system that includes medication therapies like herbal medicines as a well as non-medication therapies like acupuncture. The same organization defines herbal medicines to include herbs, herbal materials, herbal preparations and finished herbal products, that contain as active ingredients parts of plants, or other plant materials, or combinations thereof. The World Health Organization (WHO) estimates that 80% of the population living in developing countries uses TM for their primary health care needs . However002, defiIn Uganda, households possess indigenous knowledge of traditional cures for non complicated ailments. On the other hand, Traditional medicine practitioners (TMPs) are an invaluable source of specialized knowledge about TM and are very important human resources for the practice and delivery of primary health care services . The WHOAlthough a majority of people rely on TM, indigenous knowledge (IK) related to TM is getting steadily eroded[ . It is bTo control the loss of IK related to TM it is necessary to document and conserve as much of this knowledge as possible in line with WHO policy and as reflected in the different resolutions adopted by the World Health Assembly -12 and WPrevious studies in Uganda have inventoried herbal medicines and associated IK of processing and administration , in geneField research for this project was conducted between October 2008 and February 2009 in the districts of Mukono, Nakapiripirit, Kanungu and Pallisa Figure . These dThe communities in the study districts are ethnically diverse and belong to different tribes. The people of Mukono belong to the Baganda tribe. The people of Nakapiripirit are Ngakarimojong by tribe, those of Kanungu are Bakiga and the ones of Pallisa belong to the tribes of the Ateso and the Bagwere. This implies that they have different IK and exploit useful plants in different ways. All these cultural groups subsist on crop agriculture as their main source of livelihood apart from the Ngakarimajong who are nomadic cattle keepers .Data were collected using an ethnobotanical survey. The survey started off with key-informant interviews that included local politicians, elderly people, and a nursing sister as participants. In the key informants interviews the focus was on understanding health seeking behavior.The plant species used to treat ailments in the home were documented in household interviews using a questionnaire modified from that used by Almeida et al. . To seleOur interviews centered on the following types of information: Common ailments that afflict households; form of health care sought by community members; specific ailments for which people seek health care from TMPs; materials used to treat ailments in traditional medicine; how the materials are used to treat ailments; and perceptions of efficacy.http://www.ipni.org).In order to prioritize among the widely diverse herbal medicine plant species we conducted a Rapid Market Survey to determine the most important medicinal plants. According to Cunningham , highly Permission to conduct this study was sought for and granted by the Uganda National Council for Science and Technology (SS 2163). In every village we requested for and acquired an endorsement to conduct the study by the local village politicians. Before every interview, the purpose, method and end use for the data collected were explained to every respondent before requesting for permission to interview the respondent.All questionnaire data was entered into Microsoft ® Office Excel and later imported into SPSS 12.0.1 for Windows, for analysis. Frequencies were summarized and percentages calculated from the data. Chi-square was computed to detect associations between the tribe and sex as independent variables and number of remedies as the dependent variable. A Pearson correlation coefficient was computed to detect the association between age and number of remedies. The number of ailments that a respondent knew how to treat was equated to richness of IK. We also calculated the informant consensus factor (ICF) to determine the disease systems where there was highest consensus on plants used in treatments. A high consensus factor (close to 1) means that the community is confident in the choice of plants, whereas a low ICF (close to 0) means that the community is still experimenting and that the treatments may not be effective . Diseaseur represents the number of respondents mentioning a disease and, ‘T’ the number of plant species mentioned for the disease.Whereby NThe respondents interviewed in this study had attained low levels of formal education Table : the majIn this study the common diseases afflicting people in the four study districts include malaria, cough, headache, diarrhea, abdominal pain, flu, back-ache and eye diseases Figure . When peRespondents use plants to prepare TM therapies. They infrequently add animal products, inorganic materials e.g. soil, kitchen soot and water Table . The treWe documented 262 plants used to treat 78 diseases and medical conditions Table . 151 of enjokaa, snake bite, malaria, uterus infection, diarrhea, wounds, cough, headache, measles, fever, abdominal pain, common cold, worms and yellow fever (Table The informant consensus factor (ICF) was highest for meningitis, scabies, er Table . The higer Table .The knowledge to treat ailments is acquired from a variety of sources by respondents, the most important of these being parents and grandparents Figure . Gender A survey of medicinal plants sold by market vendors revealed that most of the medicinal species mentioned in interviews in this survey were not sold in the market. Table Azadirachta indica antiplasmodial activity has also been demonstrated in vivo and in vitro [Respondents interviewed in this survey have knowledge to treat 78 ailments and conditions. Herbal medicine knowledge is extensive as every respondent can, on average, mention three remedies. However, this knowledge varied from district to district. It was not possible to do a complete review of the ethnomedicinal uses of the species reported here. However, and at least for the species reported here as being the most commonly used to treat malaria, similar therapeutic claims have been reported from other parts of the world  still exists and that TM is still important in Uganda, because respondents mentioned many species and remedies used in traditional medicine and stated that they use it as a first line of health care when they fall sick. The patronage of TMPs in this study appears to be low. This is somewhat confusing given the reportedly important role that TMPs play in TM . More riThere is need to validate the efficacy and safety of the remedies reported in this study to determine whether they are effective to treat the diseases that they are claimed to treat and are safe to use. Priority species should be those that are used to treat diseases that respondents have observed to be effective and for which people have the highest agreement measured as informant consensus factor (ICF) such as meningitis (Additional file Secondly, this study was conducted in only four districts of Uganda, and showed that IK varied between districts. This means that more detailed surveys covering the whole country remain to be undertaken to complete the documentation of this knowledge in Uganda. Thirdly, a wider market survey of medicinal plants needs to be conducted to capture the whole diversity of herbal medicine species sold in markets.aEnjoka is an all inclusive term that may refer to abdominal worms. It may also mean abdominal cramps/pain which are believed to be caused by worms among other things; gonorrhea; or painful menses in femalesbSelf limiting ailments are disease conditions whose symptoms may disappear even without treatmentThe authors declare that they have no competing interests.JRST and DK conceived the study, and participated in its design and coordination. All authors helped to draft the manuscript, read and approve the final manuscript.Table S1. The most commonly used herbal medicine plants and the diseases that they treat.Click here for file


Inequity in health-care delivery for those with mental illness is widespread throughout low- and middle-income countries. In the Pacific Island countries there are many barriers to addressing the growing mental health burden. In an effort to address this problem, the WHO is coordinating the Pacific Islands Mental Health Network involving 18 countries in the Pacific region with the financial support of New Zealand Aid (NZAid). JB and DP have developed and presented mental health training to health professionals, community leaders, and social service personnel in an environment in Vanuatu that is very different from that of their usual Australian-based general practices. They discuss evidence for their work, an outline of the programme, some difficulties working across different cultures, and the enthusiasm with which the training has been greeted. Vanuatu is now well on its way to addressing the inequity of access to mental health care with a culturally appropriate and self-sustaining mental health workforce. In most high-income countries access to good quality, evidence-based health-care continues to improve. Because of the overwhelming burden of disability caused by mental health problems throughout the world, many high-income countries have begun to address the inequity of access to mental health care with improvements in policies; training; work-force; primary, secondary, and tertiary services; programmes; and public education. As a recent WHO report concludes, people with mental health conditions are among the most marginalized and vulnerable groups. It is important that they be empowered to reach their goals and participate fully in society . Governments in many developed countries are recognizing the importance of integrating mental health into primary care services and general hospitals, as well as providing public education, and protecting and promoting the human rights of people with mental disabilities. However for those in many low- and middle-income countries (LAMICs), globalization, urbanization, and rapid social change are part of a slowly worsening profile for mental health and the resources for the management of these problems do not match the increased need . ExperieVanuatu, with a population of about 220,000 people, has 22 doctors and 450 nurses spread over 83 islands. This very small health workforce mostly operates at a primary care level; there are no full-time publicly available mental health professionals and only a few people with any mental health training at all. Building up, supporting and mentoring a mental health workforce, reducing stigma in the community, training the informal mental health workforce, and advocating with Government and NGOs are all important aims of the Pacific Islands Mental Health Network (PIMHnet), a WHO initiative funded by NZAid.JB and DP, both General Practitioners (Family Physicians) in Australia, have developed and implemented intensive 3-week mental health training programmes to doctors, nurse practitioners, nurses, NGO workers, teachers, police, corrections, public health officers, and nursing lecturers over 2009 and 2010. The training has included case studies drawn from the experience of the group, an emphasis on primary health care skills, supervised visits to local villages, and the hospital and simple research techniques. In 2010 JB visited many of these professionals in their place of work, often on remote islands, to supervise, mentor, and further train them. Further visits in 2011 will aim to consolidate skills so that more health professionals can be trained and there is a strong network in the country of support for each other.Poverty, lack of education, unemployment, conflict, disasters, and gender imbalance are well known as the social determinants of mental health , 3. MentAs deaths decrease from infectious diseases such as measles, pneumonia, gastroenteritis, tuberculosis and malaria, there has been an increase in suicides and alcohol-related deaths in countries such as Eastern Europe, India, South America, and China , 3, 6. YThe World Health Organization (WHO) and World Organization of Family Doctors (WONCA) recently collaborated to write a report entitled “Integrating mental health into primary care. A global perspective” that sets out “Seven good reasons for integrating mental health into primary care” and “10 Principles for integrating mental health into primary care” (see boxes herein after) .The burden of mental disorders is great.Mental and physical health problems are interwoven.The treatment gap for mental disorders is enormous.Primary care for mental health enhances access.Primary care for mental health promotes respect of human rights.Primary care for mental health is affordable and cost effective.Primary care for mental health generates good health outcomes.Seven good reasons for integrating mental health into primary care are as follows.Policy and plans need to incorporate primary care for mental health.Advocacy is required to shift attitudes and behaviour.Adequate training of primary care workers is required.Primary care tasks must be limited and doable.Specialist mental health professionals and facilities must be available to support primary care.Patients must have access to essential psychotropic medications in primary care.Integration is a process, not an event.A mental health service coordinator is crucial.Collaboration with other government nonhealth sectors, nongovernmental organizations, village and community health workers, and volunteers is required.Financial and human resources are needed.  10 Principles for integrating mental health into primary care are as follows.The need for more mental health services in the Pacific region grew out of a situational analysis conducted by WHO which showed that most Pacific nations had growing rates of mental health problems (including suicide) but had few resources to tackle the burden . PIMHnetIn consultation with its 18 Pacific Island members, several priority areas were identified which needed to be addressed: human resource development and training,service development focused on primary care,policy and planning,law reform,advocacy.http://www.who.int/mental_health/policy/pimhnet/en/index.html.Since its inception three countries have mental health policies in place with another nine having draft policies. Two countries have new mental health laws and another five have begun planning. Thirteen countries have developed plans for human resource development and training and seven of these are already implementing them. These processes are not sequential and so, for instance, in Vanuatu, the implementation of the human resource development and training plan proceeded prior to the formal adoption of the mental health policy and strategic plan. More information on the activities of PIMHnet can be found at Vanuatu is defined by the UN as a “Least Developed Country” with approximately 75% of the population living in rural areas . AccessiThe health services in Vanuatu are divided between the Northern Health Group which has a main referral hospital at Luganville on Espiritu Santo and the Southern Healthcare Group with Vila Central Hospital on Efate Island. Each hospital has two mental health beds and a secure “safe room”. There are 5 smaller provincial hospitals; 29 health centres, each with a nurse or nurse practitioner; 74 dispensaries, each with a nurse; and 123 health aid posts and 6 mobile clinics, each with a community worker who does health promotion [Vanuatu has been a subsistence society with a culture of traditional problem-solving through chiefs in each village. There are over 110 different “mother-tongues” spoken in the country and these are the languages where the words for mood, philosophical concepts, and deeper traditional ideas are found. The common language of Bislama is a trade language with no direct translations of any of the Western words for mental health such as depression or anxiety and only a limited mood vocabulary. Social problems have always been taken to the chief to resolve, mostly in a fairly autocratic manner but each chief has had a different style and collaborative approach. Human rights issues for people with severe psychosis depended on the support of the community, the family, how dangerous they were, and what contact they had had with the criminal justice system. People with severe untreated schizophrenia, bipolar disorder and brief psychotic disorder have been given traditional medication and religious exorcism and cared for by their family and community. Women tended to move to their husband's village and look after the extended family, usually sharing gardening tasks with their husband. Life has revolved around traditional ceremonies, tending the garden, caring for the houses and village and family issues. As subsistence farming has decreased, young men have moved to the cities to drive taxis and try to get jobs. This urbanization and selling of land has broken many of the family traditions, increased poverty, increased unemployment, decreased social support, and so forth. Young people in the cities are bored and have increased substance misuse and interactions with police. Women are now more educated and want to choose between education, career, marriage, and children. Many people do not want the chiefs to make decisions on their behalf. The chiefs themselves are often feeling overwhelmed with the stress of their positions and the change in their status and are at risk of depression. Vanuatu has a strong religious background with 92% of them Christians. The church and pastors have always had a very important role in counseling and problem-solving for those in their congregation and have mostly been the only source of mental health care available for many people. However a recent survey by a psychiatrist from Australia found that there was a great deal of misunderstanding about mental illness both in the church leaders and in the congregations. 45% of those surveyed thought that mental illness was a sin, 34% due to demon possession, and 38% due to a curse .As the country changes, the health system must change with it to take into account the new illnesses that are likely to emerge. Based on prevalence rates from the World Mental Health Survey in 2004, it is estimated that 13% of the adult population are likely to have a mental health disorder, 3% of these severe . HoweverJB and DP, two general practitioners from Australia who have an interest in mental health, were asked by the WHO to develop and present a programme for PIMHNet over 3 years. This involved developing a culturally appropriate mental health training programme, training key health, and social service personnel; supervising those who have been trained in their places of work; mentoring and setting up support networks for them; presenting more advanced training; and training local doctors and nurses to be mental health trainers and mentors themselves. JB and DP also spent time networking with the formal and informal mental health stakeholders in Vanuatu, including hospital administration, government, church organization, and nongovernment organizations. first visit: nurses from Vila Central Hospital (4), NGO workers (3), nursing lecturers from Vila (2), military medic (1), government health administrators (2), and doctors from Vila Central Hospital (2);second visit: 8 nurses, nurse practitioners and nurse aides from outlying islands , and 5 social services personnel ; in every session there was someone trained during the first visit to assist with the training; they had done a two-day “Train the trainer” course before the start of the training;third visit: visiting all the doctors, nurses, and social services personnel in their workplaces; discussing cases, giving additional training, mentoring, seeing difficult patients, and training those people the nurses had trained. Training visits for health workers and the community are as follows: what is mental illness?depression,anxiety,communication skills,structured problem-solving,cognitive behavioural therapy,narrative and family therapy,alcohol and substance abuse,risk management and crisis intervention,psychosis and bipolar disorder,personality disorders,child mental health,adolescent mental health,mental health and the elderly,research skills.Programme of presentations for PIMHnet in Vanuatuare as follows:During the first visit to Vanuatu for training, a combination of teaching methods was used. The mornings were taught using an interactive didactic format and the afternoons in workshop style. In the afternoons participants brainstormed topics in groups, role-played what they had learnt in the morning, and refined skills in small group discussions. The content of the case studies and role-plays were built up over the course of the training as JB and DP developed an understanding of the problems that caused mental health issues and how they might present in Vanuatu. Many of these were very different to those in Australia—for instance, the use of kava causing social disruptions in families, the strong religious culture in the community, the role of chiefs in resolving family and community issues, arranged marriages, the importance of making “lap-lap” , young men coming to Port Vila to find work, the controversy about the use of marijuana, and so forth. Because of the importance of keeping the presentations relevant, culturally appropriate and in-tune with the needs of the participants, most of the sessions were prepared during the first visit to Vanuatu. Both JB and DP have had about 30 years of experience as General Practitioners (Family Physicians) in Australia.Many resources were used from the WHO but other important ones included JB's book on “Mental Health Across Cultures” , “Where The training sessions during the second visit were more difficult as the group that had been identified for training comprised some of the most highly trained nurse practitioners in Vanuatu and others who had no health background or experience at all. The first day was spent discussing the challenge of how to prevent the disability associated with mental health problems becoming so severe that the only avenues available to manage the situation were hospitals, police, corrections, church elders, and so forth. This was a very useful discussion because it enabled this very diverse group to focus on a common goal. Even though they came from such different backgrounds, after about the third day, the differences had almost disappeared and everyone seemed to be working at a similar level. One of the differences between the participants was the issue of clinical care, something the nurses were very familiar and comfortable with. The social services personnel brought a different perspective to many of the sessions because they insisted on discussing the philosophy behind strategies such as confidentiality, parenting, the role of spirituality in mental health, and human rights. As with the first training group, the postworkshop questionnaire showed that everyone had enjoyed the course very much, that they thought it was relevant to their current situations, that it had changed the way they related to patients with mental health problems, that their confidence in diagnosing and treating mental health problems had increased because of the course, and that they could help people with mental health problems have better lives. Most thought they could make a management plan for people with depression, anxiety, suicidal risk, crisis, or substance abuse but still felt tentative about being able to develop management plans for those with schizophrenia, bipolar disorder, or somatisation. The practical nature of this training was very different to the mental health training that some of the participants had experienced in the past. Previous training was theoretical, with an emphasis on written material and DSMIV and ICD10 diagnoses, and as a consequence health workers were not able to apply any new knowledge or skills in the clinical setting. As General Practitioners, JB and DP were able from the outset to emphasise the acquisition of skills that were practical and relevant. For instance, participants were encouraged to grade patient's illness on a Likert scale from 1 to 10 but also to scale the disability on a scale from 1 to 10. They were then able to ask what would make the patient better or worse, prepare an appropriate risk management plan, and mobilize the patient's resources. Drawings such as the “social atom” to discuss social structure and family trees for children and the “hand exercise” that helps access social and personal assets were very popular. The use of stories and humour and discovery of resilience in Narrative Therapy and the “Cultural Awareness Tool” which helps a health professional find the meaning of a situation for the patient were thought to be two particularly useful tools . These aAs the skills of the groups improved, the cases developed for the training became more realistic and difficult and they were able to revise and consolidate their knowledge and develop and communicate management plans for the role-playing cases. DP spent time with the first group on her second visit, consolidating their skills and exploring new concepts and strategies with them. This deepened their understanding and improved their confidence in using techniques such as CBT. Only the nurse practitioners and doctors in the group (4 people) were able to prescribe medication; so the emphasis in the course was on diagnosis, assessment, and psychotherapy.The third trip involved JB and the main mental health nurse from Vila Central Hospital travelling to five different islands, some of them very remote with limited electricity, accessibility, or support for the few health professionals there. Seeing people in their own communities was found to be of the utmost importance. It helped with skill development; it raised the profile of mental health and encouraged local people and other health professionals to trust the nurses who had been trained; it gave the nurses confidence that they were on the right track; it highlighted the importance of mental health being embedded in the primary health care model. The list of mental disorders was almost identical to that which a GP in Australia would see, except that most of them had no previous treatment. Because there are no words for mental health in Bislama, clinics were advertised as “Sik long bran” (Brain clinics) and so physical illnesses which can affect mental health were seen such as grand mal seizures, petit mal seizures, temporal lobe epilepsy, parkinsons disease, anaemia, vitamin B12 deficiency, hyponatraemia, liver disease, sequelae of encephalitis, sequelae of cerebral malaria, hypertension, and migraine. All of these except hypertension were clinical diagnoses as there were absolutely no facilities for testing or referral. The rest of the patients had depression, anxiety disorders, bipolar disorder, schizophrenia, substance abuse, personality disorders, and so forth. The only other difference was that of “brief psychotic disorder” which is rarely seen in developed countries . This isWestern-based ideas of confidentiality, screening tools, pattern recognition, appropriate places for consultations, management plans, and follow-up all needed to be modified to suit the environment. Consultations were held in many diverse places such as in the grass huts that served as remote nurse aid posts, in patient's houses, in the centre of the village, and in more formal settings in the hospital. Almost all patients came with family or community members, with up to ten people accompanying very sick patients with schizophrenia. Sometimes two local interpreters were needed as patients did not speak Bislama but only the local mother tongue. In every area the focal nurses, and nurse practitioners had trained other nurse practitioners, nurses and nurse aids in basic mental health awareness, diagnostic techniques, and treatment skills. They had also been considerably active in raising awareness about mental health problems in their communities. Everywhere the team went there were more people than could possibly be seen during a short visit. Many of the patients had been identified by the nurse aid who had been trained by the nurses that JB and DP had trained. In some places the local chief accompanied the patient and identified other patients who needed to be seen, and others responded to signs or announcements in church. All of the “untreated” patients with very disruptive psychosis had been treated with custom medication and had a traditional understanding of what was causing the problem. One of the most powerful health promotion tools was to say that people all over the world have this same disease with very similar symptoms and that this is an illness and not black magic. Untreated psychosis is an enormous burden and worry for families and there is a great deal of stigma associated with the community thinking there is a curse on the person. Many of the nurses in remote areas were feeling quite lonely in their quest to diagnose and treat mental health problems and were very pleased to have someone to listen to their successes and problems. Working through case studies and actually seeing patients together was a fertile ground for further training and such supervision is invaluable.Because the participants of the training on mental health worked in very different workplaces, they found that different skills were useful for them. So, for instance, the nurse in Emergency at Vila Central Hospital had enormous success with using the slow breathing techniques for people who were coming in regularly with “asthma attacks” and had decreased the number of presentations dramatically. The chief had used structured problem-solving to change the way he dealt with the people who came to see him. The nurse in the paediatric ward had used family therapy a great deal and wanted to expand her understanding of this skill. One of the doctors had found it very useful to be able to properly assess the risk of suicide and use some CBT techniques. She had also started to use medication for more people, as she felt more confident about it. One of the remote nurses had found simple narrative therapy very useful and had taught the nurses aids in the area basic diagnostic skills, the hand exercise, slow breathing, and narrative therapy skills. Another remote nurse had started a “mental health clinic” one afternoon a week and had the Likert scales for disease and disability and the “hand exercise” in every patient's notes. He had taught the two other nurses who worked with him so that they were also now doing this. The nurse in Vila Central hospital who had done further training in Australia was seeing a lot of people with schizophrenia and was doing a full mental state examination on all these patients which gave him a clearer picture of the their mental state. The police and corrections people saw a lot of people with substance abuse problems and found the assessment tools and motivational interviewing very useful. All of these practitioners were very enthusiastic about having more training as they were often seeing rapid changes in the attitudes, functionality, health, and social circumstances of patients who had previously been struggling with mental health problems but had not been able to alter the situations they were in. All the participants were eager to teach their colleagues what they had found useful and some of those who had been taught in this way had begun to teach others. As well as the training, JB and DP spent time networking with mental health stakeholders in Vanuatu, advocating with the government for more resources in mental health, mental health promotion, liaison with churches, development of templates and questionnaires for use in the communities and in hospital, and so forth. By the second visit in 2009, the Vanuatu Mental Health Policy and Strategic Plan (2009–2014) had been approved and many of the students were actively using the techniques and instruments to assist people with mental health problems in the community and the hospital. An Australian volunteer psychologist had been recruited and based in the community and support had been gained from chiefs, the church, and other NGOs to assist with mental health problems in several villages. The hospital was proceeding with delivery of mental health care and is working on a process to facilitate communication between the hospital and the community. Education in mental health was proceeding in other areas such as the military, police, and education department. Teaching evaluation and basic research skills was seen to be an integral part of the training as well as the importance of evaluating any programme so that its usefulness could be assessed and lessons learned. The groups discussed the importance of ethics and confidentiality and validated the translations of research tools. The Kessler 10 (K10) has been translated into many languages but not into Bislama . After mWork in Vanuatu as part of WHO PIMHnet has shown that equity of access to mental health care is possible when it is integrated into primary care, the workforce is properly trained and mentored, and the Government supports the process. As with many LAMICs, the high need for mental health care in the Western Pacific region was not being met because of lack of workforce, lack of culturally appropriate and practical training, limited financial resources, stigma, and the isolation of many communities. Training the primary health care workforce has begun to address this inequity. With the support of WHO and NZAid, further visits to Vanuatu will support those already trained and begin to target those who can be trainers and mentors themselves. Similar activities are happening in other Pacific Islands. It is the beginning of a new era in mental health care in Pacific Island countries.


The International Classification of Functioning, Disability and Health (ICF) is a classification of health and health-related issues, aimed at describing and measuring health and disability at both individual and population levels. Here we discuss a preliminary qualitative and quantitative analysis of the relationships used in the Activities and Participation component of ICF, and a preliminary mapping to SUMO (Suggested Upper Merged Ontology) concepts. The aim of the analysis is to identify potential logical problems within this component of ICF, and to understand whether activities and participation might be defined more formally than in the current version of ICF.In the relationship analysis, we used four predicates among those available in SUMO for processes . While at the top level subsumption was used in most cases (90%), at the lower levels the percentage of other relationships rose to 41%. Chapters were heterogeneous in the relationships used and some of the leaves of the tree seemed to represent properties or parts of the parent concept rather than subclasses. Mapping of ICF to SUMO proved partially feasible, with the activity concepts being mapped mostly  under the IntentionalProcess concept in SUMO. On the other hand, the participation concept has not been mapped to any upper level concept.Our analysis of the relationships within ICF revealed issues related to confusion between classes and their properties, incorrect classifications, and overemphasis on subsumption, confirming what already observed by other researchers. However, it also suggested some properties for Activities that could be included in a more formal model: number of agents involved, the instrument used to carry out the activity, the object of the activity, complexity of the task, and an enumeration of relevant subtasks. Terminologies and classifications are particularly crucial in the medical field, as they are widely diffused to represent knowledge in the clinical practice. Perhaps the most known terminologies and classifications are the International Classification of Diseases (ICD)  and the Ontologies are means for specifying the intended meaning of a vocabulary in a logical manner . Dependihttp://apps.who.int/classifications/icfbrowser/.The International Classification of Functioning, Disability and Health (ICF) ,5 is a cICF is a classification with a simple structure. It is divided into four main components, independent of each other: Body Functions, Body Structure, Activities and Participation, and Environmental Factors. A hierarchical structure is present, where each concept has a name, a text description, and inclusion and exclusion relationships. The first level of hierarchy is constituted of chapters. Each concept at each level has a hierarchical alphanumeric code. Figure Moreover, in its practical use, each concept is qualified by a numerical value, the interpretation of which is defined within a range specific for every chapter. However, this feature will not be considered in our analysis.WHO develops and updates a family of health care terminologies including ICF, and has embarked on an open web-based cooperation to revise ICD 11 using ontology-driven tools . The samAs reported in , a thoroMaintenance and evolution of ICF are among the tasks carried out by the WHO Family of International Classification Network, which is composed of 14 collaborating centers established at some national level institutions in the world. This work has been carried out among the activities of the Italian Center, as a basis for the development of a more formal version of ICF, in cooperation with other WHO-FIC collaborating centers.In this paper, we present an ontology-based exploration of the relationships and concepts used in the Activities and Participation component of ICF, by mapping it to an upper ontology . The aiThe Activities and Participation component describes concepts defined as follows :Activity is the execution of a task or action by an individual. Participation is involvement in a life situation.d450-d469: Walking and moving), while other chapters are directly organised into categories, i.e., three digit codes. Categories may have further subcategories. In total, there are 118 categories  and 266 subcategories.The Activities and Participation component is composed of nine chapters Table . Each chAfter a first examination of the main hierarchy of the component, we analysed together all the relationships between parent and child concepts to understand i) whether subsumption is the most appropriate relationship and, if not, which is the specific relationship; and ii) whether the current relationship could link the parent concept to a property of it rather than to a subclass. The latter step aimed at pointing out the process properties that have been considered relevant by the developers of ICF to describe human functioning and health. Particular attention was given to the lower levels of the hierarchy. The specific relationships were then chosen, when possible, among those available in SUMO.In our analysis, residual classes  were not included.To graphically document the analysis, the Freemind mindmapping software  was usedIn order to better understand whether the concepts described among ICF activities and participation are uniform or rather include different logical kinds, we attempted a mapping towards an upper level ontology. Among the available upper ontologies we chose SUMO (Suggested Upper Merged Ontology) , becauseWe converted the ClaML  represenIn our analysis, we chose to use the following four predicates among those available in SUMO for processes: Patient, Instrument, Agent, subProcess.Patient predicate was adopted whenever a child concept in ICF was a subclass of the parent concept, where the specific feature of the subclass is given by the object involved in the activity. The Instrument predicate was adopted when a child concept differed from its sibling for the tool/means used to carry out the activity. The Agent predicate was used when a child concept differed from its siblings for a different number of agents involved . The subProcess predicate was adopted to identify child concepts related to different stages of the parent concept.The While we could have used the subsumption relationship in any other case, we decided to adopt another property that we were not able to identify in SUMO to describe complexity of activities. In fact, in some classes there is a distinction between "simple" and "complex" version of the activity. As this is a sensible difference from the user point of view, we maintained such a distinction, even if the definition of "simple" and "complex" is not provided.The Activities and Participation component embodies two different concepts, namely activity and participation. ICF experts consider activity and participation as two facets of the same involvement of people in areas of life, respectively from individual and societal points of view. The ICF activity can be considered an intentional process according to SUMO. Participation is more difficult to define, although it seems to be related to a role in a scenario.When looking at the first level of the hierarchy, two cases of heterogeneity become apparent.In fact, Chapter 2  differs from the other chapters, because it provides a sort of generic classification of tasks based on complexity and other features. Unfortunately, this classification does not provide explicit linkages to the concrete activities described in the rest of the Activities and Participation component, except for examples provided in the textual description. As an example, Figure Similarly, Chapter 7  is a metamodel for social interaction.A quantitative summary of the results of the analysis is shown in Table Conversation activity, the latter two the number of agents involved.Chapters were heterogeneous in the relationships used and some of the leaves of the tree seemed to represent properties or parts of the parent concept rather than subclasses. The subtree in Figure d3550: Discussion with one person, d3551: Discussion with many people).Different chapters seemed to exhibit different patterns of relationships used. The number of involved agents appears as a relationship only in chapters 2 and 3. As already mentioned, Chapter 2 is an exception because it provides a classification of generic activities. Chapter 3 is devoted to communication, so there is a need for coding the number of people involved in communication , 11 blocks (out of 18), 22 categories (out of 118) and 21 subcategories (out of 266). Figure Applying knowledge (d160-d179), has some subclasses recognizable in SUMO , but other classes are not , thus it can be overall mapped to IntentionalPsychologycalProcess.Chapter 1 is about learning and applying knowledge. When trying to map specific ICF concepts, only few of them find a similar target in SUMO. For example, the last block of the chapter, General tasks and demands) may be generally considered a subclass of IntentionalProcess, without more specific mappings. For this reason, Chapter 2 could become the basis of a domain ontology on Activities, by providing classes to which to classify other activities, including those described in the next chapters.Chapter 2 (d310-d329 Communicating - Receiving), a sender role (d330-d349 Communicating - Producing), and a conversation part inclusive of communication devices usage (d350-d369 Conversation and use of communication devices and techniques). Since communication in SUMO is modelled in a slight different way, the conversation concept in ICF was mapped to SUMO Communication, whereas the sender side of communication was mapped (with some doubts) to ContentDevelopment. The recipient side of communication is described in ICF mainly as ability to understand the various spoken, non verbal, body messages. Thus, we mapped it to the SUMO Interpreting class, which is defined as the process of assigning a Proposition to a Text. However, it would be better mapped to a superclass of Interpreting, where the process of understanding is applied to a more generic ContentBearingObject.Chapter 3 deals with communication, which according to ICF has a recipient role .Chapters 5 (Self care) and 6 (Domestic life) are subclasses of Chapter 7 relates to interpersonal interactions and relationships, their properties, their timeline, their formality or informality, and other aspects. As such, no direct mapping can be found for most concepts.SocialInteraction, and others to more general processes.When looking at the other chapters that surely describe participation (like 8 and 9), some concepts can be mapped to SUMO Our analysis of the relationships within ICF identified some issues, confirming what already observed by Kumar and Smith on a different component , and in The formal problems described here may not be considered as limits of ICF, as well as of other traditional biomedical terminologies and classifications  represent a metaclassification that is not yet fully exploited inside ICF.To proceed towards a more formal representation of ICF, a model could be developed based on properties described in formal ontologies for the mapped classes, and adding what needed to represent the specific ICF knowledge on activities and participation. According to our findings, interesting properties for activities might include the number of agents involved, the instrument used to carry out the activity and if necessary the object (patient) of the activity, some measures of the complexity of the task, and possibly an enumeration of relevant subtasks. Although in this exploration we did not consider qualifiers role, the proposed analysis may help in driving future evolutions of ICF towards a more formally founded description of human activities.ClaML: Classification Markup Language; ICD: International Classification of Diseases; ICF: International Classification of Functioning, Disability and Health; SNOMED: Systematized Nomenclature of Medicine; SUMO: Suggested Upper Merged Ontology.The authors declare that they have no competing interests.VDM conceived the study, collaborated in the analysis and drafted the paper. AS participated in the analysis and collaborated in the writing of the final version of the paper. Both authors have read and approved the manuscript.Graphical representation of the relationships in ICF VDM-AP-map.pdf graphically describes the relationships found in the analysis of the Activities and Participation component of ICF.Click here for file