Concurrent diphtheria and infectious mononucleosis: difficulties for management, investigation and control of diphtheria in developing countries.

PubMed

Mattos-Guaraldi, A L; Damasco, P V; Gomes, D L R; Melendez, M G; Santos, L S; Marinelli, R S; Napoleão, F; Sabbadini, P S; Santos, C S; Moreira, L O; Hirata, R

2011-11-01

We report a case of concurrent diphtheria and infectious mononucleosis in an 11-year-old Brazilian child. Two days after specific treatment for diphtheria was started the patient was discharged following clinical recovery. This case highlights the difficulties in the clinical diagnosis of diphtheria in partially immunized individuals, and for the management and control of diphtheria in developing countries.

Clinical trials in "emerging markets": regulatory considerations and other factors.

PubMed

Singh, Romi; Wang, Ouhong

2013-11-01

Clinical studies are being placed in emerging markets as part of global drug development programs to access large pool of eligible patients and to benefit from a cost effective structure. However, over the last few years, the definition of "emerging markets" is being revisited, especially from a regulatory perspective. For purposes of this article, countries outside US, EU and the traditional "western countries" are discussed. Multiple factors are considered for placement of clinical studies such as adherence to Good Clinical Practice (GCP), medical infrastructure & standard of care, number of eligible patients, etc. This article also discusses other quantitative factors such as country's GDP, patent applications, healthcare expenditure, healthcare infrastructure, corruption, innovation, etc. These different factors and indexes are correlated to the number of clinical studies ongoing in the "emerging markets". R&D, healthcare expenditure, technology infrastructure, transparency, and level of innovation, show a significant correlation with the number of clinical trials being conducted in these countries. This is the first analysis of its kind to evaluate and correlate the various other factors to the number of clinical studies in a country. © 2013.

Education and training for medicines development, regulation, and clinical research in emerging countries

PubMed Central

Kerpel-Fronius, Sandor; Rosenkranz, Bernd; Allen, Elizabeth; Bass, Rolf; Mainard, Jacques D.; Dodoo, Alex; Dubois, Dominique J.; Hela, Mandisa; Kern, Steven; Massud, Joao; Silva, Honorio; Whitty, Jeremy

2015-01-01

The aim of this satellite workshop held at the 17th World Congress of Basic and Clinical Pharmacology (WCP2014) was to discuss the needs, optimal methods and practical approaches for extending education and teaching of medicines development, regulation, and clinical research to Low and Middle Income Countries (LMICs). It was generally agreed that, for efficiently treating the rapidly growing number of patients suffering from non-communicable diseases, modern drug therapy has to become available more widely and with a shorter time lag in these countries. To achieve this goal many additional experts working in medicines development, regulation, and clinical research have to be trained in parallel. The competence-oriented educational programs designed within the framework of the European Innovative Medicine Initiative-PharmaTrain (IMI-PhT) project were developed with the purpose to cover these interconnected fields. In addition, the programs can be easily adapted to the various local needs, primarily due to their modular architecture and well defined learning outcomes. Furthermore, the program is accompanied by stringent quality assurance standards which are essential for providing internationally accepted certificates. Effective cooperation between international and local experts and organizations, the involvement of the industry, health care centers and governments is essential for successful education. The initiative should also support the development of professional networks able to manage complex health care strategies. In addition it should help establish cooperation between neighboring countries for jointly managing clinical trials, as well as complex regulatory and ethical issues. PMID:25926798

Essays on Child Development in Developing Countries

ERIC Educational Resources Information Center

Humpage, Sarah Davidson

2013-01-01

This dissertation presents the results of three field experiments implemented to evaluate the effectiveness of strategies to improve the health or education of children in developing countries. In Guatemala, community health workers at randomly selected clinics were given patient tracking lists to improve their ability to remind parents when their…

[Status of research and development for control of tropical diseases: hypocrisy, indifference or lack of coordination].

PubMed

Millet, P

2006-12-01

Tropical diseases neglected by the pharmaceutical industry usually involve developing countries. Neglected diseases can now be divided into two groups. The first includes the big three infections i.e., malaria, HIV/AIDS, and tuberculosis, that present strategic and political overtones. The second group includes a host of other fatal infections including worms, trypanosomiasis, and leishmaniasis. Fundamental research on neglected diseases has been highly productive, but there has been little success in transferring research findings to a pharmaceutical industry unwilling to take the risks associated with developing new drugs on its own. However several public-private initiatives have revived hopes of developing new products with growing involvement of industries in developing countries (India and Brazil) despite the high risks associated with fluctuating demand for medicines or funding shortages. To meet the need for testing new drugs, more clinical facilities and better patient recruitment will be needed in endemic countries. Although these new efforts to control neglected diseases are encouraging, there is now a need for coordination. Clinical research in developing countries must be organized in compliance with international principles of ethics. Testing must be aimed at validating fundamental data from industrialized countries. Appropriate incentives must be given to ensure that pharmaceutical companies use research findings for new product development. In this context, the time seems ripe for the establishment of an independent laboratory for technological innovation in neglected diseases. Such a facility could not only validate scientific data but also supervise the development of clinical applications from research data.

The management of clinical laboratories in Europe: a FESCC survey. Forum of the European Societies of Clinical Chemistry and Laboratory Medicine.

PubMed

de Kieviet, Wim; Blaton, Victor; Kovacs, Gabor L; Palicka, Vladimir; Pulkki, Kari

2002-03-01

The professional duties of the specialists in clinical chemistry differ from country to country in Europe. One of the main goals of the Strategic Plan of the Forum of the European Societies of Clinical Chemistry and Laboratory Medicine (FESCC; IFCC-Europe) is to promote a high scientific and professional standard in the field of clinical chemistry and laboratory medicine in Europe. This can be stimulated by the knowledge of the local conditions in each country and by striving towards a strong and harmonised position in all the European countries. In order to enhance the knowledge of the managerial situation of the specialists in clinical chemistry in Europe, FESCC launched a survey in September 2000. This survey provides information about the position of the specialists in clinical chemistry in the various disciplines in the medical laboratories and in hospitals, and about the advisory tasks and the managerial education during the post-graduate training in clinical chemistry. Of the 35 FESCC member countries 33 have participated in the survey (94%). The results show a rather heterogeneous situation in Europe caused by the local historical developments, the differences in academic background and the relative numbers of private and physicians' office laboratories. Large differences exist between the European countries in the disciplines of laboratory medicine that are headed by a specialist in clinical chemistry. In the different countries the clinical chemistry laboratories are headed by specialists in clinical chemistry in between 20% and 100% of the laboratories. The haematology, immunology, microbiology, therapeutic drug monitoring, molecular biology and haemostasis laboratories and departments of blood banking are headed by specialists in clinical chemistry in between 0% and 100% of the laboratories. The responsibilities for the various managerial tasks of the specialists in clinical chemistry show no uniformity in Europe. In the majority of the countries the general management, the purchase of equipment and reagents and the education of technicians are in >90% the responsibility of the specialists in clinical chemistry. In most countries the majority of the specialists in clinical chemistry are members of the medical staff of the hospitals and have a position equivalent to the position of specialists in other medical disciplines. In some countries, however, it only holds true for the specialists with a medical background. In 79% of the countries the law regulates the profession of the specialists in clinical chemistry and in 60% of the countries the law regulates their position in the medical staff of the hospital. The advisory tasks to physicians, general practitioners and other users of laboratory tests are practised by >90% of the laboratories in 64% of the countries. Information is given directly to the patients by >90% of the laboratories in 30% of the countries. Only in a few countries laboratories give information to the public. The post-graduate training in clinical chemistry includes a managerial training in 58% of the countries, the study of information technology in 61% of the countries and an economy and/or a business administration study in 15% of the countries. In 27% of the countries no managerial education forms part of the post-graduate study in clinical chemistry. Harmonisation of the managerial aspects of the profession is one of the challenges for the European specialists in clinical chemistry. A European syllabus for post-graduate training could be helpful.

[Similarities between disaster areas and developing countries in terms of the lack of facilities for clinical examinations].

PubMed

Suganami, Shigeru

2012-03-01

From the experience of more than 130 emergency medical relief missions in over 50 countries/areas, the AMDA would like to propose a system of mobile clinical examinations to prepare for possible natural disasters in Japan. Such a system will require the development of vehicles equipped with a full range of laboratory equipment, which I believe will become a public property in the world, and contribute to the enhancement of medical services in disaster areas as well as in areas with less developed medical technologies. AMDA's recent medical relief activities include the support of the victims of the earthquakes in Haiti (2010) and Turkey (2011), and the flood in Thailand (2012). In these countries, the AMDA faced the lack of a clinical examination system which resulted in a huge number of patients who could not receive proper treatment after injury, or those who suffered from infectious diseases. Domestically, when the AMDA sent medical teams to the affected areas of the Great East Japan Earthquake and tsunami (2011), their activities took place mainly in evacuation shelters, where survivors needed treatment for chronic diseases and preventive care. All of these experiences highlight the importance of clinical examination in disaster areas, as well as in developing countries/areas similarly lacking basic medical services. The Japanese Society of Laboratory Medicine will surely play an important role in the development of the proposed system of mobile clinical examinations. The AMDA would like to collaborate with the JSLM in emergency relief activities and medical aid projects in areas affected by disasters or lack basic medical services.

A comparative study of interprofessional education in global health care

PubMed Central

Herath, Chulani; Zhou, Yangfeng; Gan, Yong; Nakandawire, Naomie; Gong, Yanghong; Lu, Zuxun

2017-01-01

Abstract Background: The World Health Organization (WHO) and its partners identify interprofessional (IP) collaboration in education and practice as an innovative strategy that plays an important role in mitigating the global health workforce crisis. Evidence on the practice of global health level in interprofessional education (IPE) is scarce and hampered due to the absence of aggregate information. Therefore, this systematic review was conducted to examine the incidences of IPE and summarize the main features about the IPE programs in undergraduate and postgraduate education in developed and developing countries. Methods: The PubMed, Embase, Web of Science, and Google Scholar were searched from their inception to January 31, 2016 for relevant studies regarding the development of IPE worldwide, IPE undergraduate and postgraduate programs, IP interaction in health education, IPE content, clinical placements, and teaching methods. Countries in which a study was conducted were classified as developed and developing countries according to the definition by the United Nations (UN) in 2014. Results: A total of 65 studies from 41 countries met our inclusion criteria, including 45 studies from 25 developed countries and 20 studies from 16 developing countries. Compared with developing countries, developed countries had more IPE initiatives. IPE programs were mostly at the undergraduate level. Overall, the university was the most common academic institution that provided IPE programs. The contents of the curricula were mainly designed to provide IP knowledge, skills, and values that aimed at developing IP competencies. IPE clinical placements were typically based in hospitals, community settings, or both. The didactic and interactive teaching methods varied significantly within and across universities where they conducted IPE programs. Among all health care disciplines, nursing was the discipline that conducted most of the IPE programs. Conclusion: This systematic review illustrated that the IPE programs vary substantially across countries. Many countries, especially the academic institutions are benefiting from the implementation of IPE programs. There is a need to strengthen health education policies at global level aiming at initiating IPE programs in relevant institutions. PMID:28930816

Challenges in developing national HIV guidelines: experience from the eastern Mediterranean

PubMed Central

De Weggheleire, Anja; Bortolotti, Veronique; Zolfo, Maria; Crowley, Siobhan; Colebunders, Robert; Riedner, Gabriele

2011-01-01

Abstract Objective To appraise the process of development and clinical content of national human immunodeficiency virus (HIV) clinical practice guidelines of countries in the eastern Mediterranean and to formulate recommendations for future guideline development and adaptation. Methods Twenty-three countries in the World Health Organization (WHO) Eastern Mediterranean and United Nations Children’s Fund Middle East and North Africa regions were invited to submit national HIV clinical practice guidelines for review. The guideline development methodology was assessed using an adaptation of the Appraisal of Guidelines Research and Evaluation (AGREE) instrument and guideline content, using a checklist to evaluate concordance with WHO 2006 generic guidelines. Findings Twelve countries submitted 20 guidelines developed between 2004 and 2009. Median scores were poor (i.e. < 0.6) for the methodological quality domains of rigour of development, stakeholder involvement and applicability and flexibility. Scores were better for the domains of scope and purpose (median: 0.82, interquartile range, IQR: 0.58–0.89) and clarity and presentation (median: 0.67, IQR: 0.50–0.78). Concerning guideline content, recommended first-line treatment and eligibility criteria for antiretroviral therapy (ART) in adults were in line with WHO recommendations in most guidelines. However, recommendations on antiretroviral prophylaxis for the prevention of vertical HIV transmission, diagnosis and treatment of HIV infection in infants, monitoring patients on ART, treatment failure and co-morbidities were often lacking. Conclusion The large majority of national HIV clinical practice guidelines had methodological weaknesses and content inaccuracies. Countries require assistance with the adaptation process to ensure that guidelines are valid and up to date and accurately reflect WHO global clinical care recommendations for patients with HIV. PMID:21673860

Magnitude and risk factors for postpartum symptoms: a literature review.

PubMed

Norhayati, M N; Hazlina, N H Nik; Asrenee, A R; Emilin, W M A Wan

2015-04-01

The prevalence of postpartum depression worldwide varies from 0.5% to 60.8% in the first 12 months postpartum using self-reported questionnaire. This review aims to update the current magnitude of postpartum depression based on self-reported questionnaire and clinical interview and explore its associated factors in developed and developing countries. A literature search conducted between 2005 and 2014 identified 203 studies, of which 191 used self-reported questionnaire in 42 countries and 21 used structured clinical interview in 15 countries. Nine studies used a combination of self-reported questionnaire and clinical interview. The prevalence of postpartum depression varies from 1.9% to 82.1% in developing countries and from 5.2% to 74.0% in developed countries using self-reported questionnaire. Structured clinical interview shows a much lower prevalence range from 0.1% in Finland to 26.3% in India. Antenatal depression and anxiety, previous psychiatric illness, poor marital relationship, stressful life events, negative attitude towards pregnancy, and lack of social support are significant contributors to postpartum depression. All studies are included irrespective of the methodological quality, such as small sample size and their inclusion could affect the generalizability of the results. The current prevalence of postpartum depression is much higher than that previously reported, and similar risk factors are documented. A culturally sensitive cut-off score with adequate psychometric properties of the screening instruments should be available. In future studies, examining the physical, biological, and cultural factors in qualitative studies and in those with adequate methodological qualities is recommended. Copyright © 2015 The Authors. Published by Elsevier B.V. All rights reserved.

Suicide in developing countries (2): risk factors.

PubMed

Vijayakumar, Lakshmi; John, Sujit; Pirkis, Jane; Whiteford, Harvey

2005-01-01

The majority of studies on risk factors for suicide have been conducted in developed countries, and less work has been done to systematically profile risk factors in developing countries. The current paper presents a selective review of sociodemographic, clinical, and environmental/situational risk factors in developing countries. Taken together, the evidence suggests that the profiles of risk factors in developing countries demonstrate some differences from those in developed countries. In some developing countries, at least, being female, living in a rural area, and holding religious beliefs that sanction suicide may be of more relevance to suicide risk than these factors are in developed countries. Conversely, being single or having a history of mental illness may be of less relevance. Risk factors that appear to be universal include youth or old age, low socioeconomic standing, substance use, and previous suicide attempts. Recent stressful life events play a role in both developing and developed countries, although their nature may differ (e.g., social change may have more of an influence in the former). Likewise, access to means heightens risk in both, but the specific means may vary (e.g., access to pesticides is of more relevance in developing countries). These findings have clear implications for suicide prevention, suggesting that preventive efforts that have shown promise in developed countries may need to be tailored differently to address the risk factor profile of developing countries.

The educational and professional status of clinical embryology and clinical embryologists in Europe.

PubMed

Kovačič, B; Plas, C; Woodward, B J; Verheyen, G; Prados, F J; Hreinsson, J; De los Santos, M J; Magli, M C; Lundin, K; Plancha, C E

2015-08-01

What is the recognition of clinical embryology and the current status of clinical embryologists in European countries, regarding educational levels, responsibilities and workload, and need for a formal education in assisted reproductive technology (ART)? It is striking that the profession of clinical embryology, almost 40 years after the introduction of IVF, is still not officially recognized in most European countries. Reproductive medicine has developed into a sophisticated multidisciplinary medical branch since the birth of Louise Brown 37 years ago. The European Board & College of Obstetrics and Gynaecology (EBCOG) has recognized reproductive medicine as a subspeciality and has developed a subspeciality training for gynaecologists in collaboration with the European Society for Human Reproduction and Embryology (ESHRE). However, nothing similar exists for the field of clinical embryology or for clinical embryologists. A questionnaire about the situation in clinical embryology in the period of 2012-2013 in the respective European country was sent to ESHRE National representatives (basic scientists only) in December 2013. At this time, 28 European countries had at least one basic scientist in the ESHRE Committee of National Representatives. The survey consisted of 46 numeric, dichotomous (yes/no) or descriptive questions. Answers were obtained from 27 out of 28 countries and the data were tabulated. Data about the numbers of 'ESHRE Certified Embryologists' were taken from the ESHRE Steering Committee for Embryologist Certification. In 2012, more than 7000 laboratory staff from 1349 IVF clinics in 27 European countries performed over 700 000 fresh and frozen ART cycles. Despite this, clinical embryology is only recognized as an official profession in 3 out of 27 national health systems. In most countries clinical embryologists need to be registered under another profession, and have limited possibilities for organized education in clinical embryology. Mostly they are trained for practical work by senior colleagues. ESHRE embryologist certification so far constitutes the only internationally recognized qualification; however this cannot be considered a subspecialization. Data were obtained through different methods, by involving national embryologist societies and cycle registers, collecting information from centre to centre, and in some cases by individual assessment of the situation. For these reasons, the results should be interpreted with caution. This paper presents the current status of clinical embryology and clinical embryologists in Europe and is an important step towards implementation of clinical embryology as an officially recognized profession. None. No. © The Author 2015. Published by Oxford University Press on behalf of the European Society of Human Reproduction and Embryology. All rights reserved. For Permissions, please email: journals.permissions@oup.com.

Rotavirus vaccine RIX4414 (Rotarix™): a pharmacoeconomic review of its use in the prevention of rotavirus gastroenteritis in developing countries.

PubMed

Plosker, Greg L

2011-11-01

This article provides an overview of the clinical profile of rotavirus vaccine RIX4414 (Rotarix™) in the prevention of rotavirus gastroenteritis (RVGE) in developing countries, followed by a comprehensive review of pharmacoeconomic analyses with the vaccine in low- and middle-income countries. RVGE is associated with significant morbidity and mortality among children <5 years of age in developing countries. The protective efficacy of a two-dose oral series of rotavirus vaccine RIX4414 has been demonstrated in several well designed clinical trials conducted in developing countries, and the 'real-world' effectiveness of the vaccine has also been shown in naturalistic and case-control trials after the introduction of universal vaccination programmes with RIX4414 in Latin American countries. The WHO recommends universal rotavirus vaccination programmes for all countries. Numerous modelled cost-effectiveness analyses have been conducted with rotavirus vaccine RIX4414 across a wide range of low- and middle-income countries. Although data sources and assumptions varied across studies, results of the analyses consistently showed that the introduction of the vaccine as part of a national vaccination programme would be very (or highly) cost effective compared with no rotavirus vaccination programme, according to widely used cost-effectiveness thresholds for developing countries. Vaccine price was not known at the time the analyses were conducted and had to be estimated. In sensitivity analyses, rotavirus vaccine RIX4414 generally remained cost effective at the highest of a range of possible vaccine prices considered. Despite these favourable results, decisions regarding the implementation of universal vaccination programmes with RIX4414 may also be contingent on budgetary and other factors, underscoring the importance of subsidized vaccination programmes for poor countries through the GAVI Alliance (formerly the Global Alliance for Vaccines and Immunization).

The impact of mobile health interventions on chronic disease outcomes in developing countries: a systematic review.

PubMed

Beratarrechea, Andrea; Lee, Allison G; Willner, Jonathan M; Jahangir, Eiman; Ciapponi, Agustín; Rubinstein, Adolfo

2014-01-01

Rates of chronic diseases will continue to rise in developing countries unless effective and cost-effective interventions are implemented. This review aims to discuss the impact of mobile health (m-health) on chronic disease outcomes in low- and middle-income countries (LMIC). Systematic literature searches were performed using CENTRAL, MEDLINE, EMBASE, and LILACS databases and gray literature. Scientific literature was searched to identify controlled studies evaluating cell phone voice and text message interventions to address chronic diseases in adults in low- or middle-income countries. Outcomes measured included morbidity, mortality, hospitalization rates, behavioral or lifestyle changes, process of care improvements, clinical outcomes, costs, patient-provider satisfaction, compliance, and health-related quality of life (HRQoL). From the 1,709 abstracts retrieved, 163 articles were selected for full text review, including 9 randomized controlled trials with 4,604 participants. Most of the studies addressed more than one outcome. Of the articles selected, six studied clinical outcomes, six studied processes of care, three examined healthcare costs, and two examined HRQoL. M-health positively impacted on chronic disease outcomes, improving attendance rates, clinical outcomes, and HRQoL, and was cost-effective. M-health is emerging as a promising tool to address access, coverage, and equity gaps in developing countries and low-resource settings. The results for m-health interventions showed a positive impact on chronic diseases in LMIC. However, a limiting factor of this review was the relatively small number of studies and patients enrolled, highlighting the need for more rigorous research in this area in developing countries.

Development of the ICD-10 simplified version and field test.

PubMed

Paoin, Wansa; Yuenyongsuwan, Maliwan; Yokobori, Yukiko; Endo, Hiroyoshi; Kim, Sukil

2018-05-01

The International Statistical Classification of Diseases and Related Health Problems, 10th Revision (ICD-10) has been used in various Asia-Pacific countries for more than 20 years. Although ICD-10 is a powerful tool, clinical coding processes are complex; therefore, many developing countries have not been able to implement ICD-10-based health statistics (WHO-FIC APN, 2007). This study aimed to simplify ICD-10 clinical coding processes, to modify index terms to facilitate computer searching and to provide a simplified version of ICD-10 for use in developing countries. The World Health Organization Family of International Classifications Asia-Pacific Network (APN) developed a simplified version of the ICD-10 and conducted field testing in Cambodia during February and March 2016. Ten hospitals were selected to participate. Each hospital sent a team to join a training workshop before using the ICD-10 simplified version to code 100 cases. All hospitals subsequently sent their coded records to the researchers. Overall, there were 1038 coded records with a total of 1099 ICD clinical codes assigned. The average accuracy rate was calculated as 80.71% (66.67-93.41%). Three types of clinical coding errors were found. These related to errors relating to the coder (14.56%), those resulting from the physician documentation (1.27%) and those considered system errors (3.46%). The field trial results demonstrated that the APN ICD-10 simplified version is feasible for implementation as an effective tool to implement ICD-10 clinical coding for hospitals. Developing countries may consider adopting the APN ICD-10 simplified version for ICD-10 code assignment in hospitals and health care centres. The simplified version can be viewed as an introductory tool which leads to the implementation of the full ICD-10 and may support subsequent ICD-11 adoption.

Development and Validation of Simulated Virtual Patients to Impart Early Clinical Exposure in Endocrine Physiology

ERIC Educational Resources Information Center

Gupta, Akriti; Singh, Satendra; Khaliq, Farah; Dhaliwal, Upreet; Madhu, S. V.

2018-01-01

In the country presently, preclinical medical students are not routinely exposed to real patients. Thus, when they start clinical postings, they are found to have poor clinical reasoning skills. Simulated virtual patients (SVPs) can improve clinical skills without endangering real patients. This pilot study describes the development of two SVPs in…

Challenges of audit of care on clinical quality indicators for hypertension and type 2 diabetes across four European countries.

PubMed

Suija, Kadri; Kivisto, Katrin; Sarria-Santamera, Antonio; Kokko, Simo; Liseckiene, Ida; Bredehorst, Maren; Jaruseviciene, Lina; Papp, Renata; Oona, Marje; Kalda, Ruth

2015-02-01

The purpose of the study was to measure clinical quality by doing an audit of clinical records and to compare the performance based on clinical quality indicators (CQI) for hypertension and type 2 diabetes across seven European countries: Estonia, Finland, Germany, Hungary, Italy, Lithuania and Spain. Two common chronic conditions in primary care (PC), hypertension and type 2 diabetes, were selected for audit. The assessment of CQI started with a literature review of different databases: Organization for Economic Co-operation and Development, World Health Organization, European Commission European Community Health Indicators, US National Library of Medicine. Data were collected from clinical records. Although it was agreed to obtain the clinical indicators in a similar way from each country, the specific data collection process in every country varied greatly, due to different traditions in collecting and keeping the patients' data, as well as differences in regulation regarding access to clinical information. Also, there was a huge variability across countries in the level of compliance with the indicators. Measurement of clinical performance in PC by audit is methodologically challenging: different databases provide different information, indicators of quality of care have insufficient scientific proof and there are country-specific regulations. There are large differences not only in quality of health care across Europe but also in how it is measured. © The Author 2014. Published by Oxford University Press. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

[Globalization in medical research].

PubMed

Ehni, H-J; Wiesing, U

2018-03-01

The globalization of clinical research is gaining momentum. In particular, emerging countries, such as Brazil, India, Russia and South Africa show a significant increase in clinical trials. This trend is generating various ethical problems, which are examined in the present article. Sometimes, generally accepted ethical rules, such as the evaluation of clinical trials by ethics commissions are not respected and sometimes conflicts are generated which are difficult to resolve. For instance, it is controversial which standard of care researchers and sponsors have to provide in an international study. These conflicts are exacerbated by a fundamental dilemma: more research on diseases prevalent in developing and emerging countries is necessary. At the same time, the protection of study participants in those countries creates particular challenges. In recent years, international commissions and guidelines have achieved significant progress in solving these conflicts; however, the further development has to be analyzed very carefully. Incentives for better research on neglected diseases have to be created. Undesirable developments and abuse have to be prevented by appropriate international ethical standards.

Community health workers' experiences of mobile device-enabled clinical decision support systems for maternal, newborn and child health in developing countries: a qualitative systematic review protocol.

PubMed

Dzabeng, Francis; Enuameh, Yeetey; Adjei, George; Manu, Grace; Asante, Kwaku Poku; Owusu-Agyei, Seth

2016-09-01

The objective of this review is to synthesize evidence on the experiences of community health workers (CHWs) of mobile device-enabled clinical decision support systems (CDSSs) interventions designed to support maternal newborn and child health (MNCH) in low-and middle-income countries.Specific objectives.

Evidence of the Internationalization of Clinical Endoscopy Based on Journal Metrics.

PubMed

Huh, Sun

2015-07-01

This study aims to verify the internationalization of Clinical Endoscopy based on journal metrics after the change to English-only in 2011. The results of this study serve as a starting point for developing strategies to develop Clinical Endoscopy into a top-tier international journal. The following journal metrics were analyzed from the journal's homepage or the Web of Science: the number of citable articles, number of countries of affiliation of the contributors, the number of articles supported by research grants, total citations, impact factor, citing journals, countries of citing authors, and the Hirsch index. The number of citable articles in 2011, 2012, 2013, and 2014 was 22, 81, 120, and 95, respectively. The authors were from 11 countries. Twenty-one out of 55 original articles were supported by research grants. The total citations in 2012, 2013, and 2014 were 2, 85, and 213, respectively. The impact factor was 0.670 in 2013 and 0.940 in 2014. The number of countries citing authors were from was 61. The Hirsch index was 6. The above results demonstrate that Clinical Endoscopy became an international journal, contributing to the propagation of valuable research results through an open access publishing model.

Peering into the pharmaceutical "pipeline": investigational drugs, clinical trials, and industry priorities.

PubMed

Fisher, Jill A; Cottingham, Marci D; Kalbaugh, Corey A

2015-04-01

In spite of a growing literature on pharmaceuticalization, little is known about the pharmaceutical industry's investments in research and development (R&D). Information about the drugs being developed can provide important context for existing case studies detailing the expanding--and often problematic--role of pharmaceuticals in society. To access the pharmaceutical industry's pipeline, we constructed a database of drugs for which pharmaceutical companies reported initiating clinical trials over a five-year period (July 2006-June 2011), capturing 2477 different drugs in 4182 clinical trials. Comparing drugs in the pipeline that target diseases in high-income and low-income countries, we found that the number of drugs for diseases prevalent in high-income countries was 3.46 times higher than drugs for diseases prevalent in low-income countries. We also found that the plurality of drugs in the pipeline was being developed to treat cancers (26.2%). Interpreting our findings through the lens of pharmaceuticalization, we illustrate how investigating the entire drug development pipeline provides important information about patterns of pharmaceuticalization that are invisible when only marketed drugs are considered. Copyright © 2014 Elsevier Ltd. All rights reserved.

Critical role of ethics in clinical management and public health response to the West Africa Ebola epidemic.

PubMed

Folayan, Morenike O; Haire, Bridget G; Brown, Brandon

2016-01-01

The devastation caused by the Ebola virus disease (EVD) outbreak in West Africa has brought to the fore a number of important ethical debates about how best to respond to a health crisis. These debates include issues related to prevention and containment, management of the health care workforce, clinical care, and research design, all of which are situated within the overarching moral problem of severe transnational disadvantage, which has very real and specific impacts upon the ability of citizens of EVD-affected countries to respond to a disease outbreak. Ethical issues related to prevention and containment include the appropriateness and scope of quarantine and isolation within and outside affected countries. The possibility of infection in health care workers impelled consideration of whether there is an obligation to provide health services where personal protection equipment is inadequate, alongside the issue of whether the health care workforce should have special access to experimental treatment and care interventions under development. In clinical care, ethical issues include the standards of care owed to people who comply with quarantine and isolation restrictions. Ethical issues in research include appropriate study design related to experimental vaccines and treatment interventions, and the sharing of data and biospecimens between research groups. The compassionate use of experimental drugs intersects both with research ethics and clinical care. The role of developed countries also came under scrutiny, and we concluded that developed countries have an obligation to contribute to the containment of EVD infection by contributing to the strengthening of local health care systems and infrastructure in an effort to provide fair benefits to communities engaged in research, ensuring that affected countries have ready and affordable access to any therapeutic or preventative interventions developed, and supporting affected countries on their way to recovery from the impact of EVD on their social and economic lives.

The challenges and opportunities of conducting a clinical trial in a low resource setting: the case of the Cameroon mobile phone SMS (CAMPS) trial, an investigator initiated trial.

PubMed

Mbuagbaw, Lawrence; Thabane, Lehana; Ongolo-Zogo, Pierre; Lang, Trudie

2011-06-09

Conducting clinical trials in developing countries often presents significant ethical, organisational, cultural and infrastructural challenges to researchers, pharmaceutical companies, sponsors and regulatory bodies. Globally, these regions are under-represented in research, yet this population stands to gain more from research in these settings as the burdens on health are greater than those in developed resourceful countries. However, developing countries also offer an attractive setting for clinical trials because they often have larger treatment naive populations with higher incidence rates of disease and more advanced stages. These factors can present a reduction in costs and time required to recruit patients. So, balance needs to be found where research can be encouraged and supported in order to bring maximum public health benefits to these communities. The difficulties with such trials arise from problems with obtaining valid informed consent, ethical compensation mechanisms for extremely poor populations, poor health infrastructure and considerable socio-economic and cultural divides. Ethical concerns with trials in developing countries have received attention, even though many other non-ethical issues may arise. Local investigator initiated trials also face a variety of difficulties that have not been adequately reported in literature. This paper uses the example of the Cameroon Mobile Phone SMS trial to describe in detail, the specific difficulties encountered in an investigator-initiated trial in a developing country. It highlights administrative, ethical, financial and staff related issues, proposes solutions and gives a list of additional documentation to ease the organisational process.

Something has shifted: Nursing students' global perspective following international clinical placements.

PubMed

Gower, Shelley; Duggan, Ravani; Dantas, Jaya A R; Boldy, Duncan

2017-10-01

To examine understandings of global health issues among nursing students following participation in an international clinical placement during their pre-registration university education. Universities use international clinical placements, especially in developing countries, to develop cultural awareness in students; however, little is known about the longer term influences on students' understandings of global nursing. A retrospective cross-sectional design was used, using an exploratory, descriptive qualitative approach. Individual semi-structured interviews were conducted in 2014 with a purposive sample of 25 pre-registration nursing students from four Western Australian universities who undertook clinical placements across five countries. Data were analysed using inductive thematic analysis. Findings highlight that students developed new understandings around health systems including fragility of resource access, differences in clinical practice and variances in nursing roles between settings. Students also experienced challenges but were able to appreciate alternative world viewpoints. International clinical placements can develop greater awareness and help students form realistic strategies for using their nursing skills globally. Pre-placement training in cultural awareness and health system realities, along with strong supervisory support, is critical to success. © 2017 John Wiley & Sons Ltd.

Nano/microfluidics for diagnosis of infectious diseases in developing countries

PubMed Central

Lee, Won Gu; Kim, Yun-Gon; Chung, Bong Geun; Demirci, Utkan; Khademhosseini, Ali

2010-01-01

Nano/microfluidic technologies are emerging as powerful enabling tools for diagnosis and monitoring of infectious diseases in both developed and developing countries. Miniaturized nano/microfluidic platforms that precisely manipulate small fluid volumes can be used to enable medical diagnosis in a more rapid and accurate manner. In particular, these nano/microfluidic diagnostic technologies are potentially applicable to global health applications, because they are disposable, inexpensive, portable, and easy-to-use for detection of infectious diseases. In this paper, we review recent developments in nano/microfluidic technologies for clinical point-of-care applications at resource-limited settings in developing countries. PMID:19954755

Distance learning--an educational tool for developing countries.

PubMed

Dobson, M B

2000-01-01

Many anaesthetists in small hospitals and developing countries have poor access to educational materials. The use of electronic means of publication and distribution, combined with the concepts of distance learning, can lead to better levels of knowledge and clinical practice. A project based on these principles has been set up in Zimbabwe, and is proving helpful to both trainers and trainees. All District Hospitals have been visited, and trainees in them identified. A survey has been completed to identify the subject areas in which training is most necessary. Trainees have been provided with reference materials on CD-ROM which they can access by computer (each hospital has a computer). Specialist anaesthesiologists in the country are producing interactive tutorials which can be sent out by e-mail to every hospital, and these are backed up by a programme of regular visits, seminars and clinical teaching. The programme is proving helpful to both trainees and tutors, and has the potential to be used in the future in other developing countries.

Official Positions for FRAX® clinical regarding international differences from Joint Official Positions Development Conference of the International Society for Clinical Densitometry and International Osteoporosis Foundation on FRAX®.

PubMed

Cauley, Jane A; El-Hajj Fuleihan, Ghada; Arabi, Asma; Fujiwara, Saeko; Ragi-Eis, Sergio; Calderon, Andrew; Chionh, Siok Bee; Chen, Zhao; Curtis, Jeffrey R; Danielson, Michelle E; Hanley, David A; Kroger, Heikki; Kung, Annie W C; Lesnyak, Olga; Nieves, Jeri; Pluskiewicz, Wojciech; El Rassi, Rola; Silverman, Stuart; Schott, Anne-Marie; Rizzoli, Rene; Luckey, Marjorie

2011-01-01

Osteoporosis is a serious worldwide epidemic. Increased risk of fractures is the hallmark of the disease and is associated with increased morbidity, mortality and economic burden. FRAX® is a web-based tool developed by the Sheffield WHO Collaborating Center team, that integrates clinical risk factors, femoral neck BMD, country specific mortality and fracture data and calculates the 10 year fracture probability in order to help health care professionals identify patients who need treatment. However, only 31 countries have a FRAX® calculator at the time paper was accepted for publication. In the absence of a FRAX® model for a particular country, it has been suggested to use a surrogate country for which the epidemiology of osteoporosis most closely approximates the index country. More specific recommendations for clinicians in these countries are not available. In North America, concerns have also been raised regarding the assumptions used to construct the US ethnic specific FRAX® calculators with respect to the correction factors applied to derive fracture probabilities in Blacks, Asians and Hispanics in comparison to Whites. In addition, questions were raised about calculating fracture risk in other ethnic groups e.g., Native Americans and First Canadians. In order to provide additional guidance to clinicians, a FRAX® International Task Force was formed to address specific questions raised by physicians in countries without FRAX® calculators and seeking to integrate FRAX® into their clinical practice. The main questions that the task force tried to answer were the following: The Task Force members conducted appropriate literature reviews and developed preliminary statements that were discussed and graded by a panel of experts at the ISCD-IOF joint conference. The statements approved by the panel of experts are discussed in the current paper. Copyright © 2011. Published by Elsevier Inc.

Initiating a Human Variome Project Country Node.

PubMed

AlAama, Jumana; Smith, Timothy D; Lo, Alan; Howard, Heather; Kline, Alexandria A; Lange, Matthew; Kaput, Jim; Cotton, Richard G H

2011-05-01

Genetic diseases are a pressing global health problem that requires comprehensive access to basic clinical and genetic data to counter. The creation of regional and international databases that can be easily accessed by clinicians and diagnostic labs will greatly improve our ability to accurately diagnose and treat patients with genetic disorders. The Human Variome Project is currently working in conjunction with human genetics societies to achieve this by establishing systems to collect every mutation reported by a diagnostic laboratory, clinic, or research laboratory in a country and store these within a national repository, or HVP Country Node. Nodes have already been initiated in Australia, Belgium, China, Egypt, Malaysia, and Kuwait. Each is examining how to systematically collect and share genetic, clinical, and biochemical information in a country-specific manner that is sensitive to local ethical and cultural issues. This article gathers cases of genetic data collection within countries and takes recommendations from the global community to develop a procedure for countries wishing to establish their own collection system as part of the Human Variome Project. We hope this may lead to standard practices to facilitate global collection of data and allow efficient use in clinical practice, research and therapy. © 2011 Wiley-Liss, Inc.

[First SIBEN clinical consensus: diagnostic and therapeutic approach to patent ductus arteriosus in premature newborns].

PubMed

Golombek, S G; Sola, A; Baquero, H; Borbonet, D; Cabañas, F; Fajardo, C; Goldsmit, G; Lemus, L; Miura, E; Pellicer, A; Pérez, J M; Rogido, M; Zambosco, G; van Overmeire, B

2008-11-01

To report the process and results of the first neonatal clinical consensus of the Ibero-American region. Two recognized experts in the field (Clyman and Van Overmeire) and 45 neonatologists from 23 countries were invited for active participation and collaboration. We developed 46 questions of clinical-physiological relevance in all aspects of patent ductus arteriosus (PDA). Guidelines for consensus process, literature search and future preparation of educational material and authorship were developed, reviewed and agreed by all. Participants from different countries were distributed in groups, and assigned to interact and work together to answer 3-5 questions, reviewing all global literature and local factors. Answers and summaries were received, collated and reviewed by 2 coordinators and the 2 experts. Participants and experts met in Granada, Spain for 4.5 h (lectures by experts, presentations by groups, discussion, all literature available). 31 neonatologists from 16 countries agreed to participate. Presentations by each group and general discussion were used to develop a consensus regarding: general management, availability of drugs (indomethacin vs. ibuprofen), costs, indications for echo/surgery, etc. Many steps were learnt by all present in a collaborative forum. This first consensus group of Ibero-American neonatologists SIBEN led to active and collaborative participation of neonatologists of 16 countries, improved education of all participants and ended with consensus development on clinical approaches to PDA. Furthermore, it provides recommendations for clinical care reached by consensus. Additionally, it will serve as a useful foundation for future SIBEN Consensus on other topics and it could become valuable as a model to decrease disparity in care and improve outcomes in this and other regions.

The Impact of Mobile Health Interventions on Chronic Disease Outcomes in Developing Countries: A Systematic Review

PubMed Central

Lee, Allison G.; Willner, Jonathan M.; Jahangir, Eiman; Ciapponi, Agustín; Rubinstein, Adolfo

2014-01-01

Abstract Introduction: Rates of chronic diseases will continue to rise in developing countries unless effective and cost-effective interventions are implemented. This review aims to discuss the impact of mobile health (m-health) on chronic disease outcomes in low- and middle-income countries (LMIC). Materials and Methods: Systematic literature searches were performed using CENTRAL, MEDLINE, EMBASE, and LILACS databases and gray literature. Scientific literature was searched to identify controlled studies evaluating cell phone voice and text message interventions to address chronic diseases in adults in low- or middle-income countries. Outcomes measured included morbidity, mortality, hospitalization rates, behavioral or lifestyle changes, process of care improvements, clinical outcomes, costs, patient–provider satisfaction, compliance, and health-related quality of life (HRQoL). Results: From the 1,709 abstracts retrieved, 163 articles were selected for full text review, including 9 randomized controlled trials with 4,604 participants. Most of the studies addressed more than one outcome. Of the articles selected, six studied clinical outcomes, six studied processes of care, three examined healthcare costs, and two examined HRQoL. M-health positively impacted on chronic disease outcomes, improving attendance rates, clinical outcomes, and HRQoL, and was cost-effective. Conclusions: M-health is emerging as a promising tool to address access, coverage, and equity gaps in developing countries and low-resource settings. The results for m-health interventions showed a positive impact on chronic diseases in LMIC. However, a limiting factor of this review was the relatively small number of studies and patients enrolled, highlighting the need for more rigorous research in this area in developing countries. PMID:24205809

Ethical challenges in integrating patient-care with clinical research in a resource-limited setting: perspectives from Papua New Guinea

PubMed Central

2013-01-01

Background In resource-limited settings where healthcare services are limited and poverty is common, it is difficult to ethically conduct clinical research without providing patient-care. Therefore, integration of patient-care with clinical research appears as an attractive way of conducting research while providing patient-care. In this article, we discuss the ethical implications of such approach with perspectives from Papua New Guinea. Discussion Considering the difficulties of providing basic healthcare services in developing countries, it may be argued that integration of clinical research with patient-care is an effective, rational and ethical way of conducting research. However, blending patient-care with clinical research may increase the risk of subordinating patient-care in favour of scientific gains; therapeutic misconception and inappropriate inducement; and the risk of causing health system failures due to limited capacity in developing countries to sustain the level of healthcare services sponsored by the research. Nevertheless, these ethical and administrative implications can be minimised if patient-care takes precedence over research; the input of local ethics committees and institutions are considered; and funding agencies acknowledge their ethical obligation when sponsoring research in resource-limited settings. Summary Although integration of patient-care with clinical research in developing countries appears as an attractive way of conducting research when resources are limited, careful planning and consideration on the ethical implications of such approach must be considered. PMID:23885908

Ethical challenges in integrating patient-care with clinical research in a resource-limited setting: perspectives from Papua New Guinea.

PubMed

Laman, Moses; Pomat, William; Siba, Peter; Betuela, Inoni

2013-07-26

In resource-limited settings where healthcare services are limited and poverty is common, it is difficult to ethically conduct clinical research without providing patient-care. Therefore, integration of patient-care with clinical research appears as an attractive way of conducting research while providing patient-care. In this article, we discuss the ethical implications of such approach with perspectives from Papua New Guinea. Considering the difficulties of providing basic healthcare services in developing countries, it may be argued that integration of clinical research with patient-care is an effective, rational and ethical way of conducting research. However, blending patient-care with clinical research may increase the risk of subordinating patient-care in favour of scientific gains; therapeutic misconception and inappropriate inducement; and the risk of causing health system failures due to limited capacity in developing countries to sustain the level of healthcare services sponsored by the research. Nevertheless, these ethical and administrative implications can be minimised if patient-care takes precedence over research; the input of local ethics committees and institutions are considered; and funding agencies acknowledge their ethical obligation when sponsoring research in resource-limited settings. Although integration of patient-care with clinical research in developing countries appears as an attractive way of conducting research when resources are limited, careful planning and consideration on the ethical implications of such approach must be considered.

The impact of short term clinical placement in a developing country on nursing students: A qualitative descriptive study.

PubMed

Ulvund, Ingeborg; Mordal, Elin

2017-08-01

Offering nursing students' international clinical placement during the educational program is one response to meet the need of cultural competence among nurses. This paper provides insight into the impact of clinical placement, in a developing country, on third year nursing students. In the study we investigated how short term international clinical placement impacted Norwegian nursing students' development of cultural competency. In this study we utilised a qualitative descriptive design and used individual interviews with eighteen Norwegian nursing students who had all participated in an international clinical placement. The data were analysed using the principles of systematic text condensation. In spite the international clinical placement only was four weeks, the findings suggested that real life experience culturally awakened the students and forced an ongoing process developing cultural competence. However, it is important to give students time to reflection. Although increased cultural awareness and a growing cultural competence was identified by the students undertaking international clinical placement, further research is required. It is important to investigate the best methods to support the students' reflection such that the experiences lead to learning. Copyright © 2017 Elsevier Ltd. All rights reserved.

Stereotactic radiotherapy of primary lung cancer and other targets: results of consultant meeting of the International Atomic Energy Agency.

PubMed

Nagata, Yasushi; Wulf, Joern; Lax, Ingmar; Timmerman, Robert; Zimmermann, Frank; Stojkovski, Igor; Jeremic, Branislav

2011-03-01

To evaluate the current status of stereotactic body radiotherapy (SBRT) and identify both advantages and disadvantages of its use in developing countries, a meeting composed of consultants of the International Atomic Energy Agency was held in Vienna in November 2006. Owing to continuous developments in the field, the meeting was extended by subsequent discussions and correspondence (2007-2010), which led to the summary presented here. The advantages and disadvantages of SBRT expected to be encountered in developing countries were identified. The definitions, typical treatment courses, and clinical results were presented. Thereafter, minimal methodology/technology requirements for SBRT were evaluated. Finally, characteristics of SBRT for developing countries were recommended. Patients for SBRT should be carefully selected, because single high-dose radiotherapy may cause serious complications in some serial organs at risk. Clinical experiences have been reported in some populations of lung cancer, lung oligometastases, liver cancer, pancreas cancer, and kidney cancer. Despite the disadvantages expected to be experienced in developing countries, SBRT using fewer fractions may be useful in selected patients with various extracranial cancers with favorable outcome and low toxicity. Copyright © 2011 Elsevier Inc. All rights reserved.

The Development of a Postgraduate Orthopaedic Manual Therapy Residency Program in Nairobi, Kenya.

PubMed

Cunningham, Shala; Jackson, Richard; Muli, Daniel Kangutu; McFelea, Joni

2017-01-01

There are very few opportunities for long-term, comprehensive postgraduate education in developing countries because of fiscal and human resource constraints. Therefore, physiotherapists have little opportunity following graduation to advance their skills through the improvement of clinical reasoning and treatment planning and application. To address the need for sustainable advanced instruction in physiotherapy within the country, a postgraduate Residency program was initiated in Nairobi, Kenya in 2012. The mission of the program is to graduate advanced orthopedic practitioners who can lead their communities and local profession in the advancement of clinical care and education. Since its inception, six cohorts have been initiated for a total of 90 resident participants. In addition, six program graduates are being trained to continue the Residency program and are serving as teaching assistants for the on campus modules. This training will result in a self-sustaining program by 2020. The manual therapy Residency education model allowed for advancement of the participating physiotherapists professional development utilizing evidence-based practice. This was done without altering the current education system within the country, or accessing expensive equipment. The Residency program was developed and established with the cooperation of a local education institution and a non-profit corporation in the United States. This collaboration has facilitated the advancement of orthopedic clinical standards in the country and will, hopefully, one day serve an as a template for future programs.

[Developing a harmonised system for the recognition of clinical trials for veterinary product registration].

PubMed

Maliandi, F S

2008-12-01

The increase of commerce between developing countries requires a harmonised system for accepting the results of clinical trials (CT) of veterinary products, similar to those that exist in developed countries. The objective of this paper is to propose a basis for the creation of a system that harmonises CTs for approving veterinary products (VP) for registration. Such a system would be a step towards unifying the CTs of different countries, while maintaining country-specific variations that are compatible with the scientific method, international standards, and the principles of objectivity, transparency and confidentiality. Basic requirements to be fulfilled by both private institutions and public offices are described, as are professional responsibilities and possible administrative procedures that could be adapted in each country. The conclusion reached is that a harmonised system is feasible, as has been demonstrated in numerous countries throughout the world. A harmonised system will result in a more efficient product approval process, a reduction in costs, greater transparency in controls, an improvement in the reliability of the health system, and a reduction in the time the process takes. It will also contribute to animal welfare by avoiding the need to repeat trials. The author acknowledges that there are cultural, technological and economic limitations and that these problems, and others, have yet to be overcome.

Application of a contextual instructional framework in a continuing professional development training program for physiotherapists in Rwanda.

PubMed

Dunleavy, Kim; Chevan, Julia; Sander, Antoinette P; Gasherebuka, Jean Damascene; Mann, Monika

2018-06-01

Continuing professional development is an important component of capacity building in low resource countries. The purpose of this case study is to describe the use of a contextual instructional framework to guide the processes and instructional design choices for a series of continuing professional development courses for physiotherapists in Rwanda. Four phases of the project are described: (1) program proposal, needs assessment and planning, (2) organization of the program and instructional design, (3) instructional delivery and (4) evaluation. Contextual facilitating factors and needs informed choices in each phase. The model resulted in delivery of continuing professional development to the majority of physiotherapists in Rwanda (n = 168, 0.48 rural/0.52 urban) with participants reporting improvement in skills and perceived benefit for their patients. Environmental and healthcare system factors resulted in offering the courses in rural and urban areas. Content was developed and delivered in partnership with Rwandan coinstructors. Based on the domestic needs identified in early courses, the program included advocacy and leadership activities, in addition to practical and clinical instruction. The contextual factors (environment, healthcare service organization, need for rehabilitation and status and history of the physiotherapy profession) were essential for project and instructional choices. Facilitating factors included the established professional degree and association, continuing professional development requirements, a core group of active professionals and an existing foundation from other projects. The processes and contextual considerations may be useful in countries with established professional-level education but without established postentry-level training. Implications for Rehabilitation Organizations planning continuing professional development programs may benefit from considering the context surrounding training when planning, designing and developing instruction. The surrounding context including the environment, the organization of healthcare services, the population defined need for rehabilitation, and the domestic status and history of the physiotherapy profession, is important for physiotherapy projects in countries with lower resources. Facilitating factors in low resource countries such as an established professional degree and association, continuing professional development requirements, a core group of active professionals and an existing foundation from other projects impact the success of projects. Methods that may be useful for relevance, dissemination and consistency include involvement of in-country leaders and instructors and attendance in multiple courses with consistent themes. Rehabilitation professionals in low resource countries may benefit from continuing professional development courses that emphasize practical skills, and clinical reasoning, accompanied by clinical mentoring and directed coaching that encourages knowledge transfer to the clinical setting. Active learning approaches and multiple progressive courses provide opportunities to develop peer support through professional communities of practice.

Evidence of the Internationalization of Clinical Endoscopy Based on Journal Metrics

PubMed Central

2015-01-01

Background/Aims This study aims to verify the internationalization of Clinical Endoscopy based on journal metrics after the change to English-only in 2011. The results of this study serve as a starting point for developing strategies to develop Clinical Endoscopy into a top-tier international journal. Methods The following journal metrics were analyzed from the journal's homepage or the Web of Science: the number of citable articles, number of countries of affiliation of the contributors, the number of articles supported by research grants, total citations, impact factor, citing journals, countries of citing authors, and the Hirsch index. Results The number of citable articles in 2011, 2012, 2013, and 2014 was 22, 81, 120, and 95, respectively. The authors were from 11 countries. Twenty-one out of 55 original articles were supported by research grants. The total citations in 2012, 2013, and 2014 were 2, 85, and 213, respectively. The impact factor was 0.670 in 2013 and 0.940 in 2014. The number of countries citing authors were from was 61. The Hirsch index was 6. Conclusions The above results demonstrate that Clinical Endoscopy became an international journal, contributing to the propagation of valuable research results through an open access publishing model. PMID:26240806

Clinical Spectrum of Cerebral Palsy and Associated Disability in South Egypt: A Local Survey Study

PubMed Central

Abas, Osama; Abdelaziem, Faten; Kilany, Ayman

2017-01-01

BACKGROUND: Cerebral palsy is the most common cause of motor disability in children with a prevalence of 2-10/1,000 live births in the developing areas. AIM: The epidemiology, clinical picture, and associated comorbidities in CP have been extensively studied in high-resource countries, but in low-resource areas, including Africa, those studies are still lacking. METHODS: Cerebral palsy cases were prospectively recruited from every physiotherapy centre in Bani-Mazar city, Egypt, in a cross-sectional study from May 2015 to November 2015. RESULTS: Two hundred cases were enrolled with a prevalence of 1 per 1000 live births. Within the study population, 72.5% were the spastic type, 16% were dyskinetic, 7% were ataxic, and 4.5% were hypotonic. The most common comorbidities were cognitive impairment and epilepsy affecting 77% and 38%, respectively. CONCLUSION: Cerebral palsy in developing countries has a higher prevalence and different clinical profile regarding severity and associated disability. The perinatal and high-quality neonatal care together with physical therapy and rehabilitation programs is still lacking in developing countries. PMID:28293314

Clinical Trials Infrastructure as a Quality Improvement Intervention in Low- and Middle-Income Countries.

PubMed

Denburg, Avram; Rodriguez-Galindo, Carlos; Joffe, Steven

2016-06-01

Mounting evidence suggests that participation in clinical trials confers neither advantage nor disadvantage on those enrolled. Narrow focus on the question of a "trial effect," however, distracts from a broader mechanism by which patients may benefit from ongoing clinical research. We hypothesize that the existence of clinical trials infrastructure-the organizational culture, systems, and expertise that develop as a product of sustained participation in cooperative clinical trials research-may function as a quality improvement lever, improving the quality of care and outcomes of all patients within an institution or region independent of their individual participation in trials. We further contend that this "infrastructure effect" can yield particular benefits for patients in low- and middle-income countries (LMICs). The hypothesis of an infrastructure effect as a quality improvement intervention, if correct, justifies enhanced research capacity in LMIC as a pillar of health system development.

Peering into the Pharmaceutical “Pipeline”: Investigational Drugs, Clinical Trials, and Industry Priorities

PubMed Central

Cottingham, Marci D.; Kalbaugh, Corey A.

2014-01-01

In spite of a growing literature on pharmaceuticalization, little is known about the pharmaceutical industry’s investments in research and development (R&D). Information about the drugs being developed can provide important context for existing case studies detailing the expanding – and often problematic – role of pharmaceuticals in society. To access the pharmaceutical industry’s pipeline, we constructed a database of drugs for which pharmaceutical companies reported initiating clinical trials over a five-year period (July 2006-June 2011), capturing 2,477 different drugs in 4,182 clinical trials. Comparing drugs in the pipeline that target diseases in high-income and low-income countries, we found that the number of drugs for diseases prevalent in high-income countries was 3.46 times higher than drugs for diseases prevalent in low-income countries. We also found that the plurality of drugs in the pipeline were being developed to treat cancers (26.2%). Interpreting our findings through the lens of pharmaceuticalization, we illustrate how investigating the entire drug development pipeline provides important information about patterns of pharmaceuticalization that are invisible when only marketed drugs are considered. PMID:25159693

Comparisons of hypertension-related costs from multinational clinical studies.

PubMed

Mullins, C Daniel; Sikirica, Mirko; Seneviratne, Viran; Ahn, Jeonghoon; Akhras, Kasem S

2004-01-01

This study identifies and compares the individual cost components of hospital and ambulatory services that manage the care of hypertensive patients in eight countries: the US, the UK, France, Spain, Germany, Italy, Canada and Australia. Hypertension-related costs are classified according to four major cardiovascular events: (i) acute myocardial infarction; (ii) congestive heart failure; (iii) stroke; and (iv) renal failure, which was subdivided into renal failure treated by dialysis and renal failure treated by kidney transplantation. To make cross-country costs comparisons, we used the DRG codes used in the US and DRG-like codes from each country. US cost information was obtained from hypertension data available from the literature and health economics researchers. For costs in other countries, we consulted with national health economics experts in each country, used analyses by the Research Triangle Institute, and performed Medline and international literature searches. When available, we obtained information from the countries' public and private nationally representative data sources. For cross-country currency adjustments, all currencies were converted using the Purchasing Power Parities from the Organisation for Economic Cooperation and Development, and then converted into inflation-adjusted year 2000 US dollars. There exists considerable variation in hypertension-related costs from multinational clinical studies. This study documents that costs are generally higher in the US than in other countries; however, this is not always true. In particular, costs of treating heart failure in France and the costs of renal failure without transplantation in Germany and the UK are relatively high. While analysing multinational hypertensive cost data, this study also addresses the impact of cross-country cost variations on cost analyses. During the last decade, drug-development researchers have drawn extensively upon multinational trials to resolve enrollment problems and drug-registration issues. At the same time, formulary decision-makers are increasingly demanding multinational cost-effectiveness analyses of the clinical differences found between drug-treatment regimens. Since these data are typically not captured by randomised clinical trials, standard cost estimates must be applied to the clinical trials' resource data, although such standardised calculations do not necessarily account for clinical and cost variations between countries. This paper serves as an instrument for identifying which national and event cost data are comparable for analysis as well as highlighting specific problem areas for cost data integration. Although the study focuses on hypertension-related costs, its results may provide insight for multinational cost comparisons of other diseases where similar hospitalisation costs may be analysed.

Quality improvement in neonatal care - a new paradigm for developing countries.

PubMed

Chawla, Deepak; Suresh, Gautham K

2014-12-01

Infrastructure for facility-based neonatal care has rapidly grown in India over last few years. Experience from developed countries indicates that different health facilities have varying clinical outcomes despite accounting for differences in illness severity of admitted neonates and random variation. Variation in quality of care provided at different neonatal units may account for variable clinical outcomes. Monitoring quality of care, comparing outcomes across different centers and conducting collaborative quality improvement projects can improve outcome of neonates in health facilities. Top priority should be given to establishing quality monitoring and improvement procedures at special care neonatal units and neonatal intensive care units of the country. This article presents an overview of methods of quality improvement. Literature reports of successful collaborative quality improvement projects in neonatal health are also reviewed.

Effects of procurement practices on quality of medical device or service received: a qualitative study comparing countries.

PubMed

Lingg, Myriam; Wyss, Kaspar; Durán-Arenas, Luis

2016-08-08

We know little about how procurement of a high-risk medical device (HRMD) affects clinical practice and outcomes. In health systems in high-income countries, and specifically those that maintain a national arthroplasty registry, procurement decisions are frequently guided by long-term clinical results, with the goal of ensuring at least standard quality of HRMDs. But in countries like Mexico, decision-making is often dominated by lowest acquisition price. We set out to study the impact of procurement for orthopaedic HRMDs on clinical procedures and outcomes. We based our qualitative study on 59 in-depth interviews with stakeholders from Mexico, Switzerland, Germany, and UK: orthopaedic specialists, government officials, other experts, and social security system managers or administrators. We took a healthcare delivery approach to capturing and comparing factors that affected the regulations of HRMDs and procurement processes, and to understanding connections between procurement and clinical practice. Our findings demonstrate for procurement processes that the three European countries compared to Mexico don't have similar concerns with regards to their procurement processes. Deficiencies of procurement regulations and practices identified from representatives in Mexico were almost absent in European countries. We identified three areas of deficiency: 1) HRMD regulations based on insufficiently robust clinical evidence (mainly noted by European countries); 2) Follow-up on Health Technology Assessments is inadequate (noted by Mexico) and methodology not always good enough (noted by European countries); and, 3) Lowest-acquisition price often guides procurement decisions and thus may not align with needs of clinical procedures (noted by Mexico and some European countries). Procurement processes for orthopaedic HRMDs may have an impact on clinical procedures and outcomes. A favourable approach is one where orthopaedic specialists are parties to the procurement process, and post-market surveillance data informs decision-making. Actors in the procurement process can improve their impact on clinical procedures and outcomes by developing specific strategies that better align the needs of both, procurement and clinical procedures.

FRAX® International Task Force of the 2010 Joint International Society for Clinical Densitometry & International Osteoporosis Foundation Position Development Conference.

PubMed

Cauley, Jane A; El-Hajj Fuleihan, Ghada; Luckey, Marjorie M

2011-01-01

Osteoporosis is a serious worldwide epidemic. FRAX® is a web-based tool developed by the Sheffield WHO Collaborating Center team, that integrates clinical risk factors and femoral neck BMD and calculates the 10 year fracture probability in order to help health care professionals identify patients who need treatment. However, only 31 countries have a FRAX® calculator. In the absence of a FRAX® model for a particular country, it has been suggested to use a surrogate country for which the epidemiology of osteoporosis most closely approximates the index country. More specific recommendations for clinicians in these countries are not available. In North America, concerns have also been raised regarding the assumptions used to construct the US ethnic specific FRAX® calculators with respect to the correction factors applied to derive fracture probabilities in Blacks, Asians and Hispanics in comparison to Whites. In addition, questions were raised about calculating fracture risk in other ethnic groups e.g., Native Americans and First Canadians. The International Society for Clinical Densitometry (ISCD) in conjunction with the International Osteoporosis Foundation (IOF) assembled an international panel of experts that ultimately developed joint Official Positions of the ISCD and IOF advising clinicians regarding FRAX® usage. As part of the process, the charge of the FRAX® International Task Force was to review and synthesize data regarding geographic and race/ethnic variability in hip fractures, non-hip osteoporotic fractures, and make recommendations about the use of FRAX® in ethnic groups and countries without a FRAX® calculator. This synthesis was presented to the expert panel and constitutes the data on which the subsequent Official Positions are predicated. A summary of the International Task Force composition and charge is presented here. Copyright © 2011 The International Society for Clinical Densitometry. Published by Elsevier Inc. All rights reserved.

Parental attitudes towards and perceptions of their children's participation in clinical research: a developing-country perspective.

PubMed

Nabulsi, Mona; Khalil, Yvette; Makhoul, Jihad

2011-07-01

Paediatric clinical research faces unique challenges that compromise optimal recruitment of children into clinical trials. A main barrier to enrolment of children is parental misconceptions about the research process. In developing countries, there is a knowledge gap regarding parental perceptions of and attitudes towards their children's participation in clinical trials. To explore such perceptions and attitudes in Lebanese parents. 33 in-depth interviews were conducted with parents with and without previous research experience. Interviews were tape-recorded, transcribed in colloquial Arabic, and later subjected to thematic analysis. Benefit/risk ratio assessment was a major determinant of parental consent. Fear of adverse events or painful procedures in research was a recurring theme in most interviews. Whereas perception of direct benefit to the child, trust in the physician or institution, financial gains or having a positive previous experience in research facilitated consent, a complex informed consent form and misunderstanding of the term 'randomisation' hindered parental approval of participation. Lebanese parents have perceptions of and attitudes towards children's participation in clinical trials that are similar to those reported from the industrialised world. Improving communication with parents and building trust between researchers and parents is important for successful recruitment. Investigators planning to conduct paediatric trials in developing countries need to simplify consent forms and devise new ways to explain randomisation.

Core competencies in clinical neuropsychology training across the world.

PubMed

Hessen, Erik; Hokkanen, Laura; Ponsford, Jennie; van Zandvoort, Martine; Watts, Ann; Evans, Jonathan; Haaland, Kathleen Y

2018-05-01

This work aimed to review main competency requirements from training models in countries with well-established specialties in clinical neuropsychology and to extract core competencies that likely will apply to clinical neuropsychologists regardless of regional and cultural context. We reviewed standards for post-graduate training in clinical neuropsychology from countries in Europe, Australia, and North America based on existing literature, presentations at international conferences, and from description of the training models from national psychological or neuropsychological associations. Despite differences, the reviewed models share similar core competencies considered necessary for a specialty in clinical neuropsychology: (1) In-depth knowledge of general psychology including clinical psychology (post-graduate level), ethical, and legal standards. (2) Expert knowledge about clinically relevant brain-behavioral relationships. (3) Comprehensive knowledge about, and skills in, related clinical disciplines. (4) In-depth knowledge about and skills in neuropsychological assessment, including decision-making and diagnostic competency according to current classification of diseases. (5) Competencies in the area of diversity and culture in relation to clinical neuropsychology. (6) Communication competency of neuropsychological findings and test results to relevant and diverse audiences. (7) Knowledge about and skills in psychological and neuropsychological intervention, including treatment and rehabilitation. All the models have undergone years of development in accordance with requirements of national health care systems in different parts of the world. Despite differences, the common core competency requirements across different regions of the world suggest generalizability of these competencies. We hope this summary can be useful as countries with less established neuropsychology training programs develop their models.

[Cardiovascular disease: a view from global health perspective].

PubMed

Salinas Botrán, Alejandro; Ramos Rincón, José Manuel; de Górgolas Hernández-Mora, Miguel

2013-09-07

Globalization has facilitated the movement of large number of people around the world, leading modern clinicians to attend patients with rare or forgotten diseases. In the last few years many doctors are working in developing countries as volunteers or expatriates. The aim of this article is to summarize the basic epidemiological, clinical and therapeutic knowledge of the main cardiovascular diseases that a medical doctor from a developed country may attend in a tropical rural hospital, or with challenging diseases in patients coming from developing countries. Copyright © 2012 Elsevier España, S.L. All rights reserved.

Multinational evidence-based recommendations for pain management by pharmacotherapy in inflammatory arthritis: integrating systematic literature research and expert opinion of a broad panel of rheumatologists in the 3e Initiative

PubMed Central

Colebatch, Alexandra N.; Buchbinder, Rachelle; Edwards, Christopher J.; Adams, Karen; Englbrecht, Matthias; Hazlewood, Glen; Marks, Jonathan L.; Radner, Helga; Ramiro, Sofia; Richards, Bethan L.; Tarner, Ingo H.; Aletaha, Daniel; Bombardier, Claire; Landewé, Robert B.; Müller-Ladner, Ulf; Bijlsma, Johannes W. J.; Branco, Jaime C.; Bykerk, Vivian P.; da Rocha Castelar Pinheiro, Geraldo; Catrina, Anca I.; Hannonen, Pekka; Kiely, Patrick; Leeb, Burkhard; Lie, Elisabeth; Martinez-Osuna, Píndaro; Montecucco, Carlomaurizio; Østergaard, Mikkel; Westhovens, Rene; Zochling, Jane; van der Heijde, Désirée

2012-01-01

Objective. To develop evidence-based recommendations for pain management by pharmacotherapy in patients with inflammatory arthritis (IA). Methods. A total of 453 rheumatologists from 17 countries participated in the 2010 3e (Evidence, Expertise, Exchange) Initiative. Using a formal voting process, 89 rheumatologists representing all 17 countries selected 10 clinical questions regarding the use of pain medications in IA. Bibliographic fellows undertook a systematic literature review for each question, using MEDLINE, EMBASE, Cochrane CENTRAL and 2008–09 European League Against Rheumatism (EULAR)/ACR abstracts. Relevant studies were retrieved for data extraction and quality assessment. Rheumatologists from each country used this evidence to develop a set of national recommendations. Multinational recommendations were then formulated and assessed for agreement and the potential impact on clinical practice. Results. A total of 49 242 references were identified, from which 167 studies were included in the systematic reviews. One clinical question regarding different comorbidities was divided into two separate reviews, resulting in 11 recommendations in total. Oxford levels of evidence were applied to each recommendation. The recommendations related to the efficacy and safety of various analgesic medications, pain measurement scales and pain management in the pre-conception period, pregnancy and lactation. Finally, an algorithm for the pharmacological management of pain in IA was developed. Twenty per cent of rheumatologists reported that the algorithm would change their practice, and 75% felt the algorithm was in accordance with their current practice. Conclusions. Eleven evidence-based recommendations on the management of pain by pharmacotherapy in IA were developed. They are supported by a large panel of rheumatologists from 17 countries, thus enhancing their utility in clinical practice. PMID:22447886

The pluralization of the international: Resistance and alter-standardization in regenerative stem cell medicine

PubMed Central

Rosemann, Achim; Chaisinthop, Nattaka

2016-01-01

The article explores the formation of an international politics of resistance and ‘alter-standardization’ in regenerative stem cell medicine. The absence of internationally harmonized regulatory frameworks in the clinical stem cell field and the presence of lucrative business opportunities have resulted in the formation of transnational networks adopting alternative research standards and practices. These oppose, as a universal global standard, strict evidence-based medicine clinical research protocols as defined by scientists and regulatory agencies in highly developed countries. The emergence of transnational spaces of alter-standardization is closely linked to scientific advances in rapidly developing countries such as China and India, but calls for more flexible regulatory frameworks, and the legitimization of experimental for-profit applications outside of evidence-based medical care, are emerging increasingly also within more stringently regulated countries, such as the United States and countries in the European Union. We can observe, then, a trend toward the pluralization of the standards, practices, and concepts in the stem cell field. PMID:26983174

Reinterpreting Responsiveness for Health Systems Research in Low and Middle-Income Countries.

PubMed

Pratt, Bridget; Hyder, Adnan A

2015-07-01

The ethical concept of responsiveness has largely been interpreted in the context of international clinical research. In light of the increasing conduct of externally funded health systems research (HSR) in low- and middle-income countries (LMICs), this article examines how responsiveness might be understood for such research and how it can be applied. It contends that four features (amongst others) set HSR in LMICs apart from international clinical research: a focus on systems; being context-driven; being policy-driven; and being closely linked to development objectives. These features support reinterpreting responsiveness for HSR in LMICs as responsiveness to systems needs, where health system performance assessments can be relied upon to identify systems needs, and/or responsiveness to systems priorities, which entails aligning research with HSR priorities set through country-owned processes involving national and sub-national policymakers from host countries. Both concepts may be difficult to achieve in practice. Country ownership is not an established fact for many countries and alignment to their priorities may be meaningless without it. It is argued that more work is, therefore, needed to identify strategies for how the responsiveness requirement can be ethically fulfilled for HSR in LMICs under non-ideal conditions such as where host countries have not set HSR priorities via country-owned processes. Embeddedness is proposed as one approach that could be the focus of further development. © 2014 John Wiley & Sons Ltd.

Contracting out of health services in developing countries.

PubMed

McPake, B; Banda, E E

1994-03-01

Contracting out is emerging as a common policy issue in a number of developing countries. The theoretical case for contracting out suggests many advantages in combining public finance with private provision. However, practical difficulties such as those of ensuring that competition takes place between potential contractors, that competition leads to efficiency and that contracts and the process of contracting are effectively managed, suggest that such advantages may not always be realized. Most countries are likely only to contemplate restricted contracting of small-scale non-clinical services in the short term. Prerequisites of more extensive models appear to be the development of information systems and human resources to that end. Some urban areas of larger countries may have the existing preconditions for more successful large-scale contracting.

Fungal infection in Latin American countries.

PubMed

Rios-Fabra, A; Moreno, A R; Istúriz, R E

1994-03-01

Fungal infections remain a frequent health problem in Latin American countries. Although these diseases exhibit an extraordinary heterogeneity, they have certain features in common. Most patients belong to low socioeconomic groups and live in rural areas. This article presents a general view of the most prevalent subcutaneous mycoses, with emphasis on epidemiology, clinical manifestations, laboratory diagnosis, and treatment options in the developing countries of Latin America.

Factors Contributing to Exacerbating Vulnerabilities in Global Clinical Trials

PubMed Central

da Silva, Ricardo E.; Amato, Angélica A.; Guilhem, Dirce B.; de Carvalho, Marta R.; Lima, Elisangela da C.; Novaes, Maria Rita C. G.

2018-01-01

Background: Although policies and guidelines make use of the concept of vulnerability, few define it. The European Union's directive for clinical trials does not include explanations for or the reasoning behind the designation of certain groups as vulnerable. Emerging economies from lower middle-income countries have, in recent years, had the largest average annual growth rate, as well as increase, in number of clinical trials registered in the US government's database. Nevertheless, careful supervision of research activities has to be ensured. Objective: To describe and analyze the features of the clinical trials involving vulnerable populations in various countries classified by development status and geographic region. Methods: Retrospective study that involved analysis of data obtained from the International Clinical Trials Registry Platform (ICTRP) database between 01/2014 and 12/2014 from countries with (i) highest trial densities during 2005 to 2012, (ii) highest average growth rate in clinical trials, and (iii) greatest trial capabilities. Results: Statistical analysis of this study showed that patients incapable of giving consent personally are 11.4 times more likely to be vulnerable patients than patients who are capable, and that patients in upper-middle-income countries are 1.7 times more likely to be vulnerable patients than patients from high-income countries when participating in global clinical trials. Malaysia (21%), Egypt (20%), Turkey (19%), Israel (18%), and Brazil (17%) had the highest percentages of vulnerable populations involving children. Conclusions: Although the inability to provide consent personally was a factor associated with vulnerability, arbitrary criteria may have been considered when classifying the populations of clinical trials as vulnerable. The EU Clinical Trials Register should provide guidance regarding exactly what aspects or factors should be taken into account to frame given populations as vulnerable, because vulnerability is not applicable to all risk situations. PMID:29403381

Factors Contributing to Exacerbating Vulnerabilities in Global Clinical Trials.

PubMed

da Silva, Ricardo E; Amato, Angélica A; Guilhem, Dirce B; de Carvalho, Marta R; Lima, Elisangela da C; Novaes, Maria Rita C G

2017-01-01

Background: Although policies and guidelines make use of the concept of vulnerability, few define it. The European Union's directive for clinical trials does not include explanations for or the reasoning behind the designation of certain groups as vulnerable. Emerging economies from lower middle-income countries have, in recent years, had the largest average annual growth rate, as well as increase, in number of clinical trials registered in the US government's database. Nevertheless, careful supervision of research activities has to be ensured. Objective: To describe and analyze the features of the clinical trials involving vulnerable populations in various countries classified by development status and geographic region. Methods: Retrospective study that involved analysis of data obtained from the International Clinical Trials Registry Platform (ICTRP) database between 01/2014 and 12/2014 from countries with (i) highest trial densities during 2005 to 2012, (ii) highest average growth rate in clinical trials, and (iii) greatest trial capabilities. Results: Statistical analysis of this study showed that patients incapable of giving consent personally are 11.4 times more likely to be vulnerable patients than patients who are capable, and that patients in upper-middle-income countries are 1.7 times more likely to be vulnerable patients than patients from high-income countries when participating in global clinical trials. Malaysia (21%), Egypt (20%), Turkey (19%), Israel (18%), and Brazil (17%) had the highest percentages of vulnerable populations involving children. Conclusions: Although the inability to provide consent personally was a factor associated with vulnerability, arbitrary criteria may have been considered when classifying the populations of clinical trials as vulnerable. The EU Clinical Trials Register should provide guidance regarding exactly what aspects or factors should be taken into account to frame given populations as vulnerable, because vulnerability is not applicable to all risk situations.

Facebook as a Learning Tool? A Case Study on the Appropriation of Social Network Sites from Mobile Phones in Developing Countries

ERIC Educational Resources Information Center

Pimmer, Christoph; Linxen, Sebastian; Grohbiel, Urs

2012-01-01

This exploratory research investigates how students and professionals use social network sites (SNSs) in the setting of developing and emerging countries. Data collection included focus groups consisting of medical students and faculty as well as the analysis of a Facebook site centred on medical and clinical topics. The findings show how users,…

Patterns of clinical mentorship in undergraduate nurse education: A comparative case analysis of eleven EU and non-EU countries.

PubMed

Dobrowolska, Beata; McGonagle, Ian; Kane, Roslyn; Jackson, Christine S; Kegl, Barbara; Bergin, Michael; Cabrera, Esther; Cooney-Miner, Dianne; Di Cara, Veronika; Dimoski, Zvonko; Kekus, Divna; Pajnkihar, Majda; Prlić, Nada; Sigurdardottir, Arun K; Wells, John; Palese, Alvisa

2016-01-01

In spite of the number of studies available in the field and policy documents developed both at the national and the international levels, there is no reliable data available regarding the variation of roles occupied by clinical mentors (CMs) across countries. To describe and compare the CM's role; responsibilities; qualifications; employment requirements and experience in undergraduate nurse education as enacted in 11 European Union (EU) and non- EU countries. A case study design. A panel of expert nurse educators from 11 countries within and outside of the EU (Croatia, Czech Republic, England, Iceland, Ireland, Italy, Poland, Serbia, Slovenia, Spain, and the USA). A questionnaire containing both quantitative and qualitative questions was developed and agreed by the panel using a Nominal Group Technique (NGT); four cycles of data collection and analysis were conducted involving key experts in nursing education in each country. In all countries, there are at least two types of clinical mentorship dedicated to undergraduate nursing students: the first is offered by higher education institutions, and the second is offered by health care providers. Variation was noted in terms of profile, responsibilities and professional requirements to act as a CM; however, the CM role is mainly carried out by registered nurses, and in most countries there are no special requirements in terms of education and experience. Those who act as CMs at the bedside continue to manage their usual caseload, thus the role adds to their work burden. Whilst it is imperative to have respect for the different national traditions in undergraduate nurse education, the globalisation of the nursing workforce and greater opportunities for student mobility during the course of their undergraduate education suggests that in areas such as clinical mentorship, jurisdictions, particularly within the EU, should work towards greater system harmonisation. Copyright © 2015 Elsevier Ltd. All rights reserved.

Antifungal susceptibilities of Cryptococcus neoformans.

PubMed

Archibald, Lennox K; Tuohy, Marion J; Wilson, Deborah A; Nwanyanwu, Okey; Kazembe, Peter N; Tansuphasawadikul, Somsit; Eampokalap, Boonchuay; Chaovavanich, Achara; Reller, L Barth; Jarvis, William R; Hall, Gerri S; Procop, Gary W

2004-01-01

Susceptibility profiles of medically important fungi in less-developed countries remain uncharacterized. We measured the MICs of amphotericin B, 5-flucytosine, fluconazole, itraconazole, and ketoconazole for Cryptococcus neoformans clinical isolates from Thailand, Malawi, and the United States and found no evidence of resistance or MIC profile differences among the countries.

'Mobile' health needs and opportunities in developing countries.

PubMed

Kahn, James G; Yang, Joshua S; Kahn, James S

2010-02-01

Developing countries face steady growth in the prevalence of chronic diseases, along with a continued burden from communicable diseases. "Mobile" health, or m-health-the use of mobile technologies such as cellular phones to support public health and clinical care-offers promise in responding to both types of disease burdens. Mobile technologies are widely available and can play an important role in health care at the regional, community, and individual levels. We examine various m-health applications and define the risks and benefits of each. We find positive examples but little solid evaluation of clinical or economic performance, which highlights the need for such evaluation.

Experience of isolated sleep paralysis in clinical practice in Nigeria.

PubMed

Ohaeri, J U

1992-06-01

The supernatural fears associated with the experience of isolated sleep paralysis in the culture of developing countries is sometimes associated with the evolution of somatic symptoms of psychological origin in patients predisposed to neurotic illness. Patients rarely spontaneously volunteer these fears and doctors pay them scant attention. Illustrative case histories that demonstrate the dynamics of the clinical presentation, as well as the treatment approach, are highlighted. It is hoped that doctors in general medical practice and in psychological medicine in developing countries where belief in supernatural causation of illness is rife will consider these factors in order to provide more effective treatment.

[Assessment of surgical teleconsultations in a developing country: two years of experience in Djibouti].

PubMed

Bertani, A; Menguy, P; Delmas, J M; Launay, F; Mathieu, L; Candoni, P; Dulou, R; Rongiéras, F

2012-01-01

Our objective was to assess the influence of teleconsultations on patient management and clinical outcomes in a developing country. All the surgical teleconsultations by a single surgeon (orthopedist) between November 2009 and November 2011 were recorded. Neurosurgery and pediatric orthopedics were the two most important specialities most often concerned, accounting for 67% of the 157 teleconsultations for 138 patients. The teleconsultations resolved the diagnostic uncertainties in 29 of 37 cases (78%). Advice from the expert modified management in 69% cases. Clinical outcomes were good or very good in 86% of the treated patients. This study establishes the feasibility and usefulness of surgical teleconsultations in Djibouti.

Criteria for clinical audit of the quality of hospital-based obstetric care in developing countries.

PubMed Central

Graham, W.; Wagaarachchi, P.; Penney, G.; McCaw-Binns, A.; Antwi, K. Y.; Hall, M. H.

2000-01-01

Improving the quality of obstetric care is an urgent priority in developing countries, where maternal mortality remains high. The feasibility of criterion-based clinical audit of the assessment and management of five major obstetric complications is being studied in Ghana and Jamaica. In order to establish case definitions and clinical audit criteria, a systematic review of the literature was followed by three expert panel meetings. A modified nominal group technique was used to develop consensus among experts on a final set of case definitions and criteria. Five main obstetric complications were selected and definitions were agreed. The literature review led to the identification of 67 criteria, and the panel meetings resulted in the modification and approval of 37 of these for the next stage of audit. Criterion-based audit, which has been devised and tested primarily in industrialized countries, can be adapted and applied where resources are poorer. The selection of audit criteria for such settings requires local expert opinion to be considered in addition to research evidence, so as to ensure that the criteria are realistic in relation to conditions in the field. Practical methods for achieving this are described in the present paper. PMID:10859855

Clinical neuropsychology in South Korea.

PubMed

Kim, Myung-Sun; Chey, Jeanyung

2016-11-01

Clinical neuropsychology in South Korea, albeit its relatively short history, has advanced dramatically. We review a brief history and current status of clinical neuropsychology in South Korea. The history, the educational pathway, the training pathway, the certification process, and careers in clinical neuropsychology in South Korea are reviewed. We have reviewed the neuropsychological services, including assessment and treatment, research on neurological and psychiatric populations, and neuropsychology education and the requirements related to education, training, and board examinations of those providing neuropsychological services in South Korea. We also describe how the Korean Society for Neuropsychology Research, the first and only meeting for neuropsychologists in the country established in 1999, has played a major role in how clinical neuropsychology is practiced and developed as a professional field in South Korea. Clinical neuropsychology in South Korea has achieved major progress over just a quarter of a century, and its future is promising in light of the increasing demand for neuropsychological services and advances in neuroscience in the country. Challenges that the community of clinical neuropsychologists are currently facing in South Korea, including formalizing neuropsychological curriculum and training programs and developing advanced credentialing procedures, are discussed.

Severe Maternal or Near Miss Morbidity: Implications for Public Health Surveillance and Clinical Audit.

PubMed

Kuklina, Elena V; Goodman, David A

2018-06-01

This chapter reviews the historical development of indicators to identify severe maternal morbidity/maternal near miss (SMM/MNM), and their use for public health surveillance, research, and clinical audit. While there has been progress toward identifying standard definitions for SMM/MNM within countries, there remain inconsistencies in the definition of SMM/MNM indicators and their application between countries. Using these indicators to screen for events that then trigger a clinical audit may both under identify select SMM/MNM (false negative)and over identify select SMM/MNM (false positive). Thus, indicators which support the efficient identification of SMM/MNM for the purpose of facility-based clinical audits are still needed.

Transcutaneous Electrical Nerve Stimulation (TENS) A Possible Aid for Pain Relief in Developing Countries?

PubMed Central

Tashani, O; Johnson, MI

2009-01-01

Transcutaneous electrical nerve stimulation (TENS) refers to the delivery of electrical currents through the skin to activate peripheral nerves. The technique is widely used in developed countries to relieve a wide range of acute and chronic pain conditions, including pain resulting from cancer and its treatment. There are many systematic reviews on TENS although evidence is often inconclusive because of shortcomings in randomised control trials methodology. In this overview the basic science behind TENS will be discussed, the evidence of its effectiveness in specific clinical conditions analysed and a case for its use in pain management in developing countries will be made. PMID:21483510

Longitudinal treatment of cleft lip and palate in developing countries: dentistry as part of a multidisciplinary endeavor.

PubMed

Lee, Cameron C Y; Jagtap, Rasika R; Deshpande, Gaurav S

2014-09-01

Cleft lip and palate affects roughly 1 in 600 children and predisposes patients to a lifetime of functional and esthetic discrepancies. Disparities in access as well as quality of care exist worldwide, with many children in developing countries unable to receive treatment. In the late 20th century, humanitarian medical missions emerged as a means of delivering surgical expertise to patients in resource-limited settings. These early missions took on a patient-centered approach focused solely on cleft repair, with little emphasis on treating the dental abnormalities that arose after the initial surgery. However, modern cleft care is characterized by a multidisciplinary, team-based approach with significant dental involvement. Recent cleft lip and palate endeavors have shifted from a mission-based approach to a developmental approach facilitating growth of an independent care center. This strategy focuses on creating an institution with expanded access to dental services, thus facilitating the long-term treatment inherent in modern cleft care. One clinic in a developing country that has experienced successful transitioning from a mission site to an independent craniofacial clinic is Operation Smile's Cleft Comprehensive Care Clinic in Guwahati, India. This article will summarize the rationale and planning of the clinic, underscore the team-based approach required in longitudinal treatment of cleft lip and palate, and demonstrate how treatment methodology may differ in resource-limited settings by outlining the therapeutic considerations of each provider in the Guwahati Clinic.

Metrics Survey of Industry-Sponsored Clinical Trials in Canada and Comparator Jurisdictions between 2005 and 2010

PubMed Central

Leclerc, Jean-Marie; Laberge, Normand; Marion, Jean

2012-01-01

Industry-sponsored clinical trials play a key role in the development of therapies. This survey suggests that between 2005 and 2010, research-based pharmaceutical firms worldwide initiated fewer trials and recruited fewer subjects annually. In contrast, at the country level, the clinical trial activity of such firms increased in emerging countries and in Japan. Canada's trend in the number of new trials followed that of the global industry, but the trend in new sites and newly recruited subjects fell below the global rate. Informal comparisons point to potential issues for Canada in such areas as site capacity, cost per subject and time to first subject-in. When compared to certain Western European countries and the United States, Canada remained well positioned on a number of metrics. Nonetheless, Canada faces mounting challenges from both traditional locations and emerging countries and may require coordinated efforts to remain a place of choice to conduct trials. PMID:23968618

Protecting HIV information in countries scaling up HIV services: a baseline study.

PubMed

Beck, Eduard J; Mandalia, Sundhiya; Harling, Guy; Santas, Xenophon M; Mosure, Debra; Delay, Paul R

2011-02-06

Individual-level data are needed to optimize clinical care and monitor and evaluate HIV services. Confidentiality and security of such data must be safeguarded to avoid stigmatization and discrimination of people living with HIV. We set out to assess the extent that countries scaling up HIV services have developed and implemented guidelines to protect the confidentiality and security of HIV information. Questionnaires were sent to UNAIDS field staff in 98 middle- and lower-income countries, some reportedly with guidelines (G-countries) and others intending to develop them (NG-countries). Responses were scored, aggregated and weighted to produce standard scores for six categories: information governance, country policies, data collection, data storage, data transfer and data access. Responses were analyzed using regression analyses for associations with national HIV prevalence, gross national income per capita, OECD income, receiving US PEPFAR funding, and being a G- or NG-country. Differences between G- and NG-countries were investigated using non-parametric methods. Higher information governance scores were observed for G-countries compared with NG-countries; no differences were observed between country policies or data collection categories. However, for data storage, data transfer and data access, G-countries had lower scores compared with NG-countries. No significant associations were observed between country score and HIV prevalence, per capita gross national income, OECD economic category, and whether countries had received PEPFAR funding. Few countries, including G-countries, had developed comprehensive guidelines on protecting the confidentiality and security of HIV information. Countries must develop their own guidelines, using established frameworks to guide their efforts, and may require assistance in adapting, adopting and implementing them.

Unintended consequences of Helicobacter pylori infection in children in developing countries

PubMed Central

Queiroz, Dulciene MM; Rocha, Andreia MC; Crabtree, Jean E

2013-01-01

Helicobacter pylori infection is predominantly acquired early in life. The prevalence of the infection in childhood is low in developed countries, whereas in developing countries most children are infected by 10 y of age. In poor resource settings, where malnutrition, parasitic/enteropathogen and H. pylori infection co-exist in young children, H. pylori might have potentially more diverse clinical outcomes. This paper reviews the impact of childhood H. pylori infection in developing countries that should now be the urgent focus of future research. The extra-gastric manifestations in early H. pylori infection in infants in poor resource settings might be a consequence of the infection associated initial hypochlorhydria. The potential role of H. pylori infection on iron deficiency, growth impairment, diarrheal disease, malabsorption and cognitive function is discussed in this review. PMID:23988829

Antifungal Susceptibilities of Cryptococcus neoformans

PubMed Central

Tuohy, Marion J.; Wilson, Deborah A.; Nwanyanwu, Okey; Kazembe, Peter N.; Tansuphasawadikul, Somsit; Eampokalap, Boonchuay; Chaovavanich, Achara; Reller, L.Barth; Jarvis, William R.; Hall, Gerri S.; Procop, Gary W.

2004-01-01

Susceptibility profiles of medically important fungi in less-developed countries remain uncharacterized. We measured the MICs of amphotericin B, 5-flucytosine, fluconazole, itraconazole, and ketoconazole for Cryptococcus neoformans clinical isolates from Thailand, Malawi, and the United States and found no evidence of resistance or MIC profile differences among the countries. PMID:15078612

Schizophrenia in women and children: a selective review of literature from developing countries.

PubMed

Chandra, Prabha S; Kommu, John Vijay Sagar; Rudhran, Vidyendran

2012-10-01

Women and children with psychotic disorders in developing countries may be vulnerable and have considerable social disadvantages. Gender disadvantage has implications for all health outcomes including mental illnesses. In the more relevant gender-related context we discuss several important issues which affect women with schizophrenia, namely stigma, caregiver burden, functional outcome, marriage, victimization and help-seeking. The findings indicate that there are variations in clinical and functional outcomes and age of onset of illness between different regions. Drug side effects, such as metabolic syndrome appear to be quite common, adding to disease burden in women from developing countries. Victimization and coercion may contribute to poor quality of life and health concerns such as STIs and HIV. Stigma among women with schizophrenia appears to play a major role in help-seeking, caregiver burden and issues such as marriage and parenting. Gender-sensitive care and practices are few and not well documented. Research in the area of psychoses in children and adolescents from LAMI countries is sparse and is mainly restricted to a few clinic-based studies. More research is needed on organic and medical factors contributing to childhood psychoses, pathways to care, help-seeking, and impact of early detection and community care.

Poison control centers in developing countries and Asia's need for toxicology education

DOE Office of Scientific and Technical Information (OSTI.GOV)

Makalinao, Irma R.; Awang, Rahmat

2005-09-01

Poison control centers (PCCs) in developing countries have been set up in response to the challenge of decreasing mortality and morbidity from poisoning. The services range from poison information to actual clinical treatment mostly of acute cases. Lately, PCCs have expanded from their traditional role to one that actively engages in community health studies, toxicovigilance along with treatment of chronic poisoning. Recognizing that types of poisoning and specific needs may vary from country to country, toxicology education that addresses these unique regional issues has become more necessary. Toxicology education, both formal and informal, exists in various stages of development inmore » Asia. Clearly, there are gaps that need to be addressed especially in areas where there are no poison centers or where strengthening is necessary. Collaboration between PCCs in developing countries can help augment available resources including human, analytical and technical expertise. The critical mass of trained toxicologists will fill in the demand for clinical and regulatory specialists and educators as well. This paper highlights the experiences and resources available to the Philippine and Malaysian poison centers and the strengths generated by networking and collaboration. The role of Asia Pacific Association of Medical Toxicology (APAMT) as the Science NGO representative to the Intergovernmental Forum on Chemical Safety (IFCS) forum standing committee in promoting chemical safety at the regional level will be discussed. The 'Clearinghouse on the Sound Management of Chemicals', a platform for engaging multi-stakeholder and interdisciplinary partnerships, will be described as a possible model for capacity building to advance chemical safety through education and training not only in developing countries in Asia but globally as well.« less

Latin American and Caribbean countries' baseline clinical and policy guidelines for responding to intimate partner violence and sexual violence against women.

PubMed

Stewart, Donna E; Aviles, Raquel; Guedes, Alessandra; Riazantseva, Ekaterina; MacMillan, Harriet

2015-07-15

Violence against women is a global public health problem with negative effects on physical, mental, and reproductive health. The World Health Organization (WHO) has identified intimate partner violence (IPV) and sexual violence (SV) as major targets for prevention and amelioration and recently developed clinical and policy guidelines to assist healthcare providers. This project was undertaken to determine the 2013 baseline national policies and clinical guidelines on IPV and SV within the Latin American and Caribbean (LAC) region to identify strengths and gaps requiring action. Each Pan American Health Organization/World Health Organization Regional Office for the Americas (PAHO/WHO) country focal point was contacted to request their current national policy and clinical guidelines (protocol) on IPV/SV. We augmented this by searching the internet and the United Nations Women website. Each country's policy and clinical guideline (where available) was reviewed and entered into a scoring matrix based on WHO Clinical and Policy Guidelines. A total score for each heading and subheading was developed by adding positive responses to identify LAC regional strengths and gaps. We obtained 15 national policies and 12 national clinical guidelines (protocols) from a total of 18 countries ("response" rate 66.7%). National policies were comprehensive in terms of physical, emotional, and sexual violence and recommended good intersectoral collaboration. The greatest gap was in the training of health-care providers. National Guidelines for women-centered care for IPV/SV survivors were strong in the vital areas of privacy, confidentiality, danger assessment, safety planning, and supportive reactions to disclosure. The largest gaps noted were again in training healthcare professionals and strengthening monitoring and evaluation of services. Baseline measurement of policy and clinical guidelines for IPV/SV in LAC PAHO/WHO member countries at the time of issuing the 2013 WHO Clinical and Policy Guidelines reveals some important strengths, but also serious gaps that need to be addressed. The most pressing needs are for concerted training initiatives for healthcare providers and strengthening multisectoral monitoring and evaluation of services. A future evaluation of national policies, clinical guidelines, monitoring and evaluation will need to be conducted to measure the progress of the required scaling-up process.

Lessons from across the pond: what the US can learn from European immunization programs.

PubMed

Freed, Gary L

2007-08-14

Childhood immunizations are the most effective clinical preventive services ever developed. Western European countries have a variety of governmental and non-governmental agencies involved in the development and operation of their immunization programs. Because of the range of programs in place across the European continent, various components of the US system parallel specific components of a variety of countries. Examining the experiences of other countries which have attempted to address issues now faced by the US can be valuable. However, such examinations are only of value if both the country and the policy itself to be examined are placed within the context of the US health care system and US policy constraints.

Current globalization of drug interventional clinical trials: characteristics and associated factors, 2011-2013.

PubMed

Jeong, Sohyun; Sohn, Minji; Kim, Jae Hyun; Ko, Minoh; Seo, Hee-Won; Song, Yun-Kyoung; Choi, Boyoon; Han, Nayoung; Na, Han-Sung; Lee, Jong Gu; Kim, In-Wha; Oh, Jung Mi; Lee, Euni

2017-06-21

Clinical trial globalization is a major trend for industry-sponsored clinical trials. There has been a shift in clinical trial sites towards emerging regions of Eastern Europe, Latin America, Asia, the Middle East, and Africa. Our study objectives were to evaluate the current characteristics of clinical trials and to find out the associated multiple factors which could explain clinical trial globalization and its implications for clinical trial globalization in 2011-2013. The data elements of "phase," "recruitment status," "type of sponsor," "age groups," and "design of trial" from 30 countries were extracted from the ClinicalTrials.gov website. Ten continental representative countries including the USA were selected and the design elements were compared to those of the USA. Factors associated with trial site distribution were chosen for a multilinear regression analysis. The USA, Germany, France, Canada, and United Kingdom were the "top five" countries which frequently held clinical trials. The design elements from nine continental representative countries were quite different from those of the USA; phase 1 trials were more prevalent in India (OR 1.517, p < 0.001) while phase 3 trials were much more prevalent in all nine representative countries than in the USA. A larger number of "child" age group trials was performed in Poland (OR 1.852, p < 0.001), Israel (OR 1.546, p = 0.005), and South Africa (OR 1.963, p < 0.001) than in the USA. Multivariate analysis showed that health care expenditure per capita, Economic Freedom Index, Human Capital Index, and Intellectual Property Rights Index could explain the variance of regional distribution of clinical trials by 63.6%. The globalization of clinical trials in the emerging regions of Asia, South Africa, and Eastern Europe developed in parallel with the factors of economic drive, population for recruitment, and regulatory constraints.

The EU(7)-PIM list: a list of potentially inappropriate medications for older people consented by experts from seven European countries.

PubMed

Renom-Guiteras, Anna; Meyer, Gabriele; Thürmann, Petra A

2015-07-01

The aim of the study was to develop a European list of potentially inappropriate medications (PIM) for older people, which can be used for the analysis and comparison of prescribing patterns across European countries and for clinical practice. A preliminary PIM list was developed, based on the German PRISCUS list of potentially inappropriate medications and other PIM lists from the USA, Canada and France. Thirty experts on geriatric prescribing from Estonia, Finland, France, the Netherlands, Spain and Sweden participated; eight experts performed a structured expansion of the list, suggesting further medications; twenty-seven experts participated in a two-round Delphi survey assessing the appropriateness of drugs and suggesting dose adjustments and therapeutic alternatives. Finally, twelve experts completed a brief final survey to decide upon issues requiring further consensus. Experts reached a consensus that 282 chemical substances or drug classes from 34 therapeutic groups are PIM for older people; some PIM are restricted to a certain dose or duration of use. The PIM list contains suggestions for dose adjustments and therapeutic alternatives. The European Union (EU)(7)-PIM list is a screening tool, developed with participation of experts from seven European countries, that allows identification and comparison of PIM prescribing patterns for older people across European countries. It can also be used as a guide in clinical practice, although it does not substitute the decision-making process of individualised prescribing for older people. Further research is needed to investigate the feasibility and applicability and, finally, the clinical benefits of the newly developed list.

Evaluation of vaccines against enteric infections: a clinical and public health research agenda for developing countries

PubMed Central

Clemens, John

2011-01-01

Enteric infections are a major cause of morbidity and mortality in developing countries. To date, vaccines have played a limited role in public health efforts to control enteric infections. Licensed vaccines exist for cholera and typhoid, but these vaccines are used primarily for travellers; and there are two internationally licensed vaccines for rotavirus, but they are mainly used in affluent countries. The reasons that enteric vaccines are little used in developing countries are multiple, and certainly include financial and political constraints. Also important is the need for more cogent evidence on the performance of enteric vaccines in developing country populations. A partial inventory of research questions would include: (i) does the vaccine perform well in the most relevant settings? (ii) does the vaccine perform well in all epidemiologically relevant age groups? (iii) is there adequate evidence of vaccine safety once the vaccines have been deployed in developing countries? (iv) how effective is the vaccine when given in conjunction with non-vaccine cointerventions? (v) what is the level of vaccine protection against all relevant outcomes? and (vi) what is the expected population level of vaccine protection, including both direct and herd vaccine protective effects? Provision of evidence addressing these questions will help expand the use of enteric vaccines in developing countries. PMID:21893543

The development, evolution, and modifications of ICD-10: challenges to the international comparability of morbidity data.

PubMed

Jetté, Nathalie; Quan, Hude; Hemmelgarn, Brenda; Drosler, Saskia; Maass, Christina; Moskal, Lori; Paoin, Wansa; Sundararajan, Vijaya; Gao, Song; Jakob, Robert; Ustün, Bedihran; Ghali, William A

2010-12-01

The United States is about to make a major nationwide transition from ICD-9-CM coding of hospital discharges to ICD-10-CM, a country-specific modification of the World Health Organization's ICD-10. As this transition occurs, the WHO is already in the midst of developing ICD-11. Given this context, we undertook this review to discuss: (1) the history of the International Classification of Diseases (a core information "building block" for health systems everywhere) from its introduction to the current era of ICD-11 development; (2) differences across country-specific ICD-10 clinical modifications and the challenges that these differences pose to the international comparability of morbidity data; (3) potential strategic approaches to achieving better international ICD-11 comparability. A literature review and stakeholder consultation was carried out. The various ICD-10 clinical modifications (ICD-10-AM [Australia], ICD-10-CA [Canada], ICD-10-GM [Germany], ICD-10-TM [Thailand], ICD-10-CM [United States]) were compared. These ICD-10 modifications differ in their number of codes, chapters, and subcategories. Specific conditions are present in some but not all of the modifications. ICD-11, with a similar structure to ICD-10, will function in an electronic health records environment and also provide disease descriptive characteristics (eg, causal properties, functional impact, and treatment). The threat to the comparability of international clinical morbidity is growing with the development of many country-specific ICD-10 versions. One solution to this threat is to develop a meta-database including all country-specific modifications to ensure more efficient use of people and resources, decrease omissions and errors but most importantly provide a platform for future ICD updates.

Enhancing pharmacists' role in developing countries to overcome the challenge of antimicrobial resistance: a narrative review.

PubMed

Sakeena, M H F; Bennett, Alexandra A; McLachlan, Andrew J

2018-01-01

Antimicrobial resistance (AMR) is a global health challenge and developing countries are more vulnerable to the adverse health impacts of AMR. Health care workers including pharmacists can play a key role to support the appropriate use of antimicrobials in developing countries and reduce AMR. The aim of this review is to investigate the role of pharmacists in the appropriate use of antibiotics and to identify how the pharmacists' role can be enhanced to combat AMR in developing countries. The databases MEDLINE, EMBASE, Web of Science and Google Scholar were searched for articles published between 2000 and the end of August 2017 that involved studies on the role of pharmacists in developing countries, the expanded services of pharmacists in patient care in developed countries and pharmacists' contributions in antimicrobial use in both developed and developing nations. In developing countries pharmacists role in patient care are relatively limited. However, in developed nations, the pharmacists' role has expanded to provide multifaceted services in patient care resulting in improved health outcomes from clinical services and reduced health care costs. Success stories of pharmacist-led programs in combating AMR demonstrates that appropriately trained pharmacists can be part of the solution to overcome the global challenge of AMR. Pharmacists can provide education to patients enabling them to use antibiotics appropriately. They can also provide guidance to their healthcare colleagues on appropriate antibiotic prescribing. This review highlights that appropriately trained pharmacists integrated into the health care system can make a significant impact in minimising inappropriate antibiotic use in developing countries. Strengthening and enhancing the pharmacists' role in developing countries has the potential to positively impact the global issue of AMR.

Leadership Practices of Clinical Trials Office Leaders in Academic Health Centers

ERIC Educational Resources Information Center

Naser, Diana D.

2012-01-01

In the ever-changing clinical research environment, academic health centers seek leaders who are visionary and innovative. Clinical trials offices across the country are led by individuals who are charged with promoting growth and change in order to maximize performance, develop unique research initiatives, and help institutions achieve a…

Ethical and practical challenges surrounding genetic and genomic research in developing countries.

PubMed

Nyika, Aceme

2009-11-01

The nature of some potential benefits and risks associated with genetic research is different from the types of potential benefits and risks associated with other types of health research such as clinical trials and biomedical research involving humans. Whereas most potential risks associated with biomedical research or clinical trials are mainly biological in nature, potential risks associated with genetic research are mainly of socioeconomic nature. Although the peculiarity of some of the aspects of genetic research and the complexity of the science involved are acknowledged, the extent to which these characteristics hinder firstly disclosure of information to participants and their communities and secondly comprehension of the disclosed information is a practical challenge that tends to be exaggerated in some cases. In this article, a brief overview of the various types of genetic research will be given in order to set the scene for some ethical and practical issues surrounding the research in developing countries that will be discussed subsequently. Case studies that illustrate some of the ethical and practical issues flagged will be given, followed by suggestions on possible ways of tackling some of the challenges in developing country settings. Nevertheless, genetic and genomic research could go a long way in providing knowledge that could be useful in the development of drugs and vaccines for many diseases affecting the developing countries.

Resource costing for multinational neurologic clinical trials: methods and results.

PubMed

Schulman, K; Burke, J; Drummond, M; Davies, L; Carlsson, P; Gruger, J; Harris, A; Lucioni, C; Gisbert, R; Llana, T; Tom, E; Bloom, B; Willke, R; Glick, H

1998-11-01

We present the results of a multinational resource costing study for a prospective economic evaluation of a new medical technology for treatment of subarachnoid hemorrhage within a clinical trial. The study describes a framework for the collection and analysis of international resource cost data that can contribute to a consistent and accurate intercountry estimation of cost. Of the 15 countries that participated in the clinical trial, we collected cost information in the following seven: Australia, France, Germany, the UK, Italy, Spain, and Sweden. The collection of cost data in these countries was structured through the use of worksheets to provide accurate and efficient cost reporting. We converted total average costs to average variable costs and then aggregated the data to develop study unit costs. When unit costs were unavailable, we developed an index table, based on a market-basket approach, to estimate unit costs. To estimate the cost of a given procedure, the market-basket estimation process required that cost information be available for at least one country. When cost information was unavailable in all countries for a given procedure, we estimated costs using a method based on physician-work and practice-expense resource-based relative value units. Finally, we converted study unit costs to a common currency using purchasing power parity measures. Through this costing exercise we developed a set of unit costs for patient services and per diem hospital services. We conclude by discussing the implications of our costing exercise and suggest guidelines to facilitate more effective multinational costing exercises.

Improving rates of cotrimoxazole prophylaxis in resource-limited settings: implementation of a quality improvement approach.

PubMed

Bardfield, J; Agins, B; Palumbo, M; Wei, A L; Morris, J; Marston, B

2014-12-01

To demonstrate the effectiveness of quality improvement methods to monitor and improve administration of cotrimoxazole (CTX) prophylaxis to improve health outcomes among adults living with HIV/AIDS in low resource countries. Program evaluation. HIV/AIDS health care facilities in Uganda, Mozambique, Namibia and Haiti. Performance measures based on national guidelines are developed in each country. These may include CD4 monitoring, ART adherence and uptake of CTX prophylaxis. CTX prophylaxis is routinely selected, because it has been shown to reduce HIV-related morbidity and mortality. Patient records are sampled using a standard statistical table to achieve a minimum confidence interval of 90% with a spread of ±8% in participating clinics. If an electronic medical record is available, all patients are reviewed. Routine review of performance measures, usually every 6 months, is conducted to identify gaps in care. Improvement interventions are developed and implemented at health facilities, informed by performance results, and local/national public health priorities. Median clinic rates of CTX prophylaxis. Median performance rates of CTX prophylaxis generally improved for adult HIV+ patients between 2006 and 2013 across countries, with median clinic rates higher than baseline at follow-up in 16 of 18 groups of clinics implementing CTX -focused improvement projects. Quality management offers a data-driven method to improve the quality of HIV care in low resource countries. Application of improvement principles has been shown to be effective to increase the rates of CTX prophylaxis in national HIV programs in multiple countries. © The Author 2014. Published by Oxford University Press in association with the International Society for Quality in Health Care; all rights reserved.

The Point-of-Care Laboratory in Clinical Microbiology

PubMed Central

Michel-Lepage, Audrey; Boyer, Sylvie; Raoult, Didier

2016-01-01

SUMMARY Point-of-care (POC) laboratories that deliver rapid diagnoses of infectious diseases were invented to balance the centralization of core laboratories. POC laboratories operate 24 h a day and 7 days a week to provide diagnoses within 2 h, largely based on immunochromatography and real-time PCR tests. In our experience, these tests are conveniently combined into syndrome-based kits that facilitate sampling, including self-sampling and test operations, as POC laboratories can be operated by trained operators who are not necessarily biologists. POC laboratories are a way of easily providing clinical microbiology testing for populations distant from laboratories in developing and developed countries and on ships. Modern Internet connections enable support from core laboratories. The cost-effectiveness of POC laboratories has been established for the rapid diagnosis of tuberculosis and sexually transmitted infections in both developed and developing countries. PMID:27029593

Complex care systems in developing countries: breast cancer patient navigation in Ethiopia.

PubMed

Dye, Timothy D; Bogale, Solomon; Hobden, Claire; Tilahun, Yared; Hechter, Vanessa; Deressa, Teshome; Bizé, Marion; Reeler, Anne

2010-02-01

As the global visibility and importance of breast cancer increases, especially in developing countries, ensuring that countries strengthen and develop health systems that support prevention, diagnosis, and treatment of a complex chronic disease is a priority. Understanding how breast cancer patients navigate health systems to reach appropriate levels of care is critical in assessing and improving the health system response in countries to an increasing breast cancer burden in their populations. Ethiopia has accelerated attention to breast cancer, expanding clinical and public health efforts at diagnosing and treating breast cancer earlier and more efficiently. This project used a mixed-method approach to assessing patient navigation of the healthcare system that resulted in care at the cancer referral hospital for Ethiopia (Tikur Anbessa Hospital [TAH]). In total, 69 patients representative of the entire breast cancer clinical population at TAH were interviewed. Navigation chains are widely divergent and typically involve 3 or more care nodes until they reach the referral hospital. Patients who consult traditional healers have significantly more care nodes to reach the referral hospital than others, and patients who have direct access to local and regional hospitals have the smallest number of care nodes. Patients report moving laterally from 1 health institution to another or regressing to lower levels of care, sometimes complicated by reinvolving traditional healers. The care system can be streamlined for breast cancer patients in Ethiopia to facilitate patient access to available and clinically effective diagnostic and treatment services in the country, largely through improving local primary care and hospital capacity to provide basic breast cancer services and improve detection and referral. Copyright 2009 American Cancer Society.

Breast health in developing countries.

PubMed

Yip, C H; Taib, N A

2014-12-01

Breast cancer is one of the leading cancers world-wide. While the incidence in developing countries is lower than in developed countries, the mortality is much higher. Of the estimated 1 600 000 new cases of breast cancer globally in 2012, 794 000 were in the more developed world compared to 883 000 in the less developed world; however, there were 198 000 deaths in the more developed world compared to 324 000 in the less developed world (data from Globocan 2012, IARC). Survival from breast cancer depends on two main factors--early detection and optimal treatment. In developing countries, women present with late stages of disease. The barriers to early detection are physical, such as geographical isolation, financial as well as psychosocial, including lack of education, belief in traditional medicine and lack of autonomous decision-making in the male-dominated societies that prevail in the developing world. There are virtually no population-based breast cancer screening programs in developing countries. However, before any screening program can be implemented, there must be facilities to treat the cancers that are detected. Inadequate access to optimal treatment of breast cancer remains a problem. Lack of specialist manpower, facilities and anticancer drugs contribute to the suboptimal care that a woman with breast cancer in a low-income country receives. International groups such as the Breast Health Global Initiative were set up to develop economically feasible, clinical practice guidelines for breast cancer management to improve breast health outcomes in countries with limited resources.

Nursing students' perceptions of learning in practice environments: a review.

PubMed

Henderson, Amanda; Cooke, Marie; Creedy, Debra K; Walker, Rachel

2012-04-01

Effective clinical learning requires integration of nursing students into ward activities, staff engagement to address individual student learning needs, and innovative teaching approaches. Assessing characteristics of practice environments can provide useful insights for development. This study identified predominant features of clinical learning environments from nursing students' perspectives across studies using the same measure in different countries over the last decade. Six studies, from three different countries, using the Clinical Leaning Environment Inventory (CLEI) were reviewed. Studies explored consistent trends about learning environment. Students rated sense of task accomplishment high. Affiliation also rated highly though was influenced by models of care. Feedback measuring whether students' individual needs and views were accommodated consistently rated lower. Across different countries students report similar perceptions about learning environments. Clinical learning environments are most effective in promoting safe practice and are inclusive of student learners, but not readily open to innovation and challenges to routine practices. Crown Copyright © 2011. Published by Elsevier Ltd. All rights reserved.

Neuropsychology in South Africa: confronting the challenges of specialist practice in a culturally diverse developing country.

PubMed

Watts, Ann D; Shuttleworth-Edwards, Ann B

2016-11-01

This was an invited paper on the history and current status of neuropsychology in South Africa. Information was gathered from literature searches, personal communication, and the authors' experiences while occupying relevant professional and academic positions for over 30 years. Since its origins in the 1950s, the development of neuropsychology in South Africa has faced numerous challenges, against a background of extreme sociocultural and socioeconomic disparity in the country that is on-going. The creation of the South African Clinical Neuropsychological Society in the 1980s, a credentialing and training body, gave impetus to the discipline. In the absence of a neuropsychology category within the South African professional framework, university instruction has been ad hoc with vastly different levels of competency depending on the institution involved. The small number of practitioners and/or academics involved in neuropsychology includes mainly masters, and some doctoral level psychologists registered in clinical, counseling or educational categories. A prime emphasis of neuropsychological research has been local norming of psychometric tests to facilitate valid assessment practices in the country. South Africa is on the cusp of achieving a hard-won neuropsychology professional register. It is anticipated that this development will provide impetus to the discipline by promoting training programs, the creation of neuropsychology posts, wider service delivery, and increased research funding. Despite significant challenges in a culturally diverse, developing country, neuropsychology has evolved sufficiently to warrant the creation of a separate category in the professional framework. This development will facilitate training, research, and services in the country.

Building an international network for a primary care research program: reflections on challenges and solutions in the set-up and delivery of a prospective observational study of acute cough in 13 European countries

PubMed Central

2011-01-01

Background Implementing a primary care clinical research study in several countries can make it possible to recruit sufficient patients in a short period of time that allows important clinical questions to be answered. Large multi-country studies in primary care are unusual and are typically associated with challenges requiring innovative solutions. We conducted a multi-country study and through this paper, we share reflections on the challenges we faced and some of the solutions we developed with a special focus on the study set up, structure and development of Primary Care Networks (PCNs). Method GRACE-01 was a multi-European country, investigator-driven prospective observational study implemented by 14 Primary Care Networks (PCNs) within 13 European Countries. General Practitioners (GPs) recruited consecutive patients with an acute cough. GPs completed a case report form (CRF) and the patient completed a daily symptom diary. After study completion, the coordinating team discussed the phases of the study and identified challenges and solutions that they considered might be interesting and helpful to researchers setting up a comparable study. Results The main challenges fell within three domains as follows: i) selecting, setting up and maintaining PCNs; ii) designing local context-appropriate data collection tools and efficient data management systems; and iii) gaining commitment and trust from all involved and maintaining enthusiasm. The main solutions for each domain were: i) appointing key individuals (National Network Facilitator and Coordinator) with clearly defined tasks, involving PCNs early in the development of study materials and procedures. ii) rigorous back translations of all study materials and the use of information systems to closely monitor each PCNs progress; iii) providing strong central leadership with high level commitment to the value of the study, frequent multi-method communication, establishing a coherent ethos, celebrating achievements, incorporating social events and prizes within meetings, and providing a framework for exploitation of local data. Conclusions Many challenges associated with multi-country primary care research can be overcome by engendering strong, effective communication, commitment and involvement of all local researchers. The practical solutions identified and the lessons learned in implementing the GRACE-01 study may assist in establishing other international primary care clinical research platforms. Trial registration ClinicalTrials.gov Identifier: NCT00353951 PMID:21794112

[Economic analysis of multinational clinical trials in oncology].

PubMed

Lejeune, Catherine; Lueza, Béranger; Bonastre, Julia

2018-02-01

In oncology, as in other fields of medicine, international multicentre clinical trials came into being so as to include a sufficient number of subjects to investigate a clinical situation. The existence of tight budgetary constraints and the desire to make the best use of the resources available have resulted in the development of economic evaluations associated with these trials, which, thanks to their level of evidence and their size, provide particularly relevant material. Nonetheless, economic evaluations alongside international clinical trials raise specific questions of methodology with regard to both the design and the analysis of the results. Indeed, the costs of goods and services consumed, the types and quantities of resources, and medical practices vary from one country to another and within an individual country. Economic data from the different countries involved must be available so as to study and to take into account this variability, and appropriate techniques for cost estimations and analysis must be implemented to aggregate the results from several countries. From a review of the literature, the aim of this work was to provide an overview of the specific methodological features of economic evaluations alongside international clinical trials: analysis of efficacy data from several countries, collection of resources and real costs, methods to establish the monetary value of resources, methods to aggregate results accounting for the trial effect. Copyright © 2017 Société Française du Cancer. Published by Elsevier Masson SAS. All rights reserved.

Improving health worker performance: The patient-perspective from a PBF program in Rwanda.

PubMed

Lannes, Laurence

2015-08-01

The effect of performance-based financing (PBF) on patients' perception of primary health care services in developing countries in not well documented. Data from a randomized impact evaluation in Rwanda conducted between 2006 and 2008 in 157 primary level facilities is used to explore patients' satisfaction with clinical and non-clinical services and quantify the contribution of individual and facility characteristics to satisfaction including PBF. Improvements in productivity, availability and competences of the health workforce following the implementation of PBF have a positive effect on patients' satisfaction with clinical services even if patients' satisfaction is not tied to a reward. The positive effect of PBF on non-clinical dimensions of satisfaction also suggests that PBF incentivizes providers to raise patients' satisfaction with non-clinical services if it is associated with future financial gains. It is recommended that low and middle income countries build on the experience from high income countries to better listen to patients' voice in general and include an assessment of patients' satisfaction in incentive mechanisms as a way to increase the benefits of the strategy. Copyright © 2015 Elsevier Ltd. All rights reserved.

Development and technical basis of simplified guidelines for emergency triage assessment and treatment in developing countries. WHO Integrated Management of Childhood Illness (IMCI) Referral Care Project.

PubMed

Gove, S; Tamburlini, G; Molyneux, E; Whitesell, P; Campbell, H

1999-12-01

Simplified guidelines for the emergency care of children have been developed to improve the triage and rapid initiation of appropriate emergency treatments for children presenting to hospitals in developing countries. The guidelines are part of the effort to improve referral level paediatric care within the World Health Organisation/Unicef strategy integrated management of childhood illness (IMCI), based on evidence of significant deficiencies in triage and emergency care. Existing emergency guidelines have been modified according to resource limitations and significant differences in the epidemiology of severe paediatric illness and preventable death in developing countries with raised infant and child mortality rates. In these settings, it is important to address the emergency management of diarrhoea with severe dehydration, severe malaria, severe malnutrition, and severe bacterial pneumonia, and to focus attention on sick infants younger than 2 months of age. The triage assessment relies on a few clinical signs, which can be readily taught so that it can be used by health workers with limited clinical background. The assessment has been designed so that it can be carried out quickly if negative, making it functional for triaging children in queues.

Effective coverage of primary care services in eight high-mortality countries

PubMed Central

Malata, Address; Ndiaye, Youssoupha; Kruk, Margaret E

2017-01-01

Introduction Measurement of effective coverage (quality-corrected coverage) of essential health services is critical to monitoring progress towards the Sustainable Development Goal for health. We combine facility and household surveys from eight low-income and middle-income countries to examine effective coverage of maternal and child health services. Methods We developed indices of essential clinical actions for antenatal care, family planning and care for sick children from existing guidelines and used data from direct observations of clinical visits conducted in Haiti, Kenya, Malawi, Namibia, Rwanda, Senegal, Tanzania and Uganda between 2007 and 2015 to measure quality of care delivered. We calculated healthcare coverage for each service from nationally representative household surveys and combined quality with utilisation estimates at the subnational level to quantify effective coverage. Results Health facility and household surveys yielded over 40 000 direct clinical observations and over 100 000 individual reports of healthcare utilisation. Coverage varied between services, with much greater use of any antenatal care than family planning or sick-child care, as well as within countries. Quality of care was poor, with few regions demonstrating more than 60% average performance of basic clinical practices in any service. Effective coverage across all eight countries averaged 28% for antenatal care, 26% for family planning and 21% for sick-child care. Coverage and quality were not strongly correlated at the subnational level; effective coverage varied by as much as 20% between regions within a country. Conclusion Effective coverage of three primary care services for women and children in eight countries was substantially lower than crude service coverage due to major deficiencies in care quality. Better performing regions can serve as examples for improvement. Systematic increases in the quality of care delivered—not just utilisation gains—will be necessary to progress towards truly beneficial universal health coverage. PMID:29632704

Current status and future prospects of the development of clinical Pharmacy in China: A SWOT analysis.

PubMed

Rao, Yuefeng; Zhao, Qingwei; Zhang, Xiangyi; Yang, Hongyu; Lou, Yan; Zhang, Xingguo

2016-03-01

In many industrialized countries, clinical pharmacy has developed into a separate discipline and become a vital part of inpatient care in hospitals. However, as compared to many established branches of medicine, clinical pharmacy is still in its infancy, with much room for growth, improvement, and recognition by both the medical community and patients. In this study, a widely-recognized development strategy analysis tool, Strength, Weakness, Opportunity and Threat (SWOT), was used to systematically address several key issues to the development of clinical pharmacy in China. This analysis aims to provide feasible recommendations for the development of clinical pharmacy in China by identifying current problems and growth opportunities. Full development of clinical pharmacy as a mature clinical discipline will help promote the rational use of drugs by both clinicians and patients and lead to enhanced drug efficacy and safety.

Evaluation systems for clinical governance development: a comparative study.

PubMed

Hooshmand, Elaheh; Tourani, Sogand; Ravaghi, Hamid; Ebrahimipour, Hossein

2014-01-01

Lack of scientific and confirmed researches and expert knowledge about evaluation systems for clinical governance development in Iran have made studies on different evaluation systems for clinical governance development a necessity. These studies must provide applied strategies to design criteria of implementing clinical governance for hospital's accreditation. This is a descriptive and comparative study on development of clinical governance models all over the world. Data have been gathered by reviewing related articles. Models have been studied in comprehensive review method. The evaluated models of clinical governance development were Australian, NHS, SPOCK and OPTIGOV. The final aspects extracted from these models were Responsiveness, Policies and Strategies, Organizational Structure, Allocating Resources, Education and Occupational Development, Performance Evaluation, External Evaluation, Patient Oriented Approach, Risk Management, Personnel's Participation, Information Technology, Human Resources, Research and Development, Evidence Based Medicine, Clinical Audit, Health Technology Assessment and Quality. These results are applicable for completing the present criteria which evaluating clinical governance application and provide practical framework to evaluate country's hospital on the basis of clinical governance elements.

Perceived blood transfusion safety: a cross-European comparison.

PubMed

Merz, E-M; Zijlstra, B J H; de Kort, W L A M

2016-04-01

During the past decades, blood transfusions have become an ever safer clinical procedure in developed countries. Extensive donor screening together with improved infectious disease testing has led to a minimization of risks for transfusion recipients. Still, the general public perceives the process of blood transfusion as risky. This study tested variation in perceived transfusion safety across countries and explained it with individual and country factors. We examined whether individual demographic and macro-level factors (i.e. Human Development Index and Power Distance Index) explain variation within and across European countries. We applied multilevel models to 2009 Eurobarometer data collected in 26 countries (N = 20 874). Results were largely in line with expectations derived from risk perception and power and status difference theories. Generally, women, older adults, the lower educated and those earning lower incomes perceived heightened risk. Most of the variation across Europe was explained by the Human Development Index. Risk perception regarding blood transfusions was lower in countries with higher Human Development Indices, that is countries with higher average education, life expectancy and Gross Domestic Product. This study provides new insights of how risk perception regarding blood transfusions is shaped within and across Europe. Both individual demographic factors and country characteristics play a role. © 2015 International Society of Blood Transfusion.

The pharmaceutical industry's responsibility for protecting human subjects of clinical trials in developing nations.

PubMed

Kelleher, Finnuala

2004-01-01

Pharmaceutical companies increasingly perform clinical trials in developing nations. Governments of host nations see the trials as a way to provide otherwise unaffordable medical care, while trial sponsors are drawn to those countries by lower costs, the prevalence of diseases rare in developed nations, and large numbers of impoverished patients. Local governments, however, fail to police trials, and the FDA does not monitor trials in foreign countries, resulting in the routine violation of international standards for the protection of human subjects. This Note proposes independent accreditation of those institutions involved in clinical trials--the institutional review boards which oversee trial protocol; the organizations, such as pharmaceutical companies, which sponsor the trials; and the research organizations that conduct the trials. Accreditation, similar to that used in the footwear and apparel industries, would increase the transparency of pharmaceutical trials and would enable the United States government and consumers to hold trial sponsors accountable for their actions.

Responses to the Standard for Exchange of Nonclinical Data (SEND) in non-US countries

PubMed Central

Anzai, Takayuki; Kaminishi, Masamichi; Sato, Keizo; Kaufman, Laura; Iwata, Hijiri; Nakae, Dai

2015-01-01

The Standard for the Exchange of Nonclinical Data (SEND), adopted by the US FDA, is part of a set of regulations and guidances requiring the submission of standardized electronic study data for nonclinical and clinical data submissions. SEND is the nonclinical implementation of SDTM (Study Data Tabulation Model), the standard electronic format for clinical regulatory submissions to FDA. SEND, SDTM, and the associated Controlled Terminology have been developed by CDISC (Clinical Data Interchange Standards Consortium). In order to successfully implement SEND, interdisciplinary contributions between sponsors and CROs, need a model for task allocation. This is being undertaken by the Pharmaceutical Users Software Exchange (PhUSE). Because SEND is currently the preferred submission format of the US FDA only and will become required by it starting in December 2016, only American academic societies and companies are actively involved. An exception to this is the INHAND initiative, which leads the way in standardizing terminology for toxicological pathology. On the other hand, international globalization of other clinical and nonclinical practices is not feasible because there are substantial differences between the US and non-US countries in CRO involvement in drug development. Thus, non-US countries must consider and develop approaches to SEND that meet their needs. This paper summarizes the activities of the major organizations involved in SEND development and implementation, discusses the effective use of SEND, and details a compliance scheme (research material of the Showa University School of Medicine) illustrating how pharmaceutical companies can complete a large amount of work up to an FDA application with the effective utilization of CROs and solution providers. PMID:26028814

HIV drug resistance early warning indicators in cohorts of individuals starting antiretroviral therapy between 2004 and 2009: World Health Organization global report from 50 countries.

PubMed

Bennett, Diane E; Jordan, Michael R; Bertagnolio, Silvia; Hong, Steven Y; Ravasi, Giovanni; McMahon, James H; Saadani, Ahmed; Kelley, Karen F

2012-05-01

The World Health Organization developed a set of human immunodeficiency virus drug resistance (HIVDR) early warning indicators (EWIs) to assess antiretroviral therapy clinic and program factors associated with HIVDR. EWIs are monitored by abstracting data routinely recorded in clinical records, and the results enable clinics and program managers to identify problems that should be addressed to minimize preventable emergence of HIVDR in clinic populations. As of June 2011, 50 countries monitored EWIs, covering 131 686 patients initiating antiretroviral treatment between 2004 and 2009 at 2107 clinics. HIVDR prevention is associated with patient care (appropriate prescribing and patient monitoring), patient behavior (adherence), and clinic/program management efforts to reduce treatment interruptions (follow up, retention on first-line ART, procurement and supply management of antiretroviral drugs). EWIs measure these factors and the results have been used to optimize patient and population treatment outcomes.

White Paper Report of the 2011 RAD-AID Conference on International Radiology for Developing Countries: Integrating Multidisciplinary Strategies for Imaging Services in the Developing World

PubMed Central

Mazal, Jonathan; Lexa, Frank; Starikovsky, Anna; Jimenez, Pablo; Jain, Sanjay; DeStigter, Kristen K.; Nathan, Robert; Krebs, Elizabeth; Noble, Vicki; Marks, William; Hirsh, Richard N.; Short, Brad; Sydnor, Ryan; Timmreck-Jackson, Emily; Lungren, Matthew P.; Maxfield, Charles; Azene, Ezana M.; Garra, Brian S.; Choi, Brian G.; Lewin, Jonathan S.; Mollura, Daniel J.

2016-01-01

The 2011 RAD-AID Conference on International Radiology for Developing Countries discussed data, experiences and models pertaining to radiology in the developing world, where widespread shortages of imaging services significantly reduce health care quality and increase health care disparity. This white paper from the 2011 RAD-AID Conference represents consensus advocacy of multidisciplinary strategies to improve planning, accessibility and quality of imaging services in the developing world. Conference presenters and participants discussed numerous solutions to imaging and healthcare disparities including: (1) economic development for radiology service planning, (2) public health mechanisms to address disease and prevention at the population and community levels, (3) comparative clinical models to implement various clinical and workflow strategies adapted to unique developing world community contexts, (4) education to improve training and optimize service quality, and (5) technology innovation to bring new technical capabilities to limited-resource regions. PMID:22748790

White paper report of the 2011 RAD-AID Conference on International Radiology for Developing Countries: integrating multidisciplinary strategies for imaging services in the developing world.

PubMed

Everton, Kathryn L; Mazal, Jonathan; Mollura, Daniel J

2012-07-01

The 2011 RAD-AID Conference on International Radiology for Developing Countries discussed data, experiences, and models pertaining to radiology in the developing world, where widespread shortages of imaging services significantly reduce health care quality and increase health care disparities. This white paper from the 2011 RAD-AID conference represents consensus advocacy of multidisciplinary strategies to improve the planning, accessibility, and quality of imaging services in the developing world. Conference presenters and participants discussed numerous solutions to imaging and health care disparities, including (1) economic development for radiologic service planning, (2) public health mechanisms to address disease and prevention at the population and community levels, (3) comparative clinical models to implement various clinical and workflow strategies adapted to unique developing world community contexts, (4) education to improve training and optimize service quality, and (5) technology innovation to bring new technical capabilities to limited-resource regions. Published by Elsevier Inc.

Prevalence of arthritis in India and Pakistan: a review.

PubMed

Akhter, Ehtisham; Bilal, Saira; Kiani, Adnan; Haque, Uzma

2011-07-01

Recent studies of rheumatoid arthritis worldwide suggest that prevalence of arthritis is higher in Europe and North America than in developing countries. Prevalence data for major arthritis disorders have been compiled in West for several decades, but figures from the third world are just emerging. A coordinated effort by WHO and ILAR (International League Against Rheumatism) has resulted in collecting data for countries like Philippines, China, Malaysia, Indonesia, and rural South Africa but the information about prevalence of arthritis in India and Pakistan is scarce. Since both countries, i.e., India and Pakistan, share some ethnic identity, we reviewed published literature to examine the prevalence of arthritis in these countries. Medline and Pubmed were searched for suitable articles about arthritis from 1980 and onwards. Findings from these articles were reviewed and summarized. The prevalence, clinical features, and laboratory findings of rheumatoid arthritis are compiled for both India and Pakistan. Data collected from these two countries were compared with each other, and some of the characteristics of the disease were compared with Europe and North America. It is found to be quite similar to developed countries. Additionally, juvenile rheumatoid arthritis is of different variety than reported in West. It is more of polyarticular onset type while in West pauciarticular predominates. Additionally, in systemic onset, JRA uveitis and ANA are common finding in developed countries; on the other hand, they are hardly seen in this region. Although the prevalence of arthritis in Pakistan and India is similar to Western countries, there are inherent differences (clinical features, laboratory findings) in the presentation of disease. The major strength of the study is that it is the first to pool reports to provide an estimate of the disease in the Indian subcontinent. Scarcity of data is one of the major limitations. This study helps to understand the pattern of disease in this part of country that can be stepping-stone for policy makers to draft policies that can affect target population more appropriately.

Can context justify an ethical double standard for clinical research in developing countries?

PubMed Central

Landes, Megan

2005-01-01

Background The design of clinical research deserves special caution so as to safeguard the rights of participating individuals. While the international community has agreed on ethical standards for the design of research, these frameworks still remain open to interpretation, revision and debate. Recently a breach in the consensus of how to apply these ethical standards to research in developing countries has occurred, notably beginning with the 1994 placebo-controlled trials to reduce maternal to child transmission of HIV-1 in Africa, Asia and the Caribbean. The design of these trials sparked intense debate with the inclusion of a placebo-control group despite the existence of a 'gold standard' and trial supporters grounded their justifications of the trial design on the context of scarcity in resource-poor settings. Discussion These 'contextual' apologetics are arguably an ethical loophole inherent in current bioethical methodology. However, this convenient appropriation of 'contextual' analysis simply fails to acknowledge the underpinnings of feminist ethical analysis upon which it must stand. A more rigorous analysis of the political, social, and economic structures pertaining to the global context of developing countries reveals that the bioethical principles of beneficence and justice fail to be met in this trial design. Conclusion Within this broader, and theoretically necessary, understanding of context, it becomes impossible to justify an ethical double standard for research in developing countries. PMID:16045801

Usefulness of Chinese Herbal Medicines as Host-Directed Therapeutics against Mycobacterial Infections: A Review.

PubMed

Tomioka, Haruaki

2017-01-01

The high incidence of tuberculosis (TB) in developing countries, the resurgence of TB in industrialized countries, and the worldwide increase in the prevalence of Mycobacterium avium complex infections have prompted the quest for new antimycobacterial drugs. However, the development of such chemotherapeutics is currently making very slow progress. It therefore appears that devising improved administration protocols for clinical treatment against intractable mycobacteriosis using existing chemotherapeutics is more practical than awaiting the development of novel antimycobacterial drugs. The modulation of host immune responses using immunoadjunctive agents may increase the efficacy of antimicrobial treatment against mycobacteriosis. Particularly, the mild and long-term up-regulation of host immune reactions against mycobacterial pathogens using Chinese herbal medicines (CHMs) may be beneficial for immunoadjunctive therapy. This review focuses on the current status and future prospects regarding the development of CHMs that can be useful for the clinical control of intractable mycobacterial infections.

Advancing Migrant Access to Health Services in Europe (AMASE): Protocol for a Cross-sectional Study.

PubMed

Fakoya, Ibidun; Álvarez-Del Arco, Débora; Monge, Susana; Copas, Andrew J; Gennotte, Anne-Francoise; Volny-Anne, Alain; Göpel, Siri; Touloumi, Giota; Prins, Maria; Barros, Henrique; Staehelin, Cornelia; Del Amo, Julia; Burns, Fiona M

2016-05-16

Migrants form a substantial proportion of the population affected by the human immunodeficiency virus (HIV) epidemic in Europe, yet HIV prevention for this population is hindered by poor understanding of access to care and of postmigration transmission dynamics. We present the design and methods of the advancing Migrant Access to health Services in Europe (aMASE) study, the first European cross-cultural study focused on multiple migrant populations. It aims to identify the structural, cultural, and financial barriers to HIV prevention, diagnosis, and treatment and to determine the likely country of HIV acquisition in HIV-positive migrant populations. We delivered 2 cross-sectional electronic surveys across 10 countries (Belgium, France, Germany, Greece, Italy, the Netherlands, Portugal, Spain, Switzerland, and United Kingdom). A clinic survey aimed to recruit up to 2000 HIV-positive patients from 57 HIV clinics in 9 countries. A unique study number linked anonymized questionnaire data to clinical records data (viral loads, CD4 cell counts, viral clades, etc). This questionnaire was developed by expert panel consensus and cognitively tested, and a pilot study was carried out in 2 countries. A Web-based community survey (n=1000) reached those living with HIV but not currently accessing HIV clinics, as well as HIV-negative migrants. It was developed in close collaboration with a community advisory group (CAG) made up of representatives from community organizations in 9 of the participating countries. The CAG played a key role in data collection by promoting the survey to higher-risk migrant groups (sub-Saharan Africans, Latin Americans, men who have sex with men, and people who inject drugs). The questionnaires have considerable content overlap, allowing for comparison. Questions cover ethnicity, migration, immigration status, HIV testing and treatment, health-seeking behavior, sexual risk, and drug use. The electronic questionnaires, which were available in 15 languages, allowed for complex routing, preventing respondents from answering irrelevant questions. In total, we recruited 2249 participants from 57 HIV clinics as part of the clinic survey and retrieved 1637 complete responses as part of the community survey. The findings will provide much-needed information for improving HIV prevention interventions and access to services for migrant communities.

World health dilemmas: Orphan and rare diseases, orphan drugs and orphan patients

PubMed Central

Kontoghiorghe, Christina N; Andreou, Nicholas; Constantinou, Katerina; Kontoghiorghes, George J

2014-01-01

According to global annual estimates hunger/malnutrition is the major cause of death (36 of 62 million). Cardiovascular diseases and cancer (5.44 of 13.43 million) are the major causes of death in developed countries, while lower respiratory tract infections, human immunodeficiency virus infection/acquired immunodeficiency syndrome, diarrhoeal disease, malaria and tuberculosis (10.88 of 27.12 million) are the major causes of death in developing countries with more than 70% of deaths occurring in children. The majority of approximately 800 million people with other rare diseases, including 100000 children born with thalassaemia annually receive no treatment. There are major ethical dilemmas in dealing with global health issues such as poverty and the treatment of orphan and rare diseases. Of approximately 50000 drugs about 10% are orphan drugs, with annual sales of the latter approaching 100 billion USD. In comparison, the annual revenue in 2009 from the top 12 pharmaceutical companies in Western countries was 445 billion USD and the top drug, atorvastatin, reached 100 billion USD. In the same year, the total government expenditure for health in the developing countries was 410 billion USD with only 6%-7% having been received as aid from developed countries. Drugs cost the National Health Service in the United Kingdom more than 20 billion USD or 10% of the annual health budget. Uncontrollable drug prices and marketing policies affect global health budgets, clinical practice, patient safety and survival. Fines of 5.3 billion USD were imposed on two pharmaceutical companies in the United States, the regulatory authority in France was replaced and clinicians were charged with bribery in order to overcome recent illegal practises affecting patient care. High expenditure for drug development is mainly related to marketing costs. However, only 2 million USD was spent developing the drug deferiprone (L1) for thalassaemia up to the stage of multicentre clinical trials. The criteria for drug development, price levels and use needs to be readdressed to improve drug safety and minimise costs. New global health policies based on cheaper drugs can help the treatment of many categories of orphan and rare diseases and millions of orphan patients in developing and developed countries. PMID:25332915

World health dilemmas: Orphan and rare diseases, orphan drugs and orphan patients.

PubMed

Kontoghiorghe, Christina N; Andreou, Nicholas; Constantinou, Katerina; Kontoghiorghes, George J

2014-09-26

According to global annual estimates hunger/malnutrition is the major cause of death (36 of 62 million). Cardiovascular diseases and cancer (5.44 of 13.43 million) are the major causes of death in developed countries, while lower respiratory tract infections, human immunodeficiency virus infection/acquired immunodeficiency syndrome, diarrhoeal disease, malaria and tuberculosis (10.88 of 27.12 million) are the major causes of death in developing countries with more than 70% of deaths occurring in children. The majority of approximately 800 million people with other rare diseases, including 100000 children born with thalassaemia annually receive no treatment. There are major ethical dilemmas in dealing with global health issues such as poverty and the treatment of orphan and rare diseases. Of approximately 50000 drugs about 10% are orphan drugs, with annual sales of the latter approaching 100 billion USD. In comparison, the annual revenue in 2009 from the top 12 pharmaceutical companies in Western countries was 445 billion USD and the top drug, atorvastatin, reached 100 billion USD. In the same year, the total government expenditure for health in the developing countries was 410 billion USD with only 6%-7% having been received as aid from developed countries. Drugs cost the National Health Service in the United Kingdom more than 20 billion USD or 10% of the annual health budget. Uncontrollable drug prices and marketing policies affect global health budgets, clinical practice, patient safety and survival. Fines of 5.3 billion USD were imposed on two pharmaceutical companies in the United States, the regulatory authority in France was replaced and clinicians were charged with bribery in order to overcome recent illegal practises affecting patient care. High expenditure for drug development is mainly related to marketing costs. However, only 2 million USD was spent developing the drug deferiprone (L1) for thalassaemia up to the stage of multicentre clinical trials. The criteria for drug development, price levels and use needs to be readdressed to improve drug safety and minimise costs. New global health policies based on cheaper drugs can help the treatment of many categories of orphan and rare diseases and millions of orphan patients in developing and developed countries.

Drugs, money and society (Part II).

PubMed

Walley, Tom

2010-09-01

Pharmacoeconomics started as marketing but has developed into a valuable tool in the fuller assessment of drug therapies. Its principles are now widely accepted, and many countries have government-funded agencies with responsibility for its application, most notably the National Institute for Health and Clinical Excellence in England. Many clinical pharmacologists are active in this area, and the discipline itself is part of the clinical pharmacology trainees' curriculum. Further developments will include value-based pricing and its use in cost sharing arrangements between health service and manufacturers.

Regional variation in identified cancer care needs of early-career oncologists in China, India, and Pakistan.

PubMed

Lyerly, H Kim; Fawzy, Maria R; Aziz, Zeba; Nair, Reena; Pramesh, C S; Parmar, Vani; Parikh, Purvish M; Jamal, Rozmin; Irumnaz, Azizunissa; Ren, Jun; Stockler, Martin R; Abernethy, Amy P

2015-05-01

Cancer incidence and mortality is increasing in the developing world. Inequities between low-, middle-, and high-income countries affect disease burden and the infrastructure needs in response to cancer. We surveyed early-career oncologists attending workshops in clinical research in three countries with emerging economies about their perception of the evolving cancer burden. A cross-sectional survey questionnaire was distributed at clinical trial concept development workshops held in Beijing, Lahore, Karachi, and Mumbai at major hospitals to acquire information regarding home-country health conditions and needs. A total of 100 respondents participated in the workshops held at major hospitals in the region (India = 29, China = 25, Pakistan = 42, and other = 4). Expected consensus on many issues (e.g., emergence of cancer as a significant health issue) was balanced with significant variation in priorities, opportunities, and challenges. Chinese respondents prioritized improvements in cancer-specific care and palliative care, Indian respondents favored improved cancer detection and advancing research in cancer care, and Pakistani respondents prioritized awareness of cancer and improvements in disease detection and cancer care research. For all, the most frequently cited opportunity was help in improving professional cancer education and training. Predominantly early-career oncologists attending clinical research workshops (in China, India, and Pakistan) identified needs for increasing clinical cancer research, professional education, and public awareness of cancer. Decision makers supporting efforts to reduce the burden of cancer worldwide will need to factor the specific needs and aspirations of health care providers in their country in prioritizing health policies and budgets. ©AlphaMed Press.

Globalization of psychology: Implications for the development of psychology in Ethiopia.

PubMed

Swancott, Rachel; Uppal, Gobinderjit; Crossley, Jon

2014-10-01

The present article reports on the variation of mental health resources across the globe and considers the merits or otherwise of the process of globalization in low- and middle-income countries (LMIC), with a specific emphasis on Ethiopia. Although globalization has gained momentum in recent years, there is a concern that the globalization of Western mental health frameworks is problematic, as these concepts have been developed in a different context and do not accommodate the current diversity in understanding in LMIC countries. The importance of understanding the mental health frameworks of LMIC like Ethiopia, prior to considering if and how aspects of high-income countries (HIC) conceptualizations may be appropriately imported, is therefore reflected upon. Traditional approaches in managing mental health difficulties and possible reasons for the limited engagement with clinical psychology in Ethiopia are considered. Current developments within the fields of mental health and clinical psychology in Ethiopia are discussed, and the need to develop more local research in order to increase understanding and evaluate treatment interventions is recognized. Further consideration and debate by Ethiopian mental health professionals as well as those from HIC are recommended, to promote both reciprocal learning and new local discourses about mental health.

[Clinical ethics committees in Mexico: their development in the Mexican Institute of Social Security].

PubMed

Valdez-Martínez, Edith; Bedolla, Miguel

2007-01-01

The Mexican Institute of Social Security (IMSS) considers the relevance of ethics in a similar context than other countries have developed. According to these considerations, IMSS implemented formally of system of local committees on clinical ethics (CLEC), not only to provide support when ethical dilemmas emerge, but to facilitate the development of an ethics culture among health professionals. The implementation of the CLEC network started in 2004, and since then, its number has increased across the country. Currently IMSS has 78 CLECs. Their number continues to grow due to the level of awareness about the importance of ethics for making medical decisions. In November 2006 the first CLEC national meeting was held and the need to redefine strategies to improve performance of CLECS emerged. This article reports the current situation of the CLECs in Mexico.

Impact of Human Development Index on the profile and outcomes of patients with acute coronary syndrome.

PubMed

Roy, Ambuj; Roe, Matthew T; Neely, Megan L; Cyr, Derek D; Zamoryakhin, Dmitry; Fox, Keith A A; White, Harvey D; Armstrong, Paul W; Ohman, E Magnus; Prabhakaran, Dorairaj

2015-02-01

To study the impact of national economic and human development status on patient profiles and outcomes in the setting of acute coronary syndrome (ACS). We conducted a retrospective analysis of the Targeted Platelet Inhibition to Clarify the Optimal Strategy to Medically Manage Acute Coronary Syndromes trial (TRILOGY ACS) population (51 countries; 9301 patients). Outcome measures compared baseline characteristics and clinical outcomes through 30 months by 2010 country-level United Nations Human Development Indices (HDIs) and per-capita gross national income. TRILOGY ACS enrolled 3659 patients from 27 very-high HDI countries, 3744 from 18 high-HDI countries and 1898 from 6 medium-HDI countries. Baseline characteristics of groups varied significantly, with the medium-HDI group having a lower mean age (63.0 years, vs 65.0 and 68.0 years for high-HDI and very-high HDI, respectively; p<0.001), lower baseline Global Registry of Acute Coronary Events risk score and lower rate of non-ST-segment elevation myocardial infarction (58.0%, vs 62.2% and 83.9% among high-HDI and very-high HDI, respectively). Medium-HDI and high-HDI patients had lower unadjusted 30-month rates for the composite of cardiovascular death/myocardial infarction/stroke (17.6%, 16.9% and 23.1% for medium-HDI, high-HDI and very-high HDI, respectively); this difference disappeared after adjusting for baseline characteristics. Adjusted HRs for the composite endpoint were lower in lower-income/middle-income countries vs upper-income/middle-income (0.791(95% CI 0.632 to 0.990)) and high-income countries (0.756 (95% CI 0.616 to 0.928)), with differences largely attributable to myocardial infarction rates. Clinical patient profiles differed substantially by country HDI groupings. Lower unadjusted event rates in medium-HDI countries may be explained by younger age and lower comorbidity burden among these countries' patients. This heterogeneity in patient recruitment across country HDI groupings may have important implications for future global ACS trial design. NCT00699998. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

Geographic differences in clinical characteristics and management of COPD: the EPOCA study

PubMed Central

Miravitlles, Marc; Murio, Cristina; Tirado-Conde, Gema; Levy, Gur; Muellerova, Hana; Soriano, Joan B; Ramirez-Venegas, Alejandra; Ko, Fanny WS; Canelos-Estrella, Byron; Giugno, Eduardo; Bergna, Miguel; Chérrez, Ivan; Anzueto, Antonio

2008-01-01

Aims Data on differences in clinical characteristics and management of COPD in different countries and settings are limited. We aimed to characterize the profile of patients with COPD in a number of countries and their treatment in order to evaluate adherence to recommendations of international guidelines. Method This was an observational, international, cross-sectional study on patients with physician-diagnosed COPD. Demographic and clinical characteristics, risk factors, and treatment were collected by their physician via an internet web-based questionnaire developed for the study. Results A total of 77 investigators from 17 countries provided data on 833 patients. The countries with the highest number of patients included were: Argentina (128), Ecuador (134), Spain (162), and Hong Kong (153). Overall, 79.3% were men and 81% former smokers, with a mean FEV1 = 42.7%, ranging from 34.3% in Hong Kong to 58.8% in Ecuador. Patients reported a mean of 1.6 exacerbations the previous year, with this frequency being significantly and negatively correlated with FEV1(%) (r = −0.256; p < 0.0001). Treatment with short-acting bronchodilators and theophyllines was more frequent in Ecuador and Hong Kong compared with Spain and Argentina, and in patients belonging to lower socioeconomic levels (p < 0.0001 for all comparisons). Inadequacy of treatment with inhaled corticosteroids and theophyllines was high, with significant differences among countries. Conclusions Differences in the clinical characteristics and management of COPD were significant across countries. Adherence to international guidelines appears to be low. Efforts should be made to disseminate and adapt guidelines to the socioeconomic reality of different settings. PMID:19281096

Potential use of NOACs in developing countries: pros and cons.

PubMed

Bista, Durga; Chalmers, Leanne; Bereznicki, Luke; Peterson, Gregory

2014-07-01

Although vitamin K antagonists (VKAs) are effective for long-term thromboprophylaxis in atrial fibrillation (AF), their limitations have led to widespread underutilisation, especially in the developing world. Novel oral anticoagulants (NOACs) have emerged as promising alternatives to VKAs, although there are some particular considerations and challenges to their introduction in developing countries. This review summarises the current state of antithrombotic management of AF in the developing world, explores the early evidence for the NOACs and describes some of the special considerations that must be taken into account when considering the role of the NOACs within developing countries' health care systems. A literature search was conducted via PubMed and Google Scholar to find articles published in English between the years 2000 to 2014. Search terms used were "atrial fibrillation", "oral anticoagulants", "warfarin", "NOACs", "dabigatran", "rivaroxaban", "apixaban", "edoxaban", "time in therapeutic range", "International Normalized Ratio" "cost-effectiveness", "stroke", "adverse-drug reactions" and "drug-drug interactions", together with the individual names of developing countries as listed by the World Bank. We reviewed the results of randomized clinical trials, relevant retrospective and prospective studies, case-studies and review articles. Many developing countries lack or have sporadic data on the quality of AF management, making it difficult to anticipate the potential impact of NOACs in these settings. The utilisation of anticoagulants for AF appears highly variable in developing countries. Given the issues associated with VKA therapy in many developing countries, NOACs offer some potential advantages; however, there is insufficient evidence to advocate the widespread replacement of warfarin at present. VKAs may continue to have a role in selected patients or countries, especially if alternative monitoring strategies can be utilised. The evaluation of the introduction of NOACs should consider safety, budget concerns and the quality of oral anticoagulation care achieved by each country. Prospective registries will be important in developing countries to better elucidate the comparative safety, efficacy and cost-effectiveness of NOACs and VKAs as NOACs are introduced into practice.

Caring for patients with rabies in developing countries - the neglected importance of palliative care.

PubMed

Tarantola, Arnaud; Crabol, Yoann; Mahendra, Bangalore Jayakrishnappa; In, Sotheary; Barennes, Hubert; Bourhy, Hervé; Peng, Yiksing; Ly, Sowath; Buchy, Philippe

2016-04-01

Although limited publications address clinical management of symptomatic patients with rabies in intensive care units, the overwhelming majority of human rabies cases occur in the rural setting of developing countries where healthcare workers are few, lack training and drugs. Based on our experience, we suggest how clinicians in resource-limited settings can make best use of essential drugs to provide assistance to patients with rabies and their families, at no risk to themselves. Comprehensive and compassionate patient management of furious rabies should aim to alleviate thirst, anxiety and epileptic fits using infusions, diazepam or midazolam and antipyretic drugs via intravenous or intrarectal routes. Although the patient is dying, respiratory failure must be avoided especially if the family, after being informed, wish to take the patient home alive for funereal rites to be observed. Healthcare staff should be trained and clinical guidelines should be updated to include palliative care for rabies in endemic countries. © 2016 John Wiley & Sons Ltd.

How Other Countries Use Deprivation Indices-And Why The United States Desperately Needs One.

PubMed

Phillips, Robert L; Liaw, Winston; Crampton, Peter; Exeter, Daniel J; Bazemore, Andrew; Vickery, Katherine Diaz; Petterson, Stephen; Carrozza, Mark

2016-11-01

Integrating public health and medicine to address social determinants of health is essential to achieving the Triple Aim of lower costs, improved care, and population health. There is intense interest in the United States in using social determinants of health to direct clinical and community health interventions, and to adjust quality measures and payments. The United Kingdom and New Zealand use data representing aspects of material and social deprivation from their censuses or from administrative data sets to construct indices designed to measure socioeconomic variation across communities, assess community needs, inform research, adjust clinical funding, allocate community resources, and determine policy impact. Indices provide these countries with comparable data and serve as a universal language and tool set to define organizing principles for population health. In this article we examine how these countries develop, validate, and operationalize their indices; explore their use in policy; and propose the development of a similar deprivation index for the United States. Project HOPE—The People-to-People Health Foundation, Inc.

The importance of Evolutionary Medicine in developing countries: A case for Pakistan's medical schools.

PubMed

Enam, Syed Faaiz; Hashmi, Shumaila

2018-01-01

Evolutionary Medicine (EM) is a fundamental science exploring why our bodies are plagued with disease and hindered by limitations. EM views the body as an assortment of benefits, mistakes, and compromises molded over millennia. It highlights the role of evolution in numerous diseases encountered in community and family medicine clinics of developing countries. It enables us to ask informed questions and develop novel responses to global health problems. An understanding of the field is thus crucial for budding doctors, but its study is currently limited to a handful of medical schools in high-income countries. For the developing world, Pakistan's medical schools may be excellent starting posts as the country is beset with communicable and non-communicable diseases that are shaped by evolution. Remarkably, Pakistani medical students are open to studying and incorporating EM into their training. Understanding the principles of EM could empower them to tackle growing health problems in the country. Additionally, some difficulties that western medical schools face in integrating EM into their curriculum may not be a hindrance in Pakistan. We propose solutions for the remaining challenges, including obstinate religious sentiments. Herein, we make the case that incorporating EM is particularly important in developing countries such as Pakistan and that it is achievable in its medical student body.

The importance of Evolutionary Medicine in developing countries

PubMed Central

Hashmi, Shumaila

2018-01-01

Abstract Evolutionary Medicine (EM) is a fundamental science exploring why our bodies are plagued with disease and hindered by limitations. EM views the body as an assortment of benefits, mistakes, and compromises molded over millennia. It highlights the role of evolution in numerous diseases encountered in community and family medicine clinics of developing countries. It enables us to ask informed questions and develop novel responses to global health problems. An understanding of the field is thus crucial for budding doctors, but its study is currently limited to a handful of medical schools in high-income countries. For the developing world, Pakistan's medical schools may be excellent starting posts as the country is beset with communicable and non-communicable diseases that are shaped by evolution. Remarkably, Pakistani medical students are open to studying and incorporating EM into their training. Understanding the principles of EM could empower them to tackle growing health problems in the country. Additionally, some difficulties that western medical schools face in integrating EM into their curriculum may not be a hindrance in Pakistan. We propose solutions for the remaining challenges, including obstinate religious sentiments. Herein, we make the case that incorporating EM is particularly important in developing countries such as Pakistan and that it is achievable in its medical student body. PMID:29492264

[Strategy Development for International Cooperation in the Clinical Laboratory Field].

PubMed

Kudo, Yoshiko; Osawa, Susumu

2015-10-01

The strategy of international cooperation in the clinical laboratory field was analyzed to improve the quality of intervention by reviewing documents from international organizations and the Japanese government. Based on the world development agenda, the target of action for health has shifted from communicable diseases to non-communicable diseases (NCD). This emphasizes the importance of comprehensive clinical laboratories instead of disease-specific examinations in developing countries. To achieve this goal, the World Health Organization (WHO) has disseminated to the African and Asian regions the Laboratory Quality Management System (LQMS), which is based on the same principles of the International Organization of Standardization (ISO) 15189. To execute this strategy, international experts must have competence in project management, analyze information regarding the target country, and develop a strategy for management of the LQMS with an understanding of the technical aspects of laboratory work. However, there is no appropriate pre- and post-educational system of international health for Japanese international workers. Universities and academic organizations should cooperate with the government to establish a system of education for international workers. Objectives of this education system must include: (1) training for the organization and understanding of global health issues, (2) education of the principles regarding comprehensive management of clinical laboratories, and (3) understanding the LQMS which was employed based on WHO's initiative. Achievement of these objectives will help improve the quality of international cooperation in the clinical laboratory field.

Using flash cards to engage Indonesian nursing students in reflection on their practice.

PubMed

Wanda, Dessie; Fowler, Cathrine; Wilson, Valerie

2016-03-01

Reflective practice is now widely used as a critical learning tool in undergraduate and postgraduate nursing programs in most developed countries. However in developing countries, reflective practice is in its infancy. To introduce reflective practice to postgraduate students in an Indonesian nursing education institution. This paper presents the positive meanings of reflection and reflective practice experienced by the students and the way they used reflection within their practice. A descriptive qualitative study was conducted to explore the meaning of reflection or reflective practice using flashcards. A clinical reflective practice model taking into consideration Indonesian culture was developed and applied during students' clinical placement. A few weeks post clinical placement, 21 students participated in an evaluation session. The meaning of reflection or reflective practice was explored using flash cards containing images of people and environment with different situations and events. Students were asked to choose a card that represented their viewpoints about reflective practice and share it with the group. Data were digitally captured and analyzed using thematic analysis. Reflection provided a positive experience for the students. In their own words, they discussed their journey of using reflection during the clinical placement period. The use of reflection was identified as expanding their view of nursing practice, providing a safe place to explore their experiences and clarity when they encountered challenging situations during their clinical practice. Reflecting on practice experiences resulted in increased self-awareness, and enhanced their learning. The findings indicate that reflective practice can be implemented successfully in Indonesia and may have value for other Eastern countries that share similar cultural characteristics. The use of flash cards assisted the students describe through stories their experiences of participating in this reflective practice program. Copyright © 2015 Elsevier Ltd. All rights reserved.

Establishing a harmonized haemophilia registry for countries with developing health care systems.

PubMed

Alzoebie, A; Belhani, M; Eshghi, P; Kupesiz, A O; Ozelo, M; Pompa, M T; Potgieter, J; Smith, M

2013-09-01

Over recent decades tremendous progress has been made in diagnosing and treating haemophilia and, in resource-rich countries, life expectancy of people with haemophilia (PWH) is now close to that of a healthy person. However, an estimated 70% of PWH are not diagnosed or are undertreated; the majority of whom live in countries with developing health care systems. In these countries, designated registries for people with haemophilia are often limited and comprehensive information on the natural history of the disease and treatment outcomes is lacking. Taken together, this means that planning efforts for future treatment and care of affected individuals is constrained in countries where it is most needed. Establishment of standardized national registries in these countries would be a step towards obtaining reliable sociodemographic and clinical data for an entire country. A series of consensus meetings with experts from widely differing countries with different health care systems took place to discuss concerns specific to countries with developing health care systems. As a result of these discussions, recommendations are made on parameters to include when establishing and harmonizing national registries. Such recommendations should enable countries with developing health care systems to establish standardized national haemophilia registries. Although not a primary objective, the recommendations should also help standardized data collation on an international level, enabling treatment and health care trends to be monitored across groups of countries and providing data for advocacy purposes. Greater standardization of data collation should have implications for optimizing resources for haemophilia care both nationally and internationally. © 2013 John Wiley & Sons Ltd.

World Workshop on Oral Medicine VI: an international validation study of clinical competencies for advanced training in oral medicine.

PubMed

Steele, John C; Clark, Hadleigh J; Hong, Catherine H L; Jurge, Sabine; Muthukrishnan, Arvind; Kerr, A Ross; Wray, David; Prescott-Clements, Linda; Felix, David H; Sollecito, Thomas P

2015-08-01

To explore international consensus for the validation of clinical competencies for advanced training in Oral Medicine. An electronic survey of clinical competencies was designed. The survey was sent to and completed by identified international stakeholders during a 10-week period. To be validated, an individual competency had to achieve 90% or greater consensus to keep it in its current format. Stakeholders from 31 countries responded. High consensus agreement was achieved with 93 of 101 (92%) competencies exceeding the benchmark for agreement. Only 8 warranted further attention and were reviewed by a focus group. No additional competencies were suggested. This is the first international validated study of clinical competencies for advanced training in Oral Medicine. These validated clinical competencies could provide a model for countries developing an advanced training curriculum for Oral Medicine and also inform review of existing curricula. Copyright © 2015 Elsevier Inc. All rights reserved.

Readiness of ethics review systems for a changing public health landscape in the WHO African Region.

PubMed

Motari, Marion; Ota, Martin Okechukwu; Kirigia, Joses Muthuri

2015-12-02

The increasing emphasis on research, development and innovation for health in providing solutions to the high burden of diseases in the African Region has warranted a proliferation of studies including clinical trials. This changing public health landscape requires that countries develop adequate ethics review capacities to protect and minimize risks to study participants. Therefore, this study assessed the readiness of national ethics committees to respond to challenges posed by a globalized biomedical research system which is constantly challenged by new public health threats, rapid scientific and technological advancements affecting biomedical research and development, delivery and manufacture of vaccines and therapies, and health technology transfer. This is a descriptive study, which used a questionnaire structured to elicit information on the existence of relevant national legal frameworks, mechanisms for ethical review; as well as capacity requirements for national ethics committees. The questionnaire was available in English and French and was sent to 41 of the then 46 Member States of the WHO African Region, excluding the five Lusophone Member States. Information was gathered from senior officials in ministries of health, who by virtue of their offices were considered to have expert knowledge of research ethics review systems in their respective countries. Thirty three of the 41 countries (80.5 %) responded. Thirty (90.9 %) of respondent countries had a national ethics review committee (NEC); 79 % of which were established by law. Twenty-five (83.3 %) NECs had secretarial and administrative support. Over 50 % of countries with NECs indicated a need for capacity strengthening through periodic training on international guidelines for health research (including clinical trials) ethics; and allocation of funds for administrative and secretariat support. Despite the existing training initiatives, the Region still experiences a shortage of professionals trained in health research ethics/ethicists. Committees continue to face various capacity needs especially for evaluating clinical trials, for monitoring ongoing research, database management and for accrediting institutional ethics committees. Given the growing number of clinical trials involving human participants in the African Region, there is urgent need for supporting countries without NECs to establish them; capacity strengthening where they exist; and creation of a regional network and joint ethical review mechanisms, whose membership would be open to all NECs of the Region.

The validity and clinical utility of the Disabilities of the Arm Shoulder and Hand questionnaire for hand injuries in developing country contexts: A systematic review.

PubMed

de Klerk, Susan; Buchanan, Helen; Jerosch-Herold, Christina

Systematic review. The Disabilities of the Arm Shoulder and Hand Questionnaire has multiple language versions from many countries around the world. In addition there is extensive research evidence of its psychometric properties. The purpose of this study was to systematically review the evidence available on the validity and clinical utility of the Disabilities of the Arm Shoulder and Hand as a measure of activity and participation in patients with musculoskeletal hand injuries in developing country contexts. We registered the review with international prospective register of systematic reviews prior to conducting a comprehensive literature search and extracting descriptive data. Two reviewers independently assessed methodological quality with the Consensus-Based Standards for the Selection of Health Measurement Instruments critical appraisal tool, the checklist to operationalize measurement characteristics of patient-rated outcome measures and the multidimensional model of clinical utility. Fourteen studies reporting 12 language versions met the eligibility criteria. Two language versions (Persian and Turkish) had an overall rating of good, and one (Thai) had an overall rating of excellent for cross-cultural validity. The remaining 9 language versions had an overall poor rating for cross-cultural validity. Content and construct validity and clinical utility yielded similar results. Poor quality ratings for validity and clinical utility were due to insufficient documentation of results and inadequate psychometric testing. With the increase in migration and globalization, hand therapists are likely to require a range of culturally adapted and translated versions of the Disabilities of the Arm Shoulder and Hand. Recommendations include rigorous application and reporting of cross-cultural adaptation, appropriate psychometric testing, and testing of clinical utility in routine clinical practice. Copyright © 2017 Hanley & Belfus. Published by Elsevier Inc. All rights reserved.

Clinical Practice Guidelines for the Antibiotic Treatment of Community-Acquired Urinary Tract Infections

PubMed Central

Ha, U-Syn; Lee, Seung-Ju; Yeo, Jeong Kyun; Min, Seung Ki; Lee, Heeyoung

2018-01-01

Urinary tract infections (UTIs) are infectious diseases that commonly occur in communities. Although several international guidelines for the management of UTIs have been available, clinical characteristics, etiology and antimicrobial susceptibility patterns may differ from country to country. This work represents an update of the 2011 Korean guideline for UTIs. The current guideline was developed by the update and adaptation method. This clinical practice guideline provides recommendations for the diagnosis and management of UTIs, including asymptomatic bacteriuria, acute uncomplicated cystitis, acute uncomplicated pyelonephritis, complicated pyelonephritis related to urinary tract obstruction, and acute bacterial prostatitis. This guideline targets community-acquired UTIs occurring among adult patients. Healthcare-associated UTIs, catheter-associated UTIs, and infections in immunocompromised patients were not included in this guideline. PMID:29637759

Pediatric Sepsis Guidelines: Summary for resource-limited countries

PubMed Central

Khilnani, Praveen; Singhi, Sunit; Lodha, Rakesh; Santhanam, Indumathi; Sachdev, Anil; Chugh, Krishan; Jaishree, M.; Ranjit, Suchitra; Ramachandran, Bala; Ali, Uma; Udani, Soonu; Uttam, Rajiv; Deopujari, Satish

2010-01-01

Justification: Pediatric sepsis is a commonly encountered global issue. Existing guidelines for sepsis seem to be applicable to the developed countries, and only few articles are published regarding application of these guidelines in the developing countries, especially in resource-limited countries such as India and Africa. Process: An expert representative panel drawn from all over India, under aegis of Intensive Care Chapter of Indian Academy of Pediatrics (IAP) met to discuss and draw guidelines for clinical practice and feasibility of delivery of care in the early hours in pediatric patient with sepsis, keeping in view unique patient population and limited availability of equipment and resources. Discussion included issues such as sepsis definitions, rapid cardiopulmonary assessment, feasibility of early aggressive fluid therapy, inotropic support, corticosteriod therapy, early endotracheal intubation and use of positive end expiratory pressure/mechanical ventilation, initial empirical antibiotic therapy, glycemic control, and role of immunoglobulin, blood, and blood products. Objective: To achieve a reasonable evidence-based consensus on the basis of published literature and expert opinion to formulating clinical practice guidelines applicable to resource-limited countries such as India. Recommendations: Pediatric sepsis guidelines are presented in text and flow chart format keeping resource limitations in mind for countries such as India and Africa. Levels of evidence are indicated wherever applicable. It is anticipated that once the guidelines are used and outcomes data evaluated, further modifications will be necessary. It is planned to periodically review and revise these guidelines every 3–5 years as new body of evidence accumulates. PMID:20606908

Dengue Contingency Planning: From Research to Policy and Practice.

PubMed

Runge-Ranzinger, Silvia; Kroeger, Axel; Olliaro, Piero; McCall, Philip J; Sánchez Tejeda, Gustavo; Lloyd, Linda S; Hakim, Lokman; Bowman, Leigh R; Horstick, Olaf; Coelho, Giovanini

2016-09-01

Dengue is an increasingly incident disease across many parts of the world. In response, an evidence-based handbook to translate research into policy and practice was developed. This handbook facilitates contingency planning as well as the development and use of early warning and response systems for dengue fever epidemics, by identifying decision-making processes that contribute to the success or failure of dengue surveillance, as well as triggers that initiate effective responses to incipient outbreaks. Available evidence was evaluated using a step-wise process that included systematic literature reviews, policymaker and stakeholder interviews, a study to assess dengue contingency planning and outbreak management in 10 countries, and a retrospective logistic regression analysis to identify alarm signals for an outbreak warning system using datasets from five dengue endemic countries. Best practices for managing a dengue outbreak are provided for key elements of a dengue contingency plan including timely contingency planning, the importance of a detailed, context-specific dengue contingency plan that clearly distinguishes between routine and outbreak interventions, surveillance systems for outbreak preparedness, outbreak definitions, alert algorithms, managerial capacity, vector control capacity, and clinical management of large caseloads. Additionally, a computer-assisted early warning system, which enables countries to identify and respond to context-specific variables that predict forthcoming dengue outbreaks, has been developed. Most countries do not have comprehensive, detailed contingency plans for dengue outbreaks. Countries tend to rely on intensified vector control as their outbreak response, with minimal focus on integrated management of clinical care, epidemiological, laboratory and vector surveillance, and risk communication. The Technical Handbook for Surveillance, Dengue Outbreak Prediction/ Detection and Outbreak Response seeks to provide countries with evidence-based best practices to justify the declaration of an outbreak and the mobilization of the resources required to implement an effective dengue contingency plan.

‘Research clinics’: online journal clubs between south and north for student mentoring

PubMed Central

Atkins, Salla; Varshney, Dinansha; Meragia, Elnta; Zwarenstein, Merrick; Diwan, Vishal

2016-01-01

Background Capacity development in health research is high on the agenda of many low- and middle-income countries. Objective The ARCADE projects, funded by the EU, have been working in Africa and Asia since 2011 in order to build postgraduate students’ health research capacity. In this short communication, we describe one initiative in these projects, that of research clinics – online journal clubs connecting southern and northern students and experts. Design We describe the implementation of these research clinics together with student and participant experiences. Results From 2012 to 2015, a total of seven journal clubs were presented by students and junior researchers on topics related to global health. Sessions were connected through web conferencing, connecting experts and students from different countries. Conclusions The research clinics succeeded in engaging young researchers across the globe and connecting them with global experts. The contacts and suggestions made were appreciated by students. This format has potential to contribute toward research capacity building in low- and middle-income countries. PMID:27725079

Application of Raman spectroscopy for cervical dysplasia diagnosis

PubMed Central

Kanter, Elizabeth M.; Vargis, Elizabeth; Majumder, Shovan; Keller, Matthew D.; Woeste, Emily; Rao, Gautam G.; Mahadevan-Jansen, Anita

2014-01-01

Cervical cancer is the second most common malignancy among women worldwide, with over 490000 cases diagnosed and 274000 deaths each year. Although current screening methods have dramatically reduced cervical cancer incidence and mortality in developed countries, a “See and Treat” method would be preferred, especially in developing countries. Results from our previous work have suggested that Raman spectroscopy can be used to detect cervical precancers; however, with a classification accuracy of 88%, it was not clinically applicable. In this paper, we describe how incorporating a woman's hormonal status, particularly the point in menstrual cycle and menopausal state, into our previously developed classification algorithm improves the accuracy of our method to 94%. The results of this paper bring Raman spectroscopy one step closer to being utilized in a clinical setting to diagnose cervical dysplasia. Posterior probabilities of class membership, as determined by MRDF-SMLR, for patients regardless of menopausal status, and for pre-menopausal patients only PMID:19343687

Sharing the Benefits of Research Fairly: Two Approaches

PubMed Central

Millum, Joseph

2016-01-01

Research projects sponsored by rich countries or companies and carried out in developing countries are frequently described as exploitative. One important debate about the prevention of exploitation in research centers on whether and how clinical research in developing countries should be responsive to local health problems. This paper analyses the responsiveness debate and draws out more general lessons for how policy makers can prevent exploitation in various research contexts. There are two independent ways to do this in the face of entrenched power differences: to impose restrictions on the content of benefit-sharing arrangements, and to institute independent effective oversight. Which method should be chosen is highly dependent on context. PMID:21947808

China Biobanking.

PubMed

Zhang, Yong; Li, Qiyuan; Wang, Xian; Zhou, Xiaolin

2015-01-01

Biobanks are playing increasingly important roles in clinical and translational research nowadays. China, as a country with the largest population and abundant clinical resources, attaches great importance to the development of biobanks. In recent years, with the increasing support from the Chinese government, biobanks are blooming across the country. This paper provides a detailed overview of China biobanking, which is further divided in the following four parts: (i) general introduction of the number, category and distribution of current biobanks; (ii) summarization of the current development status, and issues that Chinese biobanks are faced with; (iii) international cooperation between China and the global biobanking community; (iv) prospect of the modern twenty-first century Chinese biobanks, which would achieve standardized operation, systematic specimen management, and extensive collaboration, and thus provide support for the robust research discoveries and personalized medicine etc.

Biopharmaceutical innovation and industrial developments in South Korea, Singapore and Taiwan.

PubMed

Hsieh, Chee-Ruey; Löfgren, Hans

2009-05-01

South Korea, Singapore and Taiwan are well known as export-oriented developmental states which for decades employed industrial policy to target particular industries for government support. In the past fifteen years, these three countries all identified the biopharmaceutical industry as a strategic sector. This article explores, through economic analysis, the rationale for this decision and the strategies chosen for linking into the global bio-economy with the objective of catching up in biopharmaceuticals. The paper identifies three comparative advantages enjoyed by these countries in the biopharma sector: (1) public investments in basic research; (2) private investments in phase 1 clinical trials; and (3) a potentially significant contract research industry managing latter-stage clinical trials. Governments employ a range of industrial policies, consistent with these comparative advantages, to promote the biopharmaceutical industry, including public investment in biomedical hubs, research funding and research and development (R&D) tax credits. We argue that the most important feature of the biopharmaceutical industry in these countries is the dominant role of the public sector. That these countries have made progress in innovative capabilities is illustrated by input measures such as R&D expenditure as share of gross domestic product, number of patents granted and clinical trials, and volume of foreign direct investment. In contrast, output indicators such as approval of new chemical entities suggest that the process of catching up has only just commenced. Pharmaceutical innovation is at the stage of mainly generating inputs to integrated processes controlled by the globally incumbent firms.

An overview of Korean patients with mucopolysaccharidosis and collaboration through the Asia Pacific MPS Network.

PubMed

Cho, Sung Yoon; Sohn, Young Bae; Jin, Dong-Kyu

2014-08-01

Mucopolysaccharidosis (MPS) is a constellation of disorders characterized by the accumulation of mucopolysaccharides in tissues and organs. This accumulation results in the deterioration and degeneration of multiple organs. This paper describes the general distribution of types of MPS in patients, their clinical characteristics and genotypes, the development of animal studies and preclinical studies, enzyme replacement therapy in South Korea, and the development of idursulfase beta and clinical trials on idursulfase beta in South Korea. In addition, this paper discusses academic collaboration among specialists in MPS care in the Asia-Pacific region, which includes Japan, Taiwan, Malaysia, and South Korea, through an organization called the Asia-Pacific MPS Network (APMN). The Asia-Pacific MPS Registry, an electronic remote data entry system, has been developed by key doctors in the APMN. Rare diseases require international cooperation and collaboration to elucidate their mechanisms and carry out clinical trials; therefore, an organization such as the APMN is required. Furthermore, international collaboration among Asian countries and countries around the world will be of utmost importance in the future.

An overview of Korean patients with mucopolysaccharidosis and collaboration through the Asia Pacific MPS Network

PubMed Central

Cho, Sung Yoon; Sohn, Young Bae; Jin, Dong-Kyu

2014-01-01

Summary Mucopolysaccharidosis (MPS) is a constellation of disorders characterized by the accumulation of mucopolysaccharides in tissues and organs. This accumulation results in the deterioration and degeneration of multiple organs. This paper describes the general distribution of types of MPS in patients, their clinical characteristics and genotypes, the development of animal studies and preclinical studies, enzyme replacement therapy in South Korea, and the development of idursulfase beta and clinical trials on idursulfase beta in South Korea. In addition, this paper discusses academic collaboration among specialists in MPS care in the Asia-Pacific region, which includes Japan, Taiwan, Malaysia, and South Korea, through an organization called the Asia-Pacific MPS Network (APMN). The Asia-Pacific MPS Registry, an electronic remote data entry system, has been developed by key doctors in the APMN. Rare diseases require international cooperation and collaboration to elucidate their mechanisms and carry out clinical trials; therefore, an organization such as the APMN is required. Furthermore, international collaboration among Asian countries and countries around the world will be of utmost importance in the future. PMID:25364648

Toxoplasmosis--a global threat. Correlation of latent toxoplasmosis with specific disease burden in a set of 88 countries.

PubMed

Flegr, Jaroslav; Prandota, Joseph; Sovičková, Michaela; Israili, Zafar H

2014-01-01

Toxoplasmosis is becoming a global health hazard as it infects 30-50% of the world human population. Clinically, the life-long presence of the parasite in tissues of a majority of infected individuals is usually considered asymptomatic. However, a number of studies show that this 'asymptomatic infection' may also lead to development of other human pathologies. The purpose of the study was to collect available geoepidemiological data on seroprevalence of toxoplasmosis and search for its relationship with mortality and disability rates in different countries. Prevalence data published between 1995-2008 for women in child-bearing age were collected for 88 countries (29 European). The association between prevalence of toxoplasmosis and specific disease burden estimated with age-standardized Disability Adjusted Life Year (DALY) or with mortality, was calculated using General Linear Method with Gross Domestic Product per capita (GDP), geolatitude and humidity as covariates, and also using nonparametric partial Kendall correlation test with GDP as a covariate. The prevalence of toxoplasmosis correlated with specific disease burden in particular countries explaining 23% of variability in disease burden in Europe. The analyses revealed that for example, DALY of 23 of 128 analyzed diseases and disease categories on the WHO list showed correlations (18 positive, 5 negative) with prevalence of toxoplasmosis and another 12 diseases showed positive trends (p<0.1). For several obtained significant correlations between the seroprevalence of toxoplasmosis and specific diseases/clinical entities, possible pathophysiological, biochemical and molecular explanations are presented. The seroprevalence of toxoplasmosis correlated with various disease burden. Statistical associations does not necessarily mean causality. The precautionary principle suggests however that possible role of toxoplasmosis as a triggering factor responsible for development of several clinical entities deserves much more attention and financial support both in everyday medical practice and future clinical research.

Clinical trials for drug registrations in Asian-Pacific countries: proposal for a new paradigm from a statistical perspective.

PubMed

Shih, W J

2001-08-01

The world has become more interdependent in the movement of free trade and global markets. The regulations for approval of new drugs in the Asian markets have always been an important issue in the free trade negotiation between the U.S.- and E.U.-based international manufacturers and the Asian-Pacific countries, since pharmaceuticals are of large trade value for them. In 1998 the University of Hong Kong and the Singapore National Medical Research Council jointly hosted the first Asian Clinical Trials Conference. The Society for Clinical Trials was invited as a collaborator for the event, which signified a milestone for interaction between the East and West in the discussion of clinical trials. Many have participated in the discussion of drug approval and registration issues for the Asian region based on the drug development experience in the United States. However, there are many interesting differences between the two regions, which lead to different approval processes for new drugs developed by the U.S.- and E.U.-based international manufacturers. This article highlights some regulatory dilemmas and some key statistical concepts pertinent to these differences. The purpose of this paper is to resolve the regional regulatory and scientific dilemma. A new paradigm of sample size design and data analysis for drug approval for countries in the Asian-Pacific region is proposed. The central premise is that substantial information from multicenter studies has already shown efficacy in the United States or the European Union when a drug manufacturer seeks marketing approval in an Asian country. This leads to the idea of a "consistency trial" using the method of Bayesian most plausible prediction. The method is illustrated with an example.

Enhancing the African bioethics initiative.

PubMed

Ogundiran, Temidayo O

2004-10-15

Medical ethics has existed since the time of Hippocrates. However, formal training in bioethics did not become established until a few decades ago. Bioethics has gained a strong foothold in health sciences in the developed world, especially in Europe and North America. The situation is quite different in many developing countries. In most African countries, bioethics - as established and practiced today in the west- is either non-existent or is rudimentary. Though bioethics has come of age in the developed and some developing countries, it is still largely "foreign" to most African countries. In some parts of Africa, some bioethics conferences have been held in the past decade to create research ethics awareness and ensure conformity to international guidelines for research with human participants. This idea has arisen in recognition of the genuine need to develop capacity for reviewing the ethics of research in Africa. It is also a condition required by external sponsors of collaborative research in Africa. The awareness and interest that these conferences have aroused need to be further strengthened and extended beyond research ethics to clinical practice. By and large, bioethics education in schools that train doctors and other health care providers is the hook that anchors both research ethics and clinical ethics. This communication reviews the current situation of bioethics in Africa as it applies to research ethics workshops and proposes that in spite of the present efforts to integrate ethics into biomedical research in Africa, much still needs to be done to accomplish this. A more comprehensive approach to bioethics with an all-inclusive benefit is to incorporate formal ethics education into health training institutions in Africa.

Staphylococcus aureus disease and drug resistance in resource-limited countries in south and east Asia.

PubMed

Nickerson, Emma K; West, T Eoin; Day, Nicholas P; Peacock, Sharon J

2009-02-01

By contrast with high-income countries, Staphylococcus aureus disease ranks low on the public-health agenda in low-income countries. We undertook a literature review of S aureus disease in resource-limited countries in south and east Asia, and found that its neglected status as a developing world pathogen does not equate with low rates of disease. The incidence of the disease seems to be highest in neonates, its range of clinical manifestations is as broad as that seen in other settings, and the mortality rate associated with serious S aureus infection, such as bacteraemia, is as high as 50%. The prevalence of meticillin-resistant S aureus (MRSA) infection across much of resource-limited Asia is largely unknown. Antibiotic drugs are readily and widely available from pharmacists in most parts of Asia, where ease of purchase and frequent self-medication are likely to be major drivers in the emergence of drug resistance. In our global culture, the epidemiology of important drug-resistant pathogens in resource-limited countries is inextricably linked with the health of both developing and developed communities. An initiative is needed to raise the profile of S aureus disease in developing countries, and to define a programme of research to find practical solutions to the health-care challenges posed by this important global pathogen.

Therapeutic Ultrasound Research And Development From An Industrial And Commercial Perspective

NASA Astrophysics Data System (ADS)

Seip, Ralf

2009-04-01

The objective of this paper is to share the challenges and opportunities as viewed from an industrial and commercial perspective that one encounters when performing therapeutic ultrasound research, development, manufacturing, and sales activities. Research in therapeutic ultrasound has become an active field in the last decade, spurred by technological advances in the areas of transducer materials, control electronics, treatment monitoring techniques, an ever increasing number of clinical applications, and private and governmental funding opportunities. The development of devices and methods utilizing therapeutic ultrasound to cure or manage disease is being pursued by startup companies and large established companies alike, driven by the promise of profiting at many levels from this new and disruptive technology. Widespread penetration within the clinical community remains elusive, with current approaches focusing on very specific applications and niche markets. Challenges include difficulties in securing capital to develop the technology and undertake costly clinical trials, a regulatory landscape that varies from country to country, resistance from established practitioners, and difficulties in assembling a team with the right mix of technological savvy and business expertise. Success is possible and increasing, however, as evidenced by several companies, initiatives, and products with measurable benefits to the patient, clinician, and companies alike.

Escherichia coli O157:H7 in Ecuador: animal reservoirs, yet no human disease.

PubMed

Trueba, Gabriel; Garcés, Verónica; V, Verónica Barragan; Colman, Rebecca E; Seymour, Meagan; Vogler, Amy J; Keim, Paul

2013-05-01

Escherichia coli O157:H7 is frequently isolated from cases of diarrhea in many industrialized countries; however, it is seldom found in developing countries. The present manuscript reports the presence of E. coli O157:H7 in Ecuadorian livestock, a country where enterohemorrhagic E. coli disease in humans has never been reported. The Ecuadorian isolates were genetically related to some strains linked to clinical cases in the United States as assessed by multiple-locus variable number tandem repeat (VNTR) analysis.

Current and future trends in the prevention, treatment and control of rabies.

PubMed

Rupprecht, Charles E; Willoughby, Rodney; Slate, Dennis

2006-12-01

Rabies remains a global zoonosis of major public health, agricultural and economic significance. Dogs are the major animal reservoirs in developing regions, wildlife maintain cycles of infection even in developed countries and new viral etiological agents continue to emerge. Nearly all human rabies cases are related directly to animal bite and thus, primary disease prevention requires minimization of suspected exposures. Once exposure occurs, modern prophylaxis entails immediate wound care, local infiltration of rabies immune globulin and parenteral administration of modern cell culture vaccines in multiple doses. Pre-exposure vaccination should occur in selected population groups at risk of occupational exposure. Historically, survival from fatal rabies by at least five human patients, vaccinated prior to the onset of clinical signs, signaled initial optimism as to the theoretical utility of medical intervention. Recently, the heroic recovery of an unvaccinated teenager from clinical rabies offers hope of future specific therapy. Canine rabies elimination is the key towards ultimate reduction of the disease burden, as first illustrated in developed countries. Implementation of oral vaccination in free-ranging carnivore hosts demonstrates the feasibility of disease abatement in particular wildlife populations, such as demonstrated in Europe and North America, with an enhanced need for application to developing countries in the Americas, Africa and Eurasia.

Surgery in the Horn of Africa: a 1-year experience of an American-sponsored surgical residency in Eritrea.

PubMed

Khambaty, Fatima M; Ayas, Huda M; Mezghebe, Haile M

2010-08-01

To describe the 1-year experience of a unique postgraduate medical education program set in Eritrea, a recently war-torn country. The Partnership for Eritrea, a cooperative between The George Washington University Medical Center, Physicians for Peace, and the Eritrean Ministry of Health, formed a surgical residency program, launched January 2, 2008, in Asmara, Eritrea, to train native Eritrean surgeons. No prior residency program (to our knowledge) had existed in Eritrea. Eritrea, a country in the Horn of Africa. Five Eritrean physicians participated in the surgical residency. The number of operations performed, length of stay, antibiotic use, and intravenous fluid use. The number of operations increased and resource use decreased because of improved and standardized clinical management. The Partnership for Eritrea established a general surgical residency program that improved clinical care in a resource-poor country that previously had lacked postgraduate training. The program experience suggests a model that can be reproduced in other developing countries.

Stem cell research in pakistan; past, present and future.

PubMed

Zahra, Sayeda Anum; Muzavir, Sayed Raheel; Ashraf, Sadia; Ahmad, Aftab

2015-05-01

Stem cells have proved to have great therapeutic potential as stem cell treatment is replacing traditional ways of treatment in different disorders like cancer, aplastic anemia, stroke, heart disorders. The developed and developing countries are investing differently in this area of research so research output and clinical translation of research greatly vary among developed and developing countries. Present study was done to investigate the current status of stem cells research in Pakistan and ways to improve it. Many advanced countries (USA, UK and Canada etc.) are investing heavily in stem cell research and treatment. Different developing countries like Iran, Turkey and India are also following the developed countries and investing a lot in stem cells research. Pakistan is also making efforts in establishing this field to get desired benefits but unfortunately the progress is at very low pace. If Government plays an active role along with private sector, stem cell research in Pakistan can be boosted up. The numbers of publications from Pakistan are very less compared to developed and neighboring countries and Pakistan also has very less number of institutes working in this area of research. Stem cells research is at its initial stages in Pakistan and there is great need to bring Government, academia and industry together so they could make serious efforts to promote research in this very important field. This will help millions of patients suffering from incurable disorders and will also reduce economic loss.

Trends in authorship based on gender and nationality in published neuroscience literature.

PubMed

Dubey, Divyanshu; Sawhney, Anshudha; Atluru, Aparna; Amritphale, Amod; Dubey, Archana; Trivedi, Jaya

2016-01-01

To evaluate the disparity in authorship based on gender and nationality of institutional affiliation among journals from developed and developing countries. Original articles from two neuroscience journals, with a 5 year impact factor >15 (Neuron and Nature Neuroscience) and from two neurology journals from a developing country (Neurology India and Annals of Indian Academy of Neurology) were categorized by gender and institutional affiliation of first and senior authors. Articles were further divided by the type of research (basic/translational/clinical), study/target population (adult/pediatrics/both) and field of neurology. Data was collected for the years 2002 and 2012. There are large disparities in authorship by women and from developing countries in high impact factor neuroscience journals. However, there was a non-statistical rise in female first and senior authorship over a 10 year period. Additionally there was a significant increase in first authorship from institutions based in developing countries in the two neuroscience journals examined (P < 0.05). In the two neurology journals based in India there was a significant increase in the number of articles published by international investigators between 2002 and 2012 (P < 0.05). Over the last decade, there has been a non-statistical increase in proportion of female first and senior authors, and a significant increase in authors from developing countries in high impact factor neuroscience journals. However they continue to constitute a minority. The disparity in authorship based on gender also exists in neurology journals based in a developing country (India).

Resolving legal, ethical, and human rights challenges in HIV vaccine research.

PubMed

Patterson, D

2000-01-01

In the absence of a cure for AIDS, attention has turned to the possibility of developing a preventive vaccine for HIV infection. Yet many scientific, ethical, legal, and economic obstacles remain. At the current rate, the development and production of an effective vaccine could take 15 to 20 years or longer. If tens of millions more HIV infections and deaths are to be avoided in the coming decades, vaccine research needs to be greatly expedited. Furthermore, it must be undertaken ethically, and the products of this research must benefit people in developing countries. This article, an edited and updated version of a paper presented at "Putting Third First," addresses challenges arising in HIV preventive vaccine research in developing countries. It does not address clinical research in developing countries relating to treatments or therapeutic vaccines. Nor does it address legal and ethical issues relating to HIV vaccine research in industrialized countries, although similar issues arise in both contexts. The article concludes that while ethical codes are silent on the obligation to undertake research and development, international law provides strong legal obligations--particularly with regard to industrialized states--that should be invoked to accelerate HIV vaccine development, and distribution.

Treatment outcomes for Hodgkin lymphoma: First report from the Brazilian Prospective Registry.

PubMed

Biasoli, Irene; Castro, Nelson; Delamain, Marcia; Silveira, Talita; Farley, James; Simões, Belinda Pinto; Solza, Cristiana; Praxedes, Monica; Baiocchi, Otávio; Gaiolla, Rafael; Franceschi, Fernanda; Sola, Caroline Bonamin; Boquimpani, Carla; Clementino, Nelma; Perini, Guilherme; Pagnano, Kátia; Steffenello, Giovanna; Tabacof, Jacques; de Freitas Colli, Gilberto; Soares, Andrea; de Souza, Carmino; Chiattone, Carlos Sérgio; Milito, Cristiane; Morais, José Carlos; Spector, Nelson

2018-02-01

Data about Hodgkin lymphoma (HL) in developing countries are scarce and suggest the existence of substantial disparities in healthcare and outcomes in large areas of the world. In 2009, a prospective registry of HL was implemented in Brazil. Web-based data were contributed by 20 institutions across the country participating in the Brazilian Prospective Hodgkin's Lymphoma Registry. The aim of this study was to present the clinical features and outcomes of newly diagnosed patients with HL aged 13 to 90 years. Multivariate Cox regression models were used to estimate progression-free (PFS) and overall survival (OS) by clinical factors. A total of 674 patients with classical HL were analysed, with a median follow-up of 37 months. Median age was 30 years (13-90). The median time from the onset of symptoms to diagnosis was 6 months (0-60). Only 6% of patients had early favourable disease, while 65% had advanced disease. Stage IVB was present in 26% and a high-risk International Prognostic Score in 38%. Doxorubicin, bleomycin, vinblastine, and dacarbazine was used in 93%. The median dose of radiotherapy was 36 Gy for localized disease and 32 Gy for advanced disease. The 3 year PFS in early favourable, early unfavourable, and advanced disease were 95%, 88%, and 66%, respectively. High-risk International Prognostic Score, advanced disease, and age greater than or equal to 60 were independently associated with poorer PFS and OS; performance status greater than or equal to 2 was also associated with a poorer OS. Poor-risk patients predominated. Radiation doses for localized disease appear higher than current recommendations. Outcomes appear inferior in developing countries than in developed countries. Delayed diagnosis is probably a major factor underlying these findings. Scattered reports from developing nations suggest that many aspects of standard care in developed countries remain unmet needs for populations living in developing countries. The present report contributes to this body of data, with a proper description of what is currently achieved in urban areas in Brazil. Copyright © 2017 John Wiley & Sons, Ltd.

[Introduction of vaccination against human papillomavirus in developing countries: update and perspectives].

PubMed

Hessel, L

2009-08-01

Cervical cancer and other diseases related to human papillomavirus (HPV) represent a global public health problem. Safe and effective vaccines are now available and already used in many industrialized countries. Immunization offers the best hope for protecting the population against a disease that is the second most deadly cancer in the developing world and the first most deadly in Africa. The World Health Organization currently recommends introduction of HVP vaccination in developing countries. Widespread vaccination could be beneficial in numerous domains other than primary prevention of cervical cancer. Efforts to overcome the numerous obstacles and speed up implementation of HVP vaccination programs are now underway in many areas ranging from related scientific issues such as epidemiology and clinical research to administrative concerns such as healthcare economics, vaccination guidelines, public acceptation, program funding, and universal access. Vaccine manufacturers have committed themselves to working in partnership with national and international organizations to ensure access to HPV vaccine for all countries regardless of economic level, Although numerous issues must be resolved to optimize the use of HPV vaccines and ensure synergistic integration of vaccination, screening and treatment, current initiatives and efforts should allow introduction of HPV vaccination in developing countries in a not too distant future.

A matched pair cluster randomized implementation trail to measure the effectiveness of an intervention package aiming to decrease perinatal mortality and increase institution-based obstetric care among indigenous women in Guatemala: study protocol.

PubMed

Kestler, Edgar; Walker, Dilys; Bonvecchio, Anabelle; de Tejada, Sandra Sáenz; Donner, Allan

2013-03-21

Maternal and perinatal mortality continue to be a high priority problem on the health agendas of less developed countries. Despite the progress made in the last decade to quantify the magnitude of maternal mortality, few interventions have been implemented with the intent to measure impact directly on maternal or perinatal deaths. The success of interventions implemented in less developed countries to reduce mortality has been questioned, in terms of the tendency to maintain a clinical perspective with a focus on purely medical care separate from community-based approaches that take cultural and social aspects of maternal and perinatal deaths into account. Our innovative approach utilizes both the clinical and community perspectives; moreover, our study will report the weight that each of these components may have had on reducing perinatal mortality and increasing institution-based deliveries. A matched pair cluster-randomized trial will be conducted in clinics in four rural indigenous districts with the highest maternal mortality ratios in Guatemala. The individual clinic will serve as the unit of randomization, with 15 matched pairs of control and intervention clinics composing the final sample. Three interventions will be implemented in indigenous, rural and poor populations: a simulation training program for emergency obstetric and perinatal care, increased participation of the professional midwife in strengthening the link between traditional birth attendants (TBA) and the formal health care system, and a social marketing campaign to promote institution-based deliveries. No external intervention is planned for control clinics, although enhanced monitoring, surveillance and data collection will occur throughout the study in all clinics throughout the four districts. All obstetric events occurring in any of the participating health facilities and districts during the 18 months implementation period will be included in the analysis, controlling for the cluster design. Our main outcome measures will be the change in perinatal mortality and in the proportion of institution-based deliveries. A unique feature of this protocol is that we are not proposing an individual intervention, but rather a package of interventions, which is designed to address the complexities and realities of maternal and perinatal mortality in developing countries. To date, many other countries, has focused its efforts to decrease maternal mortality indirectly by improving infrastructure and data collection systems rather than on implementing specific interventions to directly improve outcomes. ClinicalTrial.gov,http://NCT01653626.

A matched pair cluster randomized implementation trail to measure the effectiveness of an intervention package aiming to decrease perinatal mortality and increase institution-based obstetric care among indigenous women in Guatemala: study protocol

PubMed Central

2013-01-01

Background Maternal and perinatal mortality continue to be a high priority problem on the health agendas of less developed countries. Despite the progress made in the last decade to quantify the magnitude of maternal mortality, few interventions have been implemented with the intent to measure impact directly on maternal or perinatal deaths. The success of interventions implemented in less developed countries to reduce mortality has been questioned, in terms of the tendency to maintain a clinical perspective with a focus on purely medical care separate from community-based approaches that take cultural and social aspects of maternal and perinatal deaths into account. Our innovative approach utilizes both the clinical and community perspectives; moreover, our study will report the weight that each of these components may have had on reducing perinatal mortality and increasing institution-based deliveries. Methods/Design A matched pair cluster-randomized trial will be conducted in clinics in four rural indigenous districts with the highest maternal mortality ratios in Guatemala. The individual clinic will serve as the unit of randomization, with 15 matched pairs of control and intervention clinics composing the final sample. Three interventions will be implemented in indigenous, rural and poor populations: a simulation training program for emergency obstetric and perinatal care, increased participation of the professional midwife in strengthening the link between traditional birth attendants (TBA) and the formal health care system, and a social marketing campaign to promote institution-based deliveries. No external intervention is planned for control clinics, although enhanced monitoring, surveillance and data collection will occur throughout the study in all clinics throughout the four districts. All obstetric events occurring in any of the participating health facilities and districts during the 18 months implementation period will be included in the analysis, controlling for the cluster design. Our main outcome measures will be the change in perinatal mortality and in the proportion of institution-based deliveries. Discussion A unique feature of this protocol is that we are not proposing an individual intervention, but rather a package of interventions, which is designed to address the complexities and realities of maternal and perinatal mortality in developing countries. To date, many other countries, has focused its efforts to decrease maternal mortality indirectly by improving infrastructure and data collection systems rather than on implementing specific interventions to directly improve outcomes. Trial registration ClinicalTrial.gov,http://NCT01653626. PMID:23517050

Economic efficiency of countries' clinical review processes and competitiveness on the market of human experimentation.

PubMed

Ippoliti, Roberto

2013-01-01

Clinical research is a specific phase of pharmaceutical industry's production process in which companies test candidate drugs on patients to collect clinical evidence about safety and effectiveness. Information is essential to obtain manufacturing authorization from the national drug agency and, in this way, make profits on the market. Considering this activity, however, the public stakeholder has to face a conflict of interests. On the one side, there is society's necessity to make advances in medicine and, of course, to promote pharmaceutical companies' investments in this specific phase (new generation). On the other side, there is the duty to protect patients involved in these experimental treatments (old generation). To abide by this moral duty, a protection system was developed through the years, based on two legal institutions: informed consent and institutional review board. How should an efficient protection system that would take human experimentation into account be shaped? Would it be possible for the national protection system of patients' rights to affect the choice of whether to develop a clinical trial in a given country or not? Looking at Europe and considering a protection system that is shaped around institutional review boards, this article is an empirical work that tries to give answers to these open questions. It shows how a protection system that can minimize the time necessary to start a trial can positively affect pharmaceutical clinical research, that is, the choice of pharmaceutical companies to start innovative medical treatments in a given country. Copyright © 2013 International Society for Pharmacoeconomics and Outcomes Research (ISPOR). Published by Elsevier Inc. All rights reserved.

Challenges in economic evaluation of new drugs: experience with rituximab in Hungary.

PubMed

Brodszky, Valentin; Orlewska, Ewa; Pentek, Martha; Karpati, Krisztian; Skoupa, Jana; Gulacsi, Laszlo

2010-01-01

Implementation of a new therapy into clinical practice is a complex process. Various countries have different requirements for information but most often focus on economic evaluation, which often plays a stronger role in healthcare decision making than does clinical evidence. To identify all potential challenges in economic evaluation, the case of a new biological drug, rituximab, used to treat rheumatoid arthritis, has been taken as an example. We present methods and results of economic assessment, highlighting the specific issues that should be considered in countries with economic and health care conditions similar to those of Hungary. In principle, economic evaluation requires data on characteristics of target population, disease progression, treatment impact, preferences, resource utilization and unit prices. Treatment effect/relative risk reduction and clinical practice patterns (resource use) may be more generalizable, whereas prices and baseline risk need to be jurisdiction specific. In order to address issues of transferability, investments need to be made in the collection of epidemiological and demographic data, plus data on clinical practice patterns, resource use, costs and health state valuation. In Hungary this problem has been solved through conducting a well designed 255 patient cross-sectional study. The Hungarian example shows that there should be more investment in data collection for those parameters that are thought to differ most from place to place. Owing to the similarities between Central and Eastern Europe countries in health care systems, clinical practice patterns and economic indicators, they may be able to develop partnerships to develop relevant regional databases and registries.

International Collaboration between US and Thailand on a Clinical Trial of Treatment for HIV-associated Cryptococcal Meningitis

PubMed Central

Zimmer, LO; Nolen, TL; Pramanpol, S; Wallace, D; Walker, ME; Pappas, P; Chetchotisakd, P

2010-01-01

Background International clinical trials can provide scientific and logistic benefits in spite of the many challenges. Determining whether a country, especially a developing country, is an appropriate location for the research should include in-country consultation and partnering to assess its social value for the population; that treatments are relevant for the population under study; and that the research infrastructure and ethical oversight are adequate. Collaboration increases the likelihood of study success and helps ensure that benefits accrue to recruited populations and their community. Purpose This paper describes our experiences on a bi-national study and may provide guidance for those planning to engage in future collaborations. Methods A Thai and United States team collaborated to develop and implement a Phase II clinical trial for HIV-associated cryptococcal meningitis to assess safety and tolerability of combination therapy versus standard treatment. Clinical and cultural differences, regulatory hurdles and operational issues were addressed before and during the study to ensure a successful collaboration between the 2 groups. Results The international multicenter study allowed for more rapid enrollment, reduced costs to complete the study, sharing of the benefits of research, greater generalizability of results and capacity building in Thailand; quality metrics in Thailand were equivalent to or better than those in the U.S. Conclusions Conducting successful clinical trials internationally requires early and ongoing collaboration to ensure the study meets sites’ requirements and expectations, conforms to varying national regulations, adheres to data quality standards and is responsive to the health needs of studied populations. PMID:19897055

Clinical pharmacists: The major support to Indian healthcare system in near future

PubMed Central

Deshpande, Prasanna R.; Vantipalli, Raghuram; Chaitanya Lakshmi, C. H.; Rao, E. Jagadeswara; Regmi, Bishnu; Ahad, Abdul; Nirojini, P. Sharmila

2015-01-01

Pharmacy practice is still in the initial stages of development in India, but launching of Doctor of Pharmacy (PharmD) study program has brought serious discussions about clinical pharmacy in the country. As the profession is in budding stage in the country, the patients, physicians, nurses, other healthcare providers, recruiters in pharmaceutical industries, prospective students, and their parents have numerous questions about this profession and study course. The objective of this article is to create awareness about clinical pharmacy services (CPS) and to introduce the role of clinical pharmacists (CPs). After reading this article, one will know about the usefulness of CPs in the Indian healthcare system against the current flaws in the system. The article describes the role of CPs in the hospitals, in research, in pharmaceutical/contract research companies, in community service and it also tells about the related myths and facts. Prospective job opportunities for CPs, present challenges and the possible solutions are elaborated as well. In conclusion, CPs are going to be the major support to the Indian healthcare system in near future; the reasons being (1) CPS are beneficial in many ways to improve healthcare; CPS have already proved their importance in western countries (2) India was never officially and efficiently exposed to CPS; so launching of CPS shall revolutionize the country's healthcare scenario. PMID:26229349

The SMile Card: a computerised data card for multiple sclerosis patients. SMile Card Scientific Board.

PubMed

Mancardi, G L; Uccelli, M M; Sonnati, M; Comi, G; Milanese, C; De Vincentiis, A; Battaglia, M A

2000-04-01

The SMile Card was developed as a means for computerising clinical information for the purpose of transferability, accessibility, standardisation and compilation of a national database of demographic and clinical information about multiple sclerosis (MS) patients. In many European countries, centres for MS are organised independently from one another making collaboration, consultation and patient referral complicated. Only the more highly advanced clinical centres, generally located in large urban areas, have had the possibility to utilise technical possibilities for improving the organisation of patient clinical and research information, although independently from other centres. The information system, developed utilising the Visual Basic language for Microsoft Windows 95, stores information via a 'smart card' in a database which is initiated and updated utilising a microprocessor, located at each neurological clinic. The SMile Card, currently being tested in Italy, permits patients to carry with them all relevant medical information without limitations. Neurologists are able to access and update, via the microprocessor, the patient's entire medical history and MS-related information, including the complete neurological examination and laboratory test results. The SMile Card provides MS patients and neurologists with a complete computerised archive of clinical information which is accessible throughout the country. In addition, data from the SMile Card system can be exported to other database programs.

Making stem cells count for global health.

PubMed

McMahon, Dominique S; Thorsteinsdóttir, Halla

2011-11-01

Developing countries such as China, India and Brazil are making large investments in the stem cell field. Here we argue that hands-on involvement in the field by these countries is essential if the products developed are going to be locally relevant, affordable and appropriate. However, stem cells are a high-risk investment and any global health impacts are still likely to be far off. Even if they are eventually successful, better clinical oversight and measures to ensure access are required for stem cells to have a substantial and equitable impact.

Dire need of changes in the methods for assessing university faculty productivity in developing countries.

PubMed

Sheikh, Ali Sibtain Farooq; Mohamed, Mona Adel

2015-01-01

Publishing has become a necessity for promotion of faculty in academia. The faculties in developing countries face considerable difficulties publishing due to their prime focus on clinical approaches and resources for proper research. This often leaves no room for the pressured clinicians but to pursue poor quality publications just for the sake of promotion when the time for their promotion comes. The authors suggest establishing separate promotion tracks besides research in these underprivileged areas in order to avoid infestation of original research with poor ones.

Policy and public health recommendations to promote the initiation and duration of breast-feeding in developed country settings.

PubMed

Dyson, Lisa; Renfrew, Mary J; McFadden, Alison; McCormick, Felicia; Herbert, Gill; Thomas, James

2010-01-01

To develop policy and public health recommendations for implementation at all levels by individuals and organisations working in, or related to, the field of breast-feeding promotion in developed country settings, where breast-feeding rates remain low. Two research phases, comprising (i) an assessment of the formal evidence base in developed country settings and (ii) a consultation with UK-based practitioners, service managers and commissioners, and representatives of service users. The evidence base included three systematic reviews and an Evidence Briefing. One hundred and ten studies evaluating an intervention in developed country settings were assessed for quality and awarded an overall quality rating. Studies with a poor quality rating were excluded. The resulting seventy studies examined twenty-five types of intervention for breast-feeding promotion. These formed the basis of the second consultation phase to develop the evidence-based interventions into recommendations for practice, which comprised (i) pilot consultation, (ii) electronic consultation, (iii) fieldwork meetings and (iv) workshops. Draft findings were synthesised for two rounds of stakeholder review conducted by the National Institute for Health and Clinical Excellence. Twenty-five recommendations emerged within three complementary and necessary categories, i.e. public health policy, mainstream clinical practice and local interventions. The need for national policy directives was clearly identified as a priority to address many of the barriers experienced by practitioners when trying to work across sectors, organisations and professional groups. Routine implementation of the WHO/UNICEF Baby Friendly Initiative across hospital and community services was recommended as core to breast-feeding promotion in the UK. A local mix of complementary interventions is also required.

Advancing Migrant Access to Health Services in Europe (AMASE): Protocol for a Cross-sectional Study

PubMed Central

Álvarez-del Arco, Débora; Monge, Susana; Copas, Andrew J; Gennotte, Anne-Francoise; Volny-Anne, Alain; Göpel, Siri; Touloumi, Giota; Prins, Maria; Barros, Henrique; Staehelin, Cornelia; del Amo, Julia; Burns, Fiona M

2016-01-01

Background Migrants form a substantial proportion of the population affected by the human immunodeficiency virus (HIV) epidemic in Europe, yet HIV prevention for this population is hindered by poor understanding of access to care and of postmigration transmission dynamics. Objective We present the design and methods of the advancing Migrant Access to health Services in Europe (aMASE) study, the first European cross-cultural study focused on multiple migrant populations. It aims to identify the structural, cultural, and financial barriers to HIV prevention, diagnosis, and treatment and to determine the likely country of HIV acquisition in HIV-positive migrant populations. Methods We delivered 2 cross-sectional electronic surveys across 10 countries (Belgium, France, Germany, Greece, Italy, the Netherlands, Portugal, Spain, Switzerland, and United Kingdom). A clinic survey aimed to recruit up to 2000 HIV-positive patients from 57 HIV clinics in 9 countries. A unique study number linked anonymized questionnaire data to clinical records data (viral loads, CD4 cell counts, viral clades, etc). This questionnaire was developed by expert panel consensus and cognitively tested, and a pilot study was carried out in 2 countries. A Web-based community survey (n=1000) reached those living with HIV but not currently accessing HIV clinics, as well as HIV-negative migrants. It was developed in close collaboration with a community advisory group (CAG) made up of representatives from community organizations in 9 of the participating countries. The CAG played a key role in data collection by promoting the survey to higher-risk migrant groups (sub-Saharan Africans, Latin Americans, men who have sex with men, and people who inject drugs). The questionnaires have considerable content overlap, allowing for comparison. Questions cover ethnicity, migration, immigration status, HIV testing and treatment, health-seeking behavior, sexual risk, and drug use. The electronic questionnaires, which were available in 15 languages, allowed for complex routing, preventing respondents from answering irrelevant questions. Results In total, we recruited 2249 participants from 57 HIV clinics as part of the clinic survey and retrieved 1637 complete responses as part of the community survey. Conclusions The findings will provide much-needed information for improving HIV prevention interventions and access to services for migrant communities. PMID:27185491

Corruption and research.

PubMed

Luna, Florencia

1999-07-01

Last year there was a heated debate regarding clinical trials with AZT carried out in developing countries. AIDS vaccine trials also posed various dilemmas and ethical problems. In this paper I will consider the possibility of corruption in bioethics, and international multi-centre research will be taken as an example. International clinical trials will be seen from another perspective. I will try to show that the possibility of systemic corruption should be considered when designing an international multi-centre research trial which may involve countries in very different situations regarding corruption. I will analyze three different approaches to this problem and suggest some strategies regarding their capacity to exclude the possibility of corruption.

Predictors of Desire to Institutionalization in Dementia Caregivers From a Developing Country.

PubMed

Sinha, Preeti; Yohannan, Sherin; Thirumoorthy, A; Sivakumar, Palanimuthu Thangaraju

2017-08-01

Older adults with dementia have higher rates of institutionalization than those without dementia. Desire to institutionalization (DTI) is an important factor influencing the actual institutionalization but is less well studied. This cross-sectional study examines the DTI with the scale of same name developed by Morycz, in 1985, in a sample of 50 caregivers of patients with dementia in a tertiary clinical care setting in a developing country. Caregiver burden associated with personal strain (by factor analyzed Zarit Burden Interview scale), and stress perceived out of caregiving (by Perceived Stress Scale) predicted higher DTI. Besides, those who were married had lower DTI scores. The factors which didn't affect DTI were total caregiver burden, family and social support, age of patient and caregiver, education of caregiver, severity and duration of dementia, and treatment duration. These results were different from those of developed country-based DTI studies and may indicate sociocultural differences.

Cross-cultural differences in health-related quality of life of people with epilepsy: findings from a European study.

PubMed

Buck, D; Jacoby, A; Baker, G A; Ley, H; Steen, N

1999-12-01

To examine between-country differences in health-related quality of life (HRQOL) of adults with epilepsy across a large number of European countries. Self-completion postal questionnaire sent to large sample of adults with epilepsy, recruited from epilepsy support groups or epilepsy outpatient clinics. The questionnaire was developed in English and translated. Back-translations from each language were checked for accuracy. The questionnaire sought information on clinical and socio-demographic details, and contained a number of previously validated scales of psychosocial well-being (the SF-36, the perceived impact of epilepsy scale, and a feelings of stigma scale). Controlling for socio-demographic and clinical characteristics, significant between-country differences were found in scores on the perceived impact of epilepsy scale, on seven of the eight SF-36 domains, and on the feelings of stigma scale. Respondents in Spain and the Netherlands fared consistently better, whilst those in France fared poorest, compared to those in other countries in terms of the various HRQOL measures used. Several possible reasons for the cross-cultural differences in HRQOL are proposed. Clearly, there is no single explanation and there may also be reasons which we have overlooked. This study emphasises the need for further comprehensive research in order that the position of people with epilepsy in different countries be more thoroughly understood in the social context.

A framework to link international clinical research to the promotion of justice in global health.

PubMed

Pratt, Bridget; Loff, Bebe

2014-10-01

How international research might contribute to justice in global health has not been substantively addressed by bioethics. Theories of justice from political philosophy establish obligations for parties from high-income countries owed to parties from low and middle-income countries. We have developed a new framework that is based on Jennifer Ruger's health capability paradigm to strengthen the link between international clinical research and justice in global health. The 'research for health justice' framework provides direction on three aspects of international clinical research: the research target, research capacity strengthening, and post-trial benefits. It identifies the obligations of justice owed by national governments, research funders, research sponsors, and investigators to trial participants and host communities. These obligations vary from those currently articulated in international research ethics guidelines. Ethical requirements of a different kind are needed if international clinical research is to advance global health equity. © 2012 John Wiley & Sons Ltd.

A Survey of the Current Situation of Clinical Biobanks in China.

PubMed

Li, Haiyan; Ni, Mingyu; Wang, Peng; Wang, Xiaomin

2017-06-01

The development of biomedical research urgently needs the support of a large number of high-quality clinical biospecimens. Therefore, human biobanks at different levels have been established successively in China and other countries at a significantly increasing pace in recent years. To better understand the general current state of clinical biobanks in China, we surveyed 42 clinical biobanks based in hospitals and collected information involving their management systems, sharing mechanisms, quality control systems, and informational management systems using closed questionnaire methods. Based on our current information, there has not been such a large-scale survey in China. An understanding of the status and challenges current clinical biobanks face will provide valuable insights for the construction and sustainable development of higher quality clinical biobanks.

WhatsApp in Stroke Systems: Current Use and Regulatory Concerns.

PubMed

Calleja-Castillo, Juan M; Gonzalez-Calderon, Gina

2018-01-01

Smartphone use is extremely common. Applications such as WhatsApp have billions of users and physicians are no exception. Stroke Medicine is a field where instant communication among fairly large groups is essential. In developing countries, economic limitations preclude the possibility of acquiring proper communication platforms. Thus, WhatsApp has been used as an organizational tool, for sharing clinical data, and for real time guidance of clinical care decisions. It has evolved into a cheap, accessible tool for telemedicine. Nevertheless, regulatory and privacy issues must be addressed. Some countries have implemented legislation to address this issue, while others lag behind. In this article, we present an overview on the different roles WhatsApp has acquired as a clinical tool in stroke systems and the potential privacy concerns of its use.

WhatsApp in Stroke Systems: Current Use and Regulatory Concerns

PubMed Central

Calleja-Castillo, Juan M.; Gonzalez-Calderon, Gina

2018-01-01

Smartphone use is extremely common. Applications such as WhatsApp have billions of users and physicians are no exception. Stroke Medicine is a field where instant communication among fairly large groups is essential. In developing countries, economic limitations preclude the possibility of acquiring proper communication platforms. Thus, WhatsApp has been used as an organizational tool, for sharing clinical data, and for real time guidance of clinical care decisions. It has evolved into a cheap, accessible tool for telemedicine. Nevertheless, regulatory and privacy issues must be addressed. Some countries have implemented legislation to address this issue, while others lag behind. In this article, we present an overview on the different roles WhatsApp has acquired as a clinical tool in stroke systems and the potential privacy concerns of its use. PMID:29904369

Cost structure and clinical outcome of a stem cell transplantation program in a developing country: the experience in northeast Mexico.

PubMed

Jaime-Pérez, José Carlos; Heredia-Salazar, Alberto Carlos; Cantú-Rodríguez, Olga G; Gutiérrez-Aguirre, Homero; Villarreal-Villarreal, César Daniel; Mancías-Guerra, Consuelo; Herrera-Garza, José Luís; Gómez-Almaguer, David

2015-04-01

Hematopoietic stem cell transplantation (HSCT) in developing countries is cost-limited. Our primary goal was to determine the cost structure for the HSCT program model developed over the last decade at our public university hospital and to assess its clinical outcomes. Adults and children receiving an allogeneic hematopoietic stem cell transplant from January 2010 to February 2011 at our hematology regional reference center were included. Laboratory tests, medical procedures, chemotherapy drugs, other drugs, and hospitalization costs were scrutinized to calculate the total cost for each patient and the median cost for the procedure. Data regarding clinical evolution were incorporated into the analysis. Physician fees are not charged at the institution and therefore were not included. Fifty patients were evaluated over a 1-year period. The total estimated cost for an allogeneic HSCT was $12,504. The two most expensive diseases to allograft were non-Hodgkin lymphoma ($11,760 ± $2,236) for the malignant group and thalassemia ($12,915 ± $5,170) for the nonmalignant group. Acute lymphoblastic leukemia ($11,053 ± 2,817) and acute myeloblastic leukemia ($10,251 ± $1,538) were the most frequent indications for HSCT, with 11 cases each. Median out-of-pocket expenses were $1,605, and 1-year follow-up costs amounted to $1,640, adding up to a total cost of $15,749 for the first year. The most expensive components were drugs and laboratory tests. Applying the cost structure described, HSCT is an affordable option for hematological patients living in a developing country. ©AlphaMed Press.

Responsible innovation in human germline gene editing: Background document to the recommendations of ESHG and ESHRE.

PubMed

De Wert, Guido; Heindryckx, Björn; Pennings, Guido; Clarke, Angus; Eichenlaub-Ritter, Ursula; van El, Carla G; Forzano, Francesca; Goddijn, Mariëtte; Howard, Heidi C; Radojkovic, Dragica; Rial-Sebbag, Emmanuelle; Dondorp, Wybo; Tarlatzis, Basil C; Cornel, Martina C

2018-04-01

Technological developments in gene editing raise high expectations for clinical applications, including editing of the germline. The European Society of Human Reproduction and Embryology (ESHRE) and the European Society of Human Genetics (ESHG) together developed a Background document and Recommendations to inform and stimulate ongoing societal debates. This document provides the background to the Recommendations. Germline gene editing is currently not allowed in many countries. This makes clinical applications in these countries impossible now, even if germline gene editing would become safe and effective. What were the arguments behind this legislation, and are they still convincing? If a technique could help to avoid serious genetic disorders, in a safe and effective way, would this be a reason to reconsider earlier standpoints? This Background document summarizes the scientific developments and expectations regarding germline gene editing, legal regulations at the European level, and ethics for three different settings (basic research, preclinical research and clinical applications). In ethical terms, we argue that the deontological objections (e.g., gene editing goes against nature) do not seem convincing while consequentialist objections (e.g., safety for the children thus conceived and following generations) require research, not all of which is allowed in the current legal situation in European countries. Development of this Background document and Recommendations reflects the responsibility to help society understand and debate the full range of possible implications of the new technologies, and to contribute to regulations that are adapted to the dynamics of the field while taking account of ethical considerations and societal concerns.

Hepatitis A: Old and New

PubMed Central

Cuthbert, Jennifer A.

2001-01-01

The hepatitis A virus (HAV), a picornavirus, is a common cause of hepatitis worldwide. Spread of infection is generally person to person or by oral intake after fecal contamination of skin or mucous membranes; less commonly, there is fecal contamination of food or water. Hepatitis A is endemic in developing countries, and most residents are exposed in childhood. In contrast, the adult population in developed countries demonstrates falling rates of exposure with improvements in hygiene and sanitation. The export of food that cannot be sterilized, from countries of high endemicity to areas with low rates of infection, is a potentially important source of infection. After ingestion and uptake from the gastrointestinal tract, the virus replicates in the liver and is excreted into the bile. Cellular immune responses to the virus lead to destruction of infected hepatocytes with consequent development of symptoms and signs of disease. Humoral immune responses are the basis for diagnostic serologic assays. Acute HAV infection is clinically indistinguishable from other causes of acute viral hepatitis. In young children the disease is often asymptomatic, whereas in older children and adults there may be a range of clinical manifestations from mild, anicteric infection to fulminant hepatic failure. Clinical variants include prolonged, relapsing, and cholestatic forms. Management of the acute illness is supportive, and complete recovery without sequelae is the usual outcome. Research efforts during World War II led to the development of passive immunoprophylaxis. Pooled immune serum globulin is efficacious in the prevention and attenuation of disease in exposed individuals. More recently, active immunoprophylaxis by vaccination has been accomplished. Future eradication of this disease can now be contemplated. PMID:11148002

Ethics of clinical trials in Nigeria.

PubMed

Okonta, Patrick I

2014-05-01

The conduct of clinical trials for the development and licensing of drugs is a very important aspect of healthcare. Drug research, development and promotion have grown to a multi-billion dollar global business. Like all areas of human endeavour involving generation and control of huge financial resources, it could be subject to deviant behaviour, sharp business practices and unethical practices. The main objective of this review is to highlight potential ethical challenges in the conduct of clinical trials in Nigeria and outline ways in which these can be avoided. Current international and national regulatory and ethical guidelines are reviewed to illustrate the requirements for ethical conduct of clinical trials. Past experiences of unethical conduct of clinical trials especially in developing countries along with the increasing globalisation of research makes it imperative that all players should be aware of the ethical challenges in clinical trials and the benchmarks for ethical conduct of clinical research in Nigeria.

Ethics of clinical trials in Nigeria

PubMed Central

Okonta, Patrick I.

2014-01-01

The conduct of clinical trials for the development and licensing of drugs is a very important aspect of healthcare. Drug research, development and promotion have grown to a multi-billion dollar global business. Like all areas of human endeavour involving generation and control of huge financial resources, it could be subject to deviant behaviour, sharp business practices and unethical practices. The main objective of this review is to highlight potential ethical challenges in the conduct of clinical trials in Nigeria and outline ways in which these can be avoided. Current international and national regulatory and ethical guidelines are reviewed to illustrate the requirements for ethical conduct of clinical trials. Past experiences of unethical conduct of clinical trials especially in developing countries along with the increasing globalisation of research makes it imperative that all players should be aware of the ethical challenges in clinical trials and the benchmarks for ethical conduct of clinical research in Nigeria. PMID:25013247

The problem of IVF cost in developing countries: has natural cycle IVF a place?

PubMed

Shahin, Ahmed Y

2007-07-01

Infertility represents a national health problem in some African countries. Limited financial health resources in developing countries are a major obstacle facing infertility management. IVF is the definitive line of treatment for many couples. Stimulation cycles are associated with risks of ovarian hyperstimulation syndrome and multiple pregnancy. This study evaluates the client acceptability of stimulated versus natural cycle IVF among couples attending one infertility clinic, with respect to cost and pregnancy outcome. Of the patients who were indicated for IVF, 15% (16/107) cancelled, due mostly (12/16, 75%) to financial reasons. The majority of patients who completed their IVF treatment (82/91, 90.1%) felt the price of the medical service offered was high, and 68.1% (62/91) accepted the idea of having cheaper drugs with fewer side effects but with possibly lower chances of pregnancy. Natural cycle IVF has emerged as a potential option that might be suitable for patients worldwide, especially in developing countries.

Holding up a mirror: changing obstetric practice through criterion-based clinical audit in developing countries.

PubMed

Wagaarachchi, P T; Graham, W J; Penney, G C; McCaw-Binns, A; Yeboah Antwi, K; Hall, M H

2001-08-01

The objective of the study described is to assess the feasibility and effectiveness of using a criterion-based clinical audit to measure and improve the quality of obstetric care at the district hospital level in developing countries. The focus is on the management of five life-threatening obstetric complications--hemorrhage, eclampsia, genital tract infection, obstructed labor and uterine rupture was audited using a "before and after" design. The five steps of the audit cycle were followed: establish criteria of good quality care; measure current practice (Review I); feedback findings and set targets; take action to change practice; and re-evaluate practice (Review II). Systematic literature review, panel discussions and pilot work led to the development of 31 audit criteria. Review I included 555 life-threatening complications occurring over 66 hospital-months; Review II included 342 complications over 42 hospital-months. Many common areas for improvement were identified across the four hospitals. Agreed mechanisms for achieving these improvements included clinical protocols, reviews of staffing, and training workshops. Some aspects of clinical monitoring, drug use and record keeping improved significantly between Reviews I and II. Criterion-based clinical audit in four typical district hospitals in Ghana and Jamaica is a feasible and acceptable method for quality assurance and appears to have improved the management of life-threatening obstetric complications.

Health Care Provision for People with Diabetes and Postgraduate Training of Diabetes Specialists in Eastern European Countries

PubMed Central

Doničová, Viera; Brož, Jan; Sorin, Iocara

2011-01-01

Background In many eastern European countries, information is limited regarding (1) prevalence of diabetes and its complications, (2) health care provisions for diabetes, (3) diabetes management, and (4) the structure of postgraduate training in diabetes for doctors and nurses. These have been reviewed here. Methods Source material was derived from publications and through personal communication with diabetes specialists in leading clinical centers in Bulgaria, the Czech Republic, Hungary, Poland, Romania, Russia, Slovakia, and Ukraine. Results In many countries, information about diabetes prevalence is incomplete or inaccurate with many undiagnosed cases but varies from 7.7–9.6%. Diabetic complications and adverse outcomes (blindness, amputation, and chronic renal failure) are common, with a high mortality resulting from cardiovascular disease. State-funded and private systems often exist side by side. Diabetes care is provided by diabetologists, endocrinologists, internal medicine physicians, and general practitioners, but their involvement varies considerably between countries and some have too few specialists who are located only in large centers. Specialized dietetics and foot care services are, in general, poorly developed. Insulin is freely available although analogs may incur a cost to the patient, while newer drugs (glucagon-like peptide-1 agonists, dipeptidyl peptidase-4 inhibitors) are either expensive or unavailable. Glucose monitoring is often rationed. Postgraduate training in diabetes is now well established in most countries and specialist training for nurses is being developed. Conclusions Continuing disparities with western European countries are related mainly to deficient economic resources and inadequate financial investment. Some countries have introduced national programs to improve diabetes care with better clinical outcomes being obtained following treatment initiatives. PMID:22027305

Clinical research, prophylaxis, therapy, and care for HIV disease in Africa.

PubMed Central

De Cock, K M; Lucas, S B; Lucas, S; Agness, J; Kadio, A; Gayle, H D

1993-01-01

By the end of the century, citizens of resource-poor countries will constitute 90% of the world's human immunodeficiency virus (HIV)-infected people. Clinical management of such persons in developing countries has been neglected; most AIDS research has concentrated on epidemiology, and donor agencies have generally invested in the prevention of HIV infection. The heavy burden of HIV disease in Africa requires that care for AIDS be addressed, and prevention and care should be seen as interrelated. Prevention and treatment of tuberculosis, the commonest severe infection in persons with AIDS in Africa, illustrate this interrelationship. We outline priorities for applied research on the management of HIV disease in a resource-poor environment, and discuss prophylaxis, therapy for opportunistic diseases, terminal care, and use of antiretroviral therapy. Research should define the standard of care that can realistically be demanded for HIV disease in a resource-poor environment. Research and public health programs for AIDS in developing countries must address AIDS care and attempt to reduce the widening gap between interventions available for HIV-infected persons in different parts of the world. PMID:8214225

Training in reproductive endocrinology and infertility and assisted reproductive technologies: options and worldwide needs.

PubMed

de Ziegler, Dominique; de Ziegler, Nathalie; Sean, Sokteang; Bajouh, Osama; Meldrum, David R

2015-07-01

Standardized, high-quality training in reproductive endocrinology, infertility, and assisted reproductive technologies (REI-ART) faces challenges owing to the high-tech nature of ART and the important country-to-country differences in clinical practice and regulations overseeing training. Moreover, while the training capacity of the classical by-fellowship training platforms is shrinking, an increasing demand for REI-ART specialists is coming from emerging countries. To meet this expanding need for REI-ART specialists, we propose a novel by-network model linking a reference training center to satellite practical training sites. Simulation should be used more extensively to achieve competency before initiating live clinical experience, analogous to the highly effective training systems that have been used in aviation for decades. Large ART databases that exist because of obligations to report ART activity and results constitute unique yet so far untapped sources for developing by-scenario simulation training models. Online training materials incorporating these state-of-the-art information technology tools could be developed as a means of fulfilling training needs worldwide. Copyright © 2015. Published by Elsevier Inc.

Drugs for rare disorders.

PubMed

Cremers, Serge; Aronson, Jeffrey K

2017-08-01

Estimates of the frequencies of rare disorders vary from country to country; the global average defined prevalence is 40 per 100 000 (0.04%). Some occur in only one or a few patients. However, collectively rare disorders are fairly common, affecting 6-8% of the US population, or about 30 million people, and a similar number in the European Union. Most of them affect children and most are genetically determined. Diagnosis can be difficult, partly because of variable presentations and partly because few clinicians have experience of individual rare disorders, although they may be assisted by searching databases. Relatively few rare disorders have specific pharmacological treatments (so-called orphan drugs), partly because of difficulties in designing trials large enough to determine benefits and harms alike. Incentives have been introduced to encourage the development of orphan drugs, including tax credits and research aids, simplification of marketing authorization procedures and exemption from fees, and extended market exclusivity. Consequently, the number of applications for orphan drugs has grown, as have the costs of using them, so much so that treatments may not be cost-effective. It has therefore been suggested that not-for-profit organizations that are socially motivated to reduce those costs should be tasked with producing them. A growing role for patient organizations, improved clinical and translational infrastructures, and developments in genetics have also contributed to successful drug development. The translational discipline of clinical pharmacology is an essential component in drug development, including orphan drugs. Clinical pharmacologists, skilled in basic pharmacology and its links to clinical medicine, can be involved at all stages. They can contribute to the delineation of genetic factors that determine clinical outcomes of pharmacological interventions, develop biomarkers, design and perform clinical trials, assist regulatory decision making, and conduct postmarketing surveillance and pharmacoepidemiological and pharmacoeconomic assessments. © 2017 The British Pharmacological Society.

Global regulatory developments for clinical stem cell research: diversification and challenges to collaborations.

PubMed

Rosemann, Achim; Bortz, Gabriela; Vasen, Federico; Sleeboom-Faulkner, Margaret

2016-10-01

In this article, we explore regulatory developments in stem cell medicine in seven jurisdictions: Japan, China, India, Argentina, Brazil, the USA and the EU. We will show that the research methods, ethical standards and approval procedures for the market use of clinical stem cell interventions are undergoing an important process of global diversification. We will discuss the implications of this process for international harmonization and the conduct of multicountry clinical research collaborations. It will become clear that the increasing heterogeneity of research standards and regulations in the stem cell field presents a significant challenge to international clinical trial partnerships, especially with countries that diverge from the regulatory models that have been developed in the USA and the EU.

[High fidelity simulation in Spain: from dreams to reality].

PubMed

Durá, M J; Merino, F; Abajas, R; Meneses, A; Quesada, A; González, A M

2015-01-01

Clinical simulation has emerged as a powerful new tool for the learning and assessment of different skills and attitudes in patient care, by using innovative technology such as high fidelity simulators (HFS). To describe the current state of high fidelity clinical simulation in Spain and its principal characteristics. Descriptive observational study that analyzes information on the clinical centers that have HFS in our country. There are currently a total of 80 centers with HFS in our country, mainly distributed in university centers (43), hospital and emergency centers (27), simulation centers and institutes of simulation (5), and the rest (5) associated to entities of diverse ownership. The temporal development of HFS has been slowly progressive, with a significant growth in the last 6 years. The majority (74%) have specific facilities, auxiliary equipment (60%), and professionals with a shared commitment (80%). It is already integrated into the training programs in 56% of university centers with HFS. The development of HFS has been remarkable in our country, and is mainly related to university undergraduate and postgraduate clinical medical education. It would be useful to design a network of simulation training centers of Health Sciences in Spain, which would be operational, sustainable and recognized, to optimize the use of these facilities. Copyright © 2014 Sociedad Española de Anestesiología, Reanimación y Terapéutica del Dolor. Publicado por Elsevier España, S.L.U. All rights reserved.

Monitoring and Benchmarking eHealth in the Nordic Countries.

PubMed

Nøhr, Christian; Koch, Sabine; Vimarlund, Vivian; Gilstad, Heidi; Faxvaag, Arild; Hardardottir, Gudrun Audur; Andreassen, Hege K; Kangas, Maarit; Reponen, Jarmo; Bertelsen, Pernille; Villumsen, Sidsel; Hyppönen, Hannele

2018-01-01

The Nordic eHealth Research Network, a subgroup of the Nordic Council of Ministers eHealth group, is working on developing indicators to monitor progress in availability, use and outcome of eHealth applications in the Nordic countries. This paper reports on the consecutive analysis of National eHealth policies in the Nordic countries from 2012 to 2016. Furthermore, it discusses the consequences for the development of indicators that can measure changes in the eHealth environment arising from the policies. The main change in policies is reflected in a shift towards more stakeholder involvement and intensified focus on clinical infrastructure. This change suggests developing indicators that can monitor understandability and usability of eHealth systems, and the use and utility of shared information infrastructure from the perspective of the end-users - citizens/patients and clinicians in particular.

Maternal mortality in developing countries: challenges in scaling-up priority interventions.

PubMed

Prata, Ndola; Passano, Paige; Sreenivas, Amita; Gerdts, Caitlin Elisabeth

2010-03-01

Although maternal mortality is a significant global health issue, achievements in mortality decline to date have been inadequate. A review of the interventions targeted at maternal mortality reduction demonstrates that most developing countries face tremendous challenges in the implementation of these interventions, including the availability of unreliable data and the shortage in human and financial resources, as well as limited political commitment. Examples from developing countries, such as Sri Lanka, Malaysia and Honduras, demonstrate that maternal mortality will decline when appropriate strategies are in place. Such achievable strategies need to include redoubled commitments on the part of local, national and global political bodies, concrete investments in high-yield and cost-effective interventions and the delegation of some clinical tasks from higher-level healthcare providers to mid- or lower-level healthcare providers, as well as improved health-management information systems.

A global survey of changing patterns of food allergy burden in children

PubMed Central

2013-01-01

While food allergies and eczema are among the most common chronic non-communicable diseases in children in many countries worldwide, quality data on the burden of these diseases is lacking, particularly in developing countries. This 2012 survey was performed to collect information on existing data on the global patterns and prevalence of food allergy by surveying all the national member societies of the World Allergy Organization, and some of their neighbouring countries. Data were collected from 89 countries, including published data, and changes in the health care burden of food allergy. More than half of the countries surveyed (52/89) did not have any data on food allergy prevalence. Only 10% (9/89) of countries had accurate food allergy prevalence data, based on oral food challenges (OFC). The remaining countries (23/89) had data largely based on parent-reporting of a food allergy diagnosis or symptoms, which is recognised to overestimate the prevalence of food allergy. Based on more accurate measures, the prevalence of clinical (OFC proven) food allergy in preschool children in developed countries is now as high as 10%. In large and rapidly emerging societies of Asia, such as China, where there are documented increases in food allergy, the prevalence of OFC-proven food allergy is now around 7% in pre-schoolers, comparable to the reported prevalence in European regions. While food allergy appears to be increasing in both developed and developing countries in the last 10–15 years, there is a lack of quality comparative data. This survey also highlights inequities in paediatric allergy services, availability of adrenaline auto-injectors and standardised National Anaphylaxis Action plans. In conclusion, there remains a need to gather more accurate data on the prevalence of food allergy in many developed and developing countries to better anticipate and address the rising community and health service burden of food allergy. PMID:24304599

The content of the work of clinical nurse specialists described by use of daily activity diaries.

PubMed

Oddsdóttir, Elín Jakobína; Sveinsdóttir, Herdís

2011-05-01

Evaluate the usefulness of the role of clinical nurse specialists and the content of their work by mapping their activities. The clinical work of advanced practice nursing differs in different countries, and a clear picture is lacking on what exactly advanced practice nurses do. Prospective exploratory study. The setting of the study was the largest hospital in Iceland where over half of the country's active nursing workforce are employed, including the only clinical nurse specialists. Of 19 clinical nurse specialists working at the hospital, 15 participated. Data were collected over seven days with a structured activity diary that lists 65 activities, classified into six roles and three domains. In 17 instances, the 'role activities' and 'domain activities' overlap and form 17 categories of practice. The clinical nurse specialists coded their activities at 15-minutes interval and could code up to four activities simultaneously. Daily, the clinical nurse specialists evaluated their clinical nurse specialist background. The roles that occupied the greatest proportion of the clinical nurse specialists' time were education, expert practice and 'other' activities, while the smallest proportions were in counselling, research and practice development. The domain they worked in most was the institutional domain, followed by the client/family domain and the clinical outcome management domain. All of the clinical nurse specialists reported working on two activities simultaneously, 11 of them on three activities and six on four activities. They self-assessed their background as clinical nurse specialists as being very useful. The activity diary is a useful tool for assessing the content of practice. Clinical nurse specialists spend too much time on activities related to the institution. Nurse managers are advised to provide clinical nurse specialists with ample time to develop the direct practice role in the client/family domain. The development of advanced nursing practice requires that clinical nurse specialists take an active and visible part in direct patient care. © 2011 Blackwell Publishing Ltd.

Clinical oncology in Malaysia: 1914 to present

PubMed Central

2006-01-01

A narration of the development of staff, infrastructure and buildings in the various parts of the country is given in this paper. The role of universities and other institutions of learning, public health, palliative care, nuclear medicine and cancer registries is described together with the networking that has been developed between the government, non-governmental organisations and private hospitals. The training of skilled manpower and the commencement of the Master of Clinical Oncology in the University of Malaya is highlighted. Efforts taken to improve the various aspects of cancer control which includes prevention of cancer, early detection, treatment and palliative care are covered. It is vital to ensure that cancer care services must be accessible and affordable throughout the entire health system, from the primary care level up to the centres for tertiary care, throughout the whole country. PMID:21614216

Clinical and economic impact of antibiotic resistance in developing countries: A systematic review and meta-analysis.

PubMed

Founou, Raspail Carrel; Founou, Luria Leslie; Essack, Sabiha Yusuf

2017-01-01

Despite evidence of the high prevalence of antibiotic resistant infections in developing countries, studies on the clinical and economic impact of antibiotic resistance (ABR) to inform interventions to contain its emergence and spread are limited. The aim of this study was to analyze the published literature on the clinical and economic implications of ABR in developing countries. A systematic search was carried out in Medline via PubMed and Web of Sciences and included studies published from January 01, 2000 to December 09, 2016. All papers were considered and a quality assessment was performed using the Newcastle-Ottawa quality assessment scale (NOS). Of 27 033 papers identified, 40 studies met the strict inclusion and exclusion criteria and were finally included in the qualitative and quantitative analysis. Mortality was associated with resistant bacteria, and statistical significance was evident with an odds ratio (OR) 2.828 (95%CI, 2.231-3.584; p = 0.000). ESKAPE pathogens was associated with the highest risk of mortality and with high statistical significance (OR 3.217; 95%CIs; 2.395-4.321; p = 0.001). Eight studies showed that ABR, and especially antibiotic-resistant ESKAPE bacteria significantly increased health care costs. ABR is associated with a high mortality risk and increased economic costs with ESKAPE pathogens implicated as the main cause of increased mortality. Patients with non-communicable disease co-morbidities were identified as high-risk populations.

Clinical and economic impact of antibiotic resistance in developing countries: A systematic review and meta-analysis

PubMed Central

Founou, Luria Leslie; Essack, Sabiha Yusuf

2017-01-01

Introduction Despite evidence of the high prevalence of antibiotic resistant infections in developing countries, studies on the clinical and economic impact of antibiotic resistance (ABR) to inform interventions to contain its emergence and spread are limited. The aim of this study was to analyze the published literature on the clinical and economic implications of ABR in developing countries. Methods A systematic search was carried out in Medline via PubMed and Web of Sciences and included studies published from January 01, 2000 to December 09, 2016. All papers were considered and a quality assessment was performed using the Newcastle-Ottawa quality assessment scale (NOS). Results Of 27 033 papers identified, 40 studies met the strict inclusion and exclusion criteria and were finally included in the qualitative and quantitative analysis. Mortality was associated with resistant bacteria, and statistical significance was evident with an odds ratio (OR) 2.828 (95%CI, 2.231–3.584; p = 0.000). ESKAPE pathogens was associated with the highest risk of mortality and with high statistical significance (OR 3.217; 95%CIs; 2.395–4.321; p = 0.001). Eight studies showed that ABR, and especially antibiotic-resistant ESKAPE bacteria significantly increased health care costs. Conclusion ABR is associated with a high mortality risk and increased economic costs with ESKAPE pathogens implicated as the main cause of increased mortality. Patients with non-communicable disease co-morbidities were identified as high-risk populations. PMID:29267306

Tailoring International Pressure Ulcer Prevention Guidelines for Nigeria: A Knowledge Translation Study Protocol.

PubMed

Ilesanmi, Rose Ekama; Gillespie, Brigid M; Adejumo, Prisca Olabisi; Chaboyer, Wendy

2015-07-28

The 2014 International Pressure Ulcer Prevention (PUP) Clinical Practice Guidelines (CPG) provides the most current evidence based strategies to prevent Pressure Ulcer (PU). The evidence upon which these guidelines have been developed has predominantly been generated from research conducted in developed countries. Some of these guidelines may not be feasible in developing countries due to structural and resource issues; therefore there is a need to adapt these guidelines to the context thus making it culturally acceptable. To present a protocol detailing the tailoring of international PUPCPG into a care bundle for the Nigerian context. Guided by the Knowledge to Action (KTA) framework, a two phased study will be undertaken. In Phase 1, the Delphi technique with stakeholder leaders will be used to review the current PUPCPG, identifying core strategies that are feasible to be adopted in Nigeria. These core strategies will become components of a PUP care bundle. In Phase 2, key stakeholder interviews will be used to identify the barriers, facilitators and potential implementation strategies to promote uptake of the PUP care bundle. A PUP care bundle, with three to eight components is expected to be developed from Phase 1. Implementation strategies to promote adoption of the PUP care bundle into clinical practice in selected Nigerian hospitals, is expected to result from Phase 2. Engagement of key stakeholders and consumers in the project should promote successful implementation and translate into better patient care. Using KTA, a knowledge translation framework, to guide the implementation of PUPCPG will enhance the likelihood of successful adoption in clinical practice. In implementing a PUP care bundle, developing countries face a number of challenges such as the feasibility of its components and the required resources.

National Hospital Management Portal (NHMP): a framework for e-health implementation.

PubMed

Adetiba, E; Eleanya, M; Fatumo, S A; Matthews, V O

2009-01-01

Health information represents the main basis for health decision-making process and there have been some efforts to increase access to health information in developing countries. However, most of these efforts are based on the internet which has minimal penetration especially in the rural and sub-urban part of developing countries. In this work, a platform for medical record acquisition via the ubiquitous 2.5G/3G wireless communications technologies is presented. The National Hospital Management Portal (NHMP) platform has a central database at each specific country's national hospital which could be updated/accessed from hosts at health centres, clinics, medical laboratories, teaching hospitals, private hospitals and specialist hospitals across the country. With this, doctors can have access to patients' medical records more easily, get immediate access to test results from laboratories, deliver prescription directly to pharmacists. If a particular treatment can be provided to a patient more effectively in another country, NHMP makes it simpler to organise and carry out such treatment abroad.

[Organization of out-patient psychiatric care in dementia and cognitive impairment in aged. Part II: Clinical and economic efficacy of memory clinics and Alzheimer's disease centers].

PubMed

Mikhaylova, N M

The part II of the review is focused on a history of developing of memory clinics and Alzheimer's disease centers as well as on the indices of their activity in various countries and in Russia. Approaches to the evaluation of clinical and economic efficacy of new technologies of organization of care and a role of the national programs in solving of the problem of old age dementias were considered.

Diagnostic tests in HIV management: a review of clinical and laboratory strategies to monitor HIV-infected individuals in developing countries.

PubMed Central

Kimmel, April D.; Losina, Elena; Freedberg, Kenneth A.; Goldie, Sue J.

2006-01-01

We conducted a systematic review on the performance of diagnostic tests for clinical and laboratory monitoring of HIV-infected adults in developing countries. Diagnostic test information collected from computerized databases, bibliographies and the Internet were categorized as clinical (non-laboratory patient information), immunologic (information from immunologic laboratory tests), or virologic (information from virologic laboratory tests). Of the 51 studies selected for the review 28 assessed immunologic tests, 12 virologic tests and seven clinical and immunologic tests. Methods of performance evaluation were primarily sensitivity and specificity for the clinical category and correlation coefficients for immunologic and virologic categories. In the clinical category, the majority of test performance measures was reported as >70% sensitive and >65% specific. In the immunologic category, correlation coefficients ranged from r=0.54 to r=0.99 for different CD4 count enumeration techniques, while correlation for CD4 and total lymphocyte counts was between r=0.23 and r=0.74. In the virologic category, correlation coefficients for different human immunodeficiency virus (HIV) ribonucleic acid (RNA) quantification techniques ranged from r=0.54 to r=0.90. Future research requires consensus on designing studies, and collecting and reporting data useful for decision-makers. We recommend classifying information into clinically relevant categories, using a consistent definition of disease across studies and providing measures of both association and accuracy. PMID:16878233

[The profile of Israeli travelers to developing countries: perspectives of a travel clinic].

PubMed

Stienlauf, Shmuel; Meltzer, Eyal; Leshem, Eyal; Rendi-Wagner, Pamela; Schwartz, Eli

2010-09-01

The number of Israeli travelers is increasing, including the number of travelers to developing countries. This study aimed to characterize the profile of Israeli travelers to developing countries. Data regarding demographics, travel destinations, trip duration and the purpose of travel were collected on travelers attending the pre-travel clinic at the Sheba Medical Center during a period of 9 years. Between the dates 1/1/1999 and 31/12/2007, 42,771 travelers presented for consultation at the Sheba Medical Center pre-travel clinic. The average age was 30.8 +/- 13.4 years and 54% of the travelers were males. The female proportion increased from 42% in 1999 to 49% in 2006. There was a steady increase in the number of travelers attending our clinic, except in 2003 (coinciding with the SARS epidemic). Post-army backpackers (20-25 year-old age group) were only 43% of the travelers. Children (<18 years), and elderly (>60 years) comprised 4.4% and 4.6% of the travelers, respectively. The favorite destinations were Asia (55%), followed by Latin America (27%) and Africa (13%). The distribution of travel destinations varied significantly during the study period. Of note is the sharp decline in travel to Africa following the terrorist attack in Mombassa, Kenya (November 2002). The median trip duration changed during the study period, from 30 to 45 days, between 1999-2004 and 2005-2007 respectively. The majority (87%) of voyagers traveled for pleasure, 6% went for business, and 7% were representatives of governmental organizations. This study found an increasing diversity in the traveler population (more women, more children and older travelers) and more diversity in travel destinations. Disease outbreaks and terrorist attacks had transient negative impacts on the number of travelers.

The transition to dolutegravir and other new antiretrovirals in low- and middle-income countries - what are the issues?

PubMed

Vitoria, Marco; Hill, Andrew; Ford, Nathan; Doherty, Meg; Clayden, Polly; Venter, Francois; Ripin, David; Flexner, Charles; Domanico, Paul

2018-05-09

: There are currently approximately 16 million people taking NNRTI-based first-line treatment in low- and middle-income countries. Most of these patients are using the combination of tenofovir (TDF), lamivudine (3TC) and efavirenz (EFV). The integrase inhibitor dolutegravir (DTG) has shown an improved safety profile compared to EFV in randomised studies. DTG also has a high barrier to development of drug resistance. New co-formulated tablets with TDF/3TC/DTG are being introduced into LMICs, for a median price of $75 per person-year. The prodrug of TDF, tenofovir alafenamide (TAF) is cheaper to manufacture than TDF. A combined pill with TAF/3TC/DTG is also being launched in LMICs, at a similar low price. However, the clinical development programmes for DTG and TAF did not include extensive analysis of several key populations: pregnant women, people with HIV-TB coinfection taking rifampicin-based treatment, and treatment naïve or pre-treated patients with NRTI drug resistance. In LMICs, only 50% of patients have access to regular viral load testing, and genotypic resistance testing is rarely performed. There is currently no clinical data to support switching patients from TDF/3TC/EFV directly to TDF/3TC/DTG if their viral load is either detectable or unknown. New clinical trials and observational studies will be needed to support this switch of treatment in LMICs. Clinical trials of new antiretrovirals in key populations should be conducted earlier in their development. This will ensure that new treatments can be introduced into LMICs soon after their launch in high-income countries.

Management of adult and paediatric acute lymphoblastic leukaemia in Asia: resource-stratified guidelines from the Asian Oncology Summit 2013

PubMed Central

Yeoh, Allen EJ; Tan, Daryl; Li, Chi-Kong; Hori, Hiroki; Tse, Eric; Pui, Ching-Hon

2014-01-01

The survival rates for both adult and children with acute lymphoblastic leukaemia have improved substantially in recent years with wider use of improved risk-directed therapy and supportive care. In nearly all developed countries, clinical practice guidelines have been formulated by multidisciplinary panels of leukaemia experts, with the goal of providing recommendations on standard treatment approaches based on current evidence. However, those guidelines do not take into account resource limitations in low-income countries, including financial and technical challenges. In Asia, there are huge disparities in economy and infrastructure among the countries, and even among different regions in some large countries. This review summarizes the recommendations developed for Asian countries by a panel of adult and paediatric leukaemia therapists, based on the availability of financial, skill and logistical resources, at a consensus session held as part of the 2013 Asian Oncology Summit in Bangkok, Thailand. The management strategies described here are stratified by a four-tier system (basic, limited, enhanced and maximum) based on the resources available to a particular country or region. PMID:24176570

Current stage in inflammatory bowel disease: What is next?

PubMed Central

Gómez-Gómez, Gonzalo Jesús; Masedo, Ángeles; Yela, Carmen; Martínez-Montiel, Maria del Pilar; Casís, Begoña

2015-01-01

In recent years, the incidence of inflammatory bowel disease (IBD) has been on the rise, extending to countries where it was infrequent in the past. As a result, the gap between high and low incidence countries is decreasing. The disease, therefore, has an important economic impact on the healthcare system. Advances in recent years in pharmacogenetics and clinical pharmacology have allowed for the development of treatment strategies adjusted to the patient profile. Concurrently, new drugs aimed at inflammatory targets have been developed that may expand future treatment options. This review examines advances in the optimization of existing drug treatments and the development of novel treatment options for IBD. PMID:26525013

Priority issues, study designs and geographical distribution in nutrition journals.

PubMed

Ortiz-Moncada, R; González-Zapata, L; Ruiz-Cantero, M T; Clemente-Gómez, V

2011-01-01

The increased number of articles published in nutrition is a reflection of the relevance to scientific community. The characteristics and quality of nutritional studies determine whether readers can obtain valid conclusions from them, as well as their usefulness for evidence-based strategic policies. To determine the characteristics of papers published in nutrition journals. Descriptive study design. We reviewed 330 original papers published between January-June 2007. From: American Journal of Clinical Nutrition (AJCN), Journal of Nutrition, European Journal Nutrition, European Journal of Clinical Nutrition and Public Health Nutrition. We classified them according to the subjects studied; risk factors, study design and country of origin. Almost half the papers studied healthy people (53.3%). The most frequent illness was obesity (13.9%). Food consumption is the most frequent risk factor (63.3%). Social factors appear exclusively only in 3.6% of the papers. Clinical trials were the most common analytical design (31.8%), mainly in the AJCN (45.6%). Cross-sectional studies were the most frequent type of observational design (37.9%). Ten countries produced over half of the papers (51.3%). The US publishes the highest number of papers (20.6%), whilst developing countries make only scarce contributions to scientific literature on nutrition. Most of the papers had inferential power. They generally studied both healthy and sick subjects, coinciding with the aims of international scientific policies. However, the topics covered reflect a clear bias, prioritizing problems pertaining to developed countries. Social determinants of health should also be considered, along with behavioral and biological risk factors.

Disparities in rheumatoid arthritis disease activity according to gross domestic product in 25 countries in the QUEST-RA database.

PubMed

Sokka, T; Kautiainen, H; Pincus, T; Toloza, S; da Rocha Castelar Pinheiro, G; Lazovskis, J; Hetland, M L; Peets, T; Immonen, K; Maillefert, J F; Drosos, A A; Alten, R; Pohl, C; Rojkovich, B; Bresnihan, B; Minnock, P; Cazzato, M; Bombardieri, S; Rexhepi, S; Rexhepi, M; Andersone, D; Stropuviene, S; Huisman, M; Sierakowski, S; Karateev, D; Skakic, V; Naranjo, A; Baecklund, E; Henrohn, D; Gogus, F; Badsha, H; Mofti, A; Taylor, P; McClinton, C; Yazici, Y

2009-11-01

To analyse associations between the clinical status of patients with rheumatoid arthritis (RA) and the gross domestic product (GDP) of their resident country. The Quantitative Standard Monitoring of Patients with Rheumatoid Arthritis (QUEST-RA) cohort includes clinical and questionnaire data from 6004 patients who were seen in usual care at 70 rheumatology clinics in 25 countries as of April 2008, including 18 European countries. Demographic variables, clinical characteristics, RA disease activity measures, including the disease activity score in 28 joints (DAS28), and treatment-related variables were analysed according to GDP per capita, including 14 "high GDP" countries with GDP per capita greater than US$24,000 and 11 "low GDP" countries with GDP per capita less than US$11,000. Disease activity DAS28 ranged between 3.1 and 6.0 among the 25 countries and was significantly associated with GDP (r = -0.78, 95% CI -0.56 to -0.90, r(2) = 61%). Disease activity levels differed substantially between "high GDP" and "low GDP" countries at much greater levels than according to whether patients were currently taking or not taking methotrexate, prednisone and/or biological agents. The clinical status of patients with RA was correlated significantly with GDP among 25 mostly European countries according to all disease measures, associated only modestly with the current use of antirheumatic medications. The burden of arthritis appears substantially greater in "low GDP" than in "high GDP" countries. These findings may alert healthcare professionals and designers of health policy towards improving the clinical status of patients with RA in all countries.

Recommendations for the Improved Effectiveness and Reporting of Telemedicine Programs in Developing Countries: Results of a Systematic Literature Review.

PubMed

Khanal, Sumesh; Burgon, Joseph; Leonard, Saoirse; Griffiths, Matthew; Eddowes, Lucy A

2015-11-01

A lack of decisive evidence on the impact of telemedicine on financial and clinical outcomes has not prohibited significant investment in developing countries. Understanding characteristics that facilitate effective telemedicine programs is required to allow telemedicine to be used to its full potential. This systematic review aimed to identify organizational, technological, and financial features of successful telemedicine programs providing direct clinical care in developing countries. Databases were searched, and the results were reviewed systematically according to predefined inclusion/exclusion criteria. Information on location(s), measure of success, and organizational, technological, and financial characteristics were extracted. This review was impeded by inadequate program reporting, and so a concise checklist was developed to aid improved reporting, enabling future reviews to identify key characteristics of effective programs. This systematic review identified 46 articles reporting 36 programs that fulfilled the inclusion/exclusion criteria. Programs were distributed globally, including regional, national, and international programs. Technological modalities included synchronous technology, real-time teleconsultations, and asynchronous technology. Program integration with existing systems and twinning of international institutions were identified as factors enabling program success. Other factors included simple and easy-to-use technology, ability to reduce the burden on healthcare professionals, and technology able to maintain functionality in challenging environmental circumstances. Reports describing effectiveness and costs were limited. This systematic review identified key factors associated with telemedicine program success. However, inconsistencies in reporting represent an obstacle to establishment of successful programs in developing countries by limiting the application of previous experiences. Adhering to the guidelines suggested here may allow more quantitative assessments of effectiveness and impact for future programs.

Enhancing the African bioethics initiative

PubMed Central

Ogundiran, Temidayo O

2004-01-01

Background Medical ethics has existed since the time of Hippocrates. However, formal training in bioethics did not become established until a few decades ago. Bioethics has gained a strong foothold in health sciences in the developed world, especially in Europe and North America. The situation is quite different in many developing countries. In most African countries, bioethics – as established and practiced today in the west- is either non-existent or is rudimentary. Discussion Though bioethics has come of age in the developed and some developing countries, it is still largely "foreign" to most African countries. In some parts of Africa, some bioethics conferences have been held in the past decade to create research ethics awareness and ensure conformity to international guidelines for research with human participants. This idea has arisen in recognition of the genuine need to develop capacity for reviewing the ethics of research in Africa. It is also a condition required by external sponsors of collaborative research in Africa. The awareness and interest that these conferences have aroused need to be further strengthened and extended beyond research ethics to clinical practice. By and large, bioethics education in schools that train doctors and other health care providers is the hook that anchors both research ethics and clinical ethics. Summary This communication reviews the current situation of bioethics in Africa as it applies to research ethics workshops and proposes that in spite of the present efforts to integrate ethics into biomedical research in Africa, much still needs to be done to accomplish this. A more comprehensive approach to bioethics with an all-inclusive benefit is to incorporate formal ethics education into health training institutions in Africa. PMID:15488145

Training models and status of clinical neuropsychologists in Europe: results of a survey on 30 countries.

PubMed

Hokkanen, Laura; Lettner, Sandra; Barbosa, Fernando; Constantinou, Marios; Harper, Lauren; Kasten, Erich; Mondini, Sara; Persson, Bengt; Varako, Nataliya; Hessen, Erik

2018-06-20

The aims of the study were to analyze the current European situation of specialist education and training within clinical neuropsychology, and the legal and professional status of clinical neuropsychologists in different European countries. An online survey was prepared in 2016 by a Task Force established by the European Federation of Psychological Associations, and representatives of 30 countries gave their responses. Response rate was 76%. Only three countries were reported to regulate the title of clinical neuropsychologist as well as the education and practice of clinical neuropsychologists by law. The most common university degree required to practice clinical neuropsychology was the master's degree; a doctoral degree was required in two countries. The length of the specialist education after the master's degree varied between 12 and 60 months. In one third of the countries, no commonly agreed upon model for specialist education existed. A more systematic training model and a longer duration of training were associated with independence in the work of clinical neuropsychologists. As legal regulation is mostly absent and training models differ, those actively practicing clinical neuropsychology in Europe have a very heterogeneous educational background and skill level. There is a need for a European standardization of specialist training in clinical neuropsychology. Guiding principles for establishing the common core requirements are presented.

Guidelines on treatment of perinatal depression with antidepressants: An international review

PubMed Central

Kamperman, Astrid M; Boyce, Philip; Bergink, Veerle

2018-01-01

Objective: Several countries have developed Clinical Practice Guidelines regarding treatment of perinatal depressive symptoms and perinatal use of antidepressant. We aimed to compare guidelines to guide clinicians in best clinical practice. Methods: An extensive search in guideline databases, MEDLINE and PsycINFO was performed. When no guidelines were (publicly) available online, we contacted psychiatric-, obstetric-, perinatal- and mood disorder societies of all first world countries and the five largest second world countries. Only Clinical Practice Guidelines adhering to quality criteria of the Appraisal of Guidelines for Research and Evaluation instrument and including a systematic review of evidence were included. Data extraction focussed on recommendations regarding continuation or withdrawal of antidepressants and preferred treatment in newly depressed patients. Results: Our initial search resulted in 1094 articles. After first screening, 40 full-text articles were screened. Of these, 24 were excluded for not being an official Clinical Practice Guidelines. In total, 16 Clinical Practice Guidelines were included originating from 12 countries. Eight guidelines were perinatal specific and eight were general guidelines. Conclusion: During pregnancy, four guidelines advise to continue antidepressants, while there is a lack of evidence supporting this recommendation. Five guidelines do not specifically advise or discourage continuation. For new episodes, guidelines agree on psychotherapy (especially cognitive behavioural therapy) as initial treatment for mild to moderate depression and antidepressants for severe depression, with a preference for sertraline. Paroxetine is not preferred treatment for new episodes but switching antidepressants for ongoing treatment is discouraged (three guidelines). If mothers use antidepressants, observation of the neonate is generally recommended and breastfeeding encouraged. PMID:29506399

Guidelines on treatment of perinatal depression with antidepressants: An international review.

PubMed

Molenaar, Nina M; Kamperman, Astrid M; Boyce, Philip; Bergink, Veerle

2018-04-01

Several countries have developed Clinical Practice Guidelines regarding treatment of perinatal depressive symptoms and perinatal use of antidepressant. We aimed to compare guidelines to guide clinicians in best clinical practice. An extensive search in guideline databases, MEDLINE and PsycINFO was performed. When no guidelines were (publicly) available online, we contacted psychiatric-, obstetric-, perinatal- and mood disorder societies of all first world countries and the five largest second world countries. Only Clinical Practice Guidelines adhering to quality criteria of the Appraisal of Guidelines for Research and Evaluation instrument and including a systematic review of evidence were included. Data extraction focussed on recommendations regarding continuation or withdrawal of antidepressants and preferred treatment in newly depressed patients. Our initial search resulted in 1094 articles. After first screening, 40 full-text articles were screened. Of these, 24 were excluded for not being an official Clinical Practice Guidelines. In total, 16 Clinical Practice Guidelines were included originating from 12 countries. Eight guidelines were perinatal specific and eight were general guidelines. During pregnancy, four guidelines advise to continue antidepressants, while there is a lack of evidence supporting this recommendation. Five guidelines do not specifically advise or discourage continuation. For new episodes, guidelines agree on psychotherapy (especially cognitive behavioural therapy) as initial treatment for mild to moderate depression and antidepressants for severe depression, with a preference for sertraline. Paroxetine is not preferred treatment for new episodes but switching antidepressants for ongoing treatment is discouraged (three guidelines). If mothers use antidepressants, observation of the neonate is generally recommended and breastfeeding encouraged.

Working to improve the management of sarcoma patients across Europe: a policy checklist.

PubMed

Kasper, Bernd; Lecointe-Artzner, Estelle; Wait, Suzanne; Boldon, Shannon; Wilson, Roger; Gronchi, Alessandro; Valverde, Claudia; Eriksson, Mikael; Dumont, Sarah; Drove, Nora; Kanli, Athanasia; Wartenberg, Markus

2018-04-16

The Sarcoma Policy Checklist was created by a multidisciplinary expert group to provide policymakers with priority areas to improve care for sarcoma patients. This paper draws on this research, by looking more closely at how France, Germany, Italy, Spain, Sweden and the United Kingdom are addressing each of these priority areas. It aims to highlight key gaps in research, policy and practice, as well as ongoing initiatives that may impact the future care of sarcoma patients in different European countries. A pragmatic review of the published and web-based literature was undertaken. Telephone interviews were conducted in each country with clinical and patient experts to substantiate findings. Research findings were discussed within the expert group and developed into five core policy recommendations. The five identified priority areas were: the development of designated and accredited centres of reference; more professional training; multidisciplinary care; greater incentives for research and innovation; and more rapid access to effective treatments. Most of the countries studied have ongoing initiatives addressing many of these priorities; however, many are in early stages of development, or require additional funding and resources. Gaps in access to quality care are particularly concerning in many of Europe's lower-resourced countries. Equitable access to information, clinical trials, innovative treatments and quality specialist care should be available to all sarcoma patients. Achieving this across Europe will require close collaboration between all stakeholders at both the national and European level.

The globalization of pediatric clinical trials.

PubMed

Dunne, Julia; Murphy, M Dianne; Rodriguez, William J

2012-12-01

To examine the characteristics of pediatric trials conducted under US legislation and to compare results with data from 2002 to 2007. We reviewed all pediatric trials provided to the US Food and Drug Administration in submissions that were approved between September 28, 2007 and December 21, 2010. We extracted data for each trial including age range, therapeutic indication, design, duration, and patient and center enrollment by location. Overall 346 studies on 113 drugs and biologicals enrolled 55 819 pediatric patients. The United States participated in 86% of the studies, providing 71% of the centers and 74% of the patients. Corresponding percentages for non-US countries were 43%, 29%, and 26% respectively. Developing or transition countries participated in 22% of the studies, providing 12% of the centers and 10% of the patients; our earlier analysis found corresponding percentages of 38%, 12%, and 23%. The most common therapeutic areas studied in the latter countries were infectious, neurologic, and pulmonary diseases. Seventy-eight vaccine studies enrolled 147 692 patients. The United States participated in 40% of the studies, providing 39% of the centers and 22% of the patients. Corresponding percentages for non-US countries were 74%, 61%, and 78% respectively. Developing or transition countries participated in 27% of the studies, providing 15% of the centers and 52% of the patients. The United States remains an important location for pediatric trials. Developing country involvement in pediatric drug development is not increasing, although these countries participate significantly in vaccine trials.

White Paper Report of the 2010 RAD-AID Conference on International Radiology for Developing Countries: Identifying Sustainable Strategies for Imaging Services in the Developing World

PubMed Central

Welling, Rodney D.; Azene, Ezana M.; Kalia, Vivek; Pongpirul, Krit; Starikovsky, Anna; Sydnor, Ryan; Lungren, Matthew P.; Johnson, Benjamin; Kimble, Cary; Wiktorek, Sarah; Drum, Tom; Short, Brad; Cooper, Justin; Khouri, Nagi F.; Mayo-Smith, William W.; Mahesh, Mahadevappa; Goldberg, Barry B.; Garra, Brian S.; DeStigter, Kristen K.; Lewin, Jonathan S.; Mollura, Daniel J.

2015-01-01

The 2010 RAD-AID Conference on International Radiology for Developing Countries was a multidisciplinary meeting to discuss data, experiences, and models pertaining to radiology in the developing world, where widespread shortages of imaging services reduce health care quality. The theme of this year’s conference was sustainability, with a focus on establishing and maintaining imaging services in resource-limited regions. Conference presenters and participants identified 4 important components of sustainability: (1) sustainable financing models for radiology development, (2) integration of radiology and public health, (3) sustainable clinical models and technology solutions for resource-limited regions, and (4) education and training of both developing and developed world health care personnel. PMID:21807349

"The family is the clinic, the community is the hospital": community mental health in Timor-Leste.

PubMed

Hawkins, Zoe; Tilman, Teofilo

2011-07-01

This paper describes the history and recent development of mental health services in Timor-Leste, a small developing country recovering from conflict. Challenges to effective service delivery are discussed as well as plans for future development. Timor-Leste's mental health service began just over a decade ago. Unlike many other low and middle income countries where hospital-based services predominate, the mental health model in Timor-Leste is entirely community based. However, challenges to effective mental health care delivery are similar to most developing countries and include a lack of sufficient financial resources, human resources, and mental health infrastructure. Addressing these issues successfully requires political will, a greater prioritization of mental health services, close coordination between stakeholders, as well as developments in the area of education, training and infrastructure. Greater understanding and education about the links between mental and physical health would benefit the overall health of the population, and integration of these respective policies may prove a successful method of more equitably redistributing finances and resources.

Initiating and developing clinical services, training and research in a low resource setting: the Malawi ENT experience.

PubMed

Mulwafu, Wakisa; Nyirenda, Thomas Elliot; Fagan, Johannes J; Bem, Chris; Mlumbe, Kumvana; Chitule, Jean

2014-07-01

Sub-Saharan Africa countries like Malawi have a paucity of ear, nose and throat (ENT) data, services and training opportunities. To reflect on new Malawian ENT experience and to propose guidelines to poorly resourced countries. Analysis of data predating and following establishment of ENT services in Malawi. In 2008 the first and only Malawian ENT specialist established ENT services with external funding. Fifteen clinical officers have been trained and a nurse placed at each outreach hospital. In 2012, 15,284 consultations were recorded: 543 (3.6%) from outreach clinics. Forty-nine percent needed medical treatment, while 45% needed medical advice. Surgery was performed on 2.7% of patients; 21% for foreign bodies in the nose and throat and 18% for foreign bodies and biopsies of ears. To establish accessible and sustainable specialist ENT services in a poor country requires building on an established local health delivery system, careful planning and investment in personnel, infrastructure, training and data collection. © The Author(s) 2014 Reprints and permissions: sagepub.co.uk/journalsPermissions.nav.

The Pocketable Electronic Devices in Radiation Oncology (PEDRO) Project: How the Use of Tools in Medical Decision Making is Changing?

PubMed

De Bari, Berardino; Franco, Pierfrancesco; Niyazi, Maximilian; Cornetto, Andrea Peruzzo; Qvortrup, Camilla; Martin, Arturo Navarro; Cacicedo, Jon; Fernandez, Gonçalo; Louro, Luís Vasco; Lestrade, Laëtitia; Ciammella, Patrizia; Greto, Daniela; Checkrine, Tarik; Youssef, Elkholti; Filippi, Andrea Riccardo; Poulsen, Laurids Østergaard; Alongi, Filippo

2016-04-01

To analyze the impact of mobile electronic devices (MEDs) and apps in the daily clinical activity of young radiation or clinical oncologists in 5 Western European countries (Italy, Germany, Spain, Portugal, and Denmark). A web-based questionnaire was sent to 462 young (≤40 years) members of the national radiation or clinical oncology associations of the countries involved in the study. The 15 items investigated diffusion of MEDs (smartphones and/or tablets), their impact on daily clinical activity, and the differences perceived by participants along time. A total of 386 (83.5%) of the 462 correctly filled questionnaires were statistically evaluated. Up to 65% of respondents declared to use an electronic device during their clinical activity. Conversely, 72% considered low to moderate impact of smartphones/tables on their daily practice. The daily use significantly increased from 2009 to 2012: users reporting a use ≥6 times/d raised from 5% to 39.9%. Professional needs fulfillment was declared by less than 68% of respondents and compliance to apps indications by 66%. Significant differences were seen among the countries, in particular concerning the feeling of usefulness of MEDs in the daily clinical life. The perception of the need of a comprehensive Web site containing a variety of applications (apps) for clinical use significantly differed among countries in 2009, while it was comparable in 2012. This survey showed a large diffusion of MEDs in young professionals working in radiation oncology. Looking at these data, it is important to verify the consistency of information found within apps, in order to avoid potential errors eventually detrimental for patients. "Quality assurance" criteria should be specifically developed for medical apps and a comprehensive Web site gathering all reliable applications and tools might be useful for daily clinical practice. © The Author(s) 2015.

Development of a survey instrument to investigate the primary care factors related to differences in cancer diagnosis between international jurisdictions

PubMed Central

2014-01-01

Background Survival rates following a diagnosis of cancer vary between countries. The International Cancer Benchmarking Partnership (ICBP), a collaboration between six countries with primary care led health services, was set up in 2009 to investigate the causes of these differences. Module 3 of this collaboration hypothesised that an association exists between the readiness of primary care physicians (PCP) to investigate for cancer – the ‘threshold’ risk level at which they investigate or refer to a specialist for consideration of possible cancer – and survival for that cancer (lung, colorectal and ovarian). We describe the development of an international survey instrument to test this hypothesis. Methods The work was led by an academic steering group in England. They agreed that an online survey was the most pragmatic way of identifying differences between the jurisdictions. Research questions were identified through clinical experience and expert knowledge of the relevant literature. A survey comprising a set of direct questions and five clinical scenarios was developed to investigate the hypothesis. The survey content was discussed and refined concurrently and repeatedly with international partners. The survey was validated using an iterative process in England. Following validation the survey was adapted to be relevant to the health systems operating in other jurisdictions and translated into Danish, Norwegian and Swedish, and into Canadian and Australian English. Results This work has produced a survey with face, content and cross cultural validity that will be circulated in all six countries. It could also form a benchmark for similar surveys in countries with similar health care systems. Conclusions The vignettes could also be used as educational resources. This study is likely to impact on healthcare policy and practice in participating countries. PMID:24938306

National Advisory Groups and their role in immunization policy-making processes in European countries.

PubMed

Nohynek, H; Wichmann, O; D Ancona, F

2013-12-01

During the twenty-first century, the development of national immunization programmes (NIP) has matured into robust processes where evidence-based methodologies and frameworks have increasingly been adopted. A key role in the decision-making and recommending processes is played by National Immunization Technical Advisory Groups (NITAGs). In a survey performed among European Union member states, Norway and Iceland, in February 2013, 85% of the 27 responding countries reported having established a NITAG, and of these, 45% have formal frameworks in place for the systematic development of vaccination recommendations. Independent of whether a formal framework is in place, common key factors are addressed by all NITAGs and also in countries without NITAGs. The four main factors addressed by all were: disease burden in the country, severity of the disease, vaccine effectiveness or efficacy, and vaccine safety at population level. Mathematical modelling and cost-effectiveness analyses are still not common tools. Differences in the relative weighting of these key factors, differences in data or assumptions on country-specific key factors, and differences in existing vaccination systems and financing, are likely to be reasons for differences in NITAG recommendations, and eventually NIPs, across Europe. Even if harmonization of NIPs is presently not a reasonable aim, systematic reviews and the development of mathematical/economic models could be performed at supranational level, thus sharing resources and easing the present work-load of NITAGs. Nevertheless, it has been argued that harmonization would ease central purchase of vaccines, thus reducing the price and increasing access to new vaccines. © 2013 The Authors Clinical Microbiology and Infection © 2013 European Society of Clinical Microbiology and Infectious Diseases.

Health-related quality of life in asthma studies. Can we combine data from different countries?

PubMed

Ståhl, E; Postma, D S; Juniper, E F; Svensson, K; Mear, I; Löfdahl, C-G

2003-01-01

The aim was to compare health-related quality of life (HRQL) in patients with asthma from 4 countries, and to investigate the correlations between HRQL and clinical indices.341 patients; 140 (Sweden), 54 (Norway), 65 (the Netherlands) and 82 (Greece) were treated with formoterol fumarate 4.5 microg or with terbutaline sulphate 0.5mg for 12 weeks inhaled 'on demand' via Turbuhaler. The Asthma Quality of Life Questionnaire (AQLQ) and clinical indices were assessed. The mean baseline AQLQ overall scores in Sweden (4.97), in the Netherlands (5.04), in Norway (4.68) and in Greece (4.68) were in the same range, however, with a significant difference between the four countries (p=0.038). When comparing AQLQ, activity limitation and symptoms domains, the differences between the countries were not statistically significant. The cross-sectional correlations between AQLQ overall score and the clinical indices were similar in all four countries. The magnitude of change in AQLQ was consistent with the other clinical variables. The correlations between change in AQLQ overall score and change in clinical indices were low to medium in all countries. In conclusion, the consistency of cross-sectional correlations between the AQLQ overall and clinical indices across countries supports the validity of translations of the AQLQ used in this study. There were differences in baseline values between the countries. The treatment response in AQLQ differed to the same extent as other clinical indices. When combining HRQL data from different countries, there might be cultural, gender and socio-economic differences, explaining different responses to treatment.

An automated smartphone-based diagnostic assay for point-of-care semen analysis

PubMed Central

Kanakasabapathy, Manoj Kumar; Sadasivam, Magesh; Singh, Anupriya; Preston, Collin; Thirumalaraju, Prudhvi; Venkataraman, Maanasa; Bormann, Charles L.; Draz, Mohamed Shehata; Petrozza, John C.; Shafiee, Hadi

2017-01-01

Male infertility affects up to 12% of the world’s male population and is linked to various environmental and medical conditions. Manual microscope-based testing and computer-assisted semen analysis (CASA) are the current standard methods to diagnose male infertility; however, these methods are labor-intensive, expensive, and laboratory-based. Cultural and socially dominated stigma against male infertility testing hinders a large number of men from getting tested for infertility, especially in resource-limited African countries. We describe the development and clinical testing of an automated smartphone-based semen analyzer designed for quantitative measurement of sperm concentration and motility for point-of-care male infertility screening. Using a total of 350 clinical semen specimens at a fertility clinic, we have shown that our assay can analyze an unwashed, unprocessed liquefied semen sample with <5-s mean processing time and provide the user a semen quality evaluation based on the World Health Organization (WHO) guidelines with ~98% accuracy. The work suggests that the integration of microfluidics, optical sensing accessories, and advances in consumer electronics, particularly smartphone capabilities, can make remote semen quality testing accessible to people in both developed and developing countries who have access to smartphones. PMID:28330865

Clinical Teachers' Attitudes toward the Efficacy of Evidence-Based Medicine Workshop and Self-Reported Ability in Evidence-Based Practice in Iran

ERIC Educational Resources Information Center

Kouhpayehzadeh, Jalil; Baradaran, Hamid; Arabshahi, Kamran Soltani; Knill-Jones, Robin

2006-01-01

Introduction: Evidence-based medicine (EBM) has been introduced in medical schools worldwide, but there is little known about effective methods for teaching EBM skills, particularly in developing countries. This study assesses the impact of an EBM workshop on clinical teachers' attitudes and use of EBM skills. Methods: Seventy-two clinical…

Global estimate of the incidence of clinical pneumonia among children under five years of age.

PubMed Central

Rudan, Igor; Tomaskovic, Lana; Boschi-Pinto, Cynthia; Campbell, Harry

2004-01-01

OBJECTIVE: Clinical pneumonia (defined as respiratory infections associated with clinical signs of pneumonia, principally pneumonia and bronchiolitis) in children under five years of age is still the leading cause of childhood mortality in the world. In this paper we aim to estimate the worldwide incidence of clinical pneumonia in young children. METHODS: Our estimate for the developing world is based on an analysis of published data on the incidence of clinical pneumonia from community based longitudinal studies. Among more than 2000 studies published since 1961, we identified 46 studies that reported the incidence of clinical pneumonia, and 28 of these met pre-defined quality criteria. FINDINGS: The estimate of the median incidence from those studies was 0.28 episodes per child-year (e/cy). The 25-75% interquartile range was 0.21-0.71. We assessed the plausibility of this estimate using estimates of global mortality from acute respiratory infections and reported case fatality rates for all episodes of clinical pneumonia reported in community-based studies or the case-fatality rate reported only for severe cases and estimates of the proportion of severe cases occurring in a defined population or community. CONCLUSION: The overlap between the ranges of the estimates implies that a plausible incidence estimate of clinical pneumonia for developing countries is 0.29 e/cy. This equates to an annual incidence of 150.7 million new cases, 11-20 million (7-13%) of which are severe enough to require hospital admission. In the developed world no comparable data are available. However, large population-based studies report that the incidence of community-acquired pneumonia among children less than five years old is approximately 0.026 e/cy, suggesting that more than 95% of all episodes of clinical pneumonia in young children worldwide occur in developing countries. PMID:15654403

A method for assessing the cost-effectiveness and the break-even point of clinical practice guidelines.

PubMed

Gandjour, A; Lauterbach, K W

2001-01-01

Assessing the costs and benefits of developing a clinical practice guideline is important because investments in guidelines compete with investments in other clinical programs. Despite the considerable number of guidelines in many industrialized countries, little is known about their costs and cost-effectiveness. The authors have developed specific measures to determine the cost-effectiveness of guidelines, using a German evidence-based guideline on obesity for the diagnosis and treatment of obese patients as a model. The measures are: the number of people needed to cure, the number of people needed to prevent from developing the disease in question, and the number of people to treat in order to break even.

Developing an appropriate digital hearing aid for low-resource countries: a case study.

PubMed

Israsena, P; Isaradisaikul, S; Noymai, A; Boonyanukul, S; Hemakom, A; Chinnarat, C; Navacharoen, N; Lekagul, S

2013-01-01

This paper reviews the development process and discusses the key findings which resulted from our multidisciplinary research team's effort to develop an alternative digital hearing suitable for low-resource countries such as Thailand. A cost-effective, fully programmable digital hearing aid, with its specifications benchmarking against WHO's recommendations, was systematically designed, engineered, and tested. Clinically it had undergone a full clinical trial that employed the outcome measurement protocol adopted from the APHAB, the first time implemented in Thai language. Results indicated that using the hearing aid improves user's satisfaction in terms of ease of communication, background noises, and reverberation, with clear benefit after 3 and 6 months, confirming its efficacy. In terms of engineering, the hearing aid also proved to be robust, passing all the designated tests. As the technology has successfully been transferred to a local company for the production phase, we also discuss other challenges that may arise before the device can be introduced into the market.

Effusive-constrictive pericarditis as the manifestation of an unexpected diagnosis.

PubMed

Marta, Liliana; Alves, Miguel; Peres, Marisa; Ferreira, Ricardo; Ferreira, Hugo; Leal, Margarida; Nobre, Ângelo

2015-01-01

Constrictive pericarditis is a clinical condition characterized by the appearance of signs and symptoms of right heart failure due to loss of pericardial compliance. Cardiac surgery is now one of the most frequent causes in developed countries, while tuberculosis remains the most prevalent cause in developing countries. Malignancy is a rare cause but usually has a poor prognosis. The diagnosis of constrictive pericarditis remains a clinical challenge and requires a combination of noninvasive diagnostic methods (echocardiography, cardiac magnetic resonance and computed tomography); in some cases, cardiac catheterization is needed to confirm the diagnosis. The authors present the case of a 51-year-old man, hospitalized due to cardiac tamponade. Diagnostic investigation was suggestive of tuberculous etiology. Despite directed medical therapy, the patient developed effusive-constrictive physiology. He underwent pericardiectomy and anatomopathologic study suggested a neoplastic etiology. The patient died in the postoperative period from biventricular failure. Copyright © 2014 Sociedade Portuguesa de Cardiologia. Published by Elsevier España. All rights reserved.

High-tech rural clinics and hospitals in Japan: a comparison to the Japanese average.

PubMed

Matsumoto, Masatoshi; Okayama, Masanobu; Inoue, Kazuo; Kajii, Eiji

2004-10-01

Japanese medical facilities are noted for being heavily equipped with high-tech equipment compared to other industrialised countries. Rural facilities are anecdotally said to be better equipped than facilities in other areas due to egalitarian health resource diffusion policies by public sectors whose goal is to secure fair access to modern medical technologies among the entire population. To show the technology status of rural practice and compare it to the national level. Nationwide postal survey. Questionnaires were sent to the directors of 1362 public hospitals and clinics (of the 1723 municipalities defined as 'rural' by four national laws). Information was collected about the technologies they possessed. The data were compared with figures from a national census of all hospitals and clinics. A total of 766 facilities responded (an effective response rate of 56%). Rural facilities showed higher possession rates in most comparable technologies than the national level. It is noted that almost all rural hospitals had gastroscopes and colonoscopes and their possession rates of bronchoscopes and dialysis equipment were twice as high as the national level. The discrepancy in possession rates between rural and national was even more remarkable in clinics than in hospitals. Rural clinics owned twice as many abdominal ultrasonographs, and three times as many gastroscopes, colonoscopes, defibrillators and computed tomography scanners as the national level. Rural facilities are equipped with more technology than urban ones. Government-led, tax based, technology diffusion in the entire country seems to have attained its goal. What is already known on this subject: As a general tendency in both developing and developed countries, rural medical facilities are technologically less equipped than their urban counterparts. What does this paper add?: In Japan, rural medical facilities are technologically better equipped than urban facilities.

[The place and the role of topographic and clinical anatomy in the modern system of higher medical education].

PubMed

Bol'shakov, O P

2008-01-01

Modern data on studying and teaching topographic and clinical anatomy in Russia and in the foreign countries at the boundary between the XX and the XXI centuries are analyzed. Definitions of some concepts are given; methodological and organizational bases of studying topographic and clinical anatomy are examined in historical aspect. Various approaches to the teaching and studying of these disciplines in different countries, are demonstrated. Special attention is given to the use of new technologies in teaching; the experience of virtual mode of studying of applied anatomy and surgical techniques is critically evaluated. Article presents author's own opinion and analyzes the conceptions of the foreign authors on the necessity of rational combination of computer and other modem technologies with traditional methods of work using biological materials and experiments on laboratory animals. The longstanding experience of the departments of operative surgery and clinical anatomy is summarized and the benefits of the national system of teaching of applied (topographic and clinical) anatomy are shown. Modem tendencies and priorities in the development of topographic and clinical anatomy are demonstrated.

Mobile phone text messaging to improve knowledge and practice of diabetic foot care in a developing country: Feasibility and outcomes.

PubMed

Hassan, Zeinab M

2017-06-01

To test the feasibility and effectiveness of using mobile phone text messaging to reinforce learning and the practice of diabetic foot care in a developing country. Ongoing learning reinforcement (2-3 times weekly) by text messaging followed an informal class on diabetic foot care in a community clinic setting. Subjects with cell phone access and no history of diabetic foot wounds or current wounds were recruited for participation (N = 225). Foot examinations and pretesting by survey occurred just before patients departed the clinic; the posttest survey and a final foot examination occurred 12 weeks later. The survey included basic demographic items along with items to measure knowledge and current foot care practices. One sample t tests (raw scores) and Wilcoxon signed-rank tests compared knowledge and practice before and after intervention. Initially, a majority of the sample (76%) reported poor levels of foot care. After 12 weeks <1% reported poor foot care practices. Statistical testing showed significant gains in knowledge (by score and level) and nearly unanimous compliance with daily foot examination. Mobile phone text messaging is an economical, feasible, and effective method for educators to improve diabetic self-care, even in a developing country. © 2017 John Wiley & Sons Australia, Ltd.

Lymphoedema of the lower limbs: management problems in a developing country.

PubMed

Adigun, A I; Ogundipe, O K

2008-01-01

Lymphoedema is a clinical condition involving the extremities that is characterized by accumulation of protein rich fluid within the intercellular space of the skin and the subcutaneous tissue. It most frequently occurs in the extremities. Developing countries are mostly faced with cases of secondary lymphoedema where patients present lately. In addition to swollen limbs, there are lot of skin changes on the affected limb, these create a lot of problems to the managing clinician. We hereby present five cases out of several patients managed to highlight the challenges. We review the case notes of three patients managed by our unit and present the summary of each patient. Majority of our patients present late to the hospital, mainly because of the socio-cultural and spiritual beliefs concerning the aetiology of the condition. Most of them have visited the spiritualist, herbalist and the clergymen for solution. Clinicians in the developing countries are seriously handicapped by lack of modern equipment for both diagnostic and therapeutic management of these clinical conditions. Chronic lymphoedema is a major cause of permanent disability. Excisional surgery such as Charles procedure even though old is still very much relevant in our environment. Patients need to be enlightened on the need for early presentation, adequate post-operative care and prolonged follow-up.

Ethical issues in research in low-income countries.

PubMed

Benatar, S R; Fleischer, T E

2007-06-01

During the twentieth century, spectacular developments in science, technology and medical practice coupled with economic growth have transformed health care and improved the lives of many people. Despite such progress, the world today is more inequitable than it was 50 years ago: disparities in wealth and health are widening inexorably, and infectious diseases are again becoming a major scourge and pose a threat to the lives of all. Hundreds of millions of people live in degrading poverty, with little, if any, access to health care. Recognition of this context in which much research takes place should sharpen our focus on the ethical requirements for research that could improve the health of a greater proportion of the world's population--one of the most pressing moral problems of our time. The intense debate on ethical dilemmas associated with an expanding programme of clinical research in developing countries has revealed much common ground, but has also left a residuum of controversy. We suggest that contested issues could be resolved by paying greater attention to different world views on the relationship between research and clinical care and by defining policies that both progressively improve the standard of care in research and link research to improved delivery of health care in developing countries.

Acute Sheehan's syndrome presenting as central diabetes insipidus.

PubMed

Robalo, Raquel; Pedroso, Célia; Agapito, Ana; Borges, Augusta

2012-11-06

Sheehan's syndrome occurs as a result of ischaemic pituitary necrosis due to severe postpartum haemorrhage. Improvements in obstetrical care have significantly reduced its incidence in developed countries, but postpartum pituitary infarction remains a common cause of hypopituitarism in developing countries. We report a case of severe postpartum haemorrhage followed by headache, central diabetes insipidus and failure to lactate, which prompted us to investigate and identify both anterior and posterior pituitary deficiency compatible with Sheehan's syndrome. A timely diagnosis allowed us to implement an adequate treatment and follow-up plan, which are known to improve clinical status and patient outcome.

AFOMP Policy Statement No. 3: recommendations for the education and training of medical physicists in AFOMP countries.

PubMed

Round, W H; Ng, K H; Healy, B; Rodriguez, L; Thayalan, K; Tang, F; Fukuda, S; Srivastava, R; Krisanachinda, A; Shiau, A C; Deng, X; Han, Y

2011-09-01

AFOMP recognizes that clinical medical physicists should demonstrate that they are competent to practice their profession by obtaining appropriate education, training and supervised experience in the specialties of medical physics in which they practice, as well as having a basic knowledge of other specialties. To help its member countries to achieve this, AFOMP has developed this policy to provide guidance when developing medical physicist education and training programs. The policy is compatible with the standards being promoted by the International Organization for Medical Physics and the International Medical Physics Certification Board.

Pharmacokinetic drug-drug interaction and their implication in clinical management

PubMed Central

Palleria, Caterina; Di Paolo, Antonello; Giofrè, Chiara; Caglioti, Chiara; Leuzzi, Giacomo; Siniscalchi, Antonio; De Sarro, Giovambattista; Gallelli, Luca

2013-01-01

Drug-drug interactions (DDIs) are one of the commonest causes of medication error in developed countries, particularly in the elderly due to poly-therapy, with a prevalence of 20-40%. In particular, poly-therapy increases the complexity of therapeutic management and thereby the risk of clinically important DDIs, which can both induce the development of adverse drug reactions or reduce the clinical efficacy. DDIs can be classify into two main groups: pharmacokinetic and pharmacodynamic. In this review, using Medline, PubMed, Embase, Cochrane library and Reference lists we searched articles published until June 30 2012, and we described the mechanism of pharmacokinetic DDIs focusing the interest on their clinical implications. PMID:24516494

Pharmacokinetic drug-drug interaction and their implication in clinical management.

PubMed

Palleria, Caterina; Di Paolo, Antonello; Giofrè, Chiara; Caglioti, Chiara; Leuzzi, Giacomo; Siniscalchi, Antonio; De Sarro, Giovambattista; Gallelli, Luca

2013-07-01

Drug-drug interactions (DDIs) are one of the commonest causes of medication error in developed countries, particularly in the elderly due to poly-therapy, with a prevalence of 20-40%. In particular, poly-therapy increases the complexity of therapeutic management and thereby the risk of clinically important DDIs, which can both induce the development of adverse drug reactions or reduce the clinical efficacy. DDIs can be classify into two main groups: pharmacokinetic and pharmacodynamic. In this review, using Medline, PubMed, Embase, Cochrane library and Reference lists we searched articles published until June 30 2012, and we described the mechanism of pharmacokinetic DDIs focusing the interest on their clinical implications.

The International AIDS Vaccine Initiative's Capacity Building Activities in East Africa

PubMed Central

Cochrane, Gavin; Robin, Enora; Hanlin, Rebecca; Castle-Clarke, Sophie; MacLure, Calum; Parks, Sarah; Chataway, Joanna

2016-01-01

Abstract The International AIDS Vaccine Initiative (IAVI) is one of a number of Product Development Partnerships created to bridge the gap between scientific and technological potential and the needs of low income populations in low and middle income countries. Specifically IAVI is focused on creating a preventative vaccine for HIV/AIDS. Whilst the remit of IAVI is to create new science, technology and products, its work necessarily involves a wide range of stakeholders and different constituencies in industrially developing and developed countries. Its capacity building activities relate to strengthening the ability to conduct clinical trials and are broad based, spanning scientific and technological capacity through to organisational, advocacy and broader development capabilities. The aim of this study was to deepen IAVI's understanding of how it contributes to capacity building activities in East Africa (Uganda, Kenya and Rwanda), spanning scientific and technological capacity through to organisational, advocacy and broader development capabilities. IAVI's mission to develop an HIV vaccine has become increasingly connected to wider health systems strengthening, through its clinical research activities in East Africa. Since it began its operations in the region, IAVI has made a significant contribution to training interventions to support scientific excellence and good clinical practice and invested in infrastructure and laboratories at Clinical Research Centres in East Africa. Although clear challenges still exist with ensuring sustained investment, accessing marginalized populations and demonstrating progress in capacity building, the experiences of IAVI to date suggest that substantial progress is being made towards wider health systems strengthening in the region. PMID:28083400

Human louse-transmitted infectious diseases.

PubMed

Badiaga, S; Brouqui, P

2012-04-01

Several of the infectious diseases associated with human lice are life-threatening, including epidemic typhus, relapsing fever, and trench fever, which are caused by Rickettsia prowazekii, Borrelia recurrentis, and Bartonella quintana, respectively. Although these diseases have been known for several centuries, they remain a major public health concern in populations living in poor-hygiene conditions because of war, social disruption, severe poverty, or gaps in public health management. Poor-hygiene conditions favour a higher prevalence of body lice, which are the main vectors for these diseases. Trench fever has been reported in both developing and developed countries in populations living in poor conditions, such as homeless individuals. In contrast, outbreaks of epidemic typhus and epidemic relapsing fever have occurred in jails and refugee camps in developing countries. However, reports of a significantly high seroprevalence for epidemic typhus and epidemic relapsing fever in the homeless populations of developed countries suggest that these populations remain at high risk for outbreaks of these diseases. Additionally, experimental laboratory studies have demonstrated that the body louse can transmit other emerging or re-emerging pathogens, such as Acinetobacter baumannii and Yersinia pestis. Therefore, a strict survey of louse-borne diseases and the implementation of efficient delousing strategies in these populations should be public health priorities. © 2012 The Authors. Clinical Microbiology and Infection © 2012 European Society of Clinical Microbiology and Infectious Diseases.

Disparities in rheumatoid arthritis disease activity according to gross domestic product in 25 countries in the QUEST–RA database

PubMed Central

Sokka, T; Kautiainen, H; Pincus, T; Toloza, S; da Rocha Castelar Pinheiro, G; Lazovskis, J; Hetland, M L; Peets, T; Immonen, K; Maillefert, J F; Drosos, A A; Alten, R; Pohl, C; Rojkovich, B; Bresnihan, B; Minnock, P; Cazzato, M; Bombardieri, S; Rexhepi, S; Rexhepi, M; Andersone, D; Stropuviene, S; Huisman, M; Sierakowski, S; Karateev, D; Skakic, V; Naranjo, A; Baecklund, E; Henrohn, D; Gogus, F; Badsha, H; Mofti, A; Taylor, P; McClinton, C; Yazici, Y

2009-01-01

Objective: To analyse associations between the clinical status of patients with rheumatoid arthritis (RA) and the gross domestic product (GDP) of their resident country. Methods: The Quantitative Standard Monitoring of Patients with Rheumatoid Arthritis (QUEST–RA) cohort includes clinical and questionnaire data from 6004 patients who were seen in usual care at 70 rheumatology clinics in 25 countries as of April 2008, including 18 European countries. Demographic variables, clinical characteristics, RA disease activity measures, including the disease activity score in 28 joints (DAS28), and treatment-related variables were analysed according to GDP per capita, including 14 “high GDP” countries with GDP per capita greater than US$24 000 and 11 “low GDP” countries with GDP per capita less than US$11 000. Results: Disease activity DAS28 ranged between 3.1 and 6.0 among the 25 countries and was significantly associated with GDP (r  =  −0.78, 95% CI −0.56 to −0.90, r2  =  61%). Disease activity levels differed substantially between “high GDP” and “low GDP” countries at much greater levels than according to whether patients were currently taking or not taking methotrexate, prednisone and/or biological agents. Conclusions: The clinical status of patients with RA was correlated significantly with GDP among 25 mostly European countries according to all disease measures, associated only modestly with the current use of antirheumatic medications. The burden of arthritis appears substantially greater in “low GDP” than in “high GDP” countries. These findings may alert healthcare professionals and designers of health policy towards improving the clinical status of patients with RA in all countries. PMID:19643759

Health information technology in primary health care in developing countries: a literature review.

PubMed Central

Tomasi, Elaine; Facchini, Luiz Augusto; Maia, Maria de Fatima Santos

2004-01-01

This paper explores the debate and initiatives concerning the use of information technology (IT) in primary health care in developing countries. The literature from 1992-2002 was identified from searches of the MEDLINE, Latin American and Caribbean Health Science Literature Database (LILACS), Cochrane Library and Web of Science databases. The search identified 884 references, 350 of which were classified according to the scheme described by the Pan American Health Organization (PAHO). For the analysis of advantages, problems and perspectives of IT applications and systems, 52 articles were selected according to their potential contribution to the primary health-care processes in non-developed countries. These included: 10 on electronic patient registries (EPR), 22 on process and programmatic action evaluation and management systems (PPAEM) and 20 on clinical decision-support systems (CDS). The main advantages, limitations and perspectives are discussed. PMID:15640923

A Brief History of Vaccines Against Polio.

PubMed

Vashishtha, Vipin M; Kamath, Sachidanand

2016-08-07

Poliomyelitis, a dreaded disease of the last century that had already crippled millions of people across the globe, is now on the verge of eradication thanks mainly to two polio vaccines, inactivated polio vaccine (IPV) and oral polio vaccine (OPV). Ever since their development in late 1950s and early 1960s, the journey of their early development process, clinical trials, licensure and ultimately widespread clinical use in different countries provide a fascinating tale of events. Oral polio vaccine has been the mainstay of global polio eradication initiative (GPEI) in most of the countries. With the advent of 'polio endgame', the focus has now shifted back to IPV. However, there are certain issues associated with global cessation of OPV use and universal implementation of IPV in routine immunization schedules across the globe that need to be dealt with some urgency, before proclaiming the global victory over polio.

Medical psychology services in dutch general hospitals: state of the art developments and recommendations for the future.

PubMed

Soons, Paul; Denollet, Johan

2009-06-01

In this article an overview is presented of the emergence of medical psychology in the care of somatically ill patients. The situation in the Netherlands can be considered as prototypical. For 60 years, clinical psychologists have been working in general, teaching and academic hospitals. Nowadays, they are an integrated non-medical specialism working in the medical setting of hospitals in the Netherlands, and are a full-member of the medical board. This paper discusses several topics: the position of the general hospital in the health care system in the Netherlands, the emergence of medical psychology in Dutch hospitals, the role of the professional association of medical psychologists, and the characteristics of patients seen by clinical psychologists. Following the discussion about the situation of medical psychology in other countries, recommendations are formulated for the further development of medical psychology in the Netherlands as well as in other countries.

Challenges in evaluating clinical governance systems in iran: a qualitative study.

PubMed

Hooshmand, Elaheh; Tourani, Sogand; Ravaghi, Hamid; Ebrahimipour, Hossein

2014-04-01

In spite of the pivotal role of clinical governance in enhancing quality of services provided by hospitals across the country, a scientific framework with specific criteria for evaluating hospitals has not been developed so far. This study was conducted with the aim to identify the challenges involved in evaluating systems of clinical governance in Iran. For the purposes of this qualitative study, 15 semi-structured interviews with experts in the field were conducted in 2011 and the data were analyzed using framework analysis method. Five major challenges in evaluating clinical governance include managing human resources, improving clinical quality, managing development, organizing clinical governance, and providing patient-oriented healthcare system. Healthcare system in Iran requires a clinical governance program which has a patient-oriented approach in philosophy, operation, and effectiveness in order to meet the challenges ahead.

Strangers in strange lands: a metasynthesis of lived experiences of immigrant asian nurses working in Western countries.

PubMed

Xu, Yu

2007-01-01

Nurses from Asian countries make up the majority of immigrant nurses globally. Although there are a limited number of studies on the lived experiences of Asian nurses working in Western countries, the development of nursing science will be impeded if the rich understanding gleaned from these studies is not synthesized. Using Noblit and Hare's (Meta-ethnography: Synthesizing Qualitative Studies. Newbury Park, Calif: Sage; 1988) procedures, a metasynthesis was conducted on 14 studies that met preset selection criteria. Four overarching themes emerged: (a) communication as a daunting challenge; (b) differences in nursing practice; (c) marginalization, discrimination, and exploitation; and (d) cultural differences. Based on the metasynthesis, a large narrative and expanded interpretation was constructed and implications for nursing knowledge development, clinical practice, and policy making are elaborated.

Dengue Contingency Planning: From Research to Policy and Practice

PubMed Central

Runge-Ranzinger, Silvia; Kroeger, Axel; Olliaro, Piero; McCall, Philip J.; Sánchez Tejeda, Gustavo; Lloyd, Linda S.; Hakim, Lokman; Bowman, Leigh R.; Horstick, Olaf; Coelho, Giovanini

2016-01-01

Background Dengue is an increasingly incident disease across many parts of the world. In response, an evidence-based handbook to translate research into policy and practice was developed. This handbook facilitates contingency planning as well as the development and use of early warning and response systems for dengue fever epidemics, by identifying decision-making processes that contribute to the success or failure of dengue surveillance, as well as triggers that initiate effective responses to incipient outbreaks. Methodology/Principal findings Available evidence was evaluated using a step-wise process that included systematic literature reviews, policymaker and stakeholder interviews, a study to assess dengue contingency planning and outbreak management in 10 countries, and a retrospective logistic regression analysis to identify alarm signals for an outbreak warning system using datasets from five dengue endemic countries. Best practices for managing a dengue outbreak are provided for key elements of a dengue contingency plan including timely contingency planning, the importance of a detailed, context-specific dengue contingency plan that clearly distinguishes between routine and outbreak interventions, surveillance systems for outbreak preparedness, outbreak definitions, alert algorithms, managerial capacity, vector control capacity, and clinical management of large caseloads. Additionally, a computer-assisted early warning system, which enables countries to identify and respond to context-specific variables that predict forthcoming dengue outbreaks, has been developed. Conclusions/Significance Most countries do not have comprehensive, detailed contingency plans for dengue outbreaks. Countries tend to rely on intensified vector control as their outbreak response, with minimal focus on integrated management of clinical care, epidemiological, laboratory and vector surveillance, and risk communication. The Technical Handbook for Surveillance, Dengue Outbreak Prediction/ Detection and Outbreak Response seeks to provide countries with evidence-based best practices to justify the declaration of an outbreak and the mobilization of the resources required to implement an effective dengue contingency plan. PMID:27653786

Case Study in International Cooperation: Cuba's Molecular Immunology Center and Roswell Park Cancer Institute.

PubMed

Evans, Rachel; Reid, Mary; Segal, Brahm; Abrams, Scott I; Lee, Kelvin

2018-04-01

In 1961, the USA severed diplomatic relations with Cuba, and in 1962 an embargo was imposed on trade and financial relations with that country. It was not until five decades later that the USA and Cuba would reestablish relations. This opened the way for the New York State Trade Mission to Cuba in April 2015, during which Cuba's Molecular Immunology Center and Buffalo, New York's Roswell Park Cancer Institute signed a formal agreement that would set in motion biotechnology research collaboration to address one of the most important causes of death in both countries. Significant research from Cuba led to this groundbreaking collaboration. The purpose of this paper is to discuss the development of this cooperation, from the Molecular Immunology Center's initial investigations, through the opening of a phase I clinical trial at Roswell Park Cancer Institute with therapies developed at the Center. This cooperation was responsible for the first clinical trial for CIMAvax-EGF involving advanced-stage non-small cell lung cancer patients in the USA. A license was also approved by the US Department of the Treasury's Office of Foreign Assets Control authorizing a commercial partnership for development of biotechnology products, combining the cancer research efforts of both institutions. This unusual collaboration between Cuba and the USA-the US economic embargo and travel restrictions not withstanding-opens good prospects for expanded medical research between the two countries. While political and logistical challenges remain, the shared mission and dedication of these Cuban and US scientists points the way towards relationships that can lead to development, testing, approval and use of promising new therapies for cancer patients. KEYWORDS Biotechnology, clinical trials, cancer vaccines, cancer immunotherapy, non-small cell lung cancer, NSCLC, Cuba, USA.

Cost Structure and Clinical Outcome of a Stem Cell Transplantation Program in a Developing Country: The Experience in Northeast Mexico

PubMed Central

Heredia-Salazar, Alberto Carlos; Cantú-Rodríguez, Olga G.; Gutiérrez-Aguirre, Homero; Villarreal-Villarreal, César Daniel; Mancías-Guerra, Consuelo; Herrera-Garza, José Luís; Gómez-Almaguer, David

2015-01-01

Background and Objective. Hematopoietic stem cell transplantation (HSCT) in developing countries is cost-limited. Our primary goal was to determine the cost structure for the HSCT program model developed over the last decade at our public university hospital and to assess its clinical outcomes. Materials and Methods. Adults and children receiving an allogeneic hematopoietic stem cell transplant from January 2010 to February 2011 at our hematology regional reference center were included. Laboratory tests, medical procedures, chemotherapy drugs, other drugs, and hospitalization costs were scrutinized to calculate the total cost for each patient and the median cost for the procedure. Data regarding clinical evolution were incorporated into the analysis. Physician fees are not charged at the institution and therefore were not included. Results. Fifty patients were evaluated over a 1-year period. The total estimated cost for an allogeneic HSCT was $12,504. The two most expensive diseases to allograft were non-Hodgkin lymphoma ($11,760 ± $2,236) for the malignant group and thalassemia ($12,915 ± $5,170) for the nonmalignant group. Acute lymphoblastic leukemia ($11,053 ± 2,817) and acute myeloblastic leukemia ($10,251 ± $1,538) were the most frequent indications for HSCT, with 11 cases each. Median out-of-pocket expenses were $1,605, and 1-year follow-up costs amounted to $1,640, adding up to a total cost of $15,749 for the first year. The most expensive components were drugs and laboratory tests. Conclusion. Applying the cost structure described, HSCT is an affordable option for hematological patients living in a developing country. PMID:25746343

International telepharmacy education: another venue to improve cancer care in the developing world.

PubMed

Alfaar, Ahmad S; Kamal, Sherif; Abouelnaga, Sherif; Greene, William L; Quintana, Yuri; Ribeiro, Raul C; Qaddoumi, Ibrahim A

2012-01-01

In developed countries, pharmacists play a crucial role in designing and implementing cancer treatments as part of a multidisciplinary oncology team. However, developing countries have a shortage of pharmacists, and their role is generally limited to dispensing and selling drugs. The aim of this study was to investigate the feasibility of providing clinical pharmacy educational activities via international teleconferencing to improve cancer care in developing countries. Meticulous preparation and intense promotion of the workshop were done in Egypt before the telepharmacy conferences began. Multiple connectivity tests were performed to resolve technical problems. Nine telepharmacy conferences were delivered during 3-h sessions that were held on three consecutive days. Talks were subsequently made available via Web streaming. Attendees were requested to complete a survey to measure their satisfaction with the sessions. The teleconference was attended by a total of 345 persons, and it was subsequently reviewed online via 456 log-in sessions from 10 countries. Technical issues (e.g., poor auditory quality) were resolved on the first day of the event. The rate of attendees' responses on the survey was 30.1%, and satisfaction with the event was generally good. Telecommunication is a relatively inexpensive approach that may improve pharmacy practices, especially those used to treat patients with cancer in developing countries. Special attention to patient-based telepharmacy education, including the use of cost-effective technology, should be considered.

Trends in epidemiology and management of breast cancer in developing Arab countries: a literature and registry analysis.

PubMed

El Saghir, Nagi S; Khalil, Mazen K; Eid, Toufic; El Kinge, Abdul Rahman; Charafeddine, Maya; Geara, Fady; Seoud, Muhieddine; Shamseddine, Ali I

2007-08-01

Registries and research on breast cancer in Arabic and developing countries are limited. We searched PubMed, Medline, WHO and IAEA publications, national, regional, hospital tumor registries and abstracts. We reviewed and analyzed available data on epidemiological trends and management of breast cancer in Arab countries, and compared it to current international standards of early detection, surgery and radiation therapy. Breast cancer constitutes 13-35% of all female cancers. Almost half of patients are below 50 and median age is 49-52 years as compared to 63 in industrialized nations. A recent rise of Age-Standardized Incidence Rates (ASR) is noted. Advanced disease remains very common in Egypt, Tunisia, Saudi Arabia, Syria, Palestinians and others. Mastectomy is still performed in more than 80% of women with breast cancer. There are only 84 radiation therapy centers, 256 radiation oncologists and 473 radiation technologists in all Arab countries, as compared with 1875, 3068 and 5155, respectively, in the USA, which has an equivalent population of about 300 million. Population-based screening is rarely practiced. Results from recent campaigns and studies show a positive impact of clinical breast examination leading to more early diagnosis and breast-conserving surgery. Breast cancer is the most common cancer among women in Arab countries with a young age of around 50 years at presentation. Locally advanced disease is very common and total mastectomy is the most commonly performed surgery. Awareness campaigns and value of clinical breast examination were validated in the Cairo Breast Cancer Screening Trial. More radiation centers and early detection would optimize care and reduce the currently high rate of total mastectomies. Population-based screening in those countries with affluent resources and accessible care should be implemented.

Cross-border reproductive care in North America: a pilot study testing a prospective data collection program for in vitro fertilization clinics in Canada and the United States.

PubMed

Hughes, Edward G; Sawyer, Angie; DeJean, Deirdre; Adamson, G David

2016-03-01

To develop and test a nonidentifying prospective data collection system for cross-border reproductive care (CBRC) in Canada and the United States (U.S.). Survey and cross-sectional study. Fertility clinics. Women traveling to and from Canada and the U.S. for reproductive care. None. Patients' home country, reason for crossing borders, and type of care received. Of 32 Canadian and 440 U.S. clinics contacted, seven and 46, respectively, responded to the initial questionnaire. Three out of seven Canadian and 44 out of 46 U.S. clinics reported providing CBRC. Seventy five percent agreed that nonidentifying data on country of origin and reason for travel should be collected. However, only one of seven Canadian and none of 46 U.S. clinics that expressed initial interest actually collected data, despite multiple communications. Although CBRC is a major component of assisted reproductive technology in North America (3%-10% of IVF cycles are provided to out-of-country patients in Canada and the U.S.), clinicians are not motivated to collect the simplest of data regarding CBRC patients. Despite this, reliable data are needed to help better understand the reasons for and impact of CBRC. Copyright © 2016 American Society for Reproductive Medicine. Published by Elsevier Inc. All rights reserved.

Practitioner Review: Bridging the Gap between Research and Clinical Practice in Pediatric Obesity

ERIC Educational Resources Information Center

Jelalian, Elissa; Wember, Yana Markov; Bungeroth, Heidi; Birmaher, Vered

2007-01-01

Background: Pediatric obesity is a significant public health concern, with rising prevalence rates in both developed and developing countries. This is of particular significance given that overweight children and adolescents are at increased risk for multiple medical comorbidities, as well as psychosocial and behavioral difficulties. The current…

Application of nutrient intake values (NIVs).

PubMed

Vorster, Hester H; Murphy, Suzanne P; Allen, Lindsay H; King, Janet C

2007-03-01

The process of applying nutrient intake values (NIVs) for dietary assessment, planning, and implementing programs is discussed in this paper. In addition to assessing, monitoring, and evaluating nutritional situations, applications include planning food policies, strategies, and programs for promotion of optimal nutrition and preventing and treating malnutrition (both over- and undernutrition). Other applications include nutrition education, food and nutrient legislation, marketing and labeling, research, product development, food procurement and trade (import and export), food aid, and therapeutic (clinical) nutrition. Specific examples of how NIVs are used to develop food labels, fortification policies, and food-based dietary guidelines are described. Applications in both developed and developing countries are also described. In summary, NIVs are the scientific backbone of all aspects of nutrition policy in countries and regions worldwide.

DEVELOPMENT OF AN EMERGENCY NURSING TRAINING CURRICULUM IN GHANA

PubMed Central

Bell, Sue Anne; Oteng, Rockefeller; Redman, Richard; Lapham, Jeremy; Bam, Victoria; Dzomecku, Veronica; Yakubu, Jamila; Tagoe, Nadia; Donkor, Peter

2014-01-01

The formal provision of emergency health care is a developing specialty in many sub-Saharan African countries, including Ghana. While emergency medicine training programs for physicians are on the rise, there are few established training programs for emergency nurses. The results of a unique collaboration are described between a university in the United States, a Ghanaian university and a Ghanaian teaching hospital that has developed an emergency nursing diploma program. The expected outcomes of this training program include: a) an innovative, interdisciplinary, team-based clinical training model b) a unique and low-resource emergency nursing curriculum and c) a comprehensive and sustainable training program to increase in-country retention of nurses. PMID:24631161

Telemedicine as a Tool for Europe-Africa Cooperation: A Practical Experience

NASA Astrophysics Data System (ADS)

Dinis, Manuel; Santiago, Fernando; Silva, Luís; Ferreira, Ricardo; Machado, José; Castela, Eduardo

This paper presents the experience of an Europe-Africa telemedicine network, focused on the pediatric area, and involving hospitals located in Luanda (Angola), Benguela (Angola), Praia (Cape Verde) and Coimbra (Portugal). In the scope of this network, the cooperation between these hospitals goes beyond the teleconsultation sessions. Tele-training, clinical experience exchange, patient transfer agreements and health staff training to local development of new medical capabilities are some of the involved activities. It is therefore agreed that this kind of technical and knowledge network could also be expanded to other African countries with clear benefits to the local citizens, overcoming the digital-divide and improving the cooperation between developed and developing countries.

Regulating clinical trials in India: the economics of ethics.

PubMed

Porter, Gerard

2017-07-09

The relationship between the ethical standards for the governance of clinical trials and market forces can be complex and problematic. This article uses India as a case study to explore this nexus. From the mid-2000s, India became a popular destination for foreign-sponsored clinical trials. The Indian government had sought to both attract clinical trials and ensure these would be run in line with internationally accepted ethical norms. Reports of controversial medical research, however, triggered debate about the robustness and suitability of India's regulatory system. In response to civil society pressure and interventions by the Supreme Court, the Indian government proposed additional measures aimed at strengthening protections for clinical trial participants. Whilst the reforms can be seen as a victory for human rights activists, they have also been criticised as being overly burdensome for sponsors. Indeed, their announcement prompted an exodus of clinical trials from India. Fearful of losing business to 'rival' countries, the Indian government is revisiting some of its proposals. The Indian example suggests that research ethics frameworks and national policies for economic development are increasingly intertwined. Host countries are in theory free to improve the lot of research participants, but doing so may make them appear less attractive to foreign sponsors, who can simply shift their activities to more industry-friendly jurisdictions. Although these economic pressures are unlikely to lead to a regulatory 'race to the bottom', they may limit host countries' ability to enact socially desirable reforms. © 2017 John Wiley & Sons Ltd.

Clinical trials in the Middle East and North Africa (MENA) Region: grandstanding or grandeur?

PubMed

Nair, Satish Chandrasekhar; Ibrahim, Halah; Celentano, David D

2013-11-01

Nearly 31% of the world's clinical trials are conducted outside the US and 25% of the new drug applications include data from international sites. The high population growth, demand for medication, increased prevalence of life-style related and rare genetic diseases in the MENA countries should be associated with a consequent scale-up of clinical trials in these countries. However, the region sponsors under 1% of global clinical trials. Determinants including the regulatory environment, patient protection, physician-preparedness, types of diseases, costs of trials and pace of subject recruitment, were analyzed to identify critical factors that influence barriers to the conduct clinical trials in MENA. Strategic planning by the CRO can help overcome challenges related to regulatory and oversight requirements. Barriers related to trial quality and subject protection can be mitigated by risk-based monitoring. Growing healthcare infrastructure and communication technologies provide clear advantages for subject recruitment. Low operating costs combined with the increase in pharmaceutical sales provide incentives for the future conduct of clinical trials. Although the opportunities and challenges cited are common to the MENA region, further studies are needed to assess other potential contributing variables for the conduct of clinical trials specific to each MENA country. Challenges in drug importation and site oversight can be overcome with systematic interventions. Social media network and community awareness programs can assist reductions in barriers in obtaining effective informed consents. Increasing pharmaceutical sales, population growth, high prevalence of genetic and life-style related diseases and reduced clinical trial development costs offer expanding opportunities for future clinical trials in MENA. Copyright © 2013 Elsevier Inc. All rights reserved.

Cancer initiatives in developing countries.

PubMed

Mellstedt, H

2006-06-01

The coming decades will bring dramatic increases in morbidity and mortality from cancer in the developing world. The burden of cancer is increasing globally, with an expected 20 million new cases per year in 2020, half of which will be in low- and middle-income countries. Despite an already overwhelming burden of health problems, developing countries must somehow address this cancer pandemic and their alarming share of cancer illness. Many large-scale and innovative worldwide initiatives have been launched in the fight against cancer. These programs represent colossal efforts to expand resources for health education among people and healthcare workers in developing countries and to increase awareness of cancer prevention. Many novel evidence-based and culturally-relevant programs are being implemented for screening and early prevention of common cancers. Several key initiatives are supporting clinical research, guideline development, oncology training, and appropriate technology transfer, such as access to electronic medical literature. Treatment programs are expanding access and quality of radiologic and pharmacologic therapies for cancer. These initiatives represent an unprecedented level of and cooperation among international agencies, governmental and nongovernmental organizations, international foundations, scientific societies, local institutions, and industry. This review examines the scope of need in response to the increasing burden of cancer in the developing world and major initiatives that have been created to respond to these needs.

Magnetic resonance imaging in Mexico

NASA Astrophysics Data System (ADS)

Rodriguez, A. O.; Rojas, R.; Barrios, F. A.

2001-10-01

MR imaging has experienced an important growth worldwide and in particular in the USA and Japan. This imaging technique has also shown an important rise in the number of MR imagers in Mexico. However, the development of MRI has followed a typical way of Latin American countries, which is very different from the path shown in the industrialised countries. Despite the fact that Mexico was one the very first countries to install and operate MR imagers in the world, it still lacks of qualified clinical and technical personnel. Since the first MR scanner started to operate, the number of units has grown at a moderate space that now sums up approximately 60 system installed nationwide. Nevertheless, there are no official records of the number of MR units operating, physicians and technicians involved in this imaging modality. The MRI market is dominated by two important companies: General Electric (approximately 51%) and Siemens (approximately 17.5%), the rest is shared by other five companies. According to the field intensity, medium-field systems (0.5 Tesla) represent 60% while a further 35% are 1.0 T or higher. Almost all of these units are in private hospitals and clinics: there is no high-field MR imagers in any public hospital. Because the political changes in the country, a new public plan for health care is still in the process and will be published soon this year. This plan will be determined by the new Congress. North American Free Trade Agreement (NAFTA) and president Fox. Experience acquired in the past shows that the demand for qualified professionals will grow in the new future. Therefore, systematic training of clinical and technical professionals will be in high demand to meet the needs of this technique. The National University (UNAM) and the Metropolitan University (UAM-Iztapalapa) are collaborating with diverse clinical groups in private facilities to create a systematic training program and carry out research and development in MRI

Toxoplasmosis – A Global Threat. Correlation of Latent Toxoplasmosis with Specific Disease Burden in a Set of 88 Countries

PubMed Central

Flegr, Jaroslav; Prandota, Joseph; Sovičková, Michaela; Israili, Zafar H.

2014-01-01

Background Toxoplasmosis is becoming a global health hazard as it infects 30–50% of the world human population. Clinically, the life-long presence of the parasite in tissues of a majority of infected individuals is usually considered asymptomatic. However, a number of studies show that this ‘asymptomatic infection’ may also lead to development of other human pathologies. Aims of the Study The purpose of the study was to collect available geoepidemiological data on seroprevalence of toxoplasmosis and search for its relationship with mortality and disability rates in different countries. Methods and Findings Prevalence data published between 1995–2008 for women in child-bearing age were collected for 88 countries (29 European). The association between prevalence of toxoplasmosis and specific disease burden estimated with age-standardized Disability Adjusted Life Year (DALY) or with mortality, was calculated using General Linear Method with Gross Domestic Product per capita (GDP), geolatitude and humidity as covariates, and also using nonparametric partial Kendall correlation test with GDP as a covariate. The prevalence of toxoplasmosis correlated with specific disease burden in particular countries explaining 23% of variability in disease burden in Europe. The analyses revealed that for example, DALY of 23 of 128 analyzed diseases and disease categories on the WHO list showed correlations (18 positive, 5 negative) with prevalence of toxoplasmosis and another 12 diseases showed positive trends (p<0.1). For several obtained significant correlations between the seroprevalence of toxoplasmosis and specific diseases/clinical entities, possible pathophysiological, biochemical and molecular explanations are presented. Conclusions The seroprevalence of toxoplasmosis correlated with various disease burden. Statistical associations does not necessarily mean causality. The precautionary principle suggests however that possible role of toxoplasmosis as a triggering factor responsible for development of several clinical entities deserves much more attention and financial support both in everyday medical practice and future clinical research. PMID:24662942

Strengthening medical product regulation in low- and middle-income countries.

PubMed

Preston, Charles; Valdez, Mary Lou; Bond, Katherine

2012-01-01

In summary, the case studies exploring global product supply chains and diethylene glycol poisoning in Panama, clinical trials regulation through AVAREF, premarket assurance through PEPFAR tentative approval, post-market surveillance in sub-Saharan Africa through research on drug and vaccine safety systems, and regulatory science through the creation of a low-cost meningitis vaccine for low- and middle-income countries, demonstrate the essential value of regulatory systems to low- and middle-income countries. When they work, people live; when they fail, people die. As the challenges of globalization mount, and efforts to provide medical products to low- and middle-income countries scale up, there is no better time to put regulatory system strengthening squarely on the global health and development agenda.

Regulatory challenges associated with conducting multicountry clinical trials in resource-limited settings.

PubMed

Ndebele, Paul; Blanchard-Horan, Christina; Shahkolahi, Akbar; Sanne, Ian

2014-01-01

International public health and infectious diseases research has expanded to become a global enterprise transcending national and continental borders in organized networks addressing high-impact diseases. In conducting multicountry clinical trials, sponsors and investigators have to ensure that they meet regulatory requirements in all countries in which the clinical trials will be conducted. Some of these requirements include review and approval by national drug regulatory authorities and recognized research ethics committees. A limiting factor to the efficient conduct of multicountry clinical trials is the regulatory environment in each collaborating country, with significant differences determined by various factors including the laws and the procedures used in each country. The long regulatory processes in resource-limited countries may hinder the efficient implementation of multisite clinical trials, delaying research important to the health of populations in these countries and costing millions of dollars a year.

Biopharmaceutical industry-sponsored global clinical trials in emerging countries.

PubMed

Alvarenga, Lenio Souza; Martins, Elisabeth Nogueira

2010-01-01

To evaluate biopharmaceutical industry-sponsored clinical trials placed in countries previously described as emerging regions for clinical research, and potential differences for those placed in Brazil. Data regarding recruitment of subjects for clinical trials were retrieved from www.clinicaltrials.gov on February 2nd 2009. Proportions of sites in each country were compared among emerging countries. Multiple logistic regressions were performed to evaluate whether trial placement in Brazil could be predicted by trial location in other countries and/or by trial features. A total of 8,501 trials were then active and 1,170 (13.8%) included sites in emerging countries (i.e., Argentina, Brazil, China, Czech Republic, Hungary, India, Mexico, Poland, Russia, South Korea, and South Africa). South Korea and China presented a significantly higher proportion of sites when compared to other countries (p<0.05). Multiple logistic regressions detected no negative correlation between placement in other countries when compared to Brazil. Trials involving subjects with less than 15 years of age, those with targeted recruitment of at least 1,000 subjects, and seven sponsors were identified as significant predictors of trial placement in Brazil. No clear direct competition between Brazil and other emerging countries was detected. South Korea showed the higher proportion of sites and ranked third in total number of trials, appearing as a major player in attractiveness for biopharmaceutical industry-sponsored clinical trials.

Medical informatics in medical research - the Severe Malaria in African Children (SMAC) Network's experience.

PubMed

Olola, C H O; Missinou, M A; Issifou, S; Anane-Sarpong, E; Abubakar, I; Gandi, J N; Chagomerana, M; Pinder, M; Agbenyega, T; Kremsner, P G; Newton, C R J C; Wypij, D; Taylor, T E

2006-01-01

Computers are widely used for data management in clinical trials in the developed countries, unlike in developing countries. Dependable systems are vital for data management, and medical decision making in clinical research. Monitoring and evaluation of data management is critical. In this paper we describe database structures and procedures of systems used to implement, coordinate, and sustain data management in Africa. We outline major lessons, challenges and successes achieved, and recommendations to improve medical informatics application in biomedical research in sub-Saharan Africa. A consortium of experienced research units at five sites in Africa in studying children with disease formed a new clinical trials network, Severe Malaria in African Children. In December 2000, the network introduced an observational study involving these hospital-based sites. After prototyping, relational database management systems were implemented for data entry and verification, data submission and quality assurance monitoring. Between 2000 and 2005, 25,858 patients were enrolled. Failure to meet data submission deadline and data entry errors correlated positively (correlation coefficient, r = 0.82), with more errors occurring when data was submitted late. Data submission lateness correlated inversely with hospital admissions (r = -0.62). Developing and sustaining dependable DBMS, ongoing modifications to optimize data management is crucial for clinical studies. Monitoring and communication systems are vital in multi-center networks for good data management. Data timeliness is associated with data quality and hospital admissions.

The impact of telemedicine in the postoperative care of the neurosurgery patient in an outpatient clinic: a unique perspective of this valuable resource in the developing world--an experience of more than 3000 teleconsultations.

PubMed

Dadlani, Ravi; Mani, Subramaniyan; A U, Jai Ganesh; Mohan, Dilip; Rajgopalan, Niranjana; Thakar, Sumit; Aryan, Saritha; Hegde, Alangar S

2014-01-01

Telemedicine has always been used as a teleconsultation tool in neurological emergencies (e.g., triage in head injuries, stroke, and cerebrovascular accidents). At Sri Sathya Sai Institute of Higher Medical Sciences, Bangalore, India, we have been operating two teleconsultation sessions per week for the postoperative patient population, addressing routine follow-up and semiemergent conditions in this cohort of patients. At our center more than 80% of the neurosurgical procedures are conducted in patients traveling more than 1500 km. Telemedicine as a routine tool in clinical medicine has significant financial and psychosocial benefits versus routine outpatient clinics. There are very few reports of telemedicine use in routine outpatient teleconsultations in the available neurosurgical literature; those that are present do not differentiate or analyze the use in routine versus emergency neurosurgery. We discuss the role of this underused resource in the developing countries and retrospectively analyze the clinical data in more than 1500 patients and 3000 teleconsultations during a period of 6 years. We address the financial implications, psychosocial factors, and several other factors that could make this relatively modest technology an indispensible tool in current neurosurgical practice, especially in a developing country like India. Copyright © 2014 Elsevier Inc. All rights reserved.

Development and validation of an international appraisal instrument for assessing the quality of clinical practice guidelines: the AGREE project.

PubMed

2003-02-01

International interest in clinical practice guidelines has never been greater but many published guidelines do not meet the basic quality requirements. There have been renewed calls for validated criteria to assess the quality of guidelines. To develop and validate an international instrument for assessing the quality of the process and reporting of clinical practice guideline development. The instrument was developed through a multi-staged process of item generation, selection and scaling, field testing, and refinement procedures. 100 guidelines selected from 11 participating countries were evaluated independently by 194 appraisers with the instrument. Following refinement the instrument was further field tested on three guidelines per country by a new set of 70 appraisers. The final version of the instrument contained 23 items grouped into six quality domains with a 4 point Likert scale to score each item (scope and purpose, stakeholder involvement, rigour of development, clarity and presentation, applicability, editorial independence). 95% of appraisers found the instrument useful for assessing guidelines. Reliability was acceptable for most domains (Cronbach's alpha 0.64-0.88). Guidelines produced as part of an established guideline programme had significantly higher scores on editorial independence and, after the publication of a national policy, had significantly higher quality scores on rigour of development (p<0.005). Guidelines with technical documentation had higher scores on that domain (p<0.0001). This is the first time an appraisal instrument for clinical practice guidelines has been developed and tested internationally. The instrument is sensitive to differences in important aspects of guidelines and can be used consistently and easily by a wide range of professionals from different backgrounds. The adoption of common standards should improve the consistency and quality of the reporting of guideline development worldwide and provide a framework to encourage international comparison of clinical practice guidelines.

QUEST‐RA: quantitative clinical assessment of patients with rheumatoid arthritis seen in standard rheumatology care in 15 countries

PubMed Central

Sokka, Tuulikki; Kautiainen, Hannu; Toloza, Sergio; Mäkinen, Heidi; Verstappen, Suzan M M; Hetland, Merete Lund; Naranjo, Antonio; Baecklund, Eva; Herborn, Gertraud; Rau, Rolf; Cazzato, Massimiliano; Gossec, Laure; Skakic, Vlado; Gogus, Feride; Sierakowski, Stanislaw; Bresnihan, Barry; Taylor, Peter; McClinton, Catherine; Pincus, Theodore

2007-01-01

Objective To conduct a cross‐sectional review of non‐selected consecutive outpatients with rheumatoid arthritis (RA) as part of standard clinical care in 15 countries for an overview of the characteristics of patients with RA. Methods The review included current disease activity using data from clinical assessment and a patient self‐report questionnaire, which was translated into each language. Data on demographic, disease and treatment‐related variables were collected and analysed using descriptive statistics. Variation in disease activity on DAS28 (disease activity score on 28‐joint count) within and between countries was graphically analysed. A median regression model was applied to analyse differences in disease activity between countries. Results Between January 2005 and October 2006, the QUEST‐RA (Quantitative Patient Questionnaires in Standard Monitoring of Patients with Rheumatoid Arthritis) project included 4363 patients from 48 sites in 15 countries; 78% were female, >90% Caucasian, mean age was 57 years and mean disease duration was 11.5 years. More than 80% of patients had been treated with methotrexate in all but three countries. Overall, patients had an active disease with a median DAS28 of 4.0, with a significant variation between countries (p<0.001). Among 42 sites with >50 patients included, low disease activity of DAS28 ⩽3.2 was found in the majority of patients in seven sites in five countries; in eight sites in five other countries, >50% of patients had high disease activity of DAS28 >5.1. Conclusions This international multicentre cross‐sectional database provides an overview of clinical status and treatments of patients with RA in standard clinical care in 2005–6 including countries that are infrequently involved in clinical research projects. PMID:17412740

SYMPTEK homemade foam models for client education and emergency obstetric care skills training in low-resource settings.

PubMed

Deganus, Sylvia A

2009-10-01

Clinical training for health care workers using anatomical models and simulation has become an established norm. A major requirement for this approach is the availability of lifelike training models or simulators for skills practice. Manufactured sophisticated human models such as the resuscitation neonatal dolls, the Zoë gynaecologic simulator, and other pelvic models are very expensive, and are beyond the budgets of many training programs or activities in low-resource countries. Clinical training programs in many low-resource countries suffer greatly because of this cost limitation. Yet it is also in these same poor countries that the need for skilled human resources in reproductive health is greatest. The SYMPTEK homemade models were developed in response to the need for cheaper, more readily available humanistic models for training in emergency obstetric skills and also for client education. With minimal training, a variety of cheap SYMPTEK models can easily be made, by both trainees and facilitators, from high-density latex foam material commonly used for furnishings. The models are reusable, durable, portable, and easily maintained. The uses, advantages, disadvantages, and development of the SYMPTEK foam models are described in this article.

Diagnosis and treatment for ocular tuberculosis among uveitis specialists: the international perspective.

PubMed

Lou, Susan M; Montgomery, Paul A; Larkin, Kelly L; Winthrop, Kevin; Zierhut, Manfred; Rosenbaum, James T

2015-02-01

To assess the approach of international specialists, who primarily practice in tuberculosis-endemic areas, to ocular tuberculosis (TB). International experts from India, Brazil, Taiwan, and more than 10 other countries were surveyed using two clinical cases and general questions. A total of 244 experts were sent a survey about the treatment and diagnosis of ocular tuberculosis; 65 responded (27%), of whom 34 were affiliated with practices in India, while 31 primarily practice at international sites outside of India and North America. The data from this survey were compared with the results of a similar survey sent to members of the American Uveitis Society. The survey provided normative data on how physicians evaluate patients with uveitis as well as opinions about ocular TB. Responses varied widely on topics such as tests to include in the workup of undifferentiated uveitis, initial therapy, and duration of treatment. Physicians from developing countries relied more on chest CT scans and tuberculin skin testing (TST) than their counterparts in developed countries. The approach to diagnosis and management of TB is heterogeneous worldwide. However, there are substantial differences in the clinical approach to uveitis depending on the clinician's location of practice.

Voluntariness of consent to HIV clinical research: A conceptual and empirical pilot study.

PubMed

Mamotte, Nicole; Wassenaar, Douglas

2017-09-01

Obtaining voluntary informed consent for research participation is an ethical imperative, yet there appears to be little consensus regarding what constitutes a voluntary consent decision. An instrument to assess influences on participants' consent decision and perceived voluntariness was developed and piloted in two South African HIV clinical trials. The pilot study found high levels of perceived voluntariness. The feeling of having no choice but to participate was significantly associated with lower perceived voluntariness. Overall the data suggest that it is possible to obtain voluntary and valid consent for research participants in ethically complex HIV clinical trials in a developing country context.

Development and validation of an instrument to measure nurse educator perceived confidence in clinical teaching.

PubMed

Nguyen, Van N B; Forbes, Helen; Mohebbi, Mohammadreza; Duke, Maxine

2017-12-01

Teaching nursing in clinical environments is considered complex and multi-faceted. Little is known about the role of the clinical nurse educator, specifically the challenges related to transition from clinician, or in some cases, from newly-graduated nurse to that of clinical nurse educator, as occurs in developing countries. Confidence in the clinical educator role has been associated with successful transition and the development of role competence. There is currently no valid and reliable instrument to measure clinical nurse educator confidence. This study was conducted to develop and psychometrically test an instrument to measure perceived confidence among clinical nurse educators. A multi-phase, multi-setting survey design was used. A total of 468 surveys were distributed, and 363 were returned. Data were analyzed using exploratory and confirmatory factor analyses. The instrument was successfully tested and modified in phase 1, and factorial validity was subsequently confirmed in phase 2. There was strong evidence of internal consistency, reliability, content, and convergent validity of the Clinical Nurse Educator Skill Acquisition Assessment instrument. The resulting instrument is applicable in similar contexts due to its rigorous development and validation process. © 2017 The Authors. Nursing & Health Sciences published by John Wiley & Sons Australia, Ltd.

Overview of cancer vaccines

PubMed Central

Kudrin, Alex

2012-01-01

Cancer immunotherapy has seen a tremendous number of failures and only few recent regulatory successes. This is a review dedicated to determine major regulatory and developmental issues around cancer immunotherapeutics. A three pillar approach should be used in setting a development path: discovery platforms and sufficient pool of validated tumor antigens, product development strategy enabling to bring the product closer to the patient and clinical development strategy accounting for competitive landscape, treatment paradigm, technical and commercial risks. Regulatory framework existing around cancer vaccines in the EU, US, Japan and some developing countries is outlined. In addition, the review covers some specific issues on the design and conduct of clinical trials with cancer vaccines. PMID:22894970

Clinical pathways for acute coronary syndromes in China: protocol for a hospital quality improvement initiative.

PubMed

Rong, Ye; Turnbull, Fiona; Patel, Anushka; Du, Xin; Wu, Yangfeng; Gao, Runlin

2010-09-01

Clinical pathways have been shown to be effective in improving quality of care for patients admitted to hospital for acute coronary syndromes (ACS) in high-income countries. However, their utility has not formally been evaluated in low- or middle-income countries. The Clinical Pathways for Acute Coronary Syndromes in China program is a 7-year study with the overall goal of reducing evidence-practice gaps in the management of patients admitted to hospitals in China with suspected ACS. The program comprises 2 phases: a prospective survey of current management of ACS patients to identify the areas that evidence-based patient care can be potentially improved, and a quality care initiative to maximize the use of evidence-based investigations and treatments for ACS patients in China. In this article, we outline the details of the study protocol, including key aspects of the development, implementation, and evaluation of the quality improvement initiative (clinical pathway) for management of patients with suspected ACS.

Risk factors for stillbirth in developing countries: a systematic review of the literature.

PubMed

Di Mario, Simona; Say, Lale; Lincetto, Ornella

2007-07-01

To identify risk factors for stillbirth in developing countries and to measure their impact by calculating the population attributable fraction (PAF) for each risk factor. Systematic review of published studies on risk factors for stillbirth within 3 broadly defined categories: infections, other clinical conditions, and context-dependent conditions such as socioeconomic status, maternal literacy, and receipt of antenatal care. Where statistically significant associations were found between a risk factor and occurrence of stillbirth, the PAF (the proportion of cases occurring in the total population that would be avoided if the exposure was removed) was calculated. A total of 33 studies, conducted in 31 developing countries, were included in the review. The definition of stillbirth varied widely in these studies. Risk factors for stillbirth having a PAF higher than 50% were maternal syphilis, chorioamnionitis, maternal malnutrition, lack of antenatal care, and maternal socioeconomic disadvantage. Maternal syphilis prevention, screening and treatment together with other interventions targeting universal use of antenatal care (that includes screening for syphilis) and improving the socioeconomic conditions including nutritional status of the mother, could effectively contribute towards reducing the unacceptably high burden due to stillbirth in developing countries.

Differential Globalization of Industry- and Non-Industry-Sponsored Clinical Trials.

PubMed

Atal, Ignacio; Trinquart, Ludovic; Porcher, Raphaël; Ravaud, Philippe

2015-01-01

Mapping the international landscape of clinical trials may inform global health research governance, but no large-scale data are available. Industry or non-industry sponsorship may have a major influence in this mapping. We aimed to map the global landscape of industry- and non-industry-sponsored clinical trials and its evolution over time. We analyzed clinical trials initiated between 2006 and 2013 and registered in the WHO International Clinical Trials Registry Platform (ICTRP). We mapped single-country and international trials by World Bank's income groups and by sponsorship (industry- vs. non- industry), including its evolution over time from 2006 to 2012. We identified clusters of countries that collaborated significantly more than expected in industry- and non-industry-sponsored international trials. 119,679 clinical trials conducted in 177 countries were analysed. The median number of trials per million inhabitants in high-income countries was 100 times that in low-income countries (116.0 vs. 1.1). Industry sponsors were involved in three times more trials per million inhabitants than non-industry sponsors in high-income countries (75.0 vs. 24.5) and in ten times fewer trials in low- income countries (0.08 vs. 1.08). Among industry- and non-industry-sponsored trials, 30.3% and 3.2% were international, respectively. In the industry-sponsored network of collaboration, Eastern European and South American countries collaborated more than expected; in the non-industry-sponsored network, collaboration among Scandinavian countries was overrepresented. Industry-sponsored international trials became more inter-continental with time between 2006 and 2012 (from 54.8% to 67.3%) as compared with non-industry-sponsored trials (from 42.4% to 37.2%). Based on trials registered in the WHO ICTRP we documented a substantial gap between the globalization of industry- and non-industry-sponsored clinical research. Only 3% of academic trials but 30% of industry trials are international. The latter appeared to be conducted in preferentially selected countries.

Differential Globalization of Industry- and Non-Industry–Sponsored Clinical Trials

PubMed Central

Atal, Ignacio; Trinquart, Ludovic; Porcher, Raphaël; Ravaud, Philippe

2015-01-01

Background Mapping the international landscape of clinical trials may inform global health research governance, but no large-scale data are available. Industry or non-industry sponsorship may have a major influence in this mapping. We aimed to map the global landscape of industry- and non-industry–sponsored clinical trials and its evolution over time. Methods We analyzed clinical trials initiated between 2006 and 2013 and registered in the WHO International Clinical Trials Registry Platform (ICTRP). We mapped single-country and international trials by World Bank's income groups and by sponsorship (industry- vs. non- industry), including its evolution over time from 2006 to 2012. We identified clusters of countries that collaborated significantly more than expected in industry- and non-industry–sponsored international trials. Results 119,679 clinical trials conducted in 177 countries were analysed. The median number of trials per million inhabitants in high-income countries was 100 times that in low-income countries (116.0 vs. 1.1). Industry sponsors were involved in three times more trials per million inhabitants than non-industry sponsors in high-income countries (75.0 vs. 24.5) and in ten times fewer trials in low- income countries (0.08 vs. 1.08). Among industry- and non-industry–sponsored trials, 30.3% and 3.2% were international, respectively. In the industry-sponsored network of collaboration, Eastern European and South American countries collaborated more than expected; in the non-industry–sponsored network, collaboration among Scandinavian countries was overrepresented. Industry-sponsored international trials became more inter-continental with time between 2006 and 2012 (from 54.8% to 67.3%) as compared with non-industry–sponsored trials (from 42.4% to 37.2%). Conclusions Based on trials registered in the WHO ICTRP we documented a substantial gap between the globalization of industry- and non-industry–sponsored clinical research. Only 3% of academic trials but 30% of industry trials are international. The latter appeared to be conducted in preferentially selected countries. PMID:26658791

Design of a sustainable prepolarizing magnetic resonance imaging system for infant hydrocephalus.

PubMed

Obungoloch, Johnes; Harper, Joshua R; Consevage, Steven; Savukov, Igor M; Neuberger, Thomas; Tadigadapa, Srinivas; Schiff, Steven J

2018-04-11

The need for affordable and appropriate medical technologies for developing countries continues to rise as challenges such as inadequate energy supply, limited technical expertise, and poor infrastructure persist. Low-field magnetic resonance imaging (LF MRI) is a technology that can be tailored to meet specific imaging needs within such countries. Its low power requirements and the possibility of operating in minimally shielded or unshielded environments make it especially attractive. Although the technology has been widely demonstrated over several decades, it is yet to be shown that it can be diagnostic and improve patient outcomes in clinical applications. We here demonstrate the robustness of prepolarizing MRI (PMRI) technology for assembly and deployment in developing countries for the specific application to infant hydrocephalus. Hydrocephalus treatment planning and management requires only modest spatial resolution, such that the brain can be distinguished from fluid-tissue contrast detail within the brain parenchyma is not essential. We constructed an internally shielded PMRI system based on the Lee-Whiting coil system with a 22-cm diameter of spherical volume. In an unshielded room, projection phantom images were acquired at 113 kHz with in-plane resolution of 3 mm × 3 mm, by introducing gradient fields of sufficient magnitude to dominate the 5000 ppm inhomogeneity of the readout field. The low cost, straightforward assembly, deployment potential, and maintenance requirements demonstrate the suitability of our PMRI system for developing countries. Further improvement in image spatial resolution and contrast of LF MRI will broaden its potential clinical utility beyond hydrocephalus.

Education of speech and language therapists/logopedists in selected Central and Southeastern European countries: challenges and new horizons.

PubMed

Georgieva, Dobrinka; Woźniak, Tomasz; Topbaş, Seyhun; Vitaskova, Katerina; Vukovic, Mile; Zemva, Nada; Duranovic, Mirela

2014-01-01

To provide an overview of student training in speech and language therapy/logopedics (SLT) in selected Central and Southeastern European countries (Poland, Slovenia, Bulgaria, Czech Republic, Serbia, Bosnia and Herzegovina and Turkey). Data were collected using a special questionnaire developed by Söderpalm and supplemented by Georgieva. Results from 23 SLT programs in the seven countries were collected and organized. In all these countries, SLT has roots in special education or health and is centralized in the university environment. The training programs have positive accreditation provided by the national agencies of accreditation and evaluation. Results were examined specifically for evidence of the new paradigm of evidence-based practice (EBP) according to the revised International Association of Logopedics and Phoniatrics (IALP) guidelines and the application of research-based teaching in SLT. The professional bodies that govern clinical practice in public health and/or educational fields are in the process of EBP implementation. Most speech and language therapists/logopedists in the selected countries work in an educational setting, clinical organization and/or hospital as well as in social day care centers. Except in Turkey, private practices are not regulated by the law. In the seven countries examined in this survey, SLT is progressing as a professional discipline but must be supported by government funding of SLT education and services to relevant populations. © 2015 S. Karger AG, Basel.

Health economics and surgical treatment for Parkinson's disease in a world perspective: results from an international survey.

PubMed

Jourdain, Vincent A; Schechtmann, Gastón

2014-01-01

Most studies in the field of neurosurgical treatment for movement disorders have been published by a small number of leading centers in developed countries. This study aimed to investigate the clinical practice of stereotactic neurosurgery for Parkinson's disease (PD) worldwide. Neurosurgeons were contacted via e-mail to participate in a worldwide survey. The results obtained are presented in order of the countries' economic development according to the World Bank, as well as by the source of financial support. A total of 353 neurosurgeons from 51 countries who had operated on 13,200 patients in 2009 were surveyed. Surgical procedures performed in high-income countries were more commonly financed by a public health care system. In contrast, in lower-middle-income and upper-middle-income countries, patients frequently financed surgeries themselves, and ablative surgeries were most commonly performed. Unexpectedly, ablative surgery is still used by about 65% of neurosurgeons, regardless of their country's economic status. This study provides a previously unavailable picture of the surgical aspects of PD across the globe in relation to health economics and sociodemographic factors. Global educational and training programs are warranted to raise awareness of economically viable surgical options for PD that could be adopted by public health care systems in lower-income countries. © 2014 S. Karger AG, Basel.

PDT in clinics: indications, results, and markets.

PubMed

Patrice, Thierry; Olivier, David; Bourre, Ludovic

2006-01-01

Photodynamic therapy (PDT) is based on the selective light activation of an exogenously given drug to patients. PDT acts mainly on cell membranes either of neovascular endothelial cells or of cancer cells leading to cancer cell death. Six drugs are now marketed based on clinical assays in various indications, which showed a clear cost efficiency as compared to other classical procedures. PDT is easy to handle and can be performed in medical installations fitting the conditions of health care in developing countries. Its cost effectiveness could represent an appropriate solution to the increasing number of cancers of various origin. However despite all the clinical results now available, PDT development remains slow. The reasons for this situation include cost of development, intellectual property, and competition between pharmaceutical companies.

The World Health Channel: an innovation for health and development.

PubMed

McConnell, Harry; Haile-Mariam, Tenagne; Rangarajan, S

2004-01-01

The issues of the digital divide and of accessing health information in areas of greatest need has been addressed by many. It has been a key component of the discussion of the World Summit for the Information Society and also the focus of an important new initiative, the Global Review for Health Information. Only approximately 1 in 700 people in Africa have internet access compared to a rate worldwide of approximately 10%. Access to essential health information and knowledge management for health care has been deemed a priority for the development of health systems and for the care of patients in areas with limited resources, prompting recent efforts by international organisations and by both governmental and non-governmental agencies (see Godlee et al, 2004 and McConnell, 2004). Health care in developing countries can be limited by many different resources: lack of health care workers with sufficient training, lack of diagnostic equipment, lack of treatment facilities or essential pharmaceuticals; and lack of education or expertise in many relevant areas. Much of the health care done in developing countries is by local lay persons or practitioners or by volunteers working with a variety of NGOs. These volunteers are often very dedicated young people with a vision of health-for-all that is often frustrated in the limited time they are able to spend in these areas and further constrained by meager resources (including availability of appropriate information). The availability of medical expertise and consultation depends largely on the geographical location of the health practitioner and of the patient as well as the level of integration with local practitioners and extent of outside agency involvement. Futhermore, there are often many NGOs working simultaneously on similar projects in the same region without knowledge of each other's activities. Often this occurs simply because a lack of communication exists between organisations, resulting in unnecessary duplication of effort. The availability of medical expertise and consultation depends largely on the geographical location of the health practitioner and of the patient as well as the level of integration with local practitioners and extent of outside agency involvement. The health care worker in developing countries is frequently faced with a paucity of information appropriate to the clinical situations on hand as well as a lack of locally available expertise. The lack of access to health care and other vital resources is one factor in the much lower (by approximately 1/3) life expectancy in the least developed countries campared to industrialised nations. In many developing countries there is only one doctor for 5-10,00 people, compared to a ratio of 1:200 in many developed countries. Textbooks, if they exist, may be 10-20 years out of date and are often directed more at the needs of developed countries. There is thus a growing need for wider availability of training and information on health care in developing countries and support for health care workers. There is also a need for increased communication and collaboration between governmental and non-governmental organisations working in international health to share education, resources and to coordinate efforts in areas supporting improved health care delivery. In recognition of this, the Institute for Sustainable Health Education and Development (www.ished.org) is launching the World Health Channel (WHC) in the spring of 2005 in collaboration with WorldSpace. This will allow access to critical health information in developing countries and place the emphasis on issues important for clinical care for front line health workers in these areas.

Review of national research ethics regulations and guidelines in Middle Eastern Arab countries

PubMed Central

2012-01-01

Background Research ethics guidelines are essential for conducting medical research. Recently, numerous attempts have been made to establish national clinical research documents in the countries of the Middle East. This article analyzes these documents. Methods Thirteen Arab countries in the Middle East were explored for available national codes, regulations, and guidelines concerning research ethics, and 10 documents from eight countries were found. We studied these documents, considering the ethical principles stated in the Declaration of Helsinki, the Council for International Organizations of Medical Sciences (CIOMS) guidelines, and the International Conference of Harmonization - Guidelines for Good Clinical Practice (ICH-GCP). Our paper comprises a complete list of protections, such as confidentiality, informed consent, ethics committees, and others. Results This study found different levels and kinds of research ethics regulations and guidelines in the countries examined. Two groups can be distinguished: the countries in the first group have one or more research ethics regulations or guidelines, while the countries in the second group have not yet established any. Most of the documents showed various degrees of deficiencies in regard to ethical protection. The majority of the documents that were examined refer to one or more international documents on biomedical research ethics. Conclusions Recently, a lot of efforts have been made in many countries in the Middle East. However, compared with international documents, most of the research ethics documents in use in this region demonstrate numerous deficiencies. As it relates to these documents, extensive differences could be observed in regard to development, structure, content, and reference to international guidelines. PMID:23234422

Challenges in Evaluating Clinical Governance Systems in Iran: A Qualitative Study

PubMed Central

Hooshmand, Elaheh; Tourani, Sogand; Ravaghi, Hamid; Ebrahimipour, Hossein

2014-01-01

Background: In spite of the pivotal role of clinical governance in enhancing quality of services provided by hospitals across the country, a scientific framework with specific criteria for evaluating hospitals has not been developed so far. Objectives: This study was conducted with the aim to identify the challenges involved in evaluating systems of clinical governance in Iran. Materials and Methods: For the purposes of this qualitative study, 15 semi-structured interviews with experts in the field were conducted in 2011 and the data were analyzed using framework analysis method. Results: Five major challenges in evaluating clinical governance include managing human resources, improving clinical quality, managing development, organizing clinical governance, and providing patient-oriented healthcare system. Conclusions: Healthcare system in Iran requires a clinical governance program which has a patient-oriented approach in philosophy, operation, and effectiveness in order to meet the challenges ahead. PMID:24910799

An education and motivation intervention to change clinical management of the third stage of labor - the GIRMMAHP Initiative.

PubMed

Figueras, Albert; Narváez, Edgar; Valsecia, Mabel; Vásquez, Susana; Rojas, Germán; Camilo, Angiolina; del Valle, José-María; Aguilera, Cristina

2008-12-01

Hemorrhage and hypertensive disorders are major contributors to death after delivery in developing countries. The GIRMMAHP Initiative was designed to describe the actual delivery care in five Latin American countries and to educate and motivate clinical staff at 17 hospitals with the purpose of implementing their own clinical practice guidelines to prevent postpartum hemorrhage. A multicountry education intervention was developed in four consecutive stages, using two analyses: (a) an observational study of the clinical records in eight teaching and nine nonteaching hospitals and (b) a study of the long-term changes measured 12 months after completion of an education intervention and writing a local clinical guideline. Data from 2,247 pregnant women showed that only 23.3 percent had an active management of the third stage of labor and that 22.7 percent received no prenatal care visit. These data were used to prepare local clinical practice guidelines in each participant hospital. The proportion of active management increased to 72.6 percent of deliveries at 3 months and 58.7 percent 1 year later. Use of oxytocin during the third stage of labor increased to 85.9 percent of included deliveries. The proportion of women who had postpartum hemorrhage decreased from 12.7 percent at baseline to 5 percent at 1 year after the intervention. An education intervention and discussion of actual clinical practice problems with health professionals and their involvement in drafting clinical guidelines helped improve health care quality and practitioners' adherence to these guidelines.

Ultrasound Imaging for Risk Assessment in Atherosclerosis

PubMed Central

Steinl, David C.; Kaufmann, Beat A.

2015-01-01

Atherosclerosis and its consequences like acute myocardial infarction or stroke are highly prevalent in western countries, and the incidence of atherosclerosis is rapidly rising in developing countries. Atherosclerosis is a disease that progresses silently over several decades before it results in the aforementioned clinical consequences. Therefore, there is a clinical need for imaging methods to detect the early stages of atherosclerosis and to better risk stratify patients. In this review, we will discuss how ultrasound imaging can contribute to the detection and risk stratification of atherosclerosis by (a) detecting advanced and early plaques; (b) evaluating the biomechanical consequences of atherosclerosis in the vessel wall; (c) assessing plaque neovascularization and (d) imaging the expression of disease-relevant molecules using molecular imaging. PMID:25938969

Building Learning Health Systems to Accelerate Research and Improve Outcomes of Clinical Care in Low- and Middle-Income Countries.

PubMed

English, Mike; Irimu, Grace; Agweyu, Ambrose; Gathara, David; Oliwa, Jacquie; Ayieko, Philip; Were, Fred; Paton, Chris; Tunis, Sean; Forrest, Christopher B

2016-04-01

Mike English and colleagues argue that as efforts are made towards achieving universal health coverage it is also important to build capacity to develop regionally relevant evidence to improve healthcare.

Pneumocystis and Pneumocystosis: first meeting of experts from Latin-American and Portuguese-speaking countries - a mini-review.

PubMed

Esteves, Francisco; Medrano, Francisco J; de Armas, Yaxsier; Wissmann, Gustavo; Calderón, Enrique J; Matos, Olga

2014-05-01

The Pneumocystis and Pneumocystosis: first meeting of experts from Latin-American and Portuguese-speaking countries was held in Lisbon, Portugal, on 24-26 October 2013. A total of 20 speakers from Latin America, Africa and Europe participated in the meeting. The epidemiological studies presented in this meeting begin to change the misconception that since the AIDS epidemic, Pneumocystis pneumonia (PcP) has become an infrequent disease, showing that today PcP remains a major opportunistic infection in HIV-infected patients in both developed and developing countries and an emerging problem in immunocompromised patients without HIV infection worldwide. PcP management remains a challenge. Right now, the combination of caspofungin and trimethoprim-sulfamethoxazole (TMP-SMX) is a promising therapeutic approach that needs to be assessed in controlled clinical trials.

[Tuberculosis and diabetes co-morbidity: an unresolved problem].

PubMed

Ugarte-Gil, César; Moore, David A J

2014-01-01

Co-morbidity between tuberculosis and diabetes has been described since the early 20th century. In developed countries, where there has been a decrease of infectious diseases with an increase of non-communicable diseases, as well as those countries who still have a high prevalence of infectious diseases but an increase of non-communicable diseases, it is observed that the prevalence of co-morbidity between tuberculosis and diabetes is increasing, making clinical management and control at the public health level a new challenge for health systems. This review aims to show the current available evidence that can inform research lines being developed to understand the problem. In countries like Peru, where there is an epidemiological transition, further research could allow us to understand and describe in a better way the characteristics and impact of this co-morbidity.

Nutritional screening tools for hospitalized children: methodological considerations.

PubMed

Joosten, Koen F M; Hulst, Jessie M

2014-02-01

Children who are admitted to the hospital are at a risk of developing undernutrition, especially children with an underlying disease. High percentages of both acute and chronic undernutrition have been reported in various Western countries for many years. Several nutritional screening tools have been developed for hospitalized children in the last years. This review gives an overview of the nutritional screening tools that are currently available with a focus on their aims, clinical use and validity. Copyright © 2013 Elsevier Ltd and European Society for Clinical Nutrition and Metabolism. All rights reserved.

Universal neonatal hearing screening: applications for a developing country in the Asia-Pacific region.

PubMed

Navarro-Locsin, C Gretchen

2003-01-01

Various centers around the world have implemented and evaluated universal hearing screening programs as a response to the US National Institute of Health policy statement on early identification of hearing loss. Several well conducted clinical trials have been devised to examine and evaluate various factors relevant to establishing a UNHS program. This paper aims to describe some of these factors and analyze their applications and implications for a UNHS program for a developing country in the Asia-Pacific Region. Specifically, three main issues will be discussed: hospital vs community based programs, choice of technology, and choice of screening protocol.

DOE and AID stand-alone photovoltaic activities

NASA Technical Reports Server (NTRS)

Bifano, W. J.; Ratajczak, A. F.

1983-01-01

The NASA Lewis Research Center (LeRC) is managing stand-alone photovoltaic (PV) system activities sponsored by the U.S. Department of Energy (DOE) and the U.S. Agency for International Development (AID). The DOE project includes village PV power demonstration projects in Gabon (four sites) and the Marshall Islands, PV-powered medical refrigerators in six countries, PV system microprocessor control development activities and PV-hybrid system assessments. The AID project includes a large village system in Tunisia, a water pumping/grain grinding project in Upper Volta, five medical clinics in four countries, PV-powered remote earth station application. These PV activities and summarizes significant findings to data are reviewed.

Chicken pox in pregnancy : an obstetric concern.

PubMed

Wiwanitkit, Viroj

2010-10-01

Chicken pox is a common viral infection presenting with fever and discrete vesicular lesions. This infection can be widely detected in developing countries, especially for those tropical countries. The pregnant can get chicken pox, and this becomes an important obstetrical concern. In this specific paper, the author hereby details and discusses on chicken pox in pregnancy. Clinical presentation, diagnosis, treatment, and prevention are briefly summarized. In addition, the effects of chicken pox on pregnancy as well as the vertical transmission are also documented.

CHICKEN POX IN PREGNANCY : AN OBSTETRIC CONCERN

PubMed Central

Wiwanitkit, Viroj

2010-01-01

Chicken pox is a common viral infection presenting with fever and discrete vesicular lesions. This infection can be widely detected in developing countries, especially for those tropical countries. The pregnant can get chicken pox, and this becomes an important obstetrical concern. In this specific paper, the author hereby details and discusses on chicken pox in pregnancy. Clinical presentation, diagnosis, treatment, and prevention are briefly summarized. In addition, the effects of chicken pox on pregnancy as well as the vertical transmission are also documented. PMID:21430880

[Skin eruption and itching after travel to Asia--a case report].

PubMed

Ólafsson, Guðmundur Dagur; Sigurðsson, Emil L; Sigurðardóttir, Bryndís

2015-09-01

One of the more common reasons patients seek medical advice after traveling in tropical countries are skin eruptions. Here we describe two cases of individuals who, after traveling to south east Asia, developed a skin eruption later diagnosed as cutaneous larva migrans. This particular skin condition is common among travelers to countries where the hookworm responsible is endemic. The diagnosis is based on travel history and clinical examination. The patients were treated with albendazole with good results and complete resolution of the symptoms.

First births with a simplified culture system for clinical IVF and embryo transfer.

PubMed

Van Blerkom, Jonathan; Ombelet, Willem; Klerkx, Elke; Janssen, Mia; Dhont, Nathalie; Nargund, Geeta; Campo, Rudi

2014-03-01

This study reports the outcome results from a pilot clinical trial using a simplified laboratory method for human IVF. This system reproducibly generates de novo the atmospheric and culture conditions that support normal fertilization and preimplantation embryogenesis to the hatched blastocyst stage without the need for specialized medical-grade gases or equipment. Development from insemination to the hatched blastocyst stage occurs undisturbed in a completely closed system that enables timed performance assessments for embryo selection in situ that, in this study, involved single-embryo transfers on day 3. With the simplified culture system, 8/23 embryos implanted, one miscarried at 8weeks of gestation and seven healthy babies have been born. The methodology and results are discussed with regard to how this simplified system can be adopted worldwide to meet the growing need for accessible and affordable IVF. A common notion concerning the demographics of infertility is that it is largely a phenomenon associated with developed countries, where infertility treatments are commonplace. In fact, most infertile couples reside in developing/low-resource countries where infertility diagnosis and treatment is nonexistent, inaccessible or unaffordable by the vast majority of young men and women in need. The irony of this situation is that bilateral tubal occlusions, for which IVF was originally indicated and is the most effective treatment, is by far the most common cause of their infertility. We have addressed one aspect of this issue, the IVF laboratory, as part of a wider effort by the Walking Egg Project to design and establish small, dedicated centres in developing countries to provide assisted reproduction technologies that are affordable and accessible to a wider proportion of the population in need. The methods for conventional IVF designed to addresses tubal obstructions are relatively simple and free of complex instrumentation and the highly developed infrastructure common to high-resource centres. This simplified IVF system self-generates culture conditions in a closed system. After prolonged preclinical testing, a pilot clinical study was initiated in 2012 in Genk, Belgium. The findings suggest that a significant first step has been achieved in the effort to bring advanced assisted reproduction to developed countries using a low-resource but highly effective IVF system capable of bringing modern reproductive medicine to infertile couples in low-resource societies. Copyright © 2013 Reproductive Healthcare Ltd. Published by Elsevier Ltd. All rights reserved.

Issues in the Development of Cross-Cultural Assessments of Speech and Language for Children

ERIC Educational Resources Information Center

Carter, Julie A.; Lees, Janet A.; Murira, Gladys M.; Gona, Joseph; Neville, Brian G. R.; Newton, Charles R. J. C.

2005-01-01

Background: There is an increasing demand for the assessment of speech and language in clinical and research situations in countries where there are few assessment resources. Due to the nature of cultural variation and the potential for cultural bias, new assessment tools need to be developed or existing tools require adaptation. However, there…

The Global Educational Toxicology Uniting Project (GETUP): an Analysis of the First Year of a Novel Toxicology Education Project.

PubMed

Wong, Anselm; Vohra, Rais; Ruha, Anne-Michelle; Koutsogiannis, Zeff; Graeme, Kimberlie; Dargan, Paul I; Wood, David M; Greene, Shaun L

2015-09-01

The international boundaries to medical education are becoming less marked as new technologies such as multiuser videoconferencing are developed and become more accessible to help bridge the communication gaps. The Global Educational Toxicology Uniting Project (GETUP) is aimed at connecting clinicians in countries with established clinical toxicology services to clinicians in countries without clinical toxicologists around the globe. Centers that manage or consult on toxicology cases were registered through the American College of Medical Toxicology website via Survey Monkey®. Data was analyzed retrospectively from February 2014 to January 2015. Google hangouts® was used as the main conferencing software, but some sites preferred the use of Skype®. Registration data included contact details and toxicology background and qualifications. Thirty sites in 19 different countries in Australasia, Europe, Africa, and America were registered. Twenty-eight (93 %) sites were located in a major urban center, one (3.5 %) site in a major rural center and one (3.5 %) a private practice. Expectations of GETUP included sharing toxicology cases and education (30, 100 % of sites), assistance with toxicology management guidelines (2, 7 %), assistance with providing a toxicology teaching curriculum in languages other than English (2, 7 %), and managing toxicology presentations in resource-poor settings, international collaboration, and toxicovigilance (2 sites, 7 %). Twenty-two conferences were performed during the first 12 months with a mean of 3 cases per conference. GETUP has connected countries and clinical units with and without toxicology services and will provide a platform to improve international collaboration in clinical toxicology.

Work participation in spondyloarthritis across countries: analysis from the ASAS-COMOSPA study.

PubMed

Rodrigues Manica, Santiago; Sepriano, Alexandre; Ramiro, Sofia; Pimentel Santos, Fernando; Putrik, Polina; Nikiphorou, Elena; Norton, Sam; Molto, Anna; Dougados, Maxime; van der Heijde, Désirée; Landewé, Robert B M; van den Bosch, Filip E; Boonen, Annelies

2018-06-02

To explore the role of individual and country level socioeconomic (SE) factors on employment, absenteeism and presenteeism in patients with spondyloarthritis (SpA) across 22 countries worldwide. Patients with a clinical diagnosis of SpA fulfilling the ASAS classification criteria and in working age (≤65 years) from COMOSPA were included. Outcomes of interest were employment status, absenteeism and presenteeism, assessed by the Work Productivity and Activity Impairment Specific General Health questionnaire. Three multivariable models were built (one per outcome) using mixed-effects binomial (for work status) or ordinal regressions (for absenteeism and presenteeism), with country as random effect. The contribution of SE factors at the individual-level (eg, gender, education, marital status) and country-level (healthcare expenditure (HCE) per capita, Human Development Index (HDI) and gross domestic product per capita) SE factors, independent of clinical factors, was assessed. In total, 3114 patients with SpA were included of which 1943 (62%) were employed. Physical function and comorbidities were related to all work outcomes in expected directions and disease activity also with absenteeism and presenteeism. Higher education (OR 4.2 (95% CI 3.1 to 5.6)) or living in a country with higher HCE (OR 2.3 (1.5 to 3.6)) or HDI (OR 1.9 (1.2 to 3.3)) was positively associated with being employed. Higher disease activity was associated with higher odds for absenteeism (OR 1.5 (1.3 to 1.7)) and presenteeism (OR 2.1 (1.8 to 2.4)). No significant association between individual-level and country-level SE factors and absenteeism or presenteeism was found. Higher education level and higher country SE welfare are associated with a higher likelihood of keeping patients with SpA employed. Absenteeism and presenteeism are only associated with clinical but not with individual-level or country-level SE factors. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

The current medical education system in the world.

PubMed

Nara, Nobuo; Suzuki, Toshiya; Tohda, Shuji

2011-07-04

To contribute to the innovation of the medical education system in Japan, we visited 35 medical schools and 5 institutes in 12 countries of North America, Europe, Australia and Asia in 2008-2010 and observed the education system. We met the deans, medical education committee and administration affairs and discussed about the desirable education system. We also observed the facilities of medical schools.Medical education system shows marked diversity in the world. There are three types of education course; non-graduate-entry program(non-GEP), graduate-entry program(GEP) and mixed program of non-GEP and GEP. Even in the same country, several types of medical schools coexist. Although the education methods are also various among medical schools, most of the medical schools have introduced tutorial system based on PBL or TBL and simulation-based learning to create excellent medical physicians. The medical education system is variable among countries depending on the social environment. Although the change in education program may not be necessary in Japan, we have to innovate education methods; clinical training by clinical clerkship must be made more developed to foster the training of the excellent clinical physicians, and tutorial education by PBL or TBL and simulation-based learning should be introduced more actively.

Executive summary and recommendations from WHO/UNAIDS and AAVP consultation on: 'The inclusion of adolescents in HIV vaccine trials', 16-18 March 2006 in Gaborone, Botswana.

PubMed

Osmanov, Saladin

2007-09-12

This report summarizes the discussions and recommendations from a consultation held in Gaborone, Botswana (16-19 March 2006), organized by the joint World Health Organization (WHO)/United Nations Programme on HIV/AIDS (UNAIDS) HIV Vaccine Initiative (HVI) and the African AIDS Vaccine Programme (AAVP). The consultation considered key challenges and strategies in enrolling adolescents into HIV vaccine clinical trials, relevant to developing countries, in particular in eastern and southern Africa. Approaches were identified that might address and resolve country-specific challenges related to scientific, legal, ethical, regulatory and community aspects of the involvement of adolescents in HIV vaccine trials. This executive summary is formulated for a broader dissemination of the outcomes of the meeting to the general clinical, scientific and regulatory community involved in the review, approval and monitoring of clinical trials and potential licensing of HIV vaccine candidates. Four major topics were discussed and recommendations developed with regard to: (i) criteria for products selection and clinical trial design; (ii) ethical and legal issues; (iii) community acceptance and participation; and (iv) regulatory considerations. The recommendations of this meeting were further discussed and endorsed by the WHO/UNAIDS HIV Vaccine Advisory Committee.

Undergraduate education in special needs dentistry in Malaysian and Australian dental schools.

PubMed

Ahmad, Mas S; Razak, Ishak A; Borromeo, Gelsomina L

2014-08-01

Meeting the oral health care needs of the growing population of people with special health care needs (SHCN) starts with dental students' acquisition of sound knowledge and development of clinical competence at the predoctoral level. The aim of this study was to review the level of undergraduate education in Special Needs Dentistry (SND) in Malaysian and Australian dental schools. The deans of all six Malaysian public dental schools and eight of nine Australian dental schools participated in a postal survey on current undergraduate didactic and clinical training in SND at their institutions. The results showed the number of dental schools in Malaysia with teaching in SND as a specific discipline was relatively low compared to that of Australia. However, a high percentage of Malaysian and Australian dental schools reported incorporating teaching of SND into pediatric dentistry (83.3 percent vs. 75 percent), oral medicine/oral pathology (66.7 percent vs. 75 percent), and oral surgery (66.7 percent vs. 25 percent). Most respondents said their school delivered SND clinical training in dental school clinics, hospital-based settings, and residential aged care facilities. Respondents in both countries viewed lack of faculty expertise as the greatest barrier to providing SND education. The study provides valuable information that can direct SND curriculum development in the two countries.

Scientific and regulatory challenges in evaluating clinical trial protocols for HIV-1/AIDS vaccines - A review from a regulatory perspective.

PubMed

Sheets, Rebecca L; Zhou, TieQun; Knezevic, Ivana

2016-03-01

Clinical development of prophylactic HIV/AIDS vaccines presents many scientific challenges that result in challenges for regulators reviewing clinical trial applications (CTAs). The World Health Organization (WHO) has the responsibility to provide technical support to these regulators. The search for an HIV/AIDS vaccine will only succeed through well-designed, -conducted and -controlled human efficacy studies reviewed and approved by regulators in countries worldwide, particularly in countries where the epidemic has hit hardest, such as in sub-Saharan Africa and Asia. This review summarizes the current candidates in development and focuses on challenges regulators face when reviewing CTAs, such as the evolving landscape of "standard of prevention," trials in adolescents, adaptive trial designs, correlates of protection and their analysis, and access to successful vaccines. There are many unknowns in the field of HIV/AIDS vaccine development and often, there is not a clear right or wrong approach because of the scientific challenges described in this review. Consequently, regulators should not feel that decisions need be made in isolation, when there are many available international collaborative efforts and opportunities to seek expert advice. The WHO provides many such opportunities and support to regulators across the globe. Copyright © 2016 The Authors. Published by Elsevier Ltd.. All rights reserved.

An automated smartphone-based diagnostic assay for point-of-care semen analysis.

PubMed

Kanakasabapathy, Manoj Kumar; Sadasivam, Magesh; Singh, Anupriya; Preston, Collin; Thirumalaraju, Prudhvi; Venkataraman, Maanasa; Bormann, Charles L; Draz, Mohamed Shehata; Petrozza, John C; Shafiee, Hadi

2017-03-22

Male infertility affects up to 12% of the world's male population and is linked to various environmental and medical conditions. Manual microscope-based testing and computer-assisted semen analysis (CASA) are the current standard methods to diagnose male infertility; however, these methods are labor-intensive, expensive, and laboratory-based. Cultural and socially dominated stigma against male infertility testing hinders a large number of men from getting tested for infertility, especially in resource-limited African countries. We describe the development and clinical testing of an automated smartphone-based semen analyzer designed for quantitative measurement of sperm concentration and motility for point-of-care male infertility screening. Using a total of 350 clinical semen specimens at a fertility clinic, we have shown that our assay can analyze an unwashed, unprocessed liquefied semen sample with <5-s mean processing time and provide the user a semen quality evaluation based on the World Health Organization (WHO) guidelines with ~98% accuracy. The work suggests that the integration of microfluidics, optical sensing accessories, and advances in consumer electronics, particularly smartphone capabilities, can make remote semen quality testing accessible to people in both developed and developing countries who have access to smartphones. Copyright © 2017, American Association for the Advancement of Science.

Student diversity and implications for clinical competency development amongst domestic and international speech-language pathology students.

PubMed

Attrill, Stacie; Lincoln, Michelle; McAllister, Sue

2012-06-01

International students graduating from speech-language pathology university courses must achieve the same minimum competency standards as domestic students. This study aimed to collect descriptive information about the number, origin, and placement performance of international students as well as perceptions of the performance of international students on placement. University Clinical Education Coordinators (CECs), who manage clinical placements in eight undergraduate and six graduate entry programs across the 10 participating universities in Australia and New Zealand completed a survey about 3455 international and domestic speech-language pathology students. Survey responses were analysed quantitatively and qualitatively with non-parametric statistics and thematic analysis. Results indicated that international students came from a variety of countries, but with a regional focus on the countries of Central and Southern Asia. Although domestic students were noted to experience significantly less placement failure, fewer supplementary placements, and reduced additional placement support than international students, the effect size of these relationships was consistently small and therefore weak. CECs rated international students as more frequently experiencing difficulties with communication competencies on placement. However, CECs qualitative comments revealed that culturally and linguistically diverse (CALD) students may experience more difficulties with speech-language pathology competency development than international students. Students' CALD status should be included in future investigations of factors influencing speech-language pathology competency development.

Vitamins and neural and cognitive developmental outcomes in children.

PubMed

Benton, David

2012-02-01

The role of vitamin status in the development of the brain and the subsequent functioning of the brain was considered. There are data with a range of vitamins, from animal studies and human studies in developing countries, suggesting that a clinical deficiency during the critical period when the brain is developing causes permanent damage. To date there is, however, with the exception of cases of clinical deficiency such as those that might be associated with a vegan diet, little evidence that variations in the diet of those living in industrialised countries have a lasting developmental influence. Similarly, later in life clinical deficiencies of various vitamins disrupt cognition although there is to date limited evidence that variations in the intake of single vitamins in industrialised societies influence functioning. It may well be, however, unreasonable to expect that vitamins examined in isolation will be associated with differences in cognitive functioning. The output of the brain reflects millions of metabolic processes, each potentially susceptible to any of a range of vitamins. A diet poor in one respect is likely to be poor in other respects as well. As such, the preliminary reports in double-blind placebo-controlled trials that aspects of cognition and behaviour respond to supplementation with multi-micronutrients may indicate the way forward.

Hookworm vaccines: past, present, and future.

PubMed

Loukas, Alex; Bethony, Jeffrey; Brooker, Simon; Hotez, Peter

2006-11-01

Hookworms are gastrointestinal nematodes that infect almost 1 billion people in developing countries. The main clinical symptom of human hookworm infections is iron-deficiency anaemia, a direct consequence of the intestinal blood loss resulting from the parasite's feeding behaviour. Although treatment is available and currently used for the periodic removal of adult hookworms from patients, this approach has not effectively controlled hookworm in areas of rural poverty. Furthermore, treated individuals remain susceptible to reinfection following exposure to third-stage infective hookworm larvae in the soil as early as 4-12 months after drug treatment. Therefore, a prophylactic vaccine against hookworm infection would provide an attractive additional tool for the public-health control of this disease. The feasibility of developing a vaccine is based on the previous success of an attenuated larval vaccine against canine hookworm. Several laboratory and field studies have explored the development of a human anti-hookworm vaccine, describing potential protective mechanisms and identifying candidate antigens, one of which is now in clinical trials. The current roadmap that investigators have conceived has been influenced by vaccine development for blood-feeding nematodes of livestock and companion animals; however, recombinant vaccines have yet to be developed for nematodes that parasitise animals or human beings. The roadmap also addresses the obstacles facing development of a vaccine for developing countries, where there is no commercial market.

Use of artemether-lumefantrine to treat malaria during pregnancy: what do we know and need to know?

PubMed

Mutabingwa, Theonest K; Adam, Ishag

2013-02-01

Artemether-lumefantrine is a fixed-dose combination containing 20 mg artemether/120 mg lumefantrine per tablet, used for treating uncomplicated malaria in patients weighing ≥5 kg. It is the first artemisinin-based combination registered in some European countries and in the USA. It is marketed in Europe as Riamet(®) (Novartis, Basel, Switzerland) and in malaria-endemic countries as Coartem(®) (Novartis). Safety concerns prevent early pregnancy usage, while limited postmarketing surveillance has delayed safety assessment and policy development. Large clinical studies, postmarketing surveillance and pharmacovigillance ongoing in some countries may soon bridge safety issues. Fatty diet requirements for optimal absorption, pregnancy-induced changes in pharmacokinetics, pregnancy-related anorexia and food taboos, and emerging reduced parasite sensitivity to artemisinin, challenges optimal artemether-lumefantrine dosing and efficacy during pregnancy. This evaluation addresses drug usage, safety concerns following early exposure, implications for changed pharmacokinetics and reduced parasite susceptibility. Clinical-use updates and strategies to address some knowledge gaps including key operational research are discussed.

The development, implementation and evaluation of clinical practice guidelines in Gulf Cooperation Council (GCC) countries: a systematic review of literature.

PubMed

Koornneef, Erik; Robben, Paul; Hajat, Cother; Ali, Azhar

2015-12-01

Our aim was to examine and describe the current situation in Gulf Cooperation Council (GCC) member countries regarding the development, implementation and evaluation of clinical practice guidelines (CPG). The objectives were to describe from where the studies originated, what the clinical focus was of each study and examine the methodology and the status of each study (i.e. development, dissemination, implementation and evaluation). Review of literature - two stages: stage 1: screening through an abstract review, followed by independent adjudicator; stage 2: detailed assessment and classification. Considering the widespread acceptance that CPG's are useful and effective tools for quality improvement in health care, it is worth noting that relatively few studies have been conducted in the GCC region that examine CPG. Furthermore, the reviewers found that the quality of the research methods used could be improved. The majority of the studies that were conducted evaluated the effects of guidelines and focused on the 'lifestyle diseases', in particular diabetes and cardiovascular diseases. It is also worth noting that there has been a steady increase in the number of publications over the 10 years period. More attention needs to be given to developing, disseminating, implementing and evaluating CPG's in the GCC region in order to improve the quality and safety of health care. © 2015 John Wiley & Sons, Ltd.

The "Performance of Rotavirus and Oral Polio Vaccines in Developing Countries" (PROVIDE) study: description of methods of an interventional study designed to explore complex biologic problems.

PubMed

Kirkpatrick, Beth D; Colgate, E Ross; Mychaleckyj, Josyf C; Haque, Rashidul; Dickson, Dorothy M; Carmolli, Marya P; Nayak, Uma; Taniuchi, Mami; Naylor, Caitlin; Qadri, Firdausi; Ma, Jennie Z; Alam, Masud; Walsh, Mary Claire; Diehl, Sean A; Petri, William A

2015-04-01

Oral vaccines appear less effective in children in the developing world. Proposed biologic reasons include concurrent enteric infections, malnutrition, breast milk interference, and environmental enteropathy (EE). Rigorous study design and careful data management are essential to begin to understand this complex problem while assuring research subject safety. Herein, we describe the methodology and lessons learned in the PROVIDE study (Dhaka, Bangladesh). A randomized clinical trial platform evaluated the efficacy of delayed-dose oral rotavirus vaccine as well as the benefit of an injectable polio vaccine replacing one dose of oral polio vaccine. This rigorous infrastructure supported the additional examination of hypotheses of vaccine underperformance. Primary and secondary efficacy and immunogenicity measures for rotavirus and polio vaccines were measured, as well as the impact of EE and additional exploratory variables. Methods for the enrollment and 2-year follow-up of a 700 child birth cohort are described, including core laboratory, safety, regulatory, and data management practices. Intense efforts to standardize clinical, laboratory, and data management procedures in a developing world setting provide clinical trials rigor to all outcomes. Although this study infrastructure requires extensive time and effort, it allows optimized safety and confidence in the validity of data gathered in complex, developing country settings. © The American Society of Tropical Medicine and Hygiene.

Duplex recombinase polymerase amplification assays incorporating competitive internal controls for bacterial meningitis detection.

PubMed

Higgins, Owen; Clancy, Eoin; Forrest, Matthew S; Piepenburg, Olaf; Cormican, Martin; Boo, Teck Wee; O'Sullivan, Nicola; McGuinness, Claire; Cafferty, Deirdre; Cunney, Robert; Smith, Terry J

2018-04-01

Recombinase polymerase amplification (RPA) is an isothermal nucleic acid amplification technology that provides rapid and robust infectious disease pathogen detection, ideal for point-of-care (POC) diagnostics in disease-prevalent low-resource countries. We have developed and evaluated three duplex RPA assays incorporating competitive internal controls for the detection of leading bacterial meningitis pathogens. Streptococcus pneumoniae, Neisseria meningitidis and Haemophilus influenzae singleplex RPA assays were initially developed and evaluated, demonstrating 100% specificity with limits of detection of 4.1, 8.5 and 3.9 genome copies per reaction, respectively. Each assay was further developed into internally controlled duplex RPA assays via the incorporation of internal amplification control templates. Clinical performance of each internally controlled duplex RPA assay was evaluated by testing 64 archived PCR-positive clinical samples. Compared to real-time PCR, all duplex RPA assays demonstrated 100% diagnostic specificity, with diagnostic sensitivities of 100%, 86.3% and 100% for the S. pneumoniae, N. meningitidis and H. influenzae assays, respectively. This study details the first report of internally controlled duplex RPA assays for the detection of bacterial meningitis pathogens: S. pneumoniae, N. meningitidis and H. influenzae. We have successfully demonstrated the clinical diagnostic utility of each duplex RPA assay, introducing effective diagnostic technology for POC bacterial meningitis identification in disease-prevalent developing countries. Copyright © 2018 Elsevier Inc. All rights reserved.

Developing standardised treatment for adults with myositis and different phenotypes: an international survey of current prescribing preferences.

PubMed

Tansley, Sarah; Shaddick, Gavin; Christopher-Stine, Lisa; Sharp, Charlotte; Dourmishev, Lyubomir; Maurer, Britta; Chinoy, Hector; McHugh, Neil

2016-01-01

The evidence base for treatment of the idiopathic inflammatory myopathies is extremely limited. The rarity and heterogeneity of these diseases has hampered the development of good quality clinical trials and while a range of immunomodulatory treatments are commonly used in clinical practice, as yet there are no clear guidelines directing their use. We aimed to establish current prescribing regimens used to treat adults with myositis internationally. An electronic survey based on different clinical scenarios was distributed internationally to clinicians involved in the treatment of patients with myositis. Participants were asked to select their first-line treatment preferences in each situation. A multinomial regression analysis was used to assess the influence of clinical scenario, respondent expertise and country of origin on first-line treatment choice. 107 survey responses were received. 57% of respondents considered themselves an expert in myositis and the majority of respondents were rheumatologists although responses from other specialities were also received. Pharmacological treatment with steroids and additional immunotherapy was the preference in most scenarios. First-line immunosuppressant choice was significantly influenced by the clinical scenario, the expertise of the treating physician and country of practice. Azathioprine, methotrexate and mycophenolate mofetil were the most commonly chosen agents. In the absence of available evidence, clinical experience and expert consensus often forms the basis of treatment guidelines. These results suggest that an international consensus approach would be possible in myositis and would overcome an urgent, yet unmet need for patients suffering with this difficult disease.

Health care professionals from developing countries report educational benefits after an online diabetes course.

PubMed

Wewer Albrechtsen, Nicolai J; Poulsen, Kristina W; Svensson, Lærke Ø; Jensen, Lasse; Holst, Jens J; Torekov, Signe S

2017-05-31

Medical education is a cornerstone in the global combat against diseases such as diabetes and obesity which together affect more than 500 million humans. Massive Open Online Courses (MOOCs) are educational tools for institutions to teach and share their research worldwide. Currently, millions of people have participated in evidence-based MOOCs, however educational and professional benefit(s) for course participants of such initiatives have not been addressed sufficiently. We therefore investigated if participation in a 6 week open online course in the prevention and treatment of diabetes and obesity had any impact on the knowledge, skills, and career of health care professionals contrasting participants from developing countries versus developed countries. 52.006 participants signed up and 29.469 participants were active in one of the three sessions (2014-2015) of Diabetes - a Global Challenge. Using an online based questionnaire (nine sections) software (Survey Monkey), email invitations were send out using a Coursera based database to the 29.469 course participants. Responses were analyzed and stratified, according to the United Nations stratification method, by developing and developed countries. 1.303 (4.4%) of the 29.469 completed the questionnaire. 845 of the 1303 were defined as health care professionals, including medical doctors (34%), researchers (15%), nurses (11%) and medical students (8%). Over 80% of the health care participants report educational benefits, improved knowledge about the prevention and treatment therapies of diabetes and furthermore improved professional life and practice. Over 40% reported that their professional network expanded after course participation. Study participants who did not complete all modules of the course reported similar impact as the ones that completed the entire course(P = 0.9). Participants from developing countries gained more impact on their clinical practice (94%) compared to health care professionals from developed regions (88%) (Mean of differences = 6%, P = 0.03. Based on self-reports from course participants, MOOC based medical education seems promising with respect to providing accessible and free research-based education to health professionals in both developing and developed countries. Course participants from developing countries report more benefits from course participation than their counterparts in the developed world.

Epidemiology of clinical trials of medicines in respiratory diseases in Europe and Italy.

PubMed

Bodini, Roberta; Santus, Pierachille; Di Marco, Fabiano; Aliberti, Stefano; Centanni, Stefano; Blasi, Francesco; Rizzi, Andrea; Recchia, Giuseppe

2017-04-01

Clinical trials play a key role in advancing medical knowledge, improving patient care and promoting economic growth in Europe. We have assessed the clinical trial activity in any respiratory diseases in Europe, with a specific focus on Italy. Information from public sources (EFPIA, clinicaltrials.gov, clinicaltrialsregister. eu, AIFA) was used to describe clinical trial activity of in respiratory diseases in Europe and by country. In 2015, 3908 clinical trials were reported in Europe, 386 in respiratory diseases (9.9%). Germany was the first country both as absolute number (76 trials) and as percentage within country trials (14%), followed by Poland. Spain, Italy and France were the countries with the lowest number and percentage of trials in respiratory diseases. In 2013, the Italian Drug Agency reported 9 trials with respiratory compounds in Italy (2.1% of overall trials, 12ˆ position in the therapeutic area rank), 33% in phase 2 and 66% in phase 3. No phase 1 or phase 4 trials were reported for respiratory trials. Prevalence of respiratory trials by non-profit sponsors (28.3%) was below the average for the country (38.3%). Europe has a greater potential for clinical research on drugs for respiratory diseases, particularly in countries with less activity, such as Spain, France and Italy, that should identify and implement actions to increase attractiveness for clinical trials of drugs. Copyright © 2017 Elsevier Ltd. All rights reserved.

Development of an emergency nursing training curriculum in Ghana.

PubMed

Bell, Sue Anne; Oteng, Rockefeller; Redman, Richard; Lapham, Jeremy; Bam, Victoria; Dzomecku, Veronica; Yakubu, Jamila; Tagoe, Nadia; Donkor, Peter

2014-10-01

The formal provision of emergency health care is a developing specialty in many sub-Saharan African countries, including Ghana. While emergency medicine training programs for physicians are on the rise, there are few established training programs for emergency nurses. The results of a unique collaboration are described between a university in the United States, a Ghanaian university and a Ghanaian teaching hospital that has developed an emergency nursing diploma program. The expected outcomes of this training program include: (a) an innovative, interdisciplinary, team-based clinical training model, (b) a unique and low-resource emergency nursing curriculum and (c) a comprehensive and sustainable training program to increase in-country retention of nurses. Copyright © 2014 Elsevier Ltd. All rights reserved.

Environmental enteric dysfunction is associated with altered bile acid metabolism

USDA-ARS?s Scientific Manuscript database

Environmental enteric dysfunction (EED), a clinically asymptomatic condition characterized by inflammation of the small bowel mucosa, villous atrophy, and increased gut permeability, is common among children in developing countries. Because of abnormal gut mucosa and altered gut microbiome, EED coul...

Missing in action: teacher and health worker absence in developing countries.

PubMed

Chaudhury, Nazmul; Hammer, Jeffrey; Kremer, Michael; Muralidharan, Karthik; Rogers, F Halsey

2006-01-01

In this paper, we report results from surveys in which enumerators make unannounced visits to primary schools and health clinics in Bangladesh, Ecuador, India, Indonesia, Peru and Uganda and recorded whether they found teachers and health workers in the facilities.

International Telepharmacy Education: Another Venue to Improve Cancer Care in the Developing World

PubMed Central

AlFaar, Ahmad S.; Kamal, Sherif; AbouElnaga, Sherif; Greene, William L.; Quintana, Yuri; Ribeiro, Raul C.

2012-01-01

Abstract Objective: In developed countries, pharmacists play a crucial role in designing and implementing cancer treatments as part of a multidisciplinary oncology team. However, developing countries have a shortage of pharmacists, and their role is generally limited to dispensing and selling drugs. The aim of this study was to investigate the feasibility of providing clinical pharmacy educational activities via international teleconferencing to improve cancer care in developing countries. Materials and Methods: Meticulous preparation and intense promotion of the workshop were done in Egypt before the telepharmacy conferences began. Multiple connectivity tests were performed to resolve technical problems. Nine telepharmacy conferences were delivered during 3-h sessions that were held on three consecutive days. Talks were subsequently made available via Web streaming. Attendees were requested to complete a survey to measure their satisfaction with the sessions. Results: The teleconference was attended by a total of 345 persons, and it was subsequently reviewed online via 456 log-in sessions from 10 countries. Technical issues (e.g., poor auditory quality) were resolved on the first day of the event. The rate of attendees' responses on the survey was 30.1%, and satisfaction with the event was generally good. Conclusions: Telecommunication is a relatively inexpensive approach that may improve pharmacy practices, especially those used to treat patients with cancer in developing countries. Special attention to patient-based telepharmacy education, including the use of cost-effective technology, should be considered. PMID:22667696

Pediatric and Adolescent Gynecology in Europe: Clinical Services, Standards of Care, and Training.

PubMed

Richmond, Anna; Priyanka, Sweta; Mahmood, Tahir; MacDougall, Jane; Wood, Paul

2016-06-01

To identify current clinical services and training available across Europe within pediatric and adolescent gynecology (PAG) and establish the extent to which PAG services meet current European Board and College of Obstetrics and Gynecology (EBCOG) standards. Quantitative and qualitative questionnaire. European countries that are members of the EBCOG and the European Association of Pediatric and Adolescent Gynecology. Thirty-six countries that were approached beginning in September 2013; data were obtained from 27 countries. Questionnaires with 28 stems were sent to clinical leaders in 36 European countries. National society, national standards, legislation for female genital mutilation, protocols for transition to adult services, human papilloma virus vaccination programs, sex and contraception education, safeguarding, clinical leads for PAG, delivery of PAG services, and training available for PAG. Of 36 countries, 27 responded. Seventy-seven percent had a national PAG society but only 44% had national standards in PAG. There was agreement that PAG cases should be multidisciplinary but not all have clinical networks in place to facilitate this. Human papilloma virus programs are available in some European countries and not all have legislation against female genital mutilation. A significant proportion of cases continue to be seen in adult gynecology clinics as opposed to designated PAG clinics with only 41% with processes to transfer patients into adult care. In this article we provide a framework to explore areas for improvement within PAG services and training across Europe. The EBCOG standards of care are not being adhered to in many countries because processes and clinical networks are not in place to facilitate them. Crown Copyright © 2015. Published by Elsevier Inc. All rights reserved.

Strengthening laboratory systems in resource-limited settings.

PubMed

Olmsted, Stuart S; Moore, Melinda; Meili, Robin C; Duber, Herbert C; Wasserman, Jeffrey; Sama, Preethi; Mundell, Ben; Hilborne, Lee H

2010-09-01

Considerable resources have been invested in recent years to improve laboratory systems in resource-limited settings. We reviewed published reports, interviewed major donor organizations, and conducted case studies of laboratory systems in 3 countries to assess how countries and donors have worked together to improve laboratory services. While infrastructure and the provision of services have seen improvement, important opportunities remain for further advancement. Implementation of national laboratory plans is inconsistent, human resources are limited, and quality laboratory services rarely extend to lower tier laboratories (eg, health clinics, district hospitals). Coordination within, between, and among governments and donor organizations is also frequently problematic. Laboratory standardization and quality control are improving but remain challenging, making accreditation a difficult goal. Host country governments and their external funding partners should coordinate their efforts effectively around a host country's own national laboratory plan to advance sustainable capacity development throughout a country's laboratory system.

[Satellite symposium: Asthma in the World. Asthma among children in Latin America].

PubMed

Mallol, J

2004-01-01

The prevalence of respiratory symptoms related to asthma in children from Latin America has been largely ignored. This region participated in phases I and III of the International Study of Asthma and Allergies in Childhood (ISAAC) with 17 participating centers in phase I and 78 centers in phase III. Data were obtained on asthma, rhinitis and eczema from countries and centers with markedly different climactic, cultural and environmental conditions and socioeconomic development. The results for phase I are presented herein because data from phase III are currently being revised at the ISAAC international data control center and will be officially available in the second half of 2004. Phase I provided important information on the prevalence of asthma in the participating countries and demonstrated wide variation among centers in the same country and among countries. The participating Latin American countries are all developing countries and share more or less the same problems related to low socioeconomic status. Therefore, the results and figures should be analyzed within that context. The range for accumulative and current asthma symptoms in children from the Latin American countries that participated in phase I (89,000) were as follows: the prevalence of asthma ranged from 5.5% to 28% in children aged 13-14 years and from 4.1% to 26.9% in children aged 6-7 years. The prevalence of wheezing in the previous 12 months ranged from 6.6% to 27% in children aged 13-14 years and from 8.6% to 32.1% in children aged 6-7 years. The high figures for asthma in a region with a high level of gastrointestinal parasites infestation, a high burden of acute respiratory and gastrointestinal infections occurring early in life, severe environmental and hygiene problems, suggest that these factors, considered as protective in other (developed) regions of the world, do not have the same effect in this region. Furthermore, those aggressive environmental conditions acting together from very early in life might condition different asthmatic phenotypes with more severe clinical presentation in infancy (first 2 years of life), lower atopy and enhanced airways reactivity. The present study indicates that the prevalence of asthma and related symptoms in Latin America is as high and variable as described previously for industrialized or developed regions of the world and that the environmental risk factors, mainly related with poverty, could be responsible for the different clinical and functional presentations of asthma in children from developing regions.

Development and psychometric validation of a self-administered questionnaire assessing the acceptance of influenza vaccination: the Vaccinees' Perception of Injection (VAPI©) questionnaire

PubMed Central

Chevat, Catherine; Viala-Danten, Muriel; Dias-Barbosa, Carla; Nguyen, Van Hung

2009-01-01

Background Influenza is among the most common infectious diseases. The main protection against influenza is vaccination. A self-administered questionnaire was developed and validated for use in clinical trials to assess subjects' perception and acceptance of influenza vaccination and its subsequent injection site reactions (ISR). Methods The VAPI questionnaire was developed based on interviews with vaccinees. The initial version was administered to subjects in international clinical trials comparing intradermal with intramuscular influenza vaccination. Item reduction and scale construction were carried out using principal component and multitrait analyses (n = 549). Psychometric validation of the final version was conducted per country (n = 5,543) and included construct and clinical validity and internal consistency reliability. All subjects gave their written informed consent before being interviewed or included in the clinical studies. Results The final questionnaire comprised 4 dimensions ("bother from ISR"; "arm movement"; "sleep"; "acceptability") grouping 16 items, and 5 individual items (anxiety before vaccination; bother from pain during vaccination; satisfaction with injection system; willingness to be vaccinated next year; anxiety about vaccination next year). Construct validity was confirmed for all scales in most of the countries. Internal consistency reliability was good for all versions (Cronbach's alpha ranging from 0.68 to 0.94), as was clinical validity: scores were positively correlated with the severity of ISR and pain. Conclusion The VAPI questionnaire is a valid and reliable tool, assessing the acceptance of vaccine injection and reactions following vaccination. Trial registration NCT00258934, NCT00383526, NCT00383539. PMID:19261173

The core role of the nurse practitioner: practice, professionalism and clinical leadership.

PubMed

Carryer, Jenny; Gardner, Glenn; Dunn, Sandra; Gardner, Anne

2007-10-01

To draw on empirical evidence to illustrate the core role of nurse practitioners in Australia and New Zealand. Enacted legislation provides for mutual recognition of qualifications, including nursing, between New Zealand and Australia. As the nurse practitioner role is relatively new in both countries, there is no consistency in role expectation and hence mutual recognition has not yet been applied to nurse practitioners. A study jointly commissioned by both countries' Regulatory Boards developed information on the core role of the nurse practitioner, to develop shared competency and educational standards. Reporting on this study's process and outcomes provides insights that are relevant both locally and internationally. This interpretive study used multiple data sources, including published and grey literature, policy documents, nurse practitioner program curricula and interviews with 15 nurse practitioners from the two countries. Data were analysed according to the appropriate standard for each data type and included both deductive and inductive methods. The data were aggregated thematically according to patterns within and across the interview and material data. The core role of the nurse practitioner was identified as having three components: dynamic practice, professional efficacy and clinical leadership. Nurse practitioner practice is dynamic and involves the application of high level clinical knowledge and skills in a wide range of contexts. The nurse practitioner demonstrates professional efficacy, enhanced by an extended range of autonomy that includes legislated privileges. The nurse practitioner is a clinical leader with a readiness and an obligation to advocate for their client base and their profession at the systems level of health care. A clearly articulated and research informed description of the core role of the nurse practitioner provides the basis for development of educational and practice competency standards. These research findings provide new perspectives to inform the international debate about this extended level of nursing practice. The findings from this research have the potential to achieve a standardised approach and internationally consistent nomenclature for the nurse practitioner role.

Using multicriteria decision analysis during drug development to predict reimbursement decisions.

PubMed

Williams, Paul; Mauskopf, Josephine; Lebiecki, Jake; Kilburg, Anne

2014-01-01

Pharmaceutical companies design clinical development programs to generate the data that they believe will support reimbursement for the experimental compound. The objective of the study was to present a process for using multicriteria decision analysis (MCDA) by a pharmaceutical company to estimate the probability of a positive recommendation for reimbursement for a new drug given drug and environmental attributes. The MCDA process included 1) selection of decisions makers who were representative of those making reimbursement decisions in a specific country; 2) two pre-workshop questionnaires to identify the most important attributes and their relative importance for a positive recommendation for a new drug; 3) a 1-day workshop during which participants undertook three tasks: i) they agreed on a final list of decision attributes and their importance weights, ii) they developed level descriptions for these attributes and mapped each attribute level to a value function, and iii) they developed profiles for hypothetical products 'just likely to be reimbursed'; and 4) use of the data from the workshop to develop a prediction algorithm based on a logistic regression analysis. The MCDA process is illustrated using case studies for three countries, the United Kingdom, Germany, and Spain. The extent to which the prediction algorithms for each country captured the decision processes for the workshop participants in our case studies was tested using a post-meeting questionnaire that asked the participants to make recommendations for a set of hypothetical products. The data collected in the case study workshops resulted in a prediction algorithm: 1) for the United Kingdom, the probability of a positive recommendation for different ranges of cost-effectiveness ratios; 2) for Spain, the probability of a positive recommendation at the national and regional levels; and 3) for Germany, the probability of a determination of clinical benefit. The results from the post-meeting questionnaire revealed a high predictive value for the algorithm developed using MCDA. Prediction algorithms developed using MCDA could be used by pharmaceutical companies when designing their clinical development programs to estimate the likelihood of a favourable reimbursement recommendation for different product profiles and for different positions in the treatment pathway.

Using multicriteria decision analysis during drug development to predict reimbursement decisions

PubMed Central

Williams, Paul; Mauskopf, Josephine; Lebiecki, Jake; Kilburg, Anne

2014-01-01

Background Pharmaceutical companies design clinical development programs to generate the data that they believe will support reimbursement for the experimental compound. Objective The objective of the study was to present a process for using multicriteria decision analysis (MCDA) by a pharmaceutical company to estimate the probability of a positive recommendation for reimbursement for a new drug given drug and environmental attributes. Methods The MCDA process included 1) selection of decisions makers who were representative of those making reimbursement decisions in a specific country; 2) two pre-workshop questionnaires to identify the most important attributes and their relative importance for a positive recommendation for a new drug; 3) a 1-day workshop during which participants undertook three tasks: i) they agreed on a final list of decision attributes and their importance weights, ii) they developed level descriptions for these attributes and mapped each attribute level to a value function, and iii) they developed profiles for hypothetical products ‘just likely to be reimbursed’; and 4) use of the data from the workshop to develop a prediction algorithm based on a logistic regression analysis. The MCDA process is illustrated using case studies for three countries, the United Kingdom, Germany, and Spain. The extent to which the prediction algorithms for each country captured the decision processes for the workshop participants in our case studies was tested using a post-meeting questionnaire that asked the participants to make recommendations for a set of hypothetical products. Results The data collected in the case study workshops resulted in a prediction algorithm: 1) for the United Kingdom, the probability of a positive recommendation for different ranges of cost-effectiveness ratios; 2) for Spain, the probability of a positive recommendation at the national and regional levels; and 3) for Germany, the probability of a determination of clinical benefit. The results from the post-meeting questionnaire revealed a high predictive value for the algorithm developed using MCDA. Conclusions Prediction algorithms developed using MCDA could be used by pharmaceutical companies when designing their clinical development programs to estimate the likelihood of a favourable reimbursement recommendation for different product profiles and for different positions in the treatment pathway.

Needs for Professional Education to Optimize Cervical Cancer Screenings in Low-Income Countries: a Case Study from Tanzania.

PubMed

Lavelle, Anne E; Su, Dejun; Kahesa, Crispin; Soliman, Amr S

2017-09-11

Cervical cancer is a significant health problem in many developing countries. Due to limited treatment facilities for cancer in Tanzania, a screening referral program was developed between two urban clinics and Ocean Road Cancer Institute (ORCI), the only cancer treatment center in Tanzania. This study aimed to evaluate the effectiveness of the program and to identify opportunities for professional education. The study included 139 patients who were referred to ORCI from the screening clinics of Magomeni and Temeke between January 2015 and May 2016. Abstracted data from the medical records included patient age, screening results, and treatment. Eight nurses performing screening at the three locations were interviewed about their screening experience. Over half of the referrals (51.9%) were false positives. False positive diagnosis was more common among younger patients (35.68 ± 8.6 years) (p < 0.001) and those referred from Magomeni (59.8%) (p < 0.01) than referrals of older patients (42.46 ± 11.1 years) or those from Temeke (33.3%). Interviews of nurses showed differences among clinics, including resources, experience, and documentation of screening results. The high false positive rates and the variation of accuracy of screening between the two clinics showed a need for professional education of nurses and improvement in the health systems. Continuous education of nurses may increase the effectiveness of cervical screening. Health system enhancement of screening facilities such as provision of Lugol's iodine, more space for screening, and consistency and completion of screening records are needed to increase the accuracy of cervical screening and referrals in Tanzania and other similar low-income countries.

Japanese encephalitis vaccines: current vaccines and future prospects.

PubMed

Monath, T P

2002-01-01

Vaccination against JE ideally should be practiced in all areas of Asia where the virus is responsible for human disease. The WHO has placed a high priority on the development of a new vaccine for prevention of JE. Some countries in Asia (Japan, South Korea, North Korea, Taiwan, Vietnam, Thailand, and the PRC) manufacture JE vaccines and practice childhood immunization, while other countries suffering endemic or epidemic disease (India, Nepal, Laos, Cambodia, Bangladesh, Myanmar, Malaysia, Indonesia and the Philippines) have no JE vaccine manufacturing or policy for use. With the exception of the PRC, all countries practicing JE vaccination use formalin inactivated mouse brain vaccines, which are relatively expensive and are associated with rare but clinically significant allergic and neurological adverse events. New inactivated JE vaccines manufactured in Vero cells are in advanced preclinical or early clinical development in Japan, South Korea, Taiwan, and the PRC. An empirically derived, live attenuated vaccine (SA14-14-2) is widely used in the PRC. Trials in the PRC have shown SA14-14-2 to be safe and effective when administered in a two-dose regimen, but regulatory concerns over manufacturing and control have restricted international distribution. The genetic basis of attenuation of SA14-14-2 has been partially defined. A new live attenuated vaccine (ChimeriVax-JE) that uses a reliable flavivirus vaccine--yellow fever 17D--as a live vector for the envelope genes of SA14-14-2 virus is in early clinical trials and appears to be well tolerated and immunogenic after a single dose. Vaccinia and avipox vectored vaccines have also been tested clinically, but are no longer being pursued due to restricted effectiveness mediated by anti-vector immunity. Other approaches to JE vaccines--including naked DNA, oral vaccination, and recombinant subunit vaccines--have been reviewed.

Clinical nurse specialists: essential resource for an effective NHS.

PubMed

Vidall, Cheryl; Barlow, Helen; Crowe, Maggie; Harrison, Isabel; Young, Annie

Despite emerging evidence for the clinical and financial efficacy of the clinical nurse specialist (CNS), the provision of this role is patchy across the country. There is also a risk that incumbent CNS' may be redirected to less specialist work in trusts that do not appreciate the full value of the service that these nurses provide. Optimal and equitable patient access to CNS care will require the development of a strong evidence base showing that specialist nurses not only deliver patient-focused care, but that they can also help to meet healthcare managers' objectives of streamlined, cost-effective clinical services.

Assessing Clinical Research Capacity in Vietnam: A Framework for Strengthening Capability for Clinical Trials in Developing Countries.

PubMed

Kagan, Jonathan; Giang, Dao Duc; Iademarco, Michael F; Phung, Van Tt; Lau, Chuen-Yen; Quang, Nguyen Ngo

2016-01-01

Although improving health systems promises important benefits, most developing nations lack the resources to support nationally driven clinical research. Strengthened clinical research capacity can advance national health goals by supporting greater autonomy in aligning research with national priorities. From March through June 2010, we assessed six elements of clinical research capacity in Vietnam: research agenda; clinical investigators and biostatisticians; donors and sponsors; community involvement; scientific, ethical, safety, and quality oversight; and clinical research institutions. Assessments were drawn from interviews with investigators, Ministry of Health staff members, nongovernment organizations, and U.S. Mission staff members, and document review. Observations and recommendations were shared with collaborators. Reassessment in 2015 found growth in the number of clinical trials, improved regulation in human subjects protection and community engagement, and modest advances in research agenda setting. Training and investment in institutions remain challenging. A framework for assessing clinical research capacity can affirm strengths and weaknesses and guide the coordination of capacity-building efforts.

International Clinical Trials in Latin American and Caribbean Countries: Research and Development to Meet Local Health Needs

PubMed Central

da Silva, Ricardo E.; Amato, Angélica A.; Guilhem, Dirce B.; de Carvalho, Marta R.; Novaes, Maria R. C. G.

2018-01-01

Introduction: Although international health research involves some benefits for the host countries, such as access to innovative treatments, the research itself may not be aligned with their communities' actual health needs. Objective: To map the global landscape of clinical trials run in Latin American and Caribbean countries and discuss the addressing of local health needs in the agenda of international clinical trials. Methods: The present study is a cross-sectional overview and used data referent to studies registered between 01/01/2014 and 12/31/2014 in the World Health Organization's (WHO) International Clinical Trials Registry Platform (ICTRP). Results: Non-communicable diseases such as diabetes, cancer, and asthma—studies which were financed mainly by industries—were the conditions investigated most in the region of Latin America and the Caribbean. The neglected diseases, on the other hand, such as Chagas disease, and dengue, made up 1% of the total number of studies. Hospitals and nonprofit nongovernmental organizations prioritize resources for investigating new drugs for neglected diseases, such as Chagas disease and dengue. Conclusion: The international multicenter clinical trials for investigating new drugs are aligned with the health needs of the region of Latin America and the Caribbean, when one considers the burden resulting from the non-communicable diseases in this region. However, the transmissible diseases, such as tuberculosis and AIDS, and the neglected diseases, such as Chagas disease and dengue, which have an important impact on public health in this region, continue to arouse little interest among the institutions which finance the clinical trials. PMID:29354059

Design and development of an international clinical data exchange system: the international layer function of the Dolphin Project

PubMed Central

Zhou, Tian-shu; Chu, Jian; Araki, Kenji; Yoshihara, Hiroyuki

2011-01-01

Objective At present, most clinical data are exchanged between organizations within a regional system. However, people traveling abroad may need to visit a hospital, which would make international exchange of clinical data very useful. Background Since 2007, a collaborative effort to achieve clinical data sharing has been carried out at Zhejiang University in China and Kyoto University and Miyazaki University in Japan; each is running a regional clinical information center. Methods An international layer system named Global Dolphin was constructed with several key services, sharing patients' health information between countries using a medical markup language (MML). The system was piloted with 39 test patients. Results The three regions above have records for 966 000 unique patients, which are available through Global Dolphin. Data exchanged successfully from Japan to China for the 39 study patients include 1001 MML files and 152 images. The MML files contained 197 free text-type paragraphs that needed human translation. Discussion The pilot test in Global Dolphin demonstrates that patient information can be shared across countries through international health data exchange. To achieve cross-border sharing of clinical data, some key issues had to be addressed: establishment of a super directory service across countries; data transformation; and unique one—language translation. Privacy protection was also taken into account. The system is now ready for live use. Conclusion The project demonstrates a means of achieving worldwide accessibility of medical data, by which the integrity and continuity of patients' health information can be maintained. PMID:21571747

White Paper Report of the RAD-AID Conference on International Radiology for Developing Countries: identifying challenges, opportunities, and strategies for imaging services in the developing world.

PubMed

Mollura, Daniel J; Azene, Ezana M; Starikovsky, Anna; Thelwell, Aduke; Iosifescu, Sarah; Kimble, Cary; Polin, Ann; Garra, Brian S; DeStigter, Kristen K; Short, Brad; Johnson, Benjamin; Welch, Christian; Walker, Ivy; White, David M; Javadi, Mehrbod S; Lungren, Matthew P; Zaheer, Atif; Goldberg, Barry B; Lewin, Jonathan S

2010-07-01

The RAD-AID Conference on International Radiology for Developing Countries was an assembly of individuals and organizations interested in improving access to medical imaging services in developing countries where the availability of radiology has been inadequate for both patient care and public health programs. The purpose of the meeting was to discuss data, experiences, and models pertaining to radiology in the developing world and to evaluate potential opportunities for future collaboration. Conference participants included radiologists, technologists, faculty members of academic medical institutions, and leadership of nongovernmental organizations involved in international health care and social entrepreneurship. Four main themes from the conference are presented in this white paper as important factors for the implementation and optimization of radiology in the developing world: (1) ensuring the economic sustainability of radiologic services through financial and administrative training support of health care personnel; (2) designing, testing, and deploying clinical strategies adapted for regions with limited resources; (3) structuring and improving the role of American radiology residents interested in global health service projects; and (4) implementing information technology models to support digital imaging in the developing world. Published by Elsevier Inc.

Designing for scale: development of the ReMotion Knee for global emerging markets.

PubMed

Hamner, Samuel R; Narayan, Vinesh G; Donaldson, Krista M

2013-09-01

Amputees living in developing countries have a profound need for affordable and reliable lower limb prosthetic devices. The World Health Organization estimates there are approximately 30 million amputees living in low-income countries, with up to 95% lacking access to prosthetic devices. Effective prosthetics can significantly affect the lives of these amputees by increasing opportunity for employment and providing improvements to long-term health and well-being. However, current solutions are inadequate: state-of-the-art solutions from the US and Europe are cost-prohibitive, while low-cost devices have been challenged by poor quality and/or unreliable performance, and have yet to achieve large scale impact. The introduction of new devices is hampered by the lack of a cohesive prosthetics industry in low-income areas; the current network of low-cost prosthetic clinics is informal and loosely organized with significant disparities in geography, patient volume and demographics, device procurement, clinical and logistical infrastructure, and funding. At D-Rev (Design Revolution) we are creating the ReMotion Knee, which is an affordable polycentric prosthetic knee joint that performs on par with devices in more industrialized regions, like the US and Europe. As of September 2012, over 4200 amputees have been fitted with the initial version of the ReMotion Knee through a partnership with the JaipurFoot Organization, with an 79% compliance rate after 2 years. We are currently scaling production of the ReMotion Knee using centralized manufacturing and distribution to serve the existing clinics in low-income countries and increase the availability of devices for amputees without access to appropriate care. At D-Rev, we develop products that target these customers through economically-sustainable models and provide a measurable impact in the lives of the world's amputees.

Clinical nursing and midwifery research in African countries: a scoping review.

PubMed

Sun, Carolyn; Larson, Elaine

2015-05-01

Globally, the nursing shortage has been deemed a crisis, but African countries have been hit hardest. Therefore, it is of utmost importance nurses use the best available evidence and that nursing research is targeted to address gaps in the evidence. To achieve this, an understanding of what is currently available and identification of gaps in clinical nursing research is critical. We performed a scoping review of existing literature to assess clinical nursing research conducted in all African countries over the past decade, identify gaps in clinical nursing and midwifery research, determine whether they match with health priorities for countries, and define priorities for regional clinical nursing research agendas to improve health outcomes. This is a scoping review of published clinical nursing research conducted in African countries. Systematic searches of literature published between January 01, 2004 and September 15, 2014 were performed in PubMed, Medline, CINHAL, and Embase. Research was included if it was conducted by nurses, included data obtained in African countries or regions within the African continent, published in a peer-reviewed journal with an abstract, and included patient outcomes. Abstracts were independently reviewed for inclusion by two authors. The following data were extracted: countries of publication and study, study type and design, journal, language, and topics of research. Gaps in the literature were identified. Initially, 1091 papers were identified with a final sample of 73 articles meeting inclusion criteria. Studies used 12 designs, were published in 35 journals published in five countries (including two African countries); 29% of the research was published in a single journal (Curatonis). Research was mostly qualitative (57%) and included twenty countries in Africa (38%). There were 12 major topics of study, most often midwifery/maternal/child health (43%), patient experiences (38%), and human immunodeficiency virus (HIV)/sexually transmitted infections (STIs) (36%). Areas most often studied were associated with funding sources (e.g., a large influx of funds for HIV-related research). Major and common health care problems in African countries (e.g. infectious disease other than HIV, and noncommunicable diseases such as malnutrition, diarrheal disease, hypertension and diabetes) were not subjects of the published literature, indicating a clear gap between health care needs and problems and the focus of the majority of clinical nursing research. Additionally, the shortage of doctorally prepared nurses may contribute to the lack of clinical nursing and midwifery research in African countries. Copyright © 2015 Elsevier Ltd. All rights reserved.

The use of nanoparticulates to treat breast cancer.

PubMed

Tang, Xiaomeng; Loc, Welley S; Dong, Cheng; Matters, Gail L; Butler, Peter J; Kester, Mark; Meyers, Craig; Jiang, Yixing; Adair, James H

2017-10-01

Breast cancer is a major ongoing public health issue among women in both developing and developed countries. Significant progress has been made to improve the breast cancer treatment in the past decades. However, the current clinical approaches are invasive, of low specificity and can generate severe side effects. As a rapidly developing field, nanotechnology brings promising opportunities to human cancer diagnosis and treatment. The use of nanoparticulate-based platforms overcomes biological barriers and allows prolonged blood circulation time, simultaneous tumor targeting and enhanced accumulation of drugs in tumors. Currently available and clinically applicable innovative nanoparticulate-based systems for breast cancer nanotherapies are discussed in this review.

Flexible substrate-based devices for point-of-care diagnostics

PubMed Central

Wang, ShuQi; Chinnasamy, Thiruppathiraja; Lifson, Mark; Inci, Fatih; Demirci, Utkan

2016-01-01

Point-of-care (POC) diagnostics play an important role in delivering healthcare, particularly for clinical management and disease surveillance in both developed and developing countries. Currently, the majority of POC diagnostics utilize paper substrates owing to their affordability, disposability, and mass production capability. Recently, flexible polymer substrates have been investigated due to their enhanced physicochemical properties, potential to be integrated into wearable devices with wireless communications for personalized health monitoring, and ability to be customized for POC diagnostics. Here, we focus on the latest advances in developing flexible substrate-based diagnostic devices, including paper and polymers, and their clinical applications at the POC. PMID:27344425

Flexible Substrate-Based Devices for Point-of-Care Diagnostics.

PubMed

Wang, ShuQi; Chinnasamy, Thiruppathiraja; Lifson, Mark A; Inci, Fatih; Demirci, Utkan

2016-11-01

Point-of-care (POC) diagnostics play an important role in delivering healthcare, particularly for clinical management and disease surveillance in both developed and developing countries. Currently, the majority of POC diagnostics utilize paper substrates owing to affordability, disposability, and mass production capability. Recently, flexible polymer substrates have been investigated due to their enhanced physicochemical properties, potential to be integrated into wearable devices with wireless communications for personalized health monitoring, and ability to be customized for POC diagnostics. Here, we focus on the latest advances in developing flexible substrate-based diagnostic devices, including paper and polymers, and their clinical applications. Copyright © 2016 Elsevier Ltd. All rights reserved.

Proband-only medical exome sequencing as a cost-effective first-tier genetic diagnostic test for patients without prior molecular tests and clinical diagnosis in a developing country: the China experience.

PubMed

Hu, Xuyun; Li, Niu; Xu, Yufei; Li, Guoqiang; Yu, Tingting; Yao, Ru-En; Fu, Lijun; Wang, Jiwen; Yin, Lei; Yin, Yong; Wang, Ying; Jin, Xingming; Wang, Xiumin; Wang, Jian; Shen, Yiping

2017-11-02

PurposeTo evaluate the performance of proband-only medical exome sequencing (POMES) as a cost-effective first-tier diagnostic test for pediatric patients with unselected conditions.MethodsA total of 1,323 patients were tested by POMES, which targeted 2,742 known disease-causing genes. Clinical relevant variants were Sanger-confirmed in probands and parents. We assessed the diagnostic validity and clinical utility of POMES by means of a survey questionnaire.ResultsPOMES, ordered by 136 physicians, identified 512 pathogenic or likely pathogenic variants associated with over 200 conditions. The overall diagnostic rate was 28.8%, ranging from 10% in neonatal intensive care unit patients to over 35% in pediatric intensive care unit patients. The test results had an impact on the management of the 45.1% of patients for whom there were positive findings. The average turnaround time was 57 days; the cost was $360/case.ConclusionWe adopted a relatively efficient and cost-effective approach in China for the molecular diagnosis of pediatric patients with suspected genetic conditions. While training for clinical geneticists and other specialists is lagging behind in China POMES is serving as a diagnostic equalizer for patients who do not normally receive extensive clinical evaluation and clinical diagnosis prior to testing. This Chinese experience should be applicable to other developing countries that are lacking clinical, financial, and personnel resources.GENETICS in MEDICINE advance online publication, 2 November 2017; doi:10.1038/gim.2017.195.

Abdominal ultrasonographic findings in typhoid fever: a comparison between typhoid patients and those with non-typhoidal Salmonella and Campylobacter jejuni enterocolitis.

PubMed

Kobayashi, Akira; Adachi, Yasuo; Iwata, Yoshinori; Sakai, Yoshiyuki; Shigemitu, Kazuaki; Todoroki, Miwako; Ide, Mituru

2012-03-01

Typhoid fever is a major health problem in many developing countries and its clinical features are similar to other types of bacterial enterocolitis. Definitive diagnosis by blood culture requires several days and is often unfeasible to perform in developing countries. More efficient and rapid diagnostic methods for typhoid are needed. We compared the pathological changes in the bowel and adjacent tissues of patients having typhoid fever with those having bacterial enterocolitis using ultrasonography. A characteristic of patients with non-typhoidal Salmonella and Campylobacter jejuni enterocolitis was mural thickening of the terminal ileum; only mild mural swelling or no swelling was observed in patients with typhoid fever. Mesenteric lymph nodes in patients with typhoid fever were significantly more enlarged compared to patients with other types of bacterial enterocolitis. Our findings suggest typhoid fever is not fundamentally an enteric disease but rather resembles mesenteric lymphadenopathy and ultrasound is a promising modality for diagnosing typhoid fever in developing countries.

Scalp Block for Awake Craniotomy in a Patient With a Frontal Bone Mass: A Case Report

PubMed Central

Amiri, Hamid Reza; Kouhnavard, Marjan; Safari, Saeid

2012-01-01

“Anesthesia” for awake craniotomy is a unique clinical condition that requires the anesthesiologist to provide changing states of sedation and analgesia, to ensure optimal patient comfort without interfering with electrophysiologic monitoring and patient cooperation, and also to manipulate cerebral and systemic hemodynamics while guaranteeing adequate ventilation and patency of airways. Awake craniotomy is not as popular in developing countries as in European countries. This might be due to the lack of information regarding awake craniotomy and its benefits among the neurosurgeons and anesthetists in developing countries. From the economic perspective, this procedure may decrease resource utilization by reducing the use of invasive monitoring, the duration of the operation, and the length of postoperative hospital stay. All these reasons also favor its use in the developing world, where the availability of resources still remains a challenge. In this case report we presented a successful awake craniotomy in patient with a frontal bone mass. PMID:24904791

Narrative review: tetanus-a health threat after natural disasters in developing countries.

PubMed

Afshar, Majid; Raju, Mahesh; Ansell, David; Bleck, Thomas P

2011-03-01

Tetanus is an expected complication when disasters strike in developing countries, where tetanus immunization coverage is often low or nonexistent. Collapsing structures and swirling debris inflict numerous crush injuries, fractures, and serious wounds. Clostridium tetani infects wounds contaminated with dirt, feces, or saliva and releases neurotoxins that may cause fatal disease. Clusters of infections have recently occurred after tsunamis and earthquakes in Indonesia, Kashmir, and Haiti. The emergency response to clusters of tetanus infections in developing countries after a natural disaster requires a multidisciplinary approach in the absence of an intensive care unit, readily available resources, and a functioning cold-chain system. It is essential that injured people receive immediate surgical and medical care of contaminated, open wounds with immunization and immunoglobulin therapy. Successful treatment of tetanus depends on prompt diagnosis of clinical tetanus, treatment to ensure neutralization of circulating toxin and elimination of C. tetani infection, control of spasms and convulsions, maintenance of the airway, and management of respiratory failure and autonomic dysfunction.

Intermittent Solar Ammonia Absorption Cycle (ISAAC) refrigeration for lesser developed countries

NASA Astrophysics Data System (ADS)

Erickson, Donald C.

1990-02-01

The Intermittent Solar Ammonia Absorption Cycle (ISAAC) refrigerator is a solar thermal technology which provides low cost, efficient, reliable ice-making to areas without ready access to electricity. An ISAAC refrigeration system consists of a compound parabolic solar collector, two pressure vessels, a condenser, a cold box or refrigerated space, and simple connective piping -- no moving parts or electrical components. Most parts are simple construction or plumbing grade materials, locally available in many remote areas. This technology has numerous potential benefits in lesser developed countries both by providing a cheap, reliable source of ice, and, since manufacture requires only semi-skilled labor, a source of employment to the local economy. Applications include vaccine storage for health care clinics; fish, meat, and dairy product storage; and personal consumption. Importantly, this technology increases the quality of life for people in lesser developed countries without depleting fossil fuel resources or increasing the release of greenhouse gases such as CO2 and chlorofluorocarbons.

Telemedicine as an innovative model for rebuilding medical systems in developing countries through multipartnership collaboration: the case of Albania.

PubMed

Latifi, Rifat; Dasho, Erion; Shatri, Zhaneta; Tilley, Elizabeth; Osmani, Kalterina L; Doarn, Charles R; Dogjani, Agron; Olldashi, Fatos; Koçiraj, Agim; Merrell, Ronald C

2015-06-01

The U.S. Government and other developed nations provide billions of dollars annually in relief assistance to countries around the world. The long-term benefits of this aid, however, are often difficult to elucidate. The aim of this article is to present a model of a multipartnership collaboration among U.S. governmental, nongovernmental organizations, and academia to rebuild medical systems using telemedicine as a sustainable model of foreign aid. The International Virtual e-Hospital implemented the "initiate-build-operate-transfer" strategy to establish an effective telemedicine system in Albania that includes the National Telemedicine Center and 12 regional telemedicine centers. This nationwide telemedicine network has active clinical programs, virtual educational programs, and an electronic library that has substantially improved the access to care while advancing medical education. We propose that telemedicine is an optimal, sustainable, low-cost model for rebuilding medical systems of developing countries when implemented through a multipartnership approach.

The Cultural Adaptability of Intermediate Measures of Functional Outcome in Schizophrenia*

PubMed Central

Rubin, Maureen; Fredrick, Megan M.; Mintz, Jim; Nuechterlein, Keith H.; Schooler, Nina R.; Jaeger, Judith; Peters, Nancy M.; Buller, Raimund; Marder, Stephen R.; Dube, Sanjay

2012-01-01

The Measurement and Treatment Research to Improve Cognition in Schizophrenia initiative was designed to encourage the development of cognitive enhancing agents for schizophrenia. For a medication to receive this indication, regulatory agencies require evidence of improvement in both cognition and functional outcome. Because medication trials are conducted across multiple countries, we examined ratings of the cross-cultural adaptability of 4 intermediate measures of functional outcome (Independent Living Scales, UCSD Performance-based Skills Assessment, Test of Adaptive Behavior in Schizophrenia, Cognitive Assessment Interview [CAI]) made by experienced clinical researchers at 31 sites in 8 countries. English-speaking research staff familiar with conducting medication trials rated the extent to which each subscale of each intermediate measure could be applied to their culture and to subgroups within their culture based on gender, geographic region, ethnicity, and socioeconomic status on the Cultural Adaptation Rating Scale. Ratings suggested that the CAI would be easiest to adapt across cultures. However, in a recent study, the CAI was found to have weaker psychometric properties than some of the other measures. Problems were identified for specific subscales on all the performance-based assessments across multiple countries. India, China, and Mexico presented the greatest challenges in adaptation. For international clinical trials, it would be important to use the measures that are most adaptable, to adapt subscales that are problematic for specific countries or regions, or to develop a battery composed of the subscales from different instruments that may be most acceptable across multiple cultures with minimal adaptation. PMID:21134973

A review of the organization, regulation, and financing practices of postgraduate education in clinical nursing in 12 European countries.

PubMed

Rautiainen, Elina; Vallimies-Patomäki, Marjukka

2016-01-01

The aim of this study was to generate information of postgraduate education in clinical nursing in the EU member states. Data were collected via a structured electronic questionnaire and the questionnaire was sent to the government chief nurses in 26 EU countries in May 2013. Response rate was 46% (n=12). In total, 42 domains of specialization were identified. The most common domains were intensive care, mental health, operating room, emergency care, and pediatrics. Specialization programs were organized by university in two of the respondent countries, as residency program in one country, and as a mix of them in four countries. Regulation practices varied remarkably between the countries: scope of practice, subjects, entry requirements, length of education, description of the minimum competence requirements, and education standards related to the specialization programs were most often regulated by act, decree or other regulation. In some of the countries, no registration was required beyond the initial registration, whereas in some others, registration practices varied depending on the specialization program. New information was gathered on the regulation practices of postgraduate education in clinical nursing in the European Region concerning title provision, entry requirements, and financing practices. The awarded title on specialization programs depended on the level of postgraduate education, and the title might vary between the domains. General clinical experience was included in the entry requirements in seven countries. The government was mainly responsible for financing the postgraduate education in four countries, employer in three countries, and in the rest of the countries, there was a combination of different financiers. The importance of knowledge exchange on postgraduate education across the European countries needs to be acknowledged. Information provided by this study on international regulation practices provides useful information for the policy-makers regarding the organization of the postgraduate education in clinical nursing. Copyright © 2015 Elsevier Ltd. All rights reserved.

Systematic data ingratiation of clinical trial recruitment locations for geographic-based query and visualization

PubMed Central

Luo, Jake; Chen, Weiheng; Wu, Min; Weng, Chunhua

2018-01-01

Background Prior studies of clinical trial planning indicate that it is crucial to search and screen recruitment sites before starting to enroll participants. However, currently there is no systematic method developed to support clinical investigators to search candidate recruitment sites according to their interested clinical trial factors. Objective In this study, we aim at developing a new approach to integrating the location data of over one million heterogeneous recruitment sites that are stored in clinical trial documents. The integrated recruitment location data can be searched and visualized using a map-based information retrieval method. The method enables systematic search and analysis of recruitment sites across a large amount of clinical trials. Methods The location data of more than 1.4 million recruitment sites of over 183,000 clinical trials was normalized and integrated using a geocoding method. The integrated data can be used to support geographic information retrieval of recruitment sites. Additionally, the information of over 6000 clinical trial target disease conditions and close to 4000 interventions was also integrated into the system and linked to the recruitment locations. Such data integration enabled the construction of a novel map-based query system. The system will allow clinical investigators to search and visualize candidate recruitment sites for clinical trials based on target conditions and interventions. Results The evaluation results showed that the coverage of the geographic location mapping for the 1.4 million recruitment sites was 99.8%. The evaluation of 200 randomly retrieved recruitment sites showed that the correctness of geographic information mapping was 96.5%. The recruitment intensities of the top 30 countries were also retrieved and analyzed. The data analysis results indicated that the recruitment intensity varied significantly across different countries and geographic areas. Conclusion This study contributed a new data processing framework to extract and integrate the location data of heterogeneous recruitment sites from clinical trial documents. The developed system can support effective retrieval and analysis of potential recruitment sites using target clinical trial factors. PMID:29132636

Systematic data ingratiation of clinical trial recruitment locations for geographic-based query and visualization.

PubMed

Luo, Jake; Chen, Weiheng; Wu, Min; Weng, Chunhua

2017-12-01

Prior studies of clinical trial planning indicate that it is crucial to search and screen recruitment sites before starting to enroll participants. However, currently there is no systematic method developed to support clinical investigators to search candidate recruitment sites according to their interested clinical trial factors. In this study, we aim at developing a new approach to integrating the location data of over one million heterogeneous recruitment sites that are stored in clinical trial documents. The integrated recruitment location data can be searched and visualized using a map-based information retrieval method. The method enables systematic search and analysis of recruitment sites across a large amount of clinical trials. The location data of more than 1.4 million recruitment sites of over 183,000 clinical trials was normalized and integrated using a geocoding method. The integrated data can be used to support geographic information retrieval of recruitment sites. Additionally, the information of over 6000 clinical trial target disease conditions and close to 4000 interventions was also integrated into the system and linked to the recruitment locations. Such data integration enabled the construction of a novel map-based query system. The system will allow clinical investigators to search and visualize candidate recruitment sites for clinical trials based on target conditions and interventions. The evaluation results showed that the coverage of the geographic location mapping for the 1.4 million recruitment sites was 99.8%. The evaluation of 200 randomly retrieved recruitment sites showed that the correctness of geographic information mapping was 96.5%. The recruitment intensities of the top 30 countries were also retrieved and analyzed. The data analysis results indicated that the recruitment intensity varied significantly across different countries and geographic areas. This study contributed a new data processing framework to extract and integrate the location data of heterogeneous recruitment sites from clinical trial documents. The developed system can support effective retrieval and analysis of potential recruitment sites using target clinical trial factors. Copyright © 2017 Elsevier B.V. All rights reserved.

Early results from a multi-component French public-private partnership initiative to improve participation in clinical research - CeNGEPS: a prospective before-after study.

PubMed

Bordet, Régis; Lang, Marie; Dieu, Christelle; Billon, Nathalie; Duffet, Jean-Pierre

2015-08-19

A public-private (51/49 %) partnership was initiated in 2007 in France to improve the attractiveness of French sites in industry-sponsored international clinical trials. This initiative developed and implemented a combination of structuring actions and support actions. Here we report the assessment of the impact after 6 years on participation of French study sites in industry-sponsored clinical trials. We performed a prospective before-after study of clinical research activities in French public hospitals to assess the impact of actions developed and implemented by CeNGEPS. The programme involved a combination of structuring actions (establishment of sites of excellence, national networks and dedicated clinical research assistants (CRAs)), support actions (tools, templates and training) and competitive budget allocation for sites or networks based on performance. The impact was assessed using the following performance criteria: 1) reduction of the delay to contract signature to ≤ 60 days for 80 % of the trial sites; 2) inclusion of ≥80 % of the planned number of patients by at least 80 % of trial sites; 3) closure of <15 % of trials sites without patients enrolled. In 2013, the median delay to contract signature was: 55 days, compared with 76 days in 2008 (27.6 % reduction), 50.5 % of all sites and 58 % of sites with a dedicated CRA included ≥80 % of the planned number of patients compared with 44.8 % in 2008 (12.7 % increase) and 21.3 % of all sites and 9 % of sites with a dedicated CRA closed with no patients included, compared with 26.4 % in 2008 (19.3 and 65.9 %, respectively). These results provide evidence that it is possible to improve a country's attractiveness for industry-sponsored clinical research. The two main actions, i.e. establishing sites of excellence throughout the country with well-trained, dedicated staff and establishing a national network of clinical investigators, could be adapted to other countries in Western Europe to improve Europe's attractiveness to industry-funded trials.

Role of Assessment Tests in the Stability of Intelligence Scoring of Pre-School Children with Uneven/Delayed Cognitive Profile

ERIC Educational Resources Information Center

Yang, P.; Jong, Y-J.; Hsu, H-Y.; Lung, F-W.

2011-01-01

Background: As part of an ongoing clinical service programme for pre-school children with developmental delay in an Asian developing country, we analysed the effect of three assessment tests, that is, Bayley Scale of Infant Development-II, Leiter International Performance Scale-Revised and Wechsler Preschool and Primary Scale of…

Electives: isn't it time for a change?

PubMed

Dowell, Jon; Merrylees, Neil

2009-02-01

Medical student electives are memorable learning experiences, of which approximately 40% are spent in developing countries. Students often have laudable motivation but are rarely helped to learn most effectively or contribute meaningfully whilst away. Each year an estimated 350 years of elective time is spent in developing countries (by students from the UK alone), which represents substantial opportunity. We conducted a literature search prior to developing an alternative approach towards electives based upon educational and ethical principles. Despite their anecdotal value there has been little empirical research conducted into electives. From our review we identified four key learning domains (Clinical Knowledge and Skills, Attitudes, Global Perspectives, Personal and Professional Development) and two broader issues (Institutional Benefits and Moral/Ethical Considerations). Potentially beneficial and more structured alternatives are emerging and improvements appear possible through institutional collaborations and greater planning in order to maximise the educational experience, opportunities to contribute and minimise the risks involved in electives. Electives are a highlight of clinical training but probably often represent missed opportunities. There are both educational and moral reasons for seeking more considered approaches to reduce the 'medical tourism' that can result from the current largely ad hoc arrangements.

Appropriateness of Prescriptions of Recommended Treatments in Organisation for Economic Co-operation and Development Health Systems: Findings Based on the Long-Term Registry of the European Society of Cardiology on Heart Failure.

PubMed

Maggioni, Aldo P; Van Gool, Kees; Biondi, Nelly; Urso, Renato; Klazinga, Niek; Ferrari, Roberto; Maniadakis, Nikolaos; Tavazzi, Luigi

2015-12-01

This observational study aimed to identify clinical variables and health system characteristics associated with incomplete guideline application in drug treatment of patients with chronic heart failure (HF) across 15 countries. Three data sets were used: European Society of Cardiology Heart Failure Registry, Organisation for Economic Co-operation and Development's Health System Characteristics Survey, and Organisation for Economic Co-operation and Development Health Statistics 2013. Patient and country variables were examined by multilevel, multiple logistic regression. The study population consisted of ambulatory patients with chronic HF and reduced ejection fraction. Inappropriateness of prescription of pharmacological treatments was defined as patients not prescribed at least one of the two recommended treatments (angiotensin-converting enzyme inhibitors/angiotensin-receptor blockers and beta-blockers) or treated with both medications but at suboptimal dosage and in absence of documented contraindication/intolerance. Of 4605 patients, 1097 (23.8%) received inappropriate drug prescriptions with a large variation within and across countries, with 18.5% of the total variability accounted for by between-country health structure characteristics. Patient-level characteristics such as having mitral regurgitation (odds ratio 1.4; 95% confidence interval 1.1-1.7) was significantly associated with inappropriate prescription of recommended drugs, whereas chronic obstructive pulmonary disease (odds ratio 0.7; 95% confidence interval 0.5-0.9) was associated with more appropriate prescriptions. Among the country-level variables, incentives or obligation to comply with guidelines increased the probability of prescription appropriateness. Combining clinical variables with health system characteristics is a promising exercise to explain the appropriateness of recommended drug prescriptions. Such an understanding can help decision makers to design more effective policies to improve adherence to guidelines, improve health care outcomes, and potentially reduce costs. Copyright © 2015. Published by Elsevier Inc.

Safety and efficacy of misoprostol for induction of labour in a semi-urban hospital setting.

PubMed

Loto, O M; Fadahunsi, A A; Kolade, C O

2004-09-01

Most studies on the use of misoprostol for induction of labour have been carried out in well-endowed hospitals in developed countries with state-of-the-art monitoring equipment. There is need for more studies to be conducted in facilities with limited resources, if more patients are to benefit from the low cost and effectiveness of the drug. Following Ethical Committee approval, 152 women had labour induced in our maternity unit using intravaginal misoprostol. The patients were monitored clinically using the WHO model partograph with digital palpation of uterine contractions and intermittent auscultation of fetal heart with a pinard stethoscope. One hundred and thirty-five (88.8%) of the women had a vaginal delivery, while nine (5.9%) had a caesarean section for various obstetric indications. Eight cases of uterine hyperstimulation were noted but none of uterine rupture. We conclude that misoprostol can be used safely for induction of labour in less endowed hospital settings such as in developing countries, using basic clinical tools for monitoring.

Early phase clinical trials with human immunodeficiency virus-1 and malaria vectored vaccines in The Gambia: frontline challenges in study design and implementation.

PubMed

Afolabi, Muhammed O; Adetifa, Jane U; Imoukhuede, Egeruan B; Viebig, Nicola K; Kampmann, Beate; Bojang, Kalifa

2014-05-01

Human immunodeficiency virus/acquired immune deficiency syndrome (HIV/AIDS) and malaria are among the most important infectious diseases in developing countries. Existing control strategies are unlikely to curtail these diseases in the absence of efficacious vaccines. Testing of HIV and malaria vaccines candidates start with early phase trials that are increasingly being conducted in developing countries where the burden of the diseases is high. Unique challenges, which affect planning and implementation of vaccine trials according to internationally accepted standards have thus been identified. In this review, we highlight specific challenges encountered during two early phase trials of novel HIV-1 and malaria vectored vaccine candidates conducted in The Gambia and how some of these issues were pragmatically addressed. We hope our experience will be useful for key study personnel involved in day-to-day running of similar clinical trials. It may also guide future design and implementation of vaccine trials in resource-constrained settings.

Clinical Assessment of Self-Reported Acute Flaccid Paralysis in a Population-Based Setting in Guatemala

PubMed Central

Sejvar, James J.; Lindblade, Kim A.; Arvelo, Wences; Padilla, Norma; Pringle, Kimberly; Zielinski-Gutierrez, Emily; Farnon, Eileen; Schonberger, Lawrence B.; Dueger, Erica

2010-01-01

Historically, poliovirus infection has been an important cause of acute flaccid paralysis (AFP) worldwide; however, successful elimination of wild-type poliovirus in much of the world has highlighted the importance of other causes of AFP. Despite the evolving etiology, AFP surveillance in most developing countries still focuses on poliovirus detection and fails to detect many AFP cases, particularly among adults. We assessed 41 subjects self-reporting symptoms suggestive of AFP during a population-based health survey in the Department of Santa Rosa, Guatemala. Thirty-five (85%) of the suspected cases were not hospitalized. Most subjects (37) did not have features consistent with AFP or had other diagnoses explaining weakness. We identified two adults who had not received medical attention for a clinical illness consistent with Guillain-Barré syndrome, the most important cause of non-poliovirus AFP. Usual surveillance methods for AFP, particularly in developing countries, may underestimate the true burden of non-poliovirus AFP. PMID:20348524

RETHINKING THE ROLE OF CLINICAL TRIAL DATA IN INTERNATIONAL INTELLECTUAL PROPERTY LAW: THE CASE FOR A PUBLIC GOODS APPROACH.

PubMed

Reichman, Jerome H

2009-01-01

This article describes the growth and consequences of new intellectual property rights given to pharmaceutical developers, and it advocates treating clinical trials as a public good. Although the soaring cost of clinical trials is well known and discussed, too little attention is given to the underlying rationale for allowing drug developers to recoup their costs through the new intellectual property rights provided in multilateral, regional, and bilateral agreements. Known in the US as "market exclusivity" and in Europe as "data exclusivity," these rights prohibit would-be generic producers from obtaining regulatory approval based on the original producers' undisclosed test data. Market and data exclusivity is codified in US and European domestic law as well as the North American Free Trade Agreement (NAFTA) and, to a lesser degree, the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS). Market and data exclusivity is binding an increasing number of developing countries via Free Trade Agreements (FTAs), which hinder developing countries from manufacturing generic drugs. At a minimum, negotiators should replace the norm of exclusive control over data with a liability rule, or take and pay rule, in which generic manufacturers can use original manufacturers' clinical trial data in exchange for reasonable compensation. A more fundamental solution requires questioning the status quo of proprietary clinical trial data. The conventional wisdom is that market and data exclusivity, and drug developers' consequent ability to limit competition from generics above and beyond patent protection, are a necessary incentive for drug developers to fund ever more expensive clinical trials. Clinical trial data, however, are public goods that will be undersupplied and over protected so long as private actors provide them. Moreover, manufacturers have an incentive to present clinical trial data so that they support regulatory approval at the expense of public health. Although liability rules are better than the status quo, they would not resolve the problem of treating a public good as proprietary. Governments should thus oversee and fund clinical trials as the public good that they are. Clinical tests should be awarded to the most qualified scientists through a competitive process, financed in part with the decrease in drug costs to governmental health care programs and in part with drug developers' contributions, selected to maximize social benefit, and made global via intergovernmental bodies to maximize social return. This would reduce the cost of redundant investigations to the global public health system, lower supply costs to drug consumers, and lower the breakeven point for investment in research to discover new drugs.

Drug repurposing in malignant pleural mesothelioma: a breath of fresh air?

PubMed

Boyer, Arnaud; Pasquier, Eddy; Tomasini, Pascale; Ciccolini, Joseph; Greillier, Laurent; Andre, Nicolas; Barlesi, Fabrice; Mascaux, Celine

2018-03-31

Drug repurposing is the use of known drugs for new indications. Malignant pleural mesothelioma (MPM) is a rare cancer with a poor prognosis. So far, few treatments have been approved in this disease. However, its incidence is expected to increase significantly, particularly in developing countries. Consequently, drug repurposing appears as an attractive strategy for drug development in MPM, since the known pharmacology and safety profile based on previous approvals of repurposed drugs allows for faster time-to-market for patients and lower treatment cost. This is critical in low- and middle-income countries where access to expensive drugs is limited. This review assesses the published preclinical and clinical data about drug repurposing in MPM.In this review, we identified 11 therapeutic classes that could be repositioned in mesothelioma. Most of these treatments have been evaluated in vitro , half have been evaluated in vivo in animal models of MPM and only three ( i.e. valproate, thalidomide and zoledronic acid) have been investigated in clinical trials, with limited benefits so far. Efforts could be coordinated to pursue further investigations and test promising drugs identified in preclinical experiments in appropriately designed clinical trials. Copyright ©ERS 2018.

EuCliD (European Clinical Database): a database comparing different realities.

PubMed

Marcelli, D; Kirchgessner, J; Amato, C; Steil, H; Mitteregger, A; Moscardò, V; Carioni, C; Orlandini, G; Gatti, E

2001-01-01

Quality and variability of dialysis practice are generally gaining more and more importance. Fresenius Medical Care (FMC), as provider of dialysis, has the duty to continuously monitor and guarantee the quality of care delivered to patients treated in its European dialysis units. Accordingly, a new clinical database called EuCliD has been developed. It is a multilingual and fully codified database, using as far as possible international standard coding tables. EuCliD collects and handles sensitive medical patient data, fully assuring confidentiality. The Infrastructure: a Domino server is installed in each country connected to EuCliD. All the centres belonging to a country are connected via modem to the country server. All the Domino Servers are connected via Wide Area Network to the Head Quarter Server in Bad Homburg (Germany). Inside each country server only anonymous data related to that particular country are available. The only place where all the anonymous data are available is the Head Quarter Server. The data collection is strongly supported in each country by "key-persons" with solid relationships to their respective national dialysis units. The quality of the data in EuCliD is ensured at different levels. At the end of January 2001, more than 11,000 patients treated in 135 centres located in 7 countries are already included in the system. FMC has put the patient care at the centre of its activities for many years and now is able to provide transparency to the community (Authorities, Nephrologists, Patients.....) thus demonstrating the quality of the service.

Anticipation of the Impact of Human Papillomavirus on Clinical Decision Making for the Head and Neck Cancer Patient.

PubMed

Gillison, Maura L; Restighini, Carlo

2015-12-01

Human papillomavirus (HPV) is the cause of a distinct subset of oropharyngeal cancer rising in incidence in the United States and other developed countries. This increased incidence, combined with the strong effect of tumor HPV status on survival, has had a profound effect on the head and neck cancer discipline. The multidisciplinary field of head and neck cancer is in the midst of re-evaluating evidence-based algorithms for clinical decision making, developed from clinical trials conducted in an era when HPV-negative cancer predominated. This article reviews relationships between tumor HPV status and gender, cancer incidence trends, overall survival, treatment response, racial disparities, tumor staging, risk stratification, survival post disease progression, and clinical trial design. Copyright © 2015 Elsevier Inc. All rights reserved.

The Breast Health Global Initiative: clinical practice guidelines for management of breast cancer in low- and middle-income countries.

PubMed

Yip, Cheng Har; Anderson, Benjamin O

2007-08-01

Breast cancer is an increasingly urgent problem in low- and mid-level resource countries of the world. Despite knowing the optimal management strategy based on guidelines developed in wealthy countries, clinicians are forced to provide less-than-optimal care to patients when diagnostic and/or treatment resources are lacking. For this reason, it is important to identify which resources commonly applied in resource-abundant countries most effectively fill the healthcare needs in limited-resource regions, where patients commonly present with more advanced disease at diagnosis, and to provide guidance on how new resource allocations should be made in order to maximize improvement in outcome. Established in 2002, the Breast Health Global Initiative (BHGI) created an international health alliance to develop evidence-based guidelines for countries with limited resources (low- and middle-income countries) to improve breast health outcomes. The BHGI serves as a program for international guideline development and as a hub for linkage among clinicians, governmental health agencies and advocacy groups to translate guidelines into policy and practice. The BHGI collaborated with 12 national and international health organizations, cancer societies and nongovernmental organizations to host two BHGI international summits. The evidence-based BHGI Guidelines, developed at the 2002 Global Summit, were published in 2003 as a theoretical treatise on international breast healthcare. These guidelines were then updated and expanded at the 2005 Global Summit into a fully comprehensive and flexible framework to permit incremental improvements in healthcare delivery, based upon outcomes, cost, cost-effectiveness and use of healthcare services.

Variability in recording and scoring of respiratory events during sleep in Europe: a need for uniform standards.

PubMed

Arnardottir, Erna S; Verbraecken, Johan; Gonçalves, Marta; Gjerstad, Michaela D; Grote, Ludger; Puertas, Francisco Javier; Mihaicuta, Stefan; McNicholas, Walter T; Parrino, Liborio

2016-04-01

Uniform standards for the recording and scoring of respiratory events during sleep are lacking in Europe, although many centres follow the published recommendations of the American Academy of Sleep Medicine. The aim of this study was to assess the practice for the diagnosis of sleep-disordered breathing throughout Europe. A specially developed questionnaire was sent to representatives of the 31 national sleep societies in the Assembly of National Sleep Societies of the European Sleep Research Society, and a total of 29 countries completed the questionnaire. Polysomnography was considered the primary diagnostic method for sleep apnea diagnosis in 10 (34.5%), whereas polygraphy was used primarily in six (20.7%) European countries. In the remaining 13 countries (44.8%), no preferred methodology was used. Fifteen countries (51.7%) had developed some type of national uniform standards, but these standards varied significantly in terms of scoring criteria, device specifications and quality assurance procedures between countries. Only five countries (17.2%) had published these standards. Most respondents supported the development of uniform recording and scoring criteria for Europe, which might be based partly on the existing American Academy of Sleep Medicine rules, but also take into account differences in European practice when compared to North America. This survey highlights the current varying approaches to the assessment of patients with sleep-disordered breathing throughout Europe and supports the need for the development of practice parameters in the assessment of such patients that would be suited to European clinical practice. © 2015 European Sleep Research Society.

Beyond Watches and Chocolate-Global Mental Health Elective in Switzerland.

PubMed

Schneeberger, Andres R; Weiss, Andrea; von Blumenthal, Suzanne; Lang, Undine E; Huber, Christian G; Schwartz, Bruce J

2016-08-01

Despite increasing interest in global mental health training opportunities, only a few psychiatry residency programs offer global mental health training experiences in developing countries and even fewer programs offer it in other first-world countries. The authors developed a global mental health elective giving US psychiatry residents the opportunity to visit Switzerland to study and experience the mental health care system in this European country. This elective focuses on four major learning objectives: (1) the system of training and curriculum of postgraduate psychiatry education in Switzerland, (2) clinical and organizational aspects of Swiss mental health, (3) administrative aspects of Swiss mental health care delivery, and (4) scholarly activity. This program was uniquely tailored for psychiatry residents. The preliminary experiences with US psychiatry residents show that they value this learning experience, the opportunity to access a different mental health care system, as well as the potential to build international connections with peers.

Deepening our understanding of quality improvement in Europe (DUQuE): overview of a study of hospital quality management in seven countries.

PubMed

Secanell, Mariona; Groene, Oliver; Arah, Onyebuchi A; Lopez, Maria Andrée; Kutryba, Basia; Pfaff, Holger; Klazinga, Niek; Wagner, Cordula; Kristensen, Solvejg; Bartels, Paul Daniel; Garel, Pascal; Bruneau, Charles; Escoval, Ana; França, Margarida; Mora, Nuria; Suñol, Rosa

2014-04-01

This paper provides an overview of the DUQuE (Deepening our Understanding of Quality Improvement in Europe) project, the first study across multiple countries of the European Union (EU) to assess relationships between quality management and patient outcomes at EU level. The paper describes the conceptual framework and methods applied, highlighting the novel features of this study. DUQuE was designed as a multi-level cross-sectional study with data collection at hospital, pathway, professional and patient level in eight countries. We aimed to collect data for the assessment of hospital-wide constructs from up to 30 randomly selected hospitals in each country, and additional data at pathway and patient level in 12 of these 30. A comprehensive conceptual framework was developed to account for the multiple levels that influence hospital performance and patient outcomes. We assessed hospital-specific constructs (organizational culture and professional involvement), clinical pathway constructs (the organization of care processes for acute myocardial infarction, stroke, hip fracture and deliveries), patient-specific processes and outcomes (clinical effectiveness, patient safety and patient experience) and external constructs that could modify hospital quality (external assessment and perceived external pressure). Data was gathered from 188 hospitals in 7 participating countries. The overall participation and response rate were between 75% and 100% for the assessed measures. This is the first study assessing relation between quality management and patient outcomes at EU level. The study involved a large number of respondents and achieved high response rates. This work will serve to develop guidance in how to assess quality management and makes recommendations on the best ways to improve quality in healthcare for hospital stakeholders, payers, researchers, and policy makers throughout the EU.

Towards pathogen inactivation of red blood cells and whole blood targeting viral DNA/RNA: design, technologies, and future prospects for developing countries.

PubMed

Drew, Victor J; Barro, Lassina; Seghatchian, Jerard; Burnouf, Thierry

2017-10-01

Over 110 million units of blood are collected yearly. The need for blood products is greater in developing countries, but so is the risk of contracting a transfusion-transmitted infection. Without efficient donor screening/viral testing and validated pathogen inactivation technology, the risk of transfusion-transmitted infections correlates with the infection rate of the donor population. The World Health Organization has published guidelines on good manufacturing practices in an effort to ensure a strong global standard of transfusion and blood product safety. Sub-Saharan Africa is a high-risk region for malaria, human immunodeficiency virus (HIV), hepatitis B virus and syphilis. Southeast Asia experiences high rates of hepatitis C virus. Areas with a tropical climate have an increased risk of Zika virus, Dengue virus, West Nile virus and Chikungunya, and impoverished countries face economical limitations which hinder efforts to acquire the most modern pathogen inactivation technology. These systems include Mirasol ® Pathogen Reduction Technology, INTERCEPT ® , and THERAFLEX ® . Their procedures use a chemical and ultraviolet or visible light for pathogen inactivation and significantly decrease the threat of pathogen transmission in plasma and platelets. They are licensed for use in Europe and are used in several other countries. The current interest in the blood industry is the development of pathogen inactivation technologies that can treat whole blood (WB) and red blood cell (RBC). The Mirasol system has recently undergone phase III clinical trials for treating WB in Ghana and has demonstrated some efficacy toward malaria inactivation and low risk of adverse effects. A 2 nd -generation of the INTERCEPT ® S-303 system for WB is currently undergoing a phase III clinical trial. Both methodologies are applicable for WB and components derived from virally reduced WB or RBC.

Towards pathogen inactivation of red blood cells and whole blood targeting viral DNA/RNA: design, technologies, and future prospects for developing countries

PubMed Central

Drew, Victor J.; Barro, Lassina; Seghatchian, Jerard; Burnouf, Thierry

2017-01-01

Over 110 million units of blood are collected yearly. The need for blood products is greater in developing countries, but so is the risk of contracting a transfusion-transmitted infection. Without efficient donor screening/viral testing and validated pathogen inactivation technology, the risk of transfusion-transmitted infections correlates with the infection rate of the donor population. The World Health Organization has published guidelines on good manufacturing practices in an effort to ensure a strong global standard of transfusion and blood product safety. Sub-Saharan Africa is a high-risk region for malaria, human immunodeficiency virus (HIV), hepatitis B virus and syphilis. Southeast Asia experiences high rates of hepatitis C virus. Areas with a tropical climate have an increased risk of Zika virus, Dengue virus, West Nile virus and Chikungunya, and impoverished countries face economical limitations which hinder efforts to acquire the most modern pathogen inactivation technology. These systems include Mirasol® Pathogen Reduction Technology, INTERCEPT®, and THERAFLEX®. Their procedures use a chemical and ultraviolet or visible light for pathogen inactivation and significantly decrease the threat of pathogen transmission in plasma and platelets. They are licensed for use in Europe and are used in several other countries. The current interest in the blood industry is the development of pathogen inactivation technologies that can treat whole blood (WB) and red blood cell (RBC). The Mirasol system has recently undergone phase III clinical trials for treating WB in Ghana and has demonstrated some efficacy toward malaria inactivation and low risk of adverse effects. A 2nd-generation of the INTERCEPT® S-303 system for WB is currently undergoing a phase III clinical trial. Both methodologies are applicable for WB and components derived from virally reduced WB or RBC. PMID:28488960

How to confidently teach EBM on foot: development and evaluation of a web-based e-learning course.

PubMed

Weberschock, Tobias; Sorinola, Olanrewaju; Thangaratinam, Shakila; Oude Rengerink, Katrien; Arvanitis, Theodoros N; Khan, Khalid S

2013-10-01

Scarcity of well-trained clinical tutors is a key constraint in integrating teaching of evidence-based medicine (EBM) into clinical activities. We developed a web-based educational course for clinical trainers to confidently teach EBM principles in everyday practice. Its e-learning modules defined the learning objectives and incorporated video clips of practical and effective EBM teaching methods for exploiting educational opportunities in six different clinical settings. We evaluated the course with clinical tutors in different specialties across six European countries using a questionnaire to capture learning achievement against preset objectives. Among 56 tutors, 47 participants (84%) improved their scores from baseline. The mean pre-course score was 69.2 (SD=10.4), which increased to 77.3 (SD=11.7) postcourse (p<0.0001). The effect size was moderate with a Cohen's d of 0.73. An e-learning approach incorporating videos of applied EBM teaching and learning based on real clinical scenarios in the workplace can be useful in facilitating EBM teaching on foot. It can be integrated in the continuing professional development programmes for clinical trainers.

The biological sciences in nursing: a developing country perspective.

PubMed

Kyriacos, Una; Jordan, Sue; van den Heever, Jean

2005-10-01

This paper reports a study to inform curriculum development by exploring the contribution of bioscience education programmes to nurses' clinical practice, their understanding of the rationale for practice, and their perceptions of their continuing professional development needs. The future of the health services worldwide depends on nurse education programmes equipping practitioners to deliver safe and effective patient care. In the developed world, the structure and indicative content of nursing curricula have been debated extensively. However, despite the rapid expansion in nursing roles brought about by social change, there is little information on the educational needs of nurses in developing countries. This study was undertaken in government teaching hospitals in Cape Town, South Africa in 2003. A purposive sample of 54 nurses from a range of clinical settings completed questionnaires and described critical incidents where bioscience knowledge had directed practice. Questionnaires were analysed descriptively, in the main. Analysis of critical incident reports was based on Akinsanya's bionursing model. Most nurses felt that their understanding of the biological, but not the physical sciences, was adequate or better: all felt confident with their knowledge of anatomy, compared with 57.4% (31/54) for microbiology. Respondents attributed the successes and failures of their education programmes to their teachers' delivery of content, ability to relate to practice and management of the process of learning. The biological, but not the physical, sciences were universally (96-100%) regarded as relevant to nursing. However, the critical incidents and nurses' own reports indicated a need for further education in pharmacology (40/54, 74.1%) and microbiology (29/54, 53.7%). To meet the needs of nurses in developing countries, and empower them to meet the increasingly complex demands of their expanding roles, nurse educators need to consider increasing the curriculum content in certain key areas, including pharmacology and microbiology.

Development and Implementation of a Pediatric Palliative Care Program in a Developing Country.

PubMed

Doherty, Megan; Thabet, Chloé

2018-01-01

Palliative care is recognized as an important component of care for children with cancer and other life-limiting conditions. In resource limited settings, palliative care is a key component of care for children with cancer and other life-limiting conditions. Globally, 98% of children who need palliative care live in low- or middle-income countries, where there are very few palliative care services available. There is limited evidence describing the practical considerations for the development and implementation of sustainable and cost-effective palliative care services in developing countries. Our aim is to describe the key considerations and initiatives that were successful in planning and implementing a hospital-based pediatric palliative care service specifically designed for a resource-limited setting. Bangabandu Sheikh Mujib Medical University (BSMMU) is a tertiary referral hospital in Bangladesh. Local palliative care services are very limited and focused on adult patients. In partnership with World Child Cancer, a project establishing a pediatric palliative care service was developed for children with cancer at BSMMU. We describe four key elements which were crucial for the success of this program: (1) raising awareness and sensitizing hospital administrators and clinical staff about pediatric palliative care; (2) providing education and training on pediatric palliative care for clinical staff; (3) forming a pediatric palliative care team; and (4) collecting data to characterize the need for pediatric palliative care. This model of a hospital-based pediatric palliative care service can be replicated in other resource-limited settings and can be expanded to include children with other life-limiting conditions. The development of pilot programs can generate interest among local physicians to become trained in pediatric palliative care and can be used to advocate for the palliative care needs of children.

[Systemic validation of clinical practice guidelines: the AGREE network].

PubMed

Hannes, K; Van Royen, P; Aertgeerts, B; Buntinx, F; Ramaekers, D; Chevalier, P

2005-12-01

Over recent decades, the number of available clinical practice guidelines has enormously grown. Guidelines should meet specific quality criteria to ensure good quality. There is a growing need for the developement of a set of criteria to ensure that potential biases inherent in guideline development have been properly addressed and that the recommendations for practice are valid and reliable. The AGREE-collaboration is an international network that developed an instrument to critically appraise the methodological quality of guidelines. AGREE promotes a clear strategy to produce, disseminate and evaluate guidelines of high quality. In the first phase of the international project the AGREE-instrument was tested in 11 different countries. Based on this experience the instrument was refined and optimised. In the second phase it was disseminated, promoted and evaluated in 18 participating countries. Belgium was one of them. The Belgian partner in the AGREE-project developed 3 workshops and established 13 validation committees to validate guidelines from Belgian developer groups. We collected 33 questionnaires from participants of the workshops and the validation committees, in which we asked for primary experiences and information on the usefulness and applicability of the instrument. We were also interested in the shortcomings of the instrument and potential strategies to bridge them. More efforts should be made to train methodological experts to gain certain skills for a critical appraisal of clinical practice guidelines. Promoting the AGREE-instrument will lead to a broader knowledge and use of quality criteria in guideline development and appraisal. The development and dissemination of an international list of criteria to appraise the quality of guidelines will stimulate the development of methodologically sound guidelines. International comparisons between existing guidelines will lead to a better collaboration between guideline developers throughout the world.

Management of Primary Adrenal Insufficiency: Review of Current Clinical Practice in a Developed and a Developing Country.

PubMed

Khan, Uzma; Lakhani, Om J

2017-01-01

Treatment of primary adrenal insufficiency (PAI) requires lifelong hormone replacement with glucocorticoids (GCs) and mineralocorticoids. Impaired quality of life and increased standardized mortality ratio in these patients emphasize the importance of tailoring therapy to individual needs. Role of education is paramount in improving patient compliance and in anticipating and preventing adrenal crises. Although discovery of synthetic GCs was a major breakthrough in treatment of patients with this life-threatening condition, management of PAI continues to be challenging. The obstacles for clinicians appear to vary widely across the globe. While optimization and individualization of therapy after diagnosis of PAI remain the main challenges for clinicians in the developed world, doctors in a developing country face problems at almost every stage from the diagnosis to the treatment and follow-up of these patients; cost of therapy, lack of resources, and funding are the main hindrances. Adherence to therapy and patient education are found to be common issues in most parts of the world. This commentary highlights the challenges from both developed and developing country's perspective in treating PAI; it also provides an update on current management scenario and future treatment options.

Tuberculosis associated chronic obstructive pulmonary disease.

PubMed

Sarkar, Malay; Srinivasa; Madabhavi, Irappa; Kumar, Kushal

2017-05-01

Reviewed the epidemiology, clinical characteristics, mechanisms, and treatment of tuberculosis associated chronic obstructive pulmonary disease. We searched PubMed, EMBASE, and the CINAHL from inception to June 2016. We used the following search terms: Tuberculosis, COPD, Tuberculosis associated COPD, and so forth. All types of study were chosen. Chronic obstructive pulmonary disease (COPD) and tuberculosis are significant public health problems, particularly in developing countries. Although, smoking is the conventional risk factor for COPD, nonsmoking related risk factors such as biomass fuel exposure, childhood lower-respiratory tract infections, chronic asthma, outdoor air pollution, and prior history of pulmonary tuberculosis have become important risk factors of COPD, particularly in developing countries. Past history of tuberculosis as a risk factor of chronic airflow obstruction has been reported in several studies. It may develop during the course of tuberculosis or after completion of tuberculosis treatment. Developing countries with large burden of tuberculosis can contribute significantly to the burden of chronic airflow obstruction. Prompt diagnosis and treatment of tuberculosis should be emphasized to lessen the future burden of chronic airflow obstruction. © 2017 John Wiley & Sons Ltd.

Developing a National-Level Concept Dictionary for EHR Implementations in Kenya.

PubMed

Keny, Aggrey; Wanyee, Steven; Kwaro, Daniel; Mulwa, Edwin; Were, Martin C

2015-01-01

The increasing adoption of Electronic Health Records (EHR) by developing countries comes with the need to develop common terminology standards to assure semantic interoperability. In Kenya, where the Ministry of Health has rolled out an EHR at 646 sites, several challenges have emerged including variable dictionaries across implementations, inability to easily share data across systems, lack of expertise in dictionary management, lack of central coordination and custody of a terminology service, inadequately defined policies and processes, insufficient infrastructure, among others. A Concept Working Group was constituted to address these challenges. The country settled on a common Kenya data dictionary, initially derived as a subset of the Columbia International eHealth Laboratory (CIEL)/Millennium Villages Project (MVP) dictionary. The initial dictionary scope largely focuses on clinical needs. Processes and policies around dictionary management are being guided by the framework developed by Bakhshi-Raiez et al. Technical and infrastructure-based approaches are also underway to streamline workflow for dictionary management and distribution across implementations. Kenya's approach on comprehensive common dictionary can serve as a model for other countries in similar settings.

GeoSentinel: the global emerging infections sentinel network of the International Society of Travel Medicine.

PubMed

Freedman, D O; Kozarsky, P E; Weld, L H; Cetron, M S

1999-06-01

GeoSentinel is a network of 22 member travel/tropical medicine clinics (14 in the United States and 8 in other countries) initiated in 1995 by the International Society of Travel Medicine (ISTM). GeoSentinel is based on the concept that these clinics are ideally situated to effectively detect geographic and temporal trends in morbidity among travelers. The core surveillance tool is a single-page faxable form submitted to a central data site for each post-travel patient, including immigrants, refugees, and foreign visitors. Diagnoses are entered either as specific etiologies or as syndromes and are then linked to geographic locations, reference dates, and clinical presentations. In addition, electronic communication with the larger body of worldwide ISTM member clinics is periodically done to obtain broader data collection in response to specific inquiries. The scope of GeoSentinel has broadened from the initial vision of a provider-based sentinel network tracking emerging infections at their point of entry into developed countries. Its present goals are (1) to monitor global trends in disease occurrence among travelers; (2) to ascertain risk factors and morbidity in groups of travelers categorized by travel purpose and type of traveler; (3) to respond to urgent public health queries; (4) to develop educational priorities for travelers' health; and (5) to effect a rapid response by electronically disseminating alerts to surveillance sites, to all ISTM members in 55 countries, and to public health authorities. In addition, a major byproduct of the network, and now one of its strongest assets, has been the growth of partnerships between ISTM, Centers for Disease Control and Prevention and health-care providers around the world, as well as other medical societies, government, and private organizations. The demographic data, travel patterns, and clinical presentations for the first 2813 patient records analyzed from the GeoSentinel sites are summarized in this paper.

Diagnosis of neglected tropical diseases among patients with persistent digestive disorders (diarrhoea and/or abdominal pain ≥14 days): Pierrea multi-country, prospective, non-experimental case-control study.

PubMed

Polman, Katja; Becker, Sören L; Alirol, Emilie; Bhatta, Nisha K; Bhattarai, Narayan R; Bottieau, Emmanuel; Bratschi, Martin W; Burza, Sakib; Coulibaly, Jean T; Doumbia, Mama N; Horié, Ninon S; Jacobs, Jan; Khanal, Basudha; Landouré, Aly; Mahendradhata, Yodi; Meheus, Filip; Mertens, Pascal; Meyanti, Fransiska; Murhandarwati, Elsa H; N'Goran, Eliézer K; Peeling, Rosanna W; Ravinetto, Raffaella; Rijal, Suman; Sacko, Moussa; Saye, Rénion; Schneeberger, Pierre H H; Schurmans, Céline; Silué, Kigbafori D; Thobari, Jarir A; Traoré, Mamadou S; van Lieshout, Lisette; van Loen, Harry; Verdonck, Kristien; von Müller, Lutz; Yansouni, Cédric P; Yao, Joel A; Yao, Patrick K; Yap, Peiling; Boelaert, Marleen; Chappuis, François; Utzinger, Jürg

2015-08-18

Diarrhoea still accounts for considerable mortality and morbidity worldwide. The highest burden is concentrated in tropical areas where populations lack access to clean water, adequate sanitation and hygiene. In contrast to acute diarrhoea (<14 days), the spectrum of pathogens that may give rise to persistent diarrhoea (≥14 days) and persistent abdominal pain is poorly understood. It is conceivable that pathogens causing neglected tropical diseases play a major role, but few studies investigated this issue. Clinical management and diagnostic work-up of persistent digestive disorders in the tropics therefore remain inadequate. Hence, important aspects regarding the pathogenesis, epidemiology, clinical symptomatology and treatment options for patients presenting with persistent diarrhoea and persistent abdominal pain should be investigated in multi-centric clinical studies. This multi-country, prospective, non-experimental case-control study will assess persistent diarrhoea (≥14 days; in individuals aged ≥1 year) and persistent abdominal pain (≥14 days; in children/adolescents aged 1-18 years) in up to 2000 symptomatic patients and 2000 matched controls. Subjects from Côte d'Ivoire, Indonesia, Mali and Nepal will be clinically examined and interviewed using a detailed case report form. Additionally, each participant will provide a stool sample that will be examined using a suite of diagnostic methods (i.e., microscopic techniques, rapid diagnostic tests, stool culture and polymerase chain reaction) for the presence of bacterial and parasitic pathogens. Treatment will be offered to all infected participants and the clinical treatment response will be recorded. Data obtained will be utilised to develop patient-centred clinical algorithms that will be validated in primary health care centres in the four study countries in subsequent studies. Our research will deepen the understanding of the importance of persistent diarrhoea and related digestive disorders in the tropics. A diversity of intestinal pathogens will be assessed for potential associations with persistent diarrhoea and persistent abdominal pain. Different diagnostic methods will be compared, clinical symptoms investigated and diagnosis-treatment algorithms developed for validation in selected primary health care centres. The findings from this study will improve differential diagnosis and evidence-based clinical management of digestive syndromes in the tropics. ClinicalTrials.gov; identifier: NCT02105714 .

Patient safety and communication: a new assessment for doctors trained in countries where language differs from that of the host country: results of a pilot using a domain-based assessment.

PubMed

Cushing, Annie M; Ker, Jean S; Kinnersley, Paul; McKeown, Pascal; Silverman, Jonathan; Patterson, John; Westwood, Olwyn M R

2014-06-01

Global migration of healthcare workers places responsibility on employers to comply with legal employment rights whilst ensuring patient safety remains the central goal. We describe the pilot of a communication assessment designed for doctors who trained and communicated with patients and colleagues in a different language from that of the host country. It is unique in assessing clinical communication without assessing knowledge. A 14-station OSCE was developed using a domain-based marking scheme, covering professional communication and English language skills (speaking, listening, reading and writing) in routine, acute and emotionally challenging contexts, with patients, carers and healthcare teams. Candidates (n=43), non-UK trained volunteers applying to the UK Foundation Programme, were provided with relevant station information prior to the exam. The criteria for passing the test included achieving the pass score and passing 10 or more of the 14 stations. Of the 43 candidates, nine failed on the station criteria. Two failed the pass score and also the station criteria. The Cronbach's alpha coefficient was 0.866. This pilot tested 'proof of concept' of a new domain-based communication assessment for non-UK trained doctors. The test would enable employers and regulators to verify communication competence and safety in clinical contexts, independent of clinical knowledge, for doctors who trained in a language different from that of the host country. Copyright © 2014 Elsevier Ireland Ltd. All rights reserved.

European survey on ethical and legal framework of clinical trials in paediatrics: results and perspectives.

PubMed

Altavilla, Annagrazia; Giaquinto, Carlo; Ceci, Adriana

2008-09-01

This article constitutes a synthesis and analysis of the results of the "Survey on the ethical and legal frameworks existing in Europe for paediatric clinical trials" carried out by the European network TEDDY. TEDDY is a "Network of Excellence" funded by the Sixth EU Framework Programme (FP6). It began its activities in June 2005 and it is scheduled to run until 2010. It involves 19 partners in 11 countries. The overall goal of TEDDY is to promote the availability of safe and effective medicines to children in Europe by integrating existing expertise and the good practices. In the domain of ethics, the main aim of TEDDY is raise the awareness of the public and researchers concerning issues linked to biomedical research in paediatrics, by contributing to developing the debate on the ethical and legal stakes, as well as the potential deviations, in order to ensure the best possible protection of children participating in clinical trials. This study, with twenty-seven participating countries (23 EU Member States and 4 countries associated to the Fifth and Sixth EU Framework Programme), proposes to highlight the existing differences in the legislation of European countries concerning the procedure of consent, as well as the guarantee of the paediatric expertise within the Ethics Committees which are in charge of evaluating research protocols. The study shows that, even though the Directive 2001/20/EC has been transposed, the value attributed to the consent of minors who participate in clinical trials is different depending on the European state. Despite the general rule of having the written consent of the legal representative of the minor, over a certain age (different in relation to each state) and under certain conditions, to give the consent alone to participate in biomedical research. Furthermore, there is an Ethics Committee for minors in only four countries. In addition, we illustrate the lack of information and in-depth debate in Europe concerning the ethical stakes of clinical trials in paediatrics. An overview of possible legal deviations is also presented.

Do countries rely on the World Health Organization for translating research findings into clinical guidelines? A case study.

PubMed

Noor, Ramadhani A; Geldsetzer, Pascal; Bärnighausen, Till; Fawzi, Wafaie

2016-10-06

The World Health Organization's (WHO) antiretroviral therapy (ART) guidelines have generally been adopted rapidly and with high fidelity by countries in sub-Saharan Africa. Thus far, however, WHO has not published specific guidance on nutritional care and support for (non-pregnant) adults living with HIV despite a solid evidence base for some interventions. This offers an opportunity for a case study on whether national clinical guidelines in sub-Saharan Africa provide concrete recommendations in the face of limited guidance by WHO. This study, therefore, aims to determine if national HIV treatment guidelines in sub-Saharan Africa contain specific guidance on nutritional care and support for non-pregnant adults living with HIV. We identified the most recent national HIV treatment guidelines in sub-Saharan African countries with English as an official language. Using pre-specified criteria, we determined for each guideline whether it provides guidance to clinicians on each of five components of nutritional care and support for adults living with HIV: assessment of nutritional status, dietary counseling, micronutrient supplementation, ready-to-use therapeutic or supplementary foods, and food subsidies. We found that national HIV treatment guidelines in sub-Saharan Africa generally do not contain concrete recommendations on nutritional care and support for non-pregnant adults living with HIV. Given that decisions on nutritional care and support are inevitably being made at the clinician-patient level, and that clinicians have a relative disadvantage in systematically identifying, summarizing, and weighing up research evidence compared to WHO and national governments, there is a need for more specific clinical guidance. In our view, such guidance should at a minimum recommend daily micronutrient supplements for adults living with HIV who are in pre-ART stages, regular dietary counseling, periodic assessment of anthropometric status, and additional nutritional management of undernourished patients. More broadly, our findings suggest that countries in sub-Saharan Africa look to WHO for guidance in translating evidence into clinical guidelines. It is, thus, likely that the development of concrete recommendations by WHO on nutritional interventions for people living with HIV would lead to more specific guidelines at the country-level and, ultimately, better clinical decisions and treatment outcomes.

Pressure ulcer guideline development and dissemination in Europe.

PubMed

Meesterberends, Esther; Halfens, Ruud; Lohrmann, Christa; de Wit, Rianne

2010-06-01

To explore the current state of pressure ulcer guideline development and dissemination, from national to local level (i.e. nursing homes) in six European countries: England, Germany, Italy, the Netherlands, Portugal and Sweden. Pressure ulcers are a persistent problem in healthcare institutions. Their prevalence is influenced by many factors, one of them being the development and dissemination of pressure ulcer guidelines. These are difficult and complex processes and it is not clear whether they differ between European countries. Literature review and semi-structured interviews. Interviews were conducted in six countries at national and nursing home level. Four countries had national pressure ulcer prevention and treatment guidelines. Portugal had no national guidelines and Sweden had shifted the responsibility to regional level. All participating nursing homes had pressure ulcer guidelines except those in Portugal. Control and monitoring of guideline dissemination was carried out only in Sweden and England. All countries studied have national or regional pressure ulcer prevention and treatment guidelines, except Portugal. Portugal is also the only country where none of the nursing homes included had pressure ulcer guidelines. Because the dissemination of such guidelines does not imply actual implementation, further research should focus on the implementation process. Clinical guidelines, like pressure ulcer guidelines, are important tools in guiding the care processes in healthcare institutions. Successful dissemination of guidelines from national level to individual healthcare institutions is a first and necessary step in actually applying them. Monitoring of the guideline dissemination process is therefore essential.

Social and clinical determinants of quality of life in Parkinson's disease in a Russian cohort study.

PubMed

Winter, Yaroslav; von Campenhausen, Sonja; Popov, Georgy; Reese, Jens P; Balzer-Geldsetzer, Monika; Kukshina, Anastasia; Zhukova, Tatyana V; Bertschi, Natalia; Bötzel, Kai; Gusev, Eugene; Oertel, Wolfgang H; Dodel, Richard; Guekht, Alla

2010-05-01

Parkinson's disease (PD) is a chronic neurodegenerative disorder that has a major impact on health and longevity in Eastern countries. Studies investigating health-related quality of life (HRQoL) in Eastern European and Asian countries are scarce. The objective of this cross-sectional survey was to assess HRQoL in Russian patients with PD and identify its social and clinical determinants. The study included 100 outpatients with idiopathic PD and 100 controls. Patients were consecutively recruited from the neurological department of the Russian Medical State University in Moscow between October 2004 and December 2005. Regional healthy controls were matched for age and sex. The evaluation of HRQoL was performed using the EuroQol instrument (EQ-5D and EQ VAS). Disease severity was assessed using the Unified Parkinson's Disease Rating Scale (UPDRS). Multivariate regression analyses were used to identify independent determinants of HRQoL. HRQoL was more notably decreased in PD patients than in controls (98% versus 74% of individuals with moderate or severe problems in at least one dimension of the EQ-5D (p < 0.001), respectively). As compared to patients, the controls reported a higher mean EQ VAS score (74.0 +/- 16.0 versus 47.7 +/- 16.7, p < 0.001). Social and clinical determinants of HRQoL were age, disease severity, dystonia, depression, dementia and social support. While the HRQoL of patients with PD in Western countries is predominately affected by clinical parameters, social factors play an important role in Eastern countries. Our data should be considered in the development of national healthcare programs that seek to provide better social services support for patients with PD. Copyright 2009 Elsevier Ltd. All rights reserved.

The impact of clinical social franchising on health services in low- and middle-income countries: a systematic review.

PubMed

Beyeler, Naomi; York De La Cruz, Anna; Montagu, Dominic

2013-01-01

The private sector plays a large role in health services delivery in low- and middle-income countries; yet significant gaps remain in the quality and accessibility of private sector services. Clinical social franchising, which applies the commercial franchising model to achieve social goals and improve health care, is increasingly used in developing countries to respond to these limitations. Despite the growth of this approach, limited evidence documents the effect of social franchising on improving health care quality and access. We examined peer-reviewed and grey literature to evaluate the effect of social franchising on health care quality, equity, cost-effectiveness, and health outcomes. We included all studies of clinical social franchise programs located in low- and middle-income countries. We assessed study bias using the WHO-Johns Hopkins Rigour Scale and used narrative synthesis to evaluate the findings. Of 113 identified articles, 23 were included in this review; these evaluated a small sample of franchises globally and focused on reproductive health franchises. Results varied widely across outcomes and programs. Social franchising was positively associated with increased client volume and client satisfaction. The findings on health care utilization and health impact were mixed; some studies find that franchises significantly outperform other models of health care, while others show franchises are equivalent to or worse than other private or public clinics. In two areas, cost-effectiveness and equity, social franchises were generally found to have poorer outcomes. Our review indicates that social franchising may strengthen some elements of private sector health care. However, gaps in the evidence remain. Additional research should include: further documentation of the effect of social franchising, evaluating the equity and cost-effectiveness of this intervention, and assessing the role of franchising within the context of the greater healthcare delivery system.

Improving clinical communication of students with English as a second language (ESL) using online technology: a small scale evaluation study.

PubMed

Rogan, Fran; San Miguel, Caroline

2013-09-01

Increasingly, students with English as a second language (ESL) are enrolled in nursing degrees in English speaking countries (Wang et al., 2008). However, they may be at risk of clinical practice failure due to communication difficulties associated with unfamiliar linguistic and cultural factors (Guhde, 2003). This paper describes and evaluates an innovation to assist ESL nursing students at an Australian university develop their clinical communication skills and practice readiness by providing online learning resources, using podcast and vodcast technology, that blend with classroom activities and facilitate flexible and independent learning. The innovation builds on an intensive clinical language workshop program called 'Clinically Speaking' which has evolved through a cyclical process of ongoing research to produce resources in response to students' learning needs. Whilst uptake of the resources was modest, students of ESL as well as English speaking backgrounds (ESB) found the resources improved their clinical preparation and confidence by increasing their understanding of expectations, clinical language and communication skills. The innovation, developed with a modest budget, shows potential in developing ESL and ESB students' readiness for clinical communication, enabling them to engage in clinical practice to develop competency standards required of nursing graduates and registration authorities. Copyright © 2012 Elsevier Ltd. All rights reserved.

Mental Health of HIV-Seropositive Women During Pregnancy and Postpartum Period: A Comprehensive Literature Review

PubMed Central

Dass-Brailsford, Priscilla; Nora, Diana; Talisman, Nicholas

2014-01-01

With growing numbers of HIV-seropositive (HIV+) women of child-bearing age and increased access to effective clinical protocols for preventing mother-to-child transmission (MTCT) of HIV, mental health-related factors have become increasingly relevant due to their potential to affect the women’s quality of life, obstetric outcomes and risk of MTCT. This review synthesizes evidence from 53 peer-reviewed publications examining mental health-related variables in pregnant and postpartum HIV+ women. The presentation of results is organized by the level of socioeconomic resources in the countries where studies were conducted (i.e., high-, middle-, and low-income countries). It is concluded that psychiatric symptoms, particularly depression, and mental health vulnerabilities (e.g., inadequate coping skills) are widespread among pregnant HIV+ women globally and have a potential to affect psychological well-being, quality of life and salient clinical outcomes. The current body of evidence provides rationale for developing and evaluating clinical and structural interventions aimed at improving mental health outcomes and their clinical correlates in pregnant HIV+ women. PMID:24584458

Comparing private sector family planning services to government and NGO services in Ethiopia and Pakistan: how do social franchises compare across quality, equity and cost?

PubMed Central

Shah, Nirali M; Wang, Wenjuan; Bishai, David M

2011-01-01

Policy makers in developing countries need to assess how public health programmes function across both public and private sectors. We propose an evaluation framework to assist in simultaneously tracking performance on efficiency, quality and access by the poor in family planning services. We apply this framework to field data from family planning programmes in Ethiopia and Pakistan, comparing (1) independent private sector providers; (2) social franchises of private providers; (3) non-government organization (NGO) providers; and (4) government providers on these three factors. Franchised private clinics have higher quality than non-franchised private clinics in both countries. In Pakistan, the costs per client and the proportion of poorest clients showed no differences between franchised and non-franchised private clinics, whereas in Ethiopia, franchised clinics had higher costs and fewer clients from the poorest quintile. Our results highlight that there are trade-offs between access, cost and quality of care that must be balanced as competing priorities. The relative programme performance of various service arrangements on each metric will be context specific. PMID:21729919

Comparing private sector family planning services to government and NGO services in Ethiopia and Pakistan: how do social franchises compare across quality, equity and cost?

PubMed

Shah, Nirali M; Wang, Wenjuan; Bishai, David M

2011-07-01

Policy makers in developing countries need to assess how public health programmes function across both public and private sectors. We propose an evaluation framework to assist in simultaneously tracking performance on efficiency, quality and access by the poor in family planning services. We apply this framework to field data from family planning programmes in Ethiopia and Pakistan, comparing (1) independent private sector providers; (2) social franchises of private providers; (3) non-government organization (NGO) providers; and (4) government providers on these three factors. Franchised private clinics have higher quality than non-franchised private clinics in both countries. In Pakistan, the costs per client and the proportion of poorest clients showed no differences between franchised and non-franchised private clinics, whereas in Ethiopia, franchised clinics had higher costs and fewer clients from the poorest quintile. Our results highlight that there are trade-offs between access, cost and quality of care that must be balanced as competing priorities. The relative programme performance of various service arrangements on each metric will be context specific.

The Afya Bora Fellowship: An Innovative Program Focused on Creating an Interprofessional Network of Leaders in Global Health.

PubMed

Green, Wendy M; Farquhar, Carey; Mashalla, Yohana

2017-09-01

Most current health professions education programs are focused on the development of clinical skills. As a result, they may not address the complex and interconnected nature of global health. Trainees require relevant clinical, programmatic, and leadership skills to meet the challenges of practicing in an increasingly globalized environment. To develop health care leaders within sub-Saharan Africa, the Afya Bora Consortium developed a one-year fellowship for medical doctors and nurses. Fellows from nine institutions in the United States and sub-Saharan Africa participate in 12 learning modules focused on leadership development and program management. Classroom-based training is augmented with an experiential apprenticeship component. Since 2011, 100 fellows have graduated from the program. During their apprenticeships, fellows developed projects beneficial to their development and to host organizations. The program has developed fellows' skills in leadership, lent expertise to local organizations, and built knowledge in local contexts. Most fellows have returned to their countries of origin, thus building local capacity. U.S.-based fellows examine global health challenges from regional perspectives and learn from sub-Saharan African experts and peers. The Consortium provides ongoing support to alumni through career development awards and alumni network engagement with current and past fellow cohorts. The Consortium expanded from its initial network of five countries to six and continues to seek opportunities for geographical and institutional expansion.

Music therapy research in Ibero-American countries: an overview focused on assessment and clinical evaluation.

PubMed

Sabbatella, Patricia L

2005-12-01

The aim of this article is to present an overview of some contemporary ideas concerning the status of music therapy research in Ibero-American countries, with a focus on assessment and clinical evaluation of music therapy clinical practice.

US medical specialty global health training and the global burden of disease

PubMed Central

Kerry, Vanessa B.; Walensky, Rochelle P.; Tsai, Alexander C.; Bergmark, Regan W.; Bergmark, Brian A.; Rouse, Chaturia; Bangsberg, David R.

2013-01-01

Background Rapid growth in global health activity among US medical specialty education programs has lead to heterogeneity in types of activities and global health training models. The breadth and scope of this activity is not well chronicled. Methods Using a standardized search protocol, we examined the characteristics of US medical residency global health programs by number of programs, clinical specialty, nature of activity (elective, research, extended curriculum based field training), and geographic location across seven different clinical medical residency education specialties. We tabulated programmatic activity by clinical discipline, region and country. We calculated the Spearman's rank correlation coefficient to estimate the association between programmatic activity and country–level disease burden. Results Of the 1856 programs assessed between January and June 2011, there were 380 global health residency training programs (20%) working in 141 countries. 529 individual programmatic activities (elective–based rotations, research programs, extended curriculum–based field training, or other) occurred at 1337 specific sites. The majority of the activities consisted of elective–based rotations. At the country level, disease burden had a statistically significant association with programmatic activity (Spearman's ρ = 0.17) but only explained 3% of the total variation between countries. Conclusions There were a substantial number of US medical specialty global health programs, but a relative paucity of surgical and mental health programs. Elective–based programs were more common than programs that offer longitudinal experiences. Despite heterogeneity, there was a small but statistically significant association between program location and the global burden of disease. Areas for further study include the degree to which US–based programs develop partnerships with their program sites, the significance of this activity for training, and number and breadth of programs in medical specialty global health education in other countries around the world. PMID:24363924

European survey on principles of prudent antibiotic prescribing teaching in undergraduate students.

PubMed

Pulcini, C; Wencker, F; Frimodt-Møller, N; Kern, W V; Nathwani, D; Rodríguez-Baño, J; Simonsen, G S; Vlahović-Palčevski, V; Gyssens, I C

2015-04-01

We surveyed European medical schools regarding teaching of prudent antibiotic prescribing in the undergraduate curriculum. We performed a cross-sectional survey in 13 European countries (Belgium, Croatia, Denmark, France, Germany, Italy, Netherlands, Norway, Serbia, Slovenia, Spain, Switzerland, United Kingdom) in 2013. Proportional sampling was used, resulting in the selection of two to four medical schools per country. A standardized questionnaire based on literature review and validated by a panel of experts was sent to lecturers in infectious diseases, medical microbiology and clinical pharmacology. In-depth interviews were conducted with four lecturers. Thirty-five of 37 medical schools were included in the study. Prudent antibiotic use principles were taught in all but one medical school, but only four of 13 countries had a national programme. Interactive teaching formats were used less frequently than passive formats. The teaching was mandatory for 53% of the courses and started before clinical training in 71%. We observed wide variations in exposure of students to important principles of prudent antibiotic use among countries and within the same country. Some major principles were poorly covered (e.g. reassessment and duration of antibiotic therapy, communication skills). Whereas 77% of the respondents fully agreed that the teaching of these principles should be prioritized, lack of time, mainly due to rigid curriculum policies, was the main reported barrier to implementation. Given the study design, these are probably optimistic results. Teaching of prudent antibiotic prescribing principles should be improved. National and European programmes for development of specific learning outcomes or competencies are urgently needed. Copyright © 2014 European Society of Clinical Microbiology and Infectious Diseases. Published by Elsevier Ltd. All rights reserved.

Imported human rabies cases worldwide, 1990-2012.

PubMed

Carrara, Philippe; Parola, Phillipe; Brouqui, Phillipe; Gautret, Philippe

2013-01-01

Sixty cases of human rabies in international travelers were reviewed from 1990-2012. A significant proportion of the cases were observed in migrants or their descendants when emigrating from their country of origin or after a trip to visit friends and relatives or for other reasons (43.3%). The cases were not necessarily associated with long-term travel or expatriation to endemic countries; moreover, cases were observed in travelers after short trips of two weeks or less. A predominance of male patients was observed (75.0%). The proportion of children was low (11.7%). Cases from India and Philippines were frequent (16 cases/60). In a significant proportion of cases (51.1%), diagnosis was challenging, with multiple missed diagnoses and transfers from ward to ward before the final diagnosis of rabies. Among the 28 patients whose confirmed diagnosis was obtained ante-mortem, the mean time between hospitalization and diagnosis was 7.7 days (median time: 6.0 days, range 2-30) including four cases with a diagnosis delayed by 15 or more days. In five cases, a patient traveled through one or more countries before ultimately being hospitalized. Three factors played a role in delaying the diagnosis of rabies in a number of cases: (i) a low index of suspicion for rabies in countries where the disease has been eradicated for a long time or is now rare, (ii) a negative history of animal bites or exposure to rabies, and (iii) atypical clinical presentation of the disease. Clinical symptomatology of rabies is complex and commonly confuses physicians. Furthermore, failure in diagnosing imported cases in more developed countries is most likely related to the lack of medical familiarity with even the typical clinical features of the disease.

Vaccines and vaccination for avian influenza in poultry

USDA-ARS?s Scientific Manuscript database

Avian influenza (AI) vaccines have been developed and used to protect poultry and other birds in various countries of the world. Protection is principally mediated by an immune response to the subtype-specific hemagglutinin (HA) protein. AI vaccines prevent clinical signs of disease, death, egg pr...

[Scientific production in clinical medicine and international collaboration networks in South American countries].

PubMed

Huamaní, Charles; González A, Gregorio; Curioso, Walter H; Pacheco-Romero, José

2012-04-01

International collaboration is increasingly used in biomedical research. To describe the characteristics of scientific production in Latin America and the main international collaboration networks for the period 2000 to 2009. Search for papers generated in Latin American countries in the Clinical Medicine database of ISI Web of Knowledge v.4.10 - Current Contents Connect. The country of origin of the corresponding author was considered the producing country of the paper. International collaboration was analyzed calculating the number of countries that contributed to the generation of a particular paper. Collaboration networks were graphed to determine the centrality of each network. Twelve Latin American countries participated in the production of 253,362 papers. The corresponding author was South American in 79% of these papers. Sixteen percent of papers were on clinical medicine and 36% of these were carried out in collaboration. Brazil had the highest production (22,442 papers) and the lower percentage of international collaboration (31%). North America accounts for 63% of collaborating countries. Only 8% of collaboration is between South American countries. Brazil has the highest tendency to collaborate with other South American countries. Brazil is the South American country with the highest scientific production and indicators of centrality in South America. The most common collaboration networks are with North American countries.

50 years of pediatric immunology: progress and future, a clinical perspective.

PubMed

Singh, Surjit; Gupta, Anju; Rawat, Amit

2013-01-08

Rapidly evolving advances in the field of immunology over the last few decades have impacted the practice of clinical medicine in many ways. In fact, understanding the immunological basis of disease has been pivotal in deciphering the pathogenesis of several disease processes, infective or otherwise. As of today, there is hardly any specialty of medicine which is not influenced by immunology. Pediatric rheumatological disorders, vasculitides, Human Immunodeficiency Virus (HIV) infection, Primary Immunodeficiency Diseases (PIDs) and autoimmune disorders fall under the domain of clinical immunology. This specialty is poised to emerge as a major clinical specialty in our country. The gulf between bench and bedside is narrowing down as our understanding of the complex immunological mechanisms gets better. However, a lot still needs to be done in this field as the morbidity and mortality of some of these conditions is unacceptably high in the Indian setup. A number of medical schools and institutes in the country now have the resources and the wherewithal to develop into specialized centres of clinical immunology. We need to concentrate on training more physicians and pediatricians in this field. The future is bright and the prospects exciting.

Recommendations for routine reporting on indications for cesarean delivery in developing countries.

PubMed

Stanton, Cynthia; Ronsmans, Carine

2008-09-01

Cesarean delivery rates are increasing rapidly in many developing countries, particularly among wealthy women. Poor women have lower rates, often so low that they do not reach the minimum rate of 1 percent. Little data are available on clinical indications for cesarean section, information that could assist in understanding why cesarean delivery rates have changed. This paper presents recommendations for routine reporting on indications for cesarean delivery in developing countries. These recommendations resulted from an international consultation of researchers held in February 2006 to promote the collection of comparable data to understand change in, or composition of, the cesarean delivery rate in developing countries. Data are presented from selected countries, categorizing cesareans by three classification systems. A single classification system was recommended for use in both high and low cesarean delivery rate settings, given that underuse and overuse of cesarean section are evident within many populations. The group recommended a hierarchical categorization, prioritizing cesareans performed for absolute maternal indications. Categorization among the remaining nonabsolute indications is based on the primary indication for the procedure and include maternal and fetal indications and psychosocial indications, required for high cesarean delivery rate settings. Data on indications for cesarean sections are available everywhere the procedure is performed. All that is required is compilation and review at facility and at higher levels. Advocacy within ministries of health and medical professional organizations is required to advance these recommendations since researchers have inadequately communicated the health effects of both underuse and overuse of cesarean delivery.

A Review of Literature to Understand the Complexity of Equity, Ethics and Management for Achieving Public Health Goals in India

PubMed Central

Garg, Pankaj; Nagpal, Jitender

2014-01-01

In the context of inadequate public spending on health care in India (0.9% of the GDP); government liberalized its policies in the form of subsidized lands and tax incentives, resulting in the mushrooming of private hospitals and clinics in India. Paradoxically, a robust framework was not developed for the regulation of these health care providers, resulting in disorganized health sector, inadequate financing models, and lack of prioritization of services, as well as a sub-optimal achievement of the Millennium Development Goals (MDG). We systematically reviewed the evidence base regarding regulation of private hospitals, applicability of private-public mix, state of health insurance and effective policy development for India, while seeking lessons on regulation of private health systems, from South African (a developing country) and Australian (a developed country) health care systems. PMID:24701465

Genetic counseling services and development of training programs in Malaysia.

PubMed

Lee, Juliana Mei-Har; Thong, Meow-Keong

2013-12-01

Genetic counseling service is urgently required in developing countries. In Malaysia, the first medical genetic service was introduced in 1994 at one of the main teaching hospitals in Kuala Lumpur. Two decades later, the medical genetic services have improved with the availability of genetic counseling, genetic testing and diagnosis, for both paediatric conditions and adult-onset inherited conditions, at four main centers of medical genetic services in Malaysia. Prenatal diagnosis services and assisted reproductive technologies are available at tertiary centres and private medical facilities. Positive developments include governmental recognition of Clinical Genetics as a subspecialty, increased funding for genetics services, development of medical ethics guidelines, and establishment of support groups. However, the country lacked qualified genetic counselors. Proposals were presented to policy-makers to develop genetic counseling courses. Challenges encountered included limited resources and public awareness, ethical dilemmas such as religious and social issues and inadequate genetic health professionals especially genetic counselors.

Bridging the gaps between research, policy and practice in low- and middle-income countries: a survey of health care providers

PubMed Central

Guindon, G. Emmanuel; Lavis, John N.; Becerra-Posada, Francisco; Malek-Afzali, Hossein; Shi, Guang; Yesudian, C. Ashok K.; Hoffman, Steven J.

2010-01-01

Background Gaps continue to exist between research-based evidence and clinical practice. We surveyed health care providers in 10 low- and middle-income countries about their use of research-based evidence and examined factors that may facilitate or impede such use. Methods We surveyed 1499 health care providers practising in one of four areas relevant to the Millennium Development Goals (prevention of malaria, care of women seeking contraception, care of children with diarrhea and care of patients with tuberculosis) in each of China, Ghana, India, Iran, Kazakhstan, Laos, Mexico, Pakistan, Senegal and Tanzania. Results The proportion of respondents who reported that research was likely to change their clinical practice if performed and published in their own country (84.6% and 86.0% respectively) was higher than the proportion who reported the same about research and publications from their region (66.4% and 63.1%) or from high-income countries (55.8% and 55.5%). Respondents who were most likely to report that the use of research-based evidence led to changes in their practice included those who reported using clinical practice guidelines in paper format (odds ratio [OR] 1.54, 95% confidence interval [CI] 1.03–2.28), using scientific journals from their own country in paper format (OR 1.70, 95% CI 1.26–2.28), viewing the quality of research performed in their country as above average or excellent (OR 1.93, 95% CI 1.16–3.22); trusting systematic reviews of randomized controlled trials (OR 1.59, 95% CI 1.08–2.35); and having easy access to the Internet (OR 1.90, 95% CI 1.19–3.02). Interpretation Locally conducted or published research has played an important role in changing the professional practice of health care providers surveyed in low- and middle-income countries. Increased investments in local research, or at least in locally adapted publications of research-based evidence from other settings, are therefore needed. Although access to the Internet was viewed as a significant factor in whether research-based evidence led to concrete changes in practice, few respondents reported having easy access to the Internet. Therefore, efforts to improve Internet access in clinical settings need to be accelerated. PMID:20439448

Basic ICT adoption and use by general practitioners: an analysis of primary care systems in 31 European countries.

PubMed

De Rosis, Sabina; Seghieri, Chiara

2015-08-22

There is general consensus that appropriate development and use of information and communication technologies (ICT) are crucial in the delivery of effective primary care (PC). Several countries are defining policies to support and promote a structural change of the health care system through the introduction of ICT. This study analyses the state of development of basic ICT in PC systems of 31 European countries with the aim to describe the extent of, and main purposes for, computer use by General Practitioners (GPs) across Europe. Additionally, trends over time have been analysed. Descriptive statistical analysis was performed on data from the QUALICOPC (Quality and Costs of Primary Care in Europe) survey, to describe the geographic differences in the general use of computer, and in specific computerized clinical functions for different health-related purposes such as prescribing, medication checking, generating health records and research for medical information on the Internet. While all the countries have achieved a near-universal adoption of a computer in their primary care practices, with only a few countries near or under the boundary of 90 %, the computerisation of primary care clinical functions presents a wide variability of adoption within and among countries and, in several cases (such as in the southern and central-eastern Europe), a large room for improvement. At European level, more efforts could be done to support southern and central-eastern Europe in closing the gap in adoption and use of ICT in PC. In particular, more attention seems to be need on the current usages of the computer in PC, by focusing policies and actions on the improvement of the appropriate usages that can impact on quality and costs of PC and can facilitate an interconnected health care system. However, policies and investments seem necessary but not sufficient to achieve these goals. Organizational, behavioural and also networking aspects should be taken in consideration.

Laboratory practice at the periphery in developing countries.

PubMed

Lewis, S M

2002-08-01

An effective national health service structure requires a comprehensive programme for primary health care in peripheral and rural areas. This is especially important in under-resourced countries where facilities are sparse, the population is widely dispersed and transport is limited. Haematology has a key role in diagnosis and patient management by selecting tests for their clinical relevance and utility for the specific circumstances, and ensuring their technical reliability when used in health clinics and point-of-care testing. WHO has proposed a basic menu of tests in three categories: (a) tests such as haemoglobin screen which can be performed by nurses, midwives, health-aides or community doctors, (b) tests such as haemoglobinometry, microhaematocrit and microscopic examination of stained preparations which can be performed by a technician or laboratory assistant in a health centre, (c) tests requiring greater technical expertise of a laboratory technician or trained doctor. The peripheral health clinics and district laboratories must be familiar with the guidelines on standardized methods for collecting and storing specimens and transporting them to a regional laboratory or a reference centre. A training syllabus should be provided at the health centres and district laboratories, and this should include on-site instruction from supervisors and access to training manuals and distance-learning material. A co-ordinated programme of quality assurance and standardization of test methods should be established by a reference centre or national health authority with a network which encompasses all laboratories and health clinics undertaking any tests. Each regional laboratory should foster lower level laboratories or clinics within its neighbourhood. Of particular concern is the reliable diagnosis and management of anaemia. WHO reports indicate that 40% of the world population suffer from anaemia, especially affecting pregnant women, and a high proportion of infants and children in developing countries. The Haemoglobin Colour Scale (HCS) was recently developed for WHO as a simple, cheap and portable device which reads haemoglobin within 1 g/dl of the true value. It has been validated in a number of studies and is now manufactured commercially in accordance with WHO specifications under control of a WHO Collaborating Centre. It has an important potential role in the resource-limited environment where anaemia screening presently usually depends on unreliable clinical examination.

Human germline gene editing: Recommendations of ESHG and ESHRE.

PubMed

de Wert, Guido; Pennings, Guido; Clarke, Angus; Eichenlaub-Ritter, Ursula; van El, Carla G; Forzano, Francesca; Goddijn, Mariëtte; Heindryckx, Björn; Howard, Heidi C; Radojkovic, Dragica; Rial-Sebbag, Emmanuelle; Tarlatzis, Basil C; Cornel, Martina C

2018-04-01

Technological developments in gene editing raise high expectations for clinical applications, first of all for somatic gene editing but in theory also for germline gene editing (GLGE). GLGE is currently not allowed in many countries. This makes clinical applications in these countries impossible now, even if GLGE would become safe and effective. What were the arguments behind this legislation, and are they still convincing? If a technique can help to avoid serious genetic disorders, in a safe and effective way, would this be a reason to reconsider earlier standpoints? The European Society of Human Reproduction and Embryology (ESHRE) and the European Society of Human Genetics (ESHG) together developed a Background document and Recommendations to inform and stimulate ongoing societal debates. After consulting its membership and experts, this final version of the Recommendations was endorsed by the Executive Committee and the Board of the respective Societies in May 2017. Taking account of ethical arguments, we argue that both basic and pre-clinical research regarding GLGE can be justified, with conditions. Furthermore, while clinical GLGE would be totally premature, it might become a responsible intervention in the future, but only after adequate pre-clinical research. Safety of the child and future generations is a major concern. Future discussions must also address priorities among reproductive and potential non-reproductive alternatives, such as PGD and somatic editing, if that would be safe and successful. The prohibition of human germline modification, however, needs renewed discussion among relevant stakeholders, including the general public and legislators.

Teaching immigrant and refugee health to residents: domestic global health.

PubMed

Asgary, Ramin; Smith, Clyde Lanford; Sckell, Blanca; Paccione, Gerald

2013-01-01

Half a million immigrants enter the United States annually. Clinical providers generally lack training in immigrant health. We developed a curriculum with didactic, clinical, and analytic components to advance residents' skills in immigrant and travel health. The curriculum focused on patients and their countries of origin and encompassed (a) societal, cultural, economical, and human rights profiles; (b) health system/ policies/resources/statistics, and environmental health; and (c) clinical manifestations, tropical and travel health. Residents evaluated sociocultural health beliefs and human rights abuses; performed history and physical examinations while precepted by faculty; developed specific care plans; and discussed patients in a dedicated immigrant health morning report. We assessed resident satisfaction using questionnaires and focus groups. Residents (n=20) found clinical, sociocultural, and epidemiological components the most helpful. Morning reports reinforced peer education. The immigrant health curriculum was useful for residents. Multiple teaching modules, collaboration with grassroot organizations, and an ongoing clinical component were key features.

Trends in the types and quality of childhood immunisations research output from Africa 1970-2010: mapping the evidence base.

PubMed

Machingaidze, Shingai; Hussey, Gregory D; Wiysonge, Charles S

2014-02-04

Over the past four decades, extraordinary progress has been made in establishing and improving childhood immunization programmes around Africa. In order to ensure effective and sustainable positive growth of these childhood immunisations programmes, the development, adaptation and implementation of all interventions (programme activities, new vaccines, new strategies and policies) should be informed by the best available local evidence. An assessment of the peer-reviewed literature on childhood immunization research published in English from 1970 to 2010 was conducted in PubMed and Africa-Wide databases. All study types were eligible for inclusion. A standard form was used to extract information from all studies identified as relevant and entered into a Microsoft Access database for analysis. Our initial search yielded 5436 articles from the two databases, from which 848 full text articles were identified as relevant. Among studies classified as clinical research (417), 40% were clinical trials, 24% were burden of disease/epidemiology and 36% were other clinical studies. Among studies classified as operational research (431), 77% related to programme management, 18% were policy related and 5% were related to vaccine financing. Studies were conducted in 48 African countries with six countries (South Africa, The Gambia, Nigeria, Senegal, Guinea-Bissau and Kenya) accounting for 56% of the total research output. Studies were published in 152 different journals with impact factors ranging from 0.192 to 53.29; with a median impact factor of 3.572. A similar proportion of clinical versus operational research output was found. However, an uneven distribution across Africa was observed with only six countries accounting for over half of the research output. The research conducted was of moderate to high quality, with 62% being published in journals with 2010 impact factors greater than two. Urgent attention should be given to the development of research capacity in low performing countries around Africa, with increased focus on the process of turning immunisations programme research evidence into policy and practice, as well as increased focus on issues relating to vaccine financing and sustainability in Africa.

Trends in the types and quality of childhood immunisations research output from Africa 1970–2010: mapping the evidence base

PubMed Central

2014-01-01

Background Over the past four decades, extraordinary progress has been made in establishing and improving childhood immunization programmes around Africa. In order to ensure effective and sustainable positive growth of these childhood immunisations programmes, the development, adaptation and implementation of all interventions (programme activities, new vaccines, new strategies and policies) should be informed by the best available local evidence. Methods An assessment of the peer-reviewed literature on childhood immunization research published in English from 1970 to 2010 was conducted in PubMed and Africa-Wide databases. All study types were eligible for inclusion. A standard form was used to extract information from all studies identified as relevant and entered into a Microsoft Access database for analysis. Results Our initial search yielded 5436 articles from the two databases, from which 848 full text articles were identified as relevant. Among studies classified as clinical research (417), 40% were clinical trials, 24% were burden of disease/epidemiology and 36% were other clinical studies. Among studies classified as operational research (431), 77% related to programme management, 18% were policy related and 5% were related to vaccine financing. Studies were conducted in 48 African countries with six countries (South Africa, The Gambia, Nigeria, Senegal, Guinea-Bissau and Kenya) accounting for 56% of the total research output. Studies were published in 152 different journals with impact factors ranging from 0.192 to 53.29; with a median impact factor of 3.572. Conclusion A similar proportion of clinical versus operational research output was found. However, an uneven distribution across Africa was observed with only six countries accounting for over half of the research output. The research conducted was of moderate to high quality, with 62% being published in journals with 2010 impact factors greater than two. Urgent attention should be given to the development of research capacity in low performing countries around Africa, with increased focus on the process of turning immunisations programme research evidence into policy and practice, as well as increased focus on issues relating to vaccine financing and sustainability in Africa. PMID:24495533

Hepatitis E Virus: Time to Change the Textbooks.

PubMed

Dalton, Harry R; Webb, Glynn W; Norton, Ben C; Woolson, Kathy L

Until recently, hepatitis E virus (HEV) was thought not to occur in developed countries. It is now clear that locally acquired HEV is common in such settings. HEV infection acquired in these areas differs from that in developing countries in a number of important aspects: it is caused by genotype 3 (and 4 in China and Japan), it mainly affects middle-aged/elderly males and it is zoonotic with a porcine primary host. Pig herds worldwide are infected with HEV genotype 3 and HEV has been found in the human food chain in a number of developed countries. However, the route of transmission is not fully understood, since most cases are not obviously associated with pigs/pig products. HEV can be transmitted by blood transfusion and surprisingly high numbers of asymptomatic blood donors are viremic at the time of donation: Germany 1:1,200, Netherlands 1:2,671, England 1:2,848. Our understanding of the clinical phenotype of HEV infection in humans has undergone a sea-change in recent years. Previously, HEV was thought to cause only acute self-limiting hepatitis. However, HEV may cause persistent disease in the immunocompromised. Patients with chronic HEV infection have no symptoms, but some develop rapidly progressive liver cirrhosis. The full clinical spectrum of HEV is still emerging. HEV has important extra-hepatic manifestations, which deserve further investigation. For example, HEV can cause a wide range of neurological illness. In particular, very recent data suggest that Guillain-Barré syndrome and neuralgic amyotrophy are associated with locally acquired HEV in approximately 5 and 10% of the cases, respectively. © 2016 S. Karger AG, Basel.

Mapping human resources for eye health in 21 countries of sub-Saharan Africa: current progress towards VISION 2020.

PubMed

Palmer, Jennifer J; Chinanayi, Farai; Gilbert, Alice; Pillay, Devan; Fox, Samantha; Jaggernath, Jyoti; Naidoo, Kovin; Graham, Ronnie; Patel, Daksha; Blanchet, Karl

2014-08-15

Development of human resources for eye health (HReH) is a major focus of the Global Action Plan 2014 to 2019 to reduce the prevalence of avoidable visual impairment by 25% by the year 2019. The eye health workforce is thought to be much smaller in sub-Saharan Africa than in other regions of the world but data to support this for policy-making is scarce. We collected HReH and cataract surgeries data from 21 countries in sub-Sahara to estimate progress towards key suggested population-based VISION 2020 HReH indicators and cataract surgery rates (CSR) in 2011. Routinely collected data on practitioner and surgery numbers in 2011 was requested from national eye care coordinators via electronic questionnaires. Telephone and e-mail discussions were used to determine data collection strategies that fit the national context and to verify reported data quality. Information was collected on six practitioner cadres: ophthalmologists, cataract surgeons, ophthalmic clinical officers, ophthalmic nurses, optometrists and 'mid-level refractionists' and combined with publicly available population data to calculate practitioner to population ratios and CSRs. Associations with development characteristics were conducted using Wilcoxon rank sum tests and Spearman rank correlations. HReH data was not easily available. A minority of countries had achieved the suggested VISION 2020 targets in 2011; five countries for ophthalmologists/cataract surgeons, four for ophthalmic nurses/clinical officers and two for CSR. All countries were below target for optometrists, even when other cadres who perform refractions as a primary duty were considered. The regional (sample) ratio for surgeons (ophthalmologists and cataract surgeons) was 2.9 per million population, 5.5 for ophthalmic clinical officers and nurses, 3.7 for optometrists and other refractionists, and 515 for CSR. A positive correlation between GDP and CSR as well as many practitioner ratios was observed (CSR P = 0.0042, ophthalmologists P = 0.0034, cataract surgeons, ophthalmic nurses and optometrists 0.1 > P > 0.05). With only a minority of countries in our sample having reached suggested ophthalmic cadre targets and none having reached targets for refractionists in 2011, substantially more targeted investment in HReH may be needed for VISION 2020 aims to be achieved in sub-Saharan Africa.

Mapping human resources for eye health in 21 countries of sub-Saharan Africa: current progress towards VISION 2020

PubMed Central

2014-01-01

Background Development of human resources for eye health (HReH) is a major focus of the Global Action Plan 2014 to 2019 to reduce the prevalence of avoidable visual impairment by 25% by the year 2019. The eye health workforce is thought to be much smaller in sub-Saharan Africa than in other regions of the world but data to support this for policy-making is scarce. We collected HReH and cataract surgeries data from 21 countries in sub-Sahara to estimate progress towards key suggested population-based VISION 2020 HReH indicators and cataract surgery rates (CSR) in 2011. Methods Routinely collected data on practitioner and surgery numbers in 2011 was requested from national eye care coordinators via electronic questionnaires. Telephone and e-mail discussions were used to determine data collection strategies that fit the national context and to verify reported data quality. Information was collected on six practitioner cadres: ophthalmologists, cataract surgeons, ophthalmic clinical officers, ophthalmic nurses, optometrists and ‘mid-level refractionists’ and combined with publicly available population data to calculate practitioner to population ratios and CSRs. Associations with development characteristics were conducted using Wilcoxon rank sum tests and Spearman rank correlations. Results HReH data was not easily available. A minority of countries had achieved the suggested VISION 2020 targets in 2011; five countries for ophthalmologists/cataract surgeons, four for ophthalmic nurses/clinical officers and two for CSR. All countries were below target for optometrists, even when other cadres who perform refractions as a primary duty were considered. The regional (sample) ratio for surgeons (ophthalmologists and cataract surgeons) was 2.9 per million population, 5.5 for ophthalmic clinical officers and nurses, 3.7 for optometrists and other refractionists, and 515 for CSR. A positive correlation between GDP and CSR as well as many practitioner ratios was observed (CSR P = 0.0042, ophthalmologists P = 0.0034, cataract surgeons, ophthalmic nurses and optometrists 0.1 > P > 0.05). Conclusions With only a minority of countries in our sample having reached suggested ophthalmic cadre targets and none having reached targets for refractionists in 2011, substantially more targeted investment in HReH may be needed for VISION 2020 aims to be achieved in sub-Saharan Africa. PMID:25128163

The U.S. prevention of cardiovascular disease guidelines and implications for implementation in LMIC.

PubMed

Wong, Nathan D; Moran, Andrew E

2014-12-01

The 2013 guidelines for the Prevention of Cardiovascular Disease released by the American College of Cardiology and the American Heart Association included guidelines of assessment of cardiovascular disease (CVD) risk, lifestyle management, management of overweight and obesity, and treatment of blood cholesterol. In addition, there were also 2014 guidelines on hypertension management released by members appointed to the Eighth Joint National Committee. Taken together, these guidelines, though extensively discussed and disseminated in the United States, have not been widely recognized beyond the United States, nor have their implications been considered for lower- and middle-income developing countries. With an estimated 80% of the global burden in CVD occurring in developing countries, it is important to develop strategies to adequately detect those at increased CVD risk and to manage their risk through lifestyle and where appropriate, pharmacologic means. Though certain aspects of each guideline may be suitable for implementation globally, including in developing countries, other recommendations would be unrealistic for many countries based on local epidemiology and resources. CVD prevention priorities can be set using guidance from recently published CVD prevention guidelines if appropriately modified to the context of lower- and middle-income developing countries. Establishment of global CVD prevention standards and rapid adaptation and dissemination of clinical guidelines are of paramount importance if we are to make significant progress into achieving World Health Organization 2025 goals to reduce the burden from CVD and other noncommunicable diseases. Copyright © 2014 World Heart Federation (Geneva). Published by Elsevier B.V. All rights reserved.

Which information resources are used by general practitioners for updating knowledge regarding diabetes?

PubMed

Tabatabaei-Malazy, Ozra; Nedjat, Saharnaz; Majdzadeh, Reza

2012-04-01

Little is known about the degree of utilization of information resources on diabetes by general practitioners (GPs) and its impact on their clinical behavior in developing countries. Such information is vital if GPs' diabetes knowledge is to be improved. This cross-sectional study recruited 319 GPs in the summer of 2008. Questions were about the updates on diabetes knowledge in the previous two years, utilization of information resources (domestic and foreign journals, congresses, the Internet, reference books, mass media, and peers), attitude toward the importance of each resource, and impact of each resource on clinical behavior. A total of 62% of GPs had used information resources for improving their knowledge on diabetes in the previous two years. Domestic journals accounted for the highest utilization (30%) and the highest importance score (83 points from 100); with the importance score not being affected by sex, years elapsed after graduation, and numbers of diabetic visits. Clinical behavior was not influenced by the information resources listed; whereas knowledge upgrade, irrespective of the sources utilized, had a significantly positive correlation with clinical behavior. Domestic journals constituted the main information resource utilized by the GPs; this resource, however, in tandem with the other information resources on diabetes exerted no significant impact on the GPs' clinical behavior. In contrast to the developed countries, clinical guidelines do not have any place as a source of information and or practice. Indubitably, the improvement of diabetes knowledge transfer requires serious interventions to improve information resources as well as the structure of scientific gatherings and collaborations.

Status of vaccine research and development of vaccines for GBS.

PubMed

Heath, Paul T

2016-06-03

Streptococcus agalactiae (group B streptococcus (GBS)) is the leading cause of neonatal sepsis and meningitis in many countries. Intrapartum antibiotic strategies have reduced the incidence of early-onset neonatal GBS in a number of countries but have had no impact on late onset GBS infection (LOD). In low/middle income settings, the disease burden remains uncertain although in several countries of Southern Africa appears comparable to or higher than that of high-income countries. As disease may be rapidly fulminating cases can be missed before appropriate samples are obtained and this may lead to underestimation of the true burden. Given the rapid onset and progression within hours of birth as well as the deficiencies in IAP strategies and absence of a solution for preventing LOD, it is clear that administration of a suitable vaccine in pregnancy could provide a better solution in all settings; it should also be cost effective. The current leading vaccine candidates are CPS-protein conjugate vaccines but protein-based vaccines are also in development and one has recently commenced clinical trials. Copyright © 2016 World Health Organization. Published by Elsevier Ltd.. All rights reserved.

ESCAP Expert Paper: New developments in the diagnosis and treatment of adolescent anorexia nervosa--a European perspective.

PubMed

Herpertz-Dahlmann, Beate; van Elburg, Annemarie; Castro-Fornieles, Josefina; Schmidt, Ulrike

2015-10-01

Anorexia nervosa is a potentially life-threatening disorder with a typical onset in adolescence and high rates of medical complications and psychiatric comorbidity. This article summarizes issues relating to classification in DSM-5 and presents a narrative review of key evidence-based medical and behavioral interventions for adolescent AN and subthreshold restricting eating disorders, mainly, but not exclusively published between 2012 and 2014. In addition, it systematically compares the clinical guidelines of four European countries (Germany, Spain, The Netherlands, and United Kingdom) and outlines common clinical practice, in relation to treatment settings, nutritional rehabilitation, family-oriented and individual psychotherapy, and psychopharmacological treatment. With the exception of family-based treatment, which is mainly evaluated and practiced in Anglo-American countries, the evidence base is weak, especially for medical interventions such as refeeding and pharmacological intervention. There is a need for common European research efforts, to improve the available evidence base and resulting clinical guidance.

Survey of clinical practice for irritable bowel syndrome in East asian countries.

PubMed

Fukudo, Shin; Hahm, Ki-Baik; Zhu, Qi; Sollano, Jose D; Rani, Abdul A; Syam, Ari F; Kachintorn, Udom; Suzuki, Hidekazu; Kamiya, Takeshi; Joh, Takashi; Uchiyama, Kazuhiko; Naito, Yuji; Takahashi, Shin'ichi; Kinoshita, Yoshikazu; Ueno, Fumiaki; Yamagami, Hirokazu; Chan, Francis K L; Fock, Kwong M; Arakawa, Tetsuo

2015-01-01

Sociocultural factors are important because their different effects on the features of irritable bowel syndrome (IBS) between countries will provide clues towards solving this problem. The aims of this study were to depict the clinical realities of IBS in East Asian countries and test the hypothesis that the diagnosis and treatment of IBS differ between countries. Study participants were 251 physicians involved in the clinical practice of IBS at major institutions in Japan, South Korea, China, the Philippines, Indonesia and Singapore. The questionnaire contained 45 questions focused on the clinical practice of IBS. Subjects in Japan, South Korea, China, Indonesia, the Philippines and Singapore accounted for 55.4, 17.9, 8.8, 8.0, 6.4 and 3.6% of the study cohort, respectively. Amongst East Asian physicians, the most important symptom was considered to be abdominal pain by 33.4%, whilst 24.3% regarded alternating diarrhea and constipation to be the most important symptoms. Total colonoscopy and histopathology use showed no difference among countries. Prescriptions given for mild (p < 0.0001), moderate (p < 0.0001), severe (p < 0.0001), intractable (p = 0.002), diarrheal (p < 0.0001) and constipating (p < 0.0001) patients with IBS significantly differed between the countries. Except for several minor points, IBS specialists showed no significant difference in their diagnosis and treatment of IBS when compared to nonspecialists. This survey provided data on the clinical treatment of IBS among East Asian countries. The results supported the hypothesis that the diagnosis and treatment of IBS differs between countries. © 2015 S. Karger AG, Basel.

Stem cell tourism and future stem cell tourists: policy and ethical implications.

PubMed

Einsiedel, Edna F; Adamson, Hannah

2012-04-01

Stem cell tourism is a small but growing part of the thriving global medical tourism marketplace. Much stem cell research remains at the experimental stage, with clinical trials still uncommon. However, there are over 700 clinics estimated to be operating in mostly developing countries--from Costa Rica and Argentina to China, India and Russia--that have lured many patients, mostly from industrialized countries, driven by desperation and hope, which in turn continue to fuel the growth of such tourism. While much research has focused on such dimensions as the promotions that allow such businesses to make their services known, media coverage, some patient research, and regulatory conditions for developing country clinics, little attention has been paid to the non-affected members of the general population, the future potential users of such services. This empirical study based on five focus group discussions with a diverse group of healthy adults in a Canadian city, explored participant views of patients who use stem cell tourism services, the likelihood they would avail themselves of such services if they were to suffer similar illnesses, and the conditions under which they might do so, and the impact that admonitions and advice from international expert bodies might have on their decisions. Our findings suggest that these healthy adults are sympathetic to the drivers of hope and desperation, and, despite cautions about research limitations, may seek such treatments themselves under similar conditions. These findings are discussed in the context of the policy and ethical issues raised by this form of medical tourism. © 2012 Blackwell Publishing Ltd.

JPRS Report, Science & Technology, USSR: Science & Technology Policy.

DTIC Science & Technology

1990-08-22

RESOURCE-CONSERVING AND ECOLOGI- CALLY CLEAN PROCESSES FOR METALLURGY AND CHEMISTRY : 25 MILLION RUBLES. Continuous and combined processes in metallurgy...class hydrocarbons from natural gas were developed. They are of great production importance. At the Institute of General and Inorganic Chemistry a...clinics of the country the study of the narcotic analgesic fenaridin, which was developed at the Institute of Fine Organic Chemistry , was completed. The

Prevalence and Risk Factors of Obesity among Elderly Attending Geriatric Outpatient Clinics in Mansoura City

ERIC Educational Resources Information Center

Shebl, Amany Mohamed; Hatata, El Sayed Zaki; Boughdady, Aziza Mahmoud; El-Sayed, Sally Mohammed

2015-01-01

Obesity is a major public health problem affecting all ages in both developed and developing countries. It is considered the fifth leading risk factor for deaths all over the world as about 2.8 million people die due to obesity each year directly or indirectly. Obesity in elderly is considered one of the most serious public health challenges for…

Ethical, social and economic issues in familial breast cancer: a compilation of views from the E.C. Biomed II Demonstration Project.

PubMed

Steel, M; Smyth, E; Vasen, H; Eccles, D; Evans, G; Møller, P; Hodgson, S; Stoppa-Lyonnet, D; Chang-Claude, J; Caligo, M; Morrison, P; Haites, N

1999-10-01

Demand for clinical services for familial breast cancer is continuing to rise across Europe. Service provision is far from uniform and, in most centres, its evolution has been determined by local conditions, specifically by local research interests, rather than by central planning. However, in a number of countries there is evidence of progress towards co-ordinated development and audit of clinics providing risk assessment, counselling, screening and, in some cases, prophylactic intervention. Much important information should emerge from continued observation and comparative assessment of these developments. In most countries for which relevant data are available, there is a distinct bias towards higher social class among those who avail themselves of clinic facilities (in line with findings from many other health-promotion initiatives). This should be addressed when considering future organisation of clinical services. Molecular genetic studies designed to identify the underlying mutations responsible for familial breast cancer are not generally regarded as part of the clinical service and are funded through research grants (if at all). Economic considerations suggest that there is a case for keeping this policy under review. Familial cancers throw into sharp relief certain ethical and legal issues that have received much recent attention from government advisory bodies, patients' representatives, professional commentators and the popular media. Two are of particular importance; first, the right to gain access to medical records of relatives, in order to provide accurate risk assessment for a given family member, versus the right to privacy in respect of personal medical information and, second, the obligation (or otherwise) to inform family members of their risk status if they have not actively sought that knowledge. The legal position seems to vary from country to country and, in many cases, is unclear. In view of pressures to establish uniform approaches to medical confidentiality across the EC, it is important to evaluate the experience of participants in this Demonstration Programme and to apply the principle of "non-malfeasance" in formulating regulations that should govern future practice in this field. Data on economic aspects of familial breast cancer are remarkably sparse and outdated. As evidence accrues on the influence of screening and intervention programmes on morbidity and mortality, there is a strong case for evaluating the cost-effectiveness of different models of service provision.

Lymphogranuloma venereum variant L2b-specific polymerase chain reaction: insertion used to close an epidemiological gap.

PubMed

Verweij, S P; Catsburg, A; Ouburg, S; Lombardi, A; Heijmans, R; Dutly, F; Frei, R; Morré, S A; Goldenberger, D

2011-11-01

The management of the ongoing lymphogranuloma venereum epidemic in industrialized Western countries caused by Chlamydia trachomatis variant L2b still needs improvements in diagnosis, therapy and prevention. We therefore developed the first rapid C. trachomatis variant L2b-specific polymerase chain reaction to circumvent laborious ompA gene sequencing. © 2011 The Authors. Clinical Microbiology and Infection © 2011 European Society of Clinical Microbiology and Infectious Diseases.

The clinical and economic impact of a sustained program in global plastic surgery: valuing cleft care in resource-poor settings.

PubMed

Hughes, Christopher D; Babigian, Alan; McCormack, Susan; Alkire, Blake C; Wong, Anselm; Pap, Stephen A; Vincent, Jeffrey R; Meara, John G; Castiglione, Charles; Silverman, Richard

2012-07-01

The development of surgery in low- and middle-income countries has been limited by a belief that it is too expensive to be sustainable. However, subspecialist surgical care can provide substantial clinical and economic benefits in low-resource settings. The goal of this study is to describe the clinical and economic impact of recurrent short-term plastic surgical trips in low- and middle-income countries. The authors conducted a retrospective review of clinic and operative logbooks from Hands Across the World's surgical experience in Ecuador. The authors calculated the disability-adjusted life-years averted to estimate the clinical impact of cleft repair and then calculated the economic impact of surgical intervention for cleft disease. One thousand one hundred forty-two reconstructive surgical cases were performed over 15 years. Surgery was most commonly performed for scar contractures [449 cases (39.3 percent)], of which burn scars comprised a substantial amount [215 cases (18.8 percent)]. There were 40 postoperative complications within 7 days of operation (3.5 percent), and partial wound dehiscence was the most common complication [16 of 40 (40 percent)]. Cleft disorders constituted 277 cases (24.3 percent), and 102 cases were primary cleft lip and/or palate cases. Between 396 and 1042 total disability-adjusted life-years were averted through surgery for these 102 cases of primary cleft repair. This translates to an economic benefit between $4.7 million (human capital approach) and $27.5 million (value of a statistical life approach). Plastic surgical disease is a significant source of morbidity for patients in resource-limited regions. Dedicated programs that provide essential reconstructive surgery can produce substantial clinical and economic benefits to host countries.

The Danish oral health care service for children: an international appraisal.

PubMed

Davies, G N; Downer, M C; Holloway, P J

1983-09-01

The Danish children's oral health care service has been so successful in achieving its objectives that it will need to change and adapt in order to survive. It is suggested that the service should gradually become community-based rather than child-based. This process can be commenced by introducing treatment for the elderly, the handicapped and the indigent, converting the school clinics to municipal oral health units. Although it is important that private practice is maintained, private dentists should be encouraged to work in the system part-time, leading teams of supporting auxiliary personnel trained within an integrated system. Eventually, the facilities could form the basis of primary health care centres. The lessons to be learnt from the Danish experience have a wider application to other countries. In developing countries it is obvious that they should first place limited dental resources into public health prevention and only invest in expensive treatment clinics as funds become more available. Manpower planning should ensure that personnel are not overtrained for the needs of the community. In developed countries, increasingly more resources will need to be channelled into adult dental care, and dental education must lead the profession into this new era. Difficult though these changes will be, the stable relationships that have developed between the various arms of the service under the guidance of the Danish Dental Association, will ensure that the profession will survive and flourish for the benefit of the Danish people.

Paediatric emergency and acute care in resource poor settings.

PubMed

Duke, Trevor; Cheema, Baljit

2016-02-01

Acute care of seriously ill children is a global public health issue, and there is much scope for improving quality of care in hospitals at all levels in many developing countries. We describe the current state of paediatric emergency and acute care in the least developed regions of low and middle income countries and identify gaps and requirements for improving quality. Approaches are needed which span the continuum of care: from triage and emergency treatment, the diagnostic process, identification of co-morbidities, treatment, monitoring and supportive care, discharge planning and follow-up. Improvements require support and training for health workers and quality processes. Effective training is that which is ongoing, combining good technical training in under-graduate courses and continuing professional development. Quality processes combine evidence-based guidelines, essential medicines, appropriate technology, appropriate financing of services, standards and assessment tools and training resources. While initial emergency treatment is based on common clinical syndromes, early differentiation is required for specific treatment, and this can usually be carried out clinically without expensive tests. While global strategies are important, it is what happens locally that makes a difference and is too often neglected. In rural areas in the poorest countries in the world, public doctors and nurses who provide emergency and acute care for children are revered by their communities and demonstrate daily that much can be carried out with little. © 2016 The Authors. Journal of Paediatrics and Child Health © 2016 Paediatrics and Child Health Division (Royal Australasian College of Physicians).

Quality of life associated factors in head and neck cancer patients in a developing country using the FACT-H&N.

PubMed

Bilal, Sobia; Doss, Jennifer Geraldine; Cella, David; Rogers, Simon N

2015-03-01

Health-related quality of life (HRQoL) associated factors are vital considerations prior to treatment decision-making for head and neck cancer patients. The study aimed to identify potential socio-demographic and clinical prognostic value of HRQoL in head and neck cancer patients in a developing country. The Functional Assessment of Cancer Therapy-Head and Neck (FACT-H&N)-V4 in Urdu language was administered among 361 head and neck cancer patients. Data were statistically tested through multivariate analysis of variance (MANOVA) and regression modeling to identify the potentially associated factors. Treatment status, tumor stage and tumor site had the strongest negative impact on patients HRQoL, with a statistically significant decrement in FACT summary scales (effect size >0.15). Moderate associated factors of HRQoL included treatment type, marital status, employment status and age (effect size range 0.06-0.15). Weak associated factors of HRQoL with a small effect size (>0.01-0.06) included tumor size and type, gender, education level and ethnicity. This study reports 12 socio-demographic and clinical variables that have a significant impact on HRQoL of head, and neck cancer patients, and that should be considered during treatment decision-making by multidisciplinary teams and also in future HRQoL studies conducted in other developing countries. Copyright © 2014 European Association for Cranio-Maxillo-Facial Surgery. All rights reserved.

Echocardiography findings in clinically confirmed congenital rubella syndrome cases seen at the University of Port Harcourt Teaching Hospital, Nigeria.

PubMed

Otaigbe, B E; Tabansi, P N; Agbedey, G O

2012-01-01

Congenital rubella syndrome (CRS) is known to affect thousands of children in the developing world because rubella vaccination is not available routinely in most of these countries. Among its many manifestations only congenital heart disease is life threatening. This study was undertaken to ascertain the cases of echocardiographic determined congenital heart disease in clinically confirmed CRS cases. Data of patients with clinically confirmed CRS seen over a period of 5 years in the Paediatric cardiology clinic of the University of Port Harcourt Teaching Hospital was retrieved and analysed. Seven cases (2.8 % of total cardiac cases) were seen. 6 (85.7%) cases had at least one murmur on auscultation. Patent ductus arteriosus was the commonest cardiac defect seen either in isolation or incombination with a VSD or ASD. Only one child had no cardiac defect. 4 (57.1%) of them had been admitted for heart failure at least once and 2 (28.6 %) were on anti-failure regimen, one of whom had cardiac surgery one month ago. In view of the fact that 6 (85.7%) of the patients with CRS had at least one congenital heart defect, we advocate routine echocardiography on patients with CRS to ensure early treatment and reduce mortality and morbidity.We also advocate that rubella vaccination be given routinely in developing countries.

Spectrum of Endocrine Disorders in Central Ghana

PubMed Central

Sarfo, Fred Stephen; Ansah, Eunice Oparebea; Kyei, Ishmael

2017-01-01

Background. Although an increasing burden of endocrine disorders is recorded worldwide, the greatest increase is occurring in developing countries. However, the spectrum of these disorders is not well described in most developing countries. Objective. The objective of this study was to profile the frequency of endocrine disorders and their basic demographic characteristics in an endocrine outpatient clinic in Kumasi, central Ghana. Methods. A retrospective review was conducted on endocrine disorders seen over a five-year period between January 2011 and December 2015 at the outpatient endocrine clinic of Komfo Anokye Teaching Hospital. All medical records of patients seen at the endocrine clinic were reviewed by endocrinologists and all endocrinological diagnoses were classified according to ICD-10. Results. 3070 adults enrolled for care in the endocrine outpatient service between 2011 and 2015. This comprised 2056 females and 1014 males (female : male ratio of 2.0 : 1.0) with an overall median age of 54 (IQR, 41–64) years. The commonest primary endocrine disorders seen were diabetes, thyroid, and adrenal disorders at frequencies of 79.1%, 13.1%, and 2.2%, respectively. Conclusions. Type 2 diabetes and thyroid disorders represent by far the two commonest disorders seen at the endocrine clinic. The increased frequency and wide spectrum of endocrine disorders suggest the need for well-trained endocrinologists to improve the health of the population. PMID:28326101

Absence of subtelomeric rearrangements in selected patients with mental retardation as assessed by multiprobe T FISH

PubMed Central

2012-01-01

Background Mental retardation (MR) is a heterogeneous condition that affects 2-3% of the general population and is a public health problem in developing countries. Chromosomal abnormalities are an important cause of MR and subtelomeric rearrangements (STR) have been reported in 4-35% of individuals with idiopathic MR or an unexplained developmental delay, depending on the screening tests and patient selection criteria used. Clinical checklists such as that suggested by de Vries et al. have been used to improve the predictive value of subtelomeric screening. Findings Fifteen patients (1–20 years old; five females and ten males) with moderate to severe MR from a genetics outpatient clinic of the Gaffrée and Guinle Teaching Hospital (HUGG) of the Federal University of Rio de Janeiro State (UNIRIO) were screened with Multiprobe T FISH after normal high resolution karyotyping. No subtelomeric rearrangements were detected even though the clinical score of the patients ranged from four to seven. Conclusion In developing countries, FISH-based techniques such as Multiprobe T FISH are still expensive. Although Multiprobe T FISH is a good tool for detecting STR, in this study it did not detect STR in patients with unexplained MR/developmental delay even though these patients had a marked chromosomal imbalance. Our findings also show that clinical scores are not reliable predictors of STR. PMID:23259705

Outdoor air pollution, preterm birth, and low birth weight: analysis of the world health organization global survey on maternal and perinatal health.

PubMed

Fleischer, Nancy L; Merialdi, Mario; van Donkelaar, Aaron; Vadillo-Ortega, Felipe; Martin, Randall V; Betran, Ana Pilar; Souza, João Paulo

2014-04-01

Inhaling fine particles (particulate matter with diameter ≤ 2.5 μm; PM2.5) can induce oxidative stress and inflammation, and may contribute to onset of preterm labor and other adverse perinatal outcomes. We examined whether outdoor PM2.5 was associated with adverse birth outcomes among 22 countries in the World Health Organization Global Survey on Maternal and Perinatal Health from 2004 through 2008. Long-term average (2001-2006) estimates of outdoor PM2.5 were assigned to 50-km-radius circular buffers around each health clinic where births occurred. We used generalized estimating equations to determine associations between clinic-level PM2.5 levels and preterm birth and low birth weight at the individual level, adjusting for seasonality and potential confounders at individual, clinic, and country levels. Country-specific associations were also investigated. Across all countries, adjusting for seasonality, PM2.5 was not associated with preterm birth, but was associated with low birth weight [odds ratio (OR) = 1.22; 95% CI: 1.07, 1.39 for fourth quartile of PM2.5 (> 20.2 μg/m3) compared with the first quartile (< 6.3 μg/m3)]. In China, the country with the largest PM2.5 range, preterm birth and low birth weight both were associated with the highest quartile of PM2.5 only, which suggests a possible threshold effect (OR = 2.54; CI: 1.42, 4.55 and OR = 1.99; CI: 1.06, 3.72 for preterm birth and low birth weight, respectively, for PM2.5 ≥ 36.5 μg/m3 compared with PM2.5 < 12.5 μg/m3). Outdoor PM2.5 concentrations were associated with low birth weight but not preterm birth. In rapidly developing countries, such as China, the highest levels of air pollution may be of concern for both outcomes.

Worldwide inequality in production of systematic reviews.

PubMed

Jamali, Arsia; Nedjat, Saharnaz; Heidari, Kazem; Jamali, Raika; Hassanpour, Kiana; Nedjat, Sima; Anvari, Pasha; Majdzadeh, Reza

2015-01-01

Investment in science is vital for the development and well-being of societies. This study aims to assess the scientific productivity of countries by quantifying their publication of systematic reviews taking the gross national income per capita (GNIPC) into account. Medline and ISI Web of Science were searched for systematic reviews published between 1st January 2006 and 31st December 2010. The productivity of each country was quantified by exploring the authors' affiliation. The GNIPC was used according to the World Bank Report. Concentration index (CI) was calculated as the index of inequality. CI of percentage of systematic reviews as a function of percentage of countries ranked by GNIPC was 0.82 which indicates inequality in production of systematic reviews in pro rich countries. Countries with high income produced 206.23 times more systematic reviews than low income countries, while this ratio for lower middle and upper middle countries was 9.67 and 12.97, respectively. The highest concentration index was observed in clinical sciences (0.76) and the lowest in public health (0.61). This study demonstrates a significant gap between industrialized and nonindustrialized countries in the production of systematic reviews. Addressing this gap needs tremendous national and international efforts.

Nutritional Support of Medical Practice.

ERIC Educational Resources Information Center

Schneider, Howard A., Ed.; And Others

This book is intended to assemble for the medical practitioner in the developed countries those features of nutritional science which are clearly useful and clinically applicable in day-to-day medical practice. The book contains 32 chapters structured into three parts. After a brief description from the viewpoint of human biology, the first main…

Accelerating Progress Against Cancer

Cancer.gov

Investment in cancer research is making a difference, but we still must overcome disparities in cancer incidence and mortality, and expand research to detect cancers earlier and develop more effective, less-toxic treatments. NCI supports research studies and programs across the country that are working to further advance cancer, research, and clinical care.

[Teacher Education Center.

ERIC Educational Resources Information Center

Wisconsin State Univ., La Crosse.

As universities and colleges across the country are joining local school districts in order to develop teacher training programs in joint college-school ventures, administrative organization is a limiting problem in many quarters. At a time when the concern is for clinical experience in a school setting where teacher excellence is measured in…

Development of a comprehensive and sustainable gynecologic oncology training program in western Kenya, a low resource setting.

PubMed

Rosen, Barry; Itsura, Peter; Tonui, Philip; Covens, Alan; van Lonkhuijzen, Luc; Orang'o, Elkanah Omenge

2017-08-01

To provide information on the development of a gynecologic oncology training program in a low-resource setting in Kenya. This is a review of a collaboration between Kenyan and North American physicians who worked together to develop a gynecologic oncology training in Kenya. We review the published data on the increase of cancer incidence in sub-Saharan Africa and outline the steps that were taken to develop this program. The incidence of cervical cancer in Kenya is very high and is the leading cause of cancer mortality in Kenya. WHO identifies cancer as a new epidemic affecting countries in sub-Saharan Africa. In Kenya, a country of 45 million, there is limited resources to diagnose and treat cancer. In 2009 in western Kenya, at Moi University there was no strategy to manage oncology in the Reproductive Health department. There was only 1 gynecologic oncologists in Kenya in 2009. A collaboration between Canadian and Kenya physicians resulted in development of a gynecologic oncology clinical program and initiation of fellowship training in Kenya. In the past 4 years, five fellows have graduated from a 2 year fellowship training program. Integration of data collection on all the patients as part of this program provided opportunities to do clinical research and to acquire peer reviewed grants. This is the first recognized fellowship training program in sub-Saharan Africa outside of South Africa. It is an example of a collaborative effort to improve women's health in a low-resource country. This is a Kenyan managed program through Moi University. These subspecialty trained doctors will also provide advice that will shape health care policy and provide sustainable expertise for women diagnosed with a gynecologic cancer.

Using electronic health records for clinical research: the case of the EHR4CR project.

PubMed

De Moor, Georges; Sundgren, Mats; Kalra, Dipak; Schmidt, Andreas; Dugas, Martin; Claerhout, Brecht; Karakoyun, Töresin; Ohmann, Christian; Lastic, Pierre-Yves; Ammour, Nadir; Kush, Rebecca; Dupont, Danielle; Cuggia, Marc; Daniel, Christel; Thienpont, Geert; Coorevits, Pascal

2015-02-01

To describe the IMI EHR4CR project which is designing and developing, and aims to demonstrate, a scalable, widely acceptable and efficient approach to interoperability between EHR systems and clinical research systems. The IMI EHR4CR project is combining and extending several previously isolated state-of-the-art technical components through a new approach to develop a platform for reusing EHR data to support medical research. This will be achieved through multiple but unified initiatives across different major disease areas (e.g. cardiovascular, cancer) and clinical research use cases (protocol feasibility, patient identification and recruitment, clinical trial execution and serious adverse event reporting), with various local and national stakeholders across several countries and therefore under various legal frameworks. An initial instance of the platform has been built, providing communication, security and terminology services to the eleven participating hospitals and ten pharmaceutical companies located in seven European countries. Proof-of-concept demonstrators have been built and evaluated for the protocol feasibility and patient recruitment scenarios. The specifications of the clinical trial execution and the adverse event reporting scenarios have been documented and reviewed. Through a combination of a consortium that brings collectively many years of experience from previous relevant EU projects and of the global conduct of clinical trials, of an approach to ethics that engages many important stakeholders across Europe to ensure acceptability, of a robust iterative design methodology for the platform services that is anchored on requirements of an underlying Service Oriented Architecture that has been designed to be scalable and adaptable, EHR4CR could be well placed to deliver a sound, useful and well accepted pan-European solution for the reuse of hospital EHR data to support clinical research studies. Copyright © 2014 Elsevier Inc. All rights reserved.

Stem cell therapy clinical research: A regulatory conundrum for academia.

PubMed

Nagpal, Anjali; Juttner, Chris; Hamilton-Bruce, Monica Anne; Rolan, Paul; Koblar, Simon A

2017-12-01

The encouraging pace of discovery and development in the field of regenerative medicine holds tremendous potential for bringing therapies to the clinic that may offer meaningful benefit to patients, particularly in diseases with no or suboptimal therapeutic options. Academic researchers will continue to play a critical role in developing concepts and therapies, thus determining whether regenerative medicine will be able to live up to this potential that clearly excites clinicians, researchers and patients alike. This review summarises recent developments in regulatory frameworks across different countries that aim to ensure adequate oversight of the development of regenerative medicine products, which are unique in structural and functional complexity when compared to traditional chemical drugs and fully characterised biological drugs. It discusses the implications of these developments for researchers aiming to make the challenging transition from laboratory to clinical development of these therapies and considers possible pragmatic solutions that could accelerate this process that is essential to maintain research credibility and ensure patient safety. Copyright © 2016 Elsevier B.V. All rights reserved.

Comparative evidence on harms in pediatric randomized clinical trials from less developed versus more developed countries is limited.

PubMed

Tedesco, Dario; Farid-Kapadia, Mufiza; Offringa, Martin; Bhutta, Zulfiqar A; Maldonado, Yvonne; Ioannidis, John P A; Contopoulos-Ioannidis, Despina G

2018-03-01

Evaluate comparative harm rates from medical interventions in pediatric randomized clinical trials (RCTs) from more developed (MDCs) and less developed countries (LDCs). Meta-epidemiologic empirical evaluation of Cochrane Database of Systematic Reviews (June 2014) meta-analyses reporting clinically important harm-outcomes (severe adverse events [AEs], discontinuations due to AEs, any AE, and mortality) that included at least one pediatric RCT from MDCs and at least one from LDCs. We estimated relative odds ratios (RORs) for each harm, within each meta-analysis, between RCTs from MDCs and LDCs and calculated random-effects-summary-RORs (sRORs) for each harm across multiple meta-analyses. Only 1% (26/2,363) of meta-analyses with clinically important harm-outcomes in the entire Cochrane Database of Systematic Reviews included pediatric RCTs both from MDCs and LDCs. We analyzed 26 meta-analyses with 244 data sets from pediatric RCTs, 116 from MDCs and 128 from LDCs (64 and 66 unique RCTs respectively). The summary ROR was 0.92 (95% confidence intervals: 0.78-1.08) for severe AEs; 1.13 (0.54-2.34) for discontinuations due to AEs; 1.10 (0.77-1.59) for any AE; and 0.99 (0.61-1.61) for mortality and for the all-harms-combined-end point 0.96 (0.83-1.10). Differences of ROR-point-estimates ≥2-fold between MDCs and LDCs were identified in 35% of meta-analyses. We found no major systematic differences in harm rates in pediatric trials between MDCs and LDCs, but data on harms in children were overall very limited. Copyright © 2017 Elsevier Inc. All rights reserved.

The widely used ATB FUNGUS 3 automated readings in China and its misleading high MICs of Candida spp. to azoles: challenges for developing countries' clinical microbiology labs.

PubMed

Zhang, Li; Wang, He; Xiao, Meng; Kudinha, Timothy; Mao, Lei-Li; Zhao, Hao-Ran; Kong, Fanrong; Xu, Ying-Chun

2014-01-01

The rapid development in the clinical microbiology diagnostic assays presents more challenges for developing countries than for the developed world, especially in the area of test validation before the introduction of new tests. Here we report on the misleading high MICs of Candida spp. to azoles using the ATB FUNGUS 3 (bioMérieux, La Balme-les Grottes, France) with automated readings in China to highlight the dangers of introducing a diagnostic assay without validation. ATB FUNGUS 3 is the most commonly used commercial antifungal susceptibility testing method in China. An in-depth analysis of data showed higher levels of resistance to azoles when ATB FUNGUS 3 strips were read automatically than when read visually. Based on this finding, the performance of ATB FUNGUS 3, read both visually and automatically, was evaluated by testing 218 isolates of five clinically important Candida species, using broth microdilution (BMD) following CLSI M27-A3 as the gold-standard. The overall essential agreement (EA) between ATB visual readings and BMD was 99.1%. In contrast, the ATB automated readings showed higher discrepancies with BMD, with overall EA of 86.2%, and specifically lower EA was observed for fluconazole (80.7%), voriconazole (77.5%), and itraconazole (73.4%), which was most likely due to the trailing effect of azoles. The major errors in azole drug susceptibilities by ATB automated readings is a concern in China that can result in misleading clinical antifungal drug selection and pseudo high rates of antifungal resistance. Therefore, the ATB visual reading is generally recommended. In the meantime, we propose a practical algorithm to be followed for ATB FUNGUS 3 antifungal susceptibility for Candida spp. before the improvement in the automated reading system.

Cysticerci-related single parenchymal brain enhancing lesions in non-endemic countries

PubMed Central

Del Brutto, Oscar H.; Nash, Theodore E.; Garcia, Hector H.

2012-01-01

Objective Review of case reports and case series of patients with single cysticercus granulomas in non-endemic countries to determine the characteristics of this form of neurocysticercosis in these regions. Methods MEDLINE and manual search of patients with single cysticercus granulomas diagnosed in non-endemic countries from 1991 to 2011. Abstracted data included: demographic profile, clinical manifestations, form of neurocysticercosis, and whether the disease occurred in immigrants, international travelers, or citizens from non-endemic countries who had never been abroad. Results A total of 77 patients were found. Of these, 61 (79%) were diagnosed since the year 2000. Thirty-four patients (44%) patients were immigrants from endemic countries, 18 (23%) were international travelers returning from disease-endemic areas, and the remaining 25 (33%) were citizens from non-endemic countries who had never been abroad. Most immigrants and international travelers became symptomatic two or more years after returning home. Countries with the most reported patients were Kuwait (n=18), UK (n=11), Australia (n=8), USA (n=7), Japan (n=6), and Israel (n=5). Conclusions A single cerebral cysticercus granuloma in a non-endemic country is not a rare event. As seen in endemic regions, these cases have a good prognosis although more surgical procedures are performed in non-endemic countries, likely reflecting a decrease of diagnostic suspicion for cysticercosis and an increased availability of surgical options. The mean age of the reported cases was 25 years, and immigrants most often developed the disease greater than two years after arrival into a non-endemic area, suggesting a significant delay between infection and symptoms. However, some may have been infected and developed the disease while residing in non-endemic countries. PMID:22658897

A Survey of Home Enteral Nutrition Practices and Reimbursement in the Asia Pacific Region

PubMed Central

Banks, Merrilyn D.

2018-01-01

Literature regarding the use of home enteral nutrition (HEN) and how it is reimbursed in the Asia Pacific region is limited. This research survey aims to determine the availability of HEN, the type of feeds and enteral access used, national reimbursement policies, the presence of nutrition support teams (NSTs), and clinical nutrition education in this region. An electronic questionnaire was sent to 20 clinical nutrition societies and leaders in the Asia Pacific region in August 2017, where thirteen countries responded. Comparison of HEN reimbursement and practice between countries of different income groups based on the World Bank’s data was investigated. Financial support for HEN is only available in 40% of the countries. An association was found between availability of financial support for HEN and health expenditure (r = 0.63, p = 0.021). High and middle-upper income countries use mainly commercial supplements for HEN, while lower-middle income countries use mainly blenderized diet. The presence of NSTs is limited, and only present mainly in acute settings. Sixty percent of the countries indicated an urgent need for funding and reimbursement of HEN. This survey demonstrates the varied clinical and economic situation in the Asia Pacific region. There is a lack of reimbursement, clinical support, and inadequate educational opportunities, especially for the lower-middle income countries. PMID:29443950

Ethics in neonatology: a look over Europe.

PubMed

Guimarães, Hercilia; Rocha, Gustavo; Almeda, Filipe; Brites, Marta; Van Goudoever, Johannes B; Iacoponi, Francesca; Bellieni, Carlo; Buonocore, Giuseppe

2012-07-01

Advances in perinatal medicine have dramatically improved neonatal survival. End-of-life decision making for newborns with adverse prognosis is an ethical challenge, the ethical issues are controversial and little evidence exists on attitudes and values in Europe. to assess the attitudes of the neonatal departments in perinatal clinical practice in the hospitals of European countries. a questionnaire was send to 55 NICUs from 19 European countries. Forty five (81.8%) NICUs were Level III. Religion was Christian in 90.7% and we observed that in north countries the religion is more influent on clinical decisions (p = 0.032). Gestational age was considered with no significant difference for clinical investment. North countries consider birth weight (p = 0.011) and birth weight plus gestational age (p = 0.024) important for clinical investment. In north countries ethical questions should not prevail when the decision is made (p = 0.049) and from an ethical point of view, there is no difference between withdraw a treatment and do not initiate the treatment (p = 0.029). More hospitals in south countries administer any analgesia (p = 0.007). When the resuscitation is not successful 96.2% provide comfort care. Our study reveals that cultural and religious differences influenced ethical attitudes in NICUs of the European countries.

Vaccines, inspiring innovation in health.

PubMed

Pagliusi, Sonia; Dennehy, Maureen; Kim, Hun

2018-05-19

This report covers the topics of pandemics, epidemics and partnerships, including regulatory convergence initiatives, new technologies and novel vaccines, discussed by leading public and private sector stakeholders at the 18th Annual General Meeting (AGM) of the Developing Countries Vaccine Manufacturers' Network (DCVMN). Contributions of Gavi and the vaccine industry from emerging countries to the growing global vaccine market, by improving the supply base from manufacturers in developing countries and contributing to 58% of doses, were highlighted. The Coalition for Epidemic Preparedness Innovations (CEPI), the International Vaccine Institute (IVI) and others reported on new strategies to ensure speedy progress in preclinical and clinical development of innovative vaccines for future MERS, Zika or other outbreak response. Priorities for vaccine stockpiling, to assure readiness during emergencies and to prevent outbreaks due to re-emerging diseases such as yellow fever, cholera and poliomyelitis, were outlined. The role of partnerships in improving global vaccine access, procurement and immunization coverage, and shared concerns were reviewed. The World Health Organization (WHO) and other international collaborating partners provided updates on the Product, Price and Procurement database, the prequalification of vaccines, the control of neglected tropical diseases, particularly the new rabies elimination initiative, and regulatory convergence proposals to accelerate vaccine registration in developing countries. Updates on supply chain innovations and novel vaccine platforms were presented. The discussions enabled members and partners to reflect on efficiency of research & development, supply chain tools and trends in packaging technologies improving delivery of existing vaccines, and allowing a deeper understanding of the current public-health objectives, industry financing, and global policies, required to ensure optimal investments, alignment and stability of vaccine supply in developing countries. Copyright © 2018. Published by Elsevier Ltd.

Duration of breast-feeding and the risk of childhood allergic diseases in a developing country.

PubMed

Ehlayel, Mohammad S; Bener, Abdulbari

2008-01-01

Exclusive breast-feeding (EBF) seems to reduce risk of allergies in the western countries, but there are few reports from developing countries. The purpose of this study was to assess the effect of EBF on the development of allergic diseases and eczema in a developing country. This is a cross-sectional survey done at the well-baby clinics of 11 primary health centers, Hamad Medical Corporation, Qatar. A multistage sampling design was used and a representative sample of 1500 children (0-5 years old) and mothers (18-47 years old) were surveyed between October 2006 and September 2007. Of them, 1278 mothers (85.2%) participated in the study. A confidential, anonymous questionnaire assessing breast-feeding and allergic diseases was completed by mothers bringing children for immunization. Questionnaire included allergic rhinitis, wheezing, eczema, type and duration of breast-feeding, parental smoking habits, number of siblings, family income, maternal education, and parental allergies. Univariate and multivariate statistical methods were performed for statistical analysis. More than one-half of the infants (59.3%) were on EBF. Length of breast-feeding was associated with maternal age. Prevalence of eczema (19.4%), allergic rhinitis (22.6%), and wheezing (12.7%) were significantly less frequent in those with prolonged (>6 months) compared with short-term fed infants. The association between EBF and eczema tended to be similar in children with a positive family history of atopy (p < 0.001) and eczema (p < 0.001) compared with those without. In children of developing countries, prolonged breast-feeding reduces the risk of developing allergic diseases and eczema even in the presence of maternal allergy, where it might be a practical, effective preventive measure.

A review on camel brucellosis: a zoonosis sustained by ignorance and indifference

PubMed Central

Sprague, Lisa D; Al-Dahouk, Sascha; Neubauer, Heinrich

2012-01-01

In many developing countries of Asia and Africa, camels are one of the most important sources of income for the nomadic population. With increasing urbanization, camel milk and meat have gained a wider market and commercialization and consumption of camel products are on the rise. Camel brucellosis can be encountered in all camel rearing countries with exception of Australia. High animal and herd prevalences have been reported from numerous countries, which not only pose a continuous risk for human infection, but also increase the spread of infection through uncontrolled trade of clinically inconspicuous animals. This short review aims at providing an overview on diagnostic investigations, as well as the public health and economic impact of brucellosis in old world camels. PMID:23265371

Gabon.

PubMed

1988-07-01

The country of Gabon straddles the equator on the west coast of Africa. Included in the document are brief descriptions and compilations of facts about such points as geography, people, history, type of government, political conditions, economy, foreign relations, defense, and US-Gabonese relations. The population in 1986 was estimated at 1 million, and the annual growth rate was 2.8%. Infant mortality rate is 159/1000. Life expectancy stands at 51 years. Hospitals and private clinics are available throughout most of the country for most common problems. Gabon's population declined between 1900 and 1940 as a result of a combination of historical and environmental factors. The country is one of the less densely inhabited in Africa, and a labor shortage is a major obstacle to its development.

Status of DOE and AID stand-alone photovoltaic system field tests

NASA Astrophysics Data System (ADS)

Bifano, W. J.; Delombard, R.; Ratajczak, A. F.; Scudder, L. R.

The NASA Lewis Research Center (LeRC) is managing stand-alone photovoltaic (PV) system projects sponsored by the U.S. Department of Energy (DOE) and the U.S. Agency for International Development (AID). The DOE project includes village PV power demonstration projects in Gabon (four sites) and the Marshall Islands, and PV-powered vaccine refrigerator systems in six countries. The AID project includes a large village power system, a farmhouse system and two water pumping-irrigation systems in Tunisia, a water pumping/grain grinding system in Upper Volta, five medical clinic systems in four countries, PV-powered vaccine refrigerator systems in 18 countries and a PV-powered remote earth station in Indonesia. This paper reviews these PV projects and summarizes significant findings to date.

Status of DOE and AID stand-alone photovoltaic system field tests

NASA Technical Reports Server (NTRS)

Bifano, W. J.; Delombard, R.; Ratajczak, A. F.; Scudder, L. R.

1984-01-01

The NASA Lewis Research Center (LeRC) is managing stand-alone photovoltaic (PV) system projects sponsored by the U.S. Department of Energy (DOE) and the U.S. Agency for International Development (AID). The DOE project includes village PV power demonstration projects in Gabon (four sites) and the Marshall Islands, and PV-powered vaccine refrigerator systems in six countries. The AID project includes a large village power system, a farmhouse system and two water pumping-irrigation systems in Tunisia, a water pumping/grain grinding system in Upper Volta, five medical clinic systems in four countries, PV-powered vaccine refrigerator systems in 18 countries and a PV-powered remote earth station in Indonesia. This paper reviews these PV projects and summarizes significant findings to date.

A Global Overview of the Impact of Peritoneal Dialysis First or Favored Policies: An Opinion

PubMed Central

Liu, Frank Xiaoqing; Gao, Xin; Inglese, Gary; Chuengsaman, Piyatida; Pecoits-Filho, Roberto; Yu, Alex

2015-01-01

Given the ever-increasing burden of end-stage renal disease (ESRD) in a global milieu of limited financial and health resources, interested parties continue to search for ways to optimize dialysis access. Government and payer initiatives to increase access to renal replacement therapies (RRTs), particularly peritoneal dialysis (PD) and hemodialysis (HD), may have meaningful impacts from clinical and health-economic perspectives; and despite similar clinical and humanistic outcomes between the two dialysis modalities, PD may be the more convenient and resource-conscious option. This review assessed country-specific PD-First/Favored policies and their associated background, implementation, and outcomes. It was found that barriers to policy-implementation are broadly associated with government policy, economics, provider or healthcare professional education, modality-related factors, and patient-related factors. Notably, the success of a given country's PD-Favored policy was inversely associated with the extent of HD infrastructure. It is hoped that this review will provide a foundation across countries to share lessons learned during the development and implementation of PD-First/Favored policies. PMID:25082840

Recombinant Human Insulin in Global Diabetes Management – Focus on Clinical Efficacy

PubMed Central

Mbanya, Jean Claude; Sandow, Juergen; Landgraf, Wolfgang

2017-01-01

Abstract Biosynthetic human insulin and insulin analogues are the mainstay of insulin therapy for both type 1 and type 2 diabetes although access to human insulin at affordable prices remains a global issue. The world is experiencing an exponential rise in the prevalence of diabetes presenting an urgent need to establish effective diabetes therapy in countries burdened by inadequate health care budgets, malnutrition and infectious diseases. Recombinant human insulin has replaced animal insulins and animal-based semisynthetic human insulin thereby available in sufficient quantities and at affordable prices able to provide global access to insulin therapy. In many patients, analog insulins can offer additional clinical benefit, although at a considerably higher price thus severely restricting availability in low income countries. The approval process for recombinant human insulins (i.e. biosimilars) and analogue insulins is highly variable in the developing countries in contrast to Europe and in North America, where it is well established within a strict regulatory framework. This review aims to discuss the future access to human insulin therapy in a global context with an ever increasing burden of diabetes and significant economic implications. PMID:29632602

Clinical case definition for the diagnosis of acute intussusception.

PubMed

Bines, Julie E; Ivanoff, Bernard; Justice, Frances; Mulholland, Kim

2004-11-01

Because of the reported association between intussusception and a rotavirus vaccine, future clinical trials of rotavirus vaccines will need to include intussusception surveillance in the evaluation of vaccine safety. The aim of this study is to develop and validate a clinical case definition for the diagnosis of acute intussusception. A clinical case definition for the diagnosis of acute intussusception was developed by analysis of an extensive literature review that defined the clinical presentation of intussusception in 70 developed and developing countries. The clinical case definition was then assessed for sensitivity and specificity using a retrospective chart review of hospital admissions. Sensitivity of the clinical case definition was assessed in children diagnosed with intussusception over a 6.5-year period. Specificity was assessed in patients aged <2 years admitted with bowel obstruction and in patients aged <19 years presenting with symptoms that may occur in intussusception. The clinical case definition accurately identified 185 of 191 assessable cases as "probable" intussusception and six cases as "possible" intussusception (sensitivity, 97%). No case of radiologic or surgically proven intussusception failed to be identified by the clinical case definition. The specificity of the definition in correctly identifying patients who did not have intussusception ranged from 87% to 91%. The clinical case definition for intussusception may assist in the prompt identification of patients with intussusception and may provide an important tool for the future trials of enteric vaccines.

The Globalization of Pediatric Research: An Analysis of Clinical Trials Completed for Pediatric Exclusivity

PubMed Central

Pasquali, Sara K.; Burstein, Danielle S.; Benjamin, Daniel K.; Smith, P. Brian; Li, Jennifer S.

2010-01-01

Background Recent studies have examined the globalization of clinical research. These studies focused on adult trials, and the globalization of pediatric research has not been examined to date. We evaluated the setting of published studies conducted under the US Pediatric Exclusivity Program, which provides economic incentives to pharmaceutical companies to conduct drug studies in children. Methods Published studies containing the main results of trials conducted from 1998–2007 under the Pediatric Exclusivity Provision were included. Data were extracted from each study and described, including the therapeutic area of drug studied, number of patients enrolled, number of sites, and location where the study was conducted, if reported. Results Overall, 174 trials were included (sample size 8–27,065 patients); 9% did not report any information regarding the location or number of sites where the study was conducted. Of those that did report this information, 65% were conducted in at least one country outside the US, and 11% did not have any sites in the US. Fifty-four different countries were represented and 38% of trials enrolled patients in at least one site located in a developing/transition country, including more than one third of infectious disease, cardiovascular, and allergy/immunology trials. Conclusions The majority of published pediatric trials conducted under the Pediatric Exclusivity Provision included sites outside of the US, and over a third of trials enrolled patients in developing/transition countries. While there are many potential benefits to the globalization of pediatric research, this trend also raises certain scientific and ethical concerns which require further evaluation. PMID:20732941

A Quality Model to Select Patients in Cupping Therapy Clinics: A New Tool for Ensuring Safety in Clinical Practice.

PubMed

Aboushanab, Tamer; AlSanad, Saud

2018-06-08

Cupping therapy is a popular treatment in various countries and regions, including Saudi Arabia. Cupping therapy is regulated in Saudi Arabia by the National Center for Complementary and Alternative Medicine (NCCAM), Ministry of Health. The authors recommend that this quality model for selecting patients in cupping clinics - first version (QMSPCC-1) - be used routinely as part of clinical practice and quality management in cupping clinics. The aim of the quality model is to ensure the safety of patients and to introduce and facilitate quality and auditing processes in cupping therapy clinics. Clinical evaluation of this tool is recommended. Continued development, re-evaluation and reassessment of this tool are important. Copyright © 2018. Published by Elsevier B.V.

The diffusion of organ transplantation in Western Europe.

PubMed

Rigter, H; Bos, M A

1990-11-01

The moment of introduction of clinical organ transplantations varied in Western Europe from country to country. In retrospect, one can distinguish pioneering countries (most notably the U.K. and France), and countries that were early or late adopters of the new technologies. An early start did not necessarily lead to extensive diffusion of organ transplantations, as shown by the example of the U.K. In general, Western Europe is lagging behind the U.S.A. In diffusion of organ transplantation technologies. With few exceptions, the introduction and diffusion of organ transplantations in Western Europe have been largely autonomous developments, not regulated by government or third party payers and only slowed down by lack of organs, facilities or funds. The lack of organs has been reduced by the activities of organ procurement and exchange organisations, and perhaps by legislation promoting organ donation. Nevertheless, the growth of the number of patients waiting for an organ is in almost all countries outpacing the increase in availability of organs.

Proper management of rheumatoid arthritis in Latin America. What the guidelines say?

PubMed

Brenol, Claiton V; Nava, Jorge Ivan Gamez; Soriano, Enrique R

2015-03-01

To analyze characteristics of clinical practice guidelines (CPGs) for the management of rheumatoid arthritis (RA) developed in Latin American (LA) countries and to describe the knowledge, use, and barriers for their implementation perceived among LA rheumatologists, a comprehensive literature search including Medline, PubMed, Cochrane Library, LILACS and Scielo was performed. The Appraisal of Guidelines for Research and Evaluation (AGREE) instrument was applied for evaluation. A survey was sent to PANLAR members containing questions related to knowledge about guidelines, application of the recommendations, and difficulties in implementing CPGs. Eight guidelines were identified. Most guidelines were evidence based (62 %), but in only 37 % a systematic literature search was done. None of the guidelines included patients' views and preferences, and only few of them stated an updating procedure. Funding body independence and disclosure of conflicts of interest were rarely reported. The survey was answered by 214 rheumatologists from all Latin American countries. Most rheumatologist reported knowledge and use of clinical guidelines, mainly international ones. In general, rheumatologist felt that guidelines apply to only a minority of patients seen in daily clinical practice. Limited access expensive drugs, suggested by the guidelines, was the most frequent barrier to guidelines implementation that was reported. A good number of guidelines on the treatment of rheumatoid arthritis have been developed in Latin America. Most of them are lacking some of the components recognized for high-quality clinical guidelines development. In spite that most rheumatologist know and apply guidelines, access to drugs is still a very important barrier to their implementation in Latin America.

Multinational evidence-based recommendations for the diagnosis and management of gout: integrating systematic literature review and expert opinion of a broad panel of rheumatologists in the 3e initiative

PubMed Central

Sivera, Francisca; Andrés, Mariano; Carmona, Loreto; Kydd, Alison S R; Moi, John; Seth, Rakhi; Sriranganathan, Melonie; van Durme, Caroline; van Echteld, Irene; Vinik, Ophir; Wechalekar, Mihir D; Aletaha, Daniel; Bombardier, Claire; Buchbinder, Rachelle; Edwards, Christopher J; Landewé, Robert B; Bijlsma, Johannes W; Branco, Jaime C; Burgos-Vargas, Rubén; Catrina, Anca I; Elewaut, Dirk; Ferrari, Antonio J L; Kiely, Patrick; Leeb, Burkhard F; Montecucco, Carlomaurizio; Müller-Ladner, Ulf; Østergaard, Mikkel; Zochling, Jane; Falzon, Louise; van der Heijde, Désirée M

2014-01-01

We aimed to develop evidence-based multinational recommendations for the diagnosis and management of gout. Using a formal voting process, a panel of 78 international rheumatologists developed 10 key clinical questions pertinent to the diagnosis and management of gout. Each question was investigated with a systematic literature review. Medline, Embase, Cochrane CENTRAL and abstracts from 2010–2011 European League Against Rheumatism and American College of Rheumatology meetings were searched in each review. Relevant studies were independently reviewed by two individuals for data extraction and synthesis and risk of bias assessment. Using this evidence, rheumatologists from 14 countries (Europe, South America and Australasia) developed national recommendations. After rounds of discussion and voting, multinational recommendations were formulated. Each recommendation was graded according to the level of evidence. Agreement and potential impact on clinical practice were assessed. Combining evidence and clinical expertise, 10 recommendations were produced. One recommendation referred to the diagnosis of gout, two referred to cardiovascular and renal comorbidities, six focused on different aspects of the management of gout (including drug treatment and monitoring), and the last recommendation referred to the management of asymptomatic hyperuricaemia. The level of agreement with the recommendations ranged from 8.1 to 9.2 (mean 8.7) on a 1–10 scale, with 10 representing full agreement. Ten recommendations on the diagnosis and management of gout were established. They are evidence-based and supported by a large panel of rheumatologists from 14 countries, enhancing their utility in clinical practice. PMID:23868909

Clinical presentation of acute Q fever in lanzarote (Canary Islands): a 2-year prospective study.

PubMed

Pascual Velasco, F; Borobio Enciso, M V; González Lama, Z; Carrascosa Porras, M

1996-01-01

The clinical manifestations of acute Q fever may differ markedly from country to country. In this regard, fever and hepatitis seem to be the dominant clinical features of acute Coxiella burnetii infection in Lanzarote, Canary Islands. A possible interaction between environmental factors and some strains of C. burnetii could explain the different clinical presentations of acute Q fever.

[Psychiatric specialty training in Greece: Comparative analysis of educational programs (2000 vs 2014)].

PubMed

Margariti, M; Papageorgiou, Ch

2017-01-01

Modern educational programs for specialization in psychiatry should follow the developments in psychiatric science, both in the part of acquired knowledge about mental disorders and their treatment, as well as in the part of clinical practice in the diverse spectrum of modern psychiatric services. In Greece, the institutional framework for psychiatric training during specialization has yet to modernize and conform to European standards. For the moment, it is covered by a 1994 Presidential Decree, which briefly describes the time of specialization in psychiatry and the duration of clinical practice in the relevant educational subjects. This study presents a comparative analysis of training in the specialty of Psychiatry in two distinct periods (2000 vs 2014). Already by the year 2000, psychiatric training showed many structural weaknesses. The areas of clinical experience, theoretical and psychotherapeutic training have shown wide divergences among training centers, and limited potential for convergence with European standards under the existing framework. Important exceptions were certain university clinics, with the bulk of future psychiatrists in the country falling short of educational benefits. Fifteen years later and under the burden of the consequences of the economic crisis, the institutional framework has not yet changed, and the overall situation seems to have deteriorated dramatically. The number of training centers offering full specialization and the number of psychiatrists who receive training increased in reverse proportion to the number of specialized psychiatrists employed in hospitals, which has been drastically reduced due to restrictive measures on staff recruitment. Almost all training indicators show deterioration, but mainly the area of theoretical training shows the most dramatic degradation. Nevertheless, it is noteworthy that nowadays several psychiatric clinics endeavor to develop training programs in conjunction with psychiatric services not under their own administration, a practice not provided for in the current legislative framework. At the same time, there is an increase in the number of training centers that adopt some statutory procedures to monitor and evaluate trainees during the training process. The long-term restrictions recorded however, reveal the difficulty hospitals and psychiatric clinics have in developing training programs responding to the full range of modern clinical and theoretical training in psychiatry independently and autonomously. The recent economic crisis in the country and the attempts for much needed administrational reforms, create now more than ever the appropriate conditions for a reform of the educational framework for specialization in psychiatry, taking into account national resources and future expectations for the mental health system of our country.

Developing and sustaining adolescent-friendly health services: A multiple case study from Ecuador and Peru.

PubMed

Goicolea, Isabel; Coe, Anna-Britt; San Sebastián, Miguel; Hurtig, Anna-Karin

2017-08-01

Adolescent-Friendly Health Services (AFHSs) are those that are accessible, acceptable, equitable, appropriate and effective for different youth sub-populations. This study investigated the process through which four clinics in two countries - Peru and Ecuador - introduced, developed and sustained AFHSs. A multiple case study design was chosen, and data from each clinic were collected through document review, observations and informant interviews. National level data were also collected. Data were analysed following thematic analysis. The findings showed that the process of introducing, developing and sustaining AFHSs was long term, and required a creative team effort and collaboration between donors, public institutions and health providers. The motivation and external support was crucial to initiating and sustaining the implementation of AFHSs. Health facilities' transformation into AFHSs was linked to the broader organisation of country health systems, and the evolution of national adolescent health policies. In Peru, the centralised approach to AFHSs introduction facilitated the dissemination of a comprehensive national model to health facilities, but dependency on national directives made it more difficult to systemise them when ideological and organisational changes occurred. In Ecuador, a less centralised approach to introducing AFHSs made for easier integration of the AFHSs model.

Management of asthma: the essentials of good clinical practice.

PubMed

Aït-Khaled, N; Enarson, D A

2006-02-01

Asthma is a condition that affects all countries worldwide. It is a chronic, disabling condition that diminishes the quality of life and the economic prosperity of those who live with it. The majority of persons living with asthma are from developing countries. Asthma management necessitates long-term treatment that is expensive, making it less accessible to poor people. The cost of medications is the key factor preventing people living with asthma from having access to care that has the potential to relieve their suffering, improve their quality of life and enhance their economic status. Asthma is a disease caused by environmental exposures. Genetic factors predispose certain people to developing asthma once they are exposed to the causative agents, and certain factors can trigger symptomatic episodes of asthma in those who have already developed the disease. Certain clinical characteristics differentiate asthma from other chronic lung conditions. The most important of these is that the symptoms and functional disability caused by asthma vary from one occasion to another. In those with less severe asthma, they may be present on some occasions and not others; in those with more severe asthma, their degree of severity varies from one time to another.

Challenges and opportunities in RSV vaccine development: Meeting report from FDA/NIH workshop.

PubMed

Roberts, Jeffrey N; Graham, Barney S; Karron, Ruth A; Munoz, Flor M; Falsey, Ann R; Anderson, Larry J; Marshall, V; Kim, Sonnie; Beeler, Judy A

2016-09-22

Respiratory syncytial virus (RSV) is the most common cause of serious acute lower respiratory illness in infants and young children and a significant cause of disease burden in the elderly and immunocompromised. There are no licensed RSV vaccines to address this significant public health need. While advances in vaccine technologies have led to a recent resurgence in RSV vaccine development, the immune correlates of protection against RSV and the immunology of vaccine-associated enhanced respiratory disease (ERD) remain poorly understood. FDA's Center for Biologics Evaluation and Research (CBER) and NIH's National Institute of Allergy and Infectious Diseases (NIAID) organized and co-sponsored an RSV Vaccines Workshop in Bethesda, Maryland on June 1 and 2, 2015. The goal of the conference was to convene scientists, regulators, and industry stakeholders to discuss approaches to RSV vaccine development within the context of three target populations - infants and children, pregnant women, and individuals >60years of age. The agenda included topics related to RSV vaccine development in general, as well as considerations specific to each target population, such as clinical and serological endpoints. The meeting focused on vaccine development for high income countries (HIC), because issues relevant to vaccine development for low and middle income countries (LMIC) have been discussed in other forums. This manuscript summarizes the discussion of clinical, scientific, and regulatory perspectives, research gaps, and lessons learned. Copyright © 2016.

Capacity Building in Global Mental Health: Professional Training

PubMed Central

Fricchione, Gregory L; Borba, Christina P C; Alem, Atalay; Shibre, Teshome; Carney, Julia R; Henderson, David C

2012-01-01

We suggest that the optimal approach to building capacity in global mental health care will require partnerships between professional resources in high-income countries and promising health-related institutions in low- and middle-income countries. The result of these partnerships will be sustainable academic relationships that can educate a new generation of in-country primary care physicians and, eventually, specialized health professionals. Research capabilities will be an essential educational component to inform policy and practice, and to ensure careful outcome measurements of training and of intervention, prevention, and promotion strategies. The goal of these academic centers of excellence will be to develop quality, in-country clinical and research professionals, and to build a productive environment for these professionals to advance their careers locally. In sum, this article discusses human capacity building in global mental health, provides recommendations for training, and offers examples of recent initiatives. (Harv Rev Psychiatry 2012;20:47–57.) PMID:22335182

Ethical issues in transnational "mail order" oocyte donation.

PubMed

Heng, B C

2006-12-01

The rising demand for donor oocytes in developed countries has led to what is referred to as transnational or international oocyte donation, or the outsourcing of oocyte donation to poorer countries. In a further twist, frozen sperm from a recipient's partner can also be mailed to a foreign clinic to fertilize donor oocytes, and the resulting embryos are mailed back, cryopreserved, for transfer to the recipient. Among the numerous ethical concerns raised by this practice of mail order oocyte donation, the most obvious are that underprivileged women from poorer countries are often exploited; fertility physicians from richer counties abdicate responsibility for the welfare of donors; and responsibility could become an issue of contention if transmission of disease to the oocyte recipient or congenital defects in offspring born from such oocyte donation were to occur. Moreover, savings from utilizing donors from poorer countries ought to be shared with oocyte recipients.

Prevalence of metastasis at diagnosis of osteosarcoma: an international comparison

PubMed Central

Marko, Tracy A.; Diessner, Brandon J.; Spector, Logan G.

2016-01-01

Background Osteosarcoma is the most common primary malignant bone tumor in many countries, with metastatic disease responsible for most patient deaths. This study compares the prevalence of metastatic osteosarcoma at diagnosis across countries to inform the critical question of whether diagnostic delay or tumor biology drives metastases development prior to diagnosis. Procedure A literature search of the PubMed database was conducted to compare the prevalence of metastatic disease at the time of OS diagnosis between countries. A pooled prevalence with 95% confidence intervals was calculated for each study meeting inclusion criteria. Studies were grouped for analysis based on human development index (HDI) scores. Results Our analysis found an 18% (95% CI: 15%, 20%) average global pooled proportion of metastasis at osteosarcoma diagnosis. The average prevalence of metastasis at diagnosis increased as HDI groupings decreased, with very high HDI, high HDI, and medium/ low HDI groups found to be 15% (95% CI: 13%, 17%), 20% (95% CI: 14%, 28%), and 31% (95% CI: 15%, 52%), respectively. Conclusions Our evidence suggests there is a biological baseline for metastatic OS at diagnosis, which is observed in countries with very high HDI. In countries with medium/ low HDI, where there are more barriers to accessing healthcare, the higher prevalence of metastasis may result from treatment delay or an artificial prevalence inflation due to patients with less severe symptoms not presenting to clinic. Additional research in countries with medium/ low HDI may reveal that earlier detection and treatment could improve patient outcomes in those countries. PMID:26929018

Women's perceptions of iron deficiency and anemia prevention and control in eight developing countries.

PubMed

Galloway, Rae; Dusch, Erin; Elder, Leslie; Achadi, Endang; Grajeda, Ruben; Hurtado, Elena; Favin, Mike; Kanani, Shubhada; Marsaban, Julie; Meda, Nicolas; Moore, K Mona; Morison, Linda; Raina, Neena; Rajaratnam, Jolly; Rodriquez, Javier; Stephen, Chitra

2002-08-01

The World Health Organization estimates that 58% of pregnant women in developing countries are anemic. In spite of the fact that most ministries of health in developing countries have policies to provide pregnant women with iron in a supplement form, maternal anemia prevalence has not declined significantly where large-scale programs have been evaluated. During the period 1991-98, the MotherCare Project and its partners conducted qualitative research to determine the major barriers and facilitators of iron supplementation programs for pregnant women in eight developing countries. Research results were used to develop pilot program strategies and interventions to reduce maternal anemia. Across-region results were examined and some differences were found but the similarity in the way women view anemia and react to taking iron tablets was more striking than differences encountered by region, country or ethnic group. While women frequently recognize symptoms of anemia, they do not know the clinical term for anemia. Half of women in all countries consider these symptoms to be a priority health concern that requires action and half do not. Those women who visit prenatal health services are often familiar with iron supplements, but commonly do not know why they are prescribed. Contrary to the belief that women stop taking iron tablets mainly due to negative side effects, only about one-third of women reported that they experienced negative side effects in these studies. During iron supplementation trials in five of the countries, only about one-tenth of the women stopped taking the tablets due to side effects. The major barrier to effective supplementation programs is inadequate supply. Additional barriers include inadequate counseling and distribution of iron tablets, difficult access and poor utilization of prenatal health care services, beliefs against consuming medications during pregnancy, and in most countries, fears that taking too much iron may cause too much blood or a big baby, making delivery more difficult. Facilitators include women's recognition of improved physical well being with the alleviation of symptoms of anemia, particularly fatigue, a better appetite, increased appreciation of benefits for the fetus, and subsequent increased demand for prevention and treatment of iron deficiency and anemia.

Social network analysis of international scientific collaboration on psychiatry research.

PubMed

Wu, Ying; Duan, Zhiguang

2015-01-01

Mental disorder is harmful to human health, effects social life seriously and still brings a heavy burden for countries all over the world. Scientific collaboration has become the indispensable choice for progress in the field of biomedicine. However, there have been few scientific publications on scientific collaboration in psychiatry research so far. The aim of this study was to measure the activities of scientific collaboration in psychiatry research at the level of authors, institutions and countries. We retrieved 36557 papers about psychiatry from Science Ciation Index Expanded (SCI-Expanded) in web of science. Additionally, some methods such as social network analysis (SNA), K-plex analysis and Core-Periphery were used in this study. Collaboration has been increasing at the level of authors, institutions and countries in psychiatry in the last ten years. We selected the top 100 prolific authors, institutions and 30 countries to construct collaborative map respectively. Freedman, R and Seidman, LJ were the central authors, Harvard university was the central institution and the USA was the central country of the whole network. Notably, the rate of economic development of countries affected collaborative behavior. The results show that we should encourage multiple collaboration types in psychiatry research as they not only help researchers to master the current research hotspots but also provide scientific basis for clinical research on psychiatry and suggest policies to promote the development of this area.

Clinical investigations for SUS, the Brazilian public health system.

PubMed

Paula, Ana Patrícia de; Giozza, Silvana Pereira; Pereira, Michelle Zanon; Boaventura, Patrícia Souza; Santos, Leonor Maria Pacheco; Sachetti, Camile Giaretta; Tamayo, César Omar Carranza; Kowalski, Clarissa Campos Guaragna; Elias, Flavia Tavares Silva; Serruya, Suzanne Jacob; Guimarães, Reinaldo

2012-01-01

Scientific and technological development is crucial for advancing the Brazilian health system and for promoting quality of life. The way in which the Brazilian Ministry of Health has supported clinical research to provide autonomy, self-sufficiency, competitiveness and innovation for the healthcare industrial production complex, in accordance with the National Policy on Science, Technology and Innovation in Healthcare, was analyzed. Descriptive investigation, based on secondary data, conducted at the Department of Science and Technology, Ministry of Health. The Ministry of Health's research management database, PesquisaSaúde, was analyzed from 2002 to 2009, using the key word "clinical research" in the fields "primary sub-agenda" or "secondary sub-agenda". The 368 projects retrieved were sorted into six categories: basic biomedical research, preclinical studies, expanded clinical research, clinical trials, infrastructure support and health technology assessment. From a structured review on "clinical research funding", results from selected countries are presented and discussed. The amount invested was R$ 140 million. The largest number of projects supported "basic biomedical research", while the highest amounts invested were in "clinical trials" and "infrastructure support". The southeastern region had the greatest proportion of projects and financial resources. In some respects, Brazil is ahead of other BRICS countries (Russia, India, China and South Africa), especially with regard to establishing a National Clinical Research Network. The Ministry of Health ensured investments to encourage clinical research in Brazil and contributed towards promoting cohesion between investigators, health policies and the healthcare industrial production complex.

Integrated management of childhood illness: a summary of first experiences.

PubMed Central

Lambrechts, T.; Bryce, J.; Orinda, V.

1999-01-01

The strategy of Integrated Management of Childhood Illness (IMCI) aims to reduce child mortality and morbidity in developing countries by combining improved management of common childhood illnesses with proper nutrition and immunization. The strategy includes interventions to improve the skills of health workers, the health system, and family and community practices. This article describes the experience of the first countries to adopt and implement the IMCI interventions, the clinical guidelines dealing with the major causes of morbidity and mortality in children, and the training package on these guidelines for health workers in first-level health facilities. The most relevant lessons learned and how these lessons have served as a basis for developing a broader IMCI strategy are described. PMID:10444882

Ecoepidemiology of Cryptococcus gattii in Developing Countries

PubMed Central

Hagen, Ferry; Pinheiro, Rosangela L.; Muro, Marisol D.; Meis, Jacques F.; Queiroz-Telles, Flávio

2017-01-01

Cryptococcosis is a systemic infection caused by species of the encapsulated yeast Cryptococcus. The disease may occur in immunocompromised and immunocompetent hosts and is acquired by the inhalation of infectious propagules present in the environment. Cryptococcus is distributed in a plethora of ecological niches, such as soil, pigeon droppings, and tree hollows, and each year new reservoirs are discovered, which helps researchers to better understand the epidemiology of the disease. In this review, we describe the ecoepidemiology of the C. gattii species complex focusing on clinical cases and ecological reservoirs in developing countries from different continents. We also discuss some important aspects related to the antifungal susceptibility of different species within the C. gattii species complex and bring new insights on the revised Cryptococcus taxonomy. PMID:29371578

Retinopathy of prematurity in Indonesia: Incidence and risk factors.

PubMed

Edy Siswanto, J; Sauer, Pieter Jj

2017-01-01

Retinopathy of prematurity (ROP) is a vaso-proliferative disease of the eye, which mainly affects preterm newborn infants with an incompletely vascularized retina. The incidence of ROP has increased in industrialized countries due to the increased survival of extremely low birth weight (ELBW) infants. ROP is also increasing in developing countries like Indonesia, where it is most likely due to the improved survival of ELBW infants. To ascertain the incidence of ROP and possible risk factors associated with the development of ROP in preterm infants in Indonesia. We reviewed the literature on the incidence and potential risk factors for the development of ROP in Indonesia, obtained data from three referral eye clinics and added data from our institution. The reported incidence of all stages of ROP in infants with a gestational age of <32 weeks ranged from 18-30%. One study showed that ROP also occurred at older gestational ages. Blindness due to ROP was seen in infants up to 35 weeks and with a birth weight of 2000 g. Retinopathy of prematurity is an important cause of ocular morbidity and blindness in Indonesia. The overall incidence of ROP in infants born below 32 weeks in Indonesia is higher than in developed countries, and it is seen in infants with older gestational ages. This might be due to a less strict monitoring during the use of oxygen in Indonesia compared to industrialized countries.

Epidemiology and clinical relevance of Pneumocystis jirovecii Frenkel, 1976 dihydropteroate synthase gene mutations.

PubMed

Matos, O; Esteves, F

2010-09-01

A review was conducted to examine the published works that studied the prevalence of Pneumocystis jirovecii dihydropteroate synthase (DHPS) mutations in patients with P. jirovecii pneumonia (PcP), in develop and developing countries, and that focused the problem of the possible association of these mutations with exposure to sulpha or sulphone drugs and their influence in the PcP outcome. Studies conducted in United States of America presented higher P. jirovecii mutations rates, in comparison with European countries, and in developing countries, lower rates of DHPS mutations were reported, due to limited use of sulpha drugs. A significant association was reported between the use of sulpha or sulphone agents for PcP prophylaxis in HIV-infected patients and the presence of DHPS mutations. However these mutations were also detected in PcP patients who were not currently receiving sulpha or sulphone agents. The outcome and mortality of HIV-infected patients with PcP harbouring DHPS gene mutations were related primarily to the underlying severity of illness and the initial severity of PcP, more than to the presence of mutations.

Genetic counseling globally: Where are we now?

PubMed Central

Laurino, Mercy Ygoña; Barlow‐Stewart, Kristine; Wessels, Tina‐Marié; Macaulay, Shelley; Austin, Jehannine; Middleton, Anna

2018-01-01

The genetic counseling profession is continuing to develop globally, with countries in various stages of development. In some, the profession has been in existence for decades and is increasingly recognized as an important provider of allied health, while in others it is just beginning. In this article, we describe the current global landscape of the genetic counseling specialty field's professional development. Using examples of the United States, United Kingdom, Canada, Australia, South Africa, and various countries in Asia, we highlight the following: (a) status of genetic counseling training programs, (b) availability of credentialing through government and professional bodies (certification, registration, and licensure), and potential for international reciprocity, (c) scope of clinical practice, and (d) health‐care system disparities and cultural differences impacting on practice. The successful global implementation of precision medicine will require both an increased awareness of the importance of the profession of “genetic counselor” and flexibility in how genetic counselors are incorporated into each country's health‐care market. In turn, this will require more collaboration within and across nations, along with continuing engagement of existing genetic counseling professional societies. PMID:29575600

Rotavirus Vaccines: an Overview

PubMed Central

Dennehy, Penelope H.

2008-01-01

Rotavirus infection is the most common cause of severe diarrhea disease in infants and young children worldwide and continues to have a major global impact on childhood morbidity and mortality. Vaccination is the only control measure likely to have a significant impact on the incidence of severe dehydrating rotavirus disease. In 1999, a highly efficacious rotavirus vaccine licensed in the United States, RotaShield, was withdrawn from the market after 14 months because of its association with intussusception. Two new live, oral, attenuated rotavirus vaccines were licensed in 2006: the pentavalent bovine-human reassortant vaccine (RotaTeq) and the monovalent human rotavirus vaccine (Rotarix). Both vaccines have demonstrated very good safety and efficacy profiles in large clinical trials in western industrialized countries and in Latin America. Careful surveillance has not revealed any increased risk of intussusception in the vaccinated groups with either vaccine. The new rotavirus vaccines are now introduced for routine use in a number of industrialized and developing countries. These new safe and effective rotavirus vaccines offer the best hope of reducing the toll of acute rotavirus gastroenteritis in both developed and developing countries. PMID:18202442

Continuing professional development crediting system for specialists in laboratory medicine within 28 EFLM national societies.

PubMed

Topic, Elizabeta; Beletic, Andjelo; Zima, Tomas

2013-01-01

Continuing professional development (CPD) with corresponding crediting system is recognized as essential for the laboratory medicine specialists to provide optimal service for the patients. Article presents results of the survey evaluating current CPD crediting practice among members of European Federation of Clinical Chemistry and Laboratory Medicine (EFLM). A questionnaire had been forwarded to presidents/national representatives of all EFLM members, with invitation to provide information about CPD programmes and crediting policies, as well as feedback on individual CPD categories, through scoring their relevance. Complete or partial answers were received from 28 of 38 members. In 23 countries, CPD programmes exist and earn credits, with 19 of them offering access to non-medical scientists. CPD activities are evaluated in all participating countries, regardless to the existence of an official CPD programme. Among participating members with mandatory specialists' licensing (22/28), CPD is a prerequisite for relicensing in 13 countries. Main categories recognized as CPD are: continuing education (24 countries), article/book (17/14 countries) authorship and distance learning (14 countries). The highest median score of relevance (20) is allocated to professional training, editor/authorship and official activities in professional organizations, with the first category showing the least variation among scores. Majority of EFLM members have developed CPD programmes, regularly evaluated and accompanied by crediting systems. Programmes differ in accessibility for non-medical scientists and impact on relicensing eligibility. Continuing education, authorship and e-learning are mainly recognized as CPD activities, although the professional training is appreciated as the most important individual CPD category.

Continuing professional development crediting system for specialists in laboratory medicine within 28 EFLM national societies

PubMed Central

Topic, Elizabeta; Beletic, Andjelo; Zima, Tomas

2013-01-01

Introduction: Continuing professional development (CPD) with corresponding crediting system is recognized as essential for the laboratory medicine specialists to provide optimal service for the patients. Article presents results of the survey evaluating current CPD crediting practice among members of European Federation of Clinical Chemistry and Laboratory Medicine (EFLM). Materials and methods: A questionnaire had been forwarded to presidents/national representatives of all EFLM members, with invitation to provide information about CPD programmes and crediting policies, as well as feedback on individual CPD categories, through scoring their relevance. Results: Complete or partial answers were received from 28 of 38 members. In 23 countries, CPD programmes exist and earn credits, with 19 of them offering access to non-medical scientists. CPD activities are evaluated in all participating countries, regardless to the existence of an official CPD programme. Among participating members with mandatory specialists’ licensing (22/28), CPD is a prerequisite for relicensing in 13 countries. Main categories recognized as CPD are: continuing education (24 countries), article/book (17/14 countries) authorship and distance learning (14 countries). The highest median score of relevance (20) is allocated to professional training, editor/authorship and official activities in professional organizations, with the first category showing the least variation among scores. Conclusions: Majority of EFLM members have developed CPD programmes, regularly evaluated and accompanied by crediting systems. Programmes differ in accessibility for non-medical scientists and impact on relicensing eligibility. Continuing education, authorship and e-learning are mainly recognized as CPD activities, although the professional training is appreciated as the most important individual CPD category. PMID:24266304

Clinical profile of children with kerosene aspiration.

PubMed

Venkatesh, C; Sriram, P; Adhisivam, B; Mahadevan, S

2011-07-01

Accidental aspiration of kerosene is a common problem among children in developing countries. This descriptive study involved the retrospective analysis of children admitted with kerosene aspiration in a tertiary care hospital in South India for a year. Kerosene aspiration contributed to 60.4% of poisoning cases. Boys aged less than three years and from a rural background formed a significant proportion. Tachypnoea, cough and crepitations were the predominant clinical findings. Male gender and malnutrition (weight for age <80%) were significantly associated with prolonged hospital stay.

Practice of clinical forensic medicine in Sri Lanka: does it need a new era?

PubMed

Kodikara, Sarathchandra

2012-07-01

Clinical forensic medicine is a sub-specialty of forensic medicine and is intimately associated with the justice system of a country. Practice of clinical forensic medicine is evolving, but deviates from one jurisdiction to another. Most English-speaking countries practice clinical forensic medicine and forensic pathology separately while most non-English-speaking countries practice forensic medicine which includes clinical forensic medicine and forensic pathology. Unlike the practice of forensic pathology, several countries have informal arrangements to deal with forensic patients and there are no international standards of practice or training in this discipline. Besides, this is rarely a topic of discussion. In the adversarial justice system in Sri Lanka, the designated Government Medical Officers practice both clinical forensic medicine and forensic pathology. Practice of clinical forensic medicine, and its teaching and training in Sri Lanka depicts unique features. However, this system has not undergone a significant revision for many decades. In this communication, the existing legal framework, current procedure of practice, examination for drunkenness, investigations, structure of referrals, reports, subsequent legal procedures, undergraduate, in-service, and postgraduate training are discussed with suggestions for reforms. Copyright © 2012 Elsevier Ireland Ltd. All rights reserved.

Dollars and sense. Efforts to reduce perinatal transmission fuel the debate over "haves" and "have nots".

PubMed

Melcombe, L

1998-07-01

HIV has become the single greatest contributor to child mortality in developing countries. Although clinical trials of azidovudine (AZT) in the US and Europe have revealed reductions of 43-66% in perinatal HIV transmission, the cost of this treatment regimen is prohibitive in developing countries. Of interest are recent findings that a short course of AZT (three oral doses daily beginning at 36 weeks' gestation and every 3 hours during labor) produces a 50% reduction in perinatal HIV transmission. The pharmaceutical firm Glaxo Wellcome has announced it will negotiate reduced AZT pricing with developing countries to increase treatment access. It is acknowledged, however, that discounted prices may still remain beyond the reach of countries in sub-Saharan Africa, for example. Even if discounted prices were complemented by other funding sources, the health infrastructure required to provide widespread counseling, testing, and treatment is not in place. Also problematic is the possibility that infants who are protected from perinatal HIV transmission will become infected postnatally as a result of lack of safe alternatives to breast-feeding. Moreover, unless treatment with triple-combination therapies and protease inhibitors is provided to HIV-infected women, their children will face increased mortality risks as a result of orphanhood.

A Canada-Bangladesh partnership for nurse education: case study.

PubMed

Berland, A; Richards, J; Lund, K D

2010-09-01

To describe the lessons learned from a partnership in nurse education between a Bangladesh university and a group of Canadian volunteers. In the host country, nursing enjoys low status and pay, which adversely affect professional standards. The paper describes implementation details of training a core of nurses to international standards, using limited resources. The first cohort received their Bachelor of Nursing degrees in 2009. The Bangladeshi partners benefit from access to up-to-date curriculum materials, current clinical expertise, and interaction with visiting faculty and students. The Canadian nursing instructors enjoy professional development opportunities; visiting Canadian students gain exposure to a practice setting in a low-income country. These include the importance of (1) integrating nurse training with a general university able to provide core courses (e.g. English as second language, computer training), (2) countering the low status of nursing and inculcating a caring attitude among students, and (3) instilling critical thinking as opposed to rote learning. Next, the following were identified: mechanisms to support networking in the local health system, sharing of resources (e.g. electronic course material adapted to host country context), and assuring programme quality. The paper will be of interest to those concerned with nurse education and human resource development in less developed countries.

Technical Health Training Manual. Volume 1. Training for Development. Peace Corps Information Collection & Exchange Training Manual No. T-35a.

ERIC Educational Resources Information Center

Clark, Mari; And Others

This manual is designed as a resource for trainers who provide preservice training, either in-country or state-side, to health specialists and generalists assigned to health projects at the community and clinical levels. The training is intended to assist the volunteer in developing knowledge and skill in the areas of primary health care and the…

Technical Health Training Manual. Volume 2. Training for Development. Peace Corps Information Collection & Exchange Training Manual No. T-35a.

ERIC Educational Resources Information Center

Clark, Mari; And Others

This manual is designed as a resource for trainers who provide preservice training, either in-country or state-side, to health specialists and generalists assigned to health projects at the community and clinical levels. The training is intended to assist the volunteer in developing knowledge and skill in the areas of primary health care and the…

Artificial intelligence: contemporary applications and future compass.

PubMed

Khanna, Sunali

2010-08-01

The clinical use of information technology in the dental profession has increased substantially in the past 10 to 20 years. In most developing countries an insufficiency of medical and dental specialists has increased the mortality of patients suffering from various diseases. Employing technology, especially artificial intelligence technology, in medical and dental application could reduce cost, time, human expertise and medical error. This approach has the potential to revolutionise the dental public health scenario in developing countries. Clinical decision support systems (CDSS) are computer programs that are designed to provide expert support for health professionals. The applications in dental sciences vary from dental emergencies to differential diagnosis of orofacial pain, radiographic interpretations, analysis of facial growth in orthodontia to prosthetic dentistry. However, despite the recognised need for CDSS, the implementation of these systems has been limited and slow. This can be attributed to lack of formal evaluation of the systems, challenges in developing standard representations, cost and practitioner scepticism about the value and feasibility of CDSS. Increasing public awareness of safety and quality has accelerated the adoption of generic knowledge based CDSS. Information technology applications for dental practice continue to develop rapidly and will hopefully contribute to reduce the morbidity and mortality of oral and maxillofacial diseases and in turn impact patient care.

Access to biologicals in Crohn’s disease in ten European countries

PubMed Central

Péntek, Márta; Lakatos, Peter L; Oorsprong, Talitha; Gulácsi, László; Pavlova, Milena; Groot, Wim; Rencz, Fanni; Brodszky, Valentin; Baji, Petra; Crohn’s Disease Research Group

2017-01-01

AIM To analyze access (availability, affordability and acceptability) to biologicals for Crohn’s disease (CD) in ten European countries and to explore the associations between these dimensions, the uptake of biologicals and economic development. METHODS A questionnaire-based survey combined with desk research was carried out in May 2016. Gastroenterologists from the Czech Republic, France, Germany, Hungary, Latvia, Poland, Romania, Slovakia, Spain and Sweden were invited to participate and provide data on the availability of biologicals/biosimilars, reimbursement criteria, clinical practice and prices, and use of biologicals. An availability score was developed to evaluate the restrictiveness of eligibility and administrative criteria applied in the countries. Affordability was defined as the annual cost of treatment as a share of gross domestic product (GDP) per capita. Correlations with the uptake of biologicals, dimensions of access and GDP per capita were calculated. RESULTS At the time of the survey, infliximab and adalimumab were reimbursed in all ten countries, and vedolizumab was reimbursed in five countries (France, Germany, Latvia, Slovakia, Sweden). Reimbursement criteria were the least strict in Sweden and Germany, and the strictest in Hungary, Poland and Slovakia. Between countries, the annual cost of different biological treatments differed 1.6-3.3-fold. Treatments were the most affordable in Sweden (13%-37% of the GDP per capita) and the least affordable in the Central and Eastern European countries, especially in Hungary (87%-124%) and Romania (141%-277%). Biosimilars made treatments more affordable by driving down the annual costs. The number of patients with CD on biologicals per 100000 population was strongly correlated with GDP per capita (0.91), although substantial differences were found in the uptake among countries with similar economic development. Correlation between the number of patients with CD on biologicals per 100000 population and the availability and affordability was also strong (-0.75, -0.69 respectively). CONCLUSION Substantial inequalities in access to biologicals were largely associated with GDP. To explain differences in access among countries with similar development needs further research on acceptance. PMID:28974896

Education, training, and practice among nordic neuropsychologists. Results from a professional practices survey.

PubMed

Norup, A; Egeland, J; Løvstad, M; Nybo, T; Persson, B A; Rivera, D; Schanke, A-K; Sigurdardottir, S; Arango-Lasprilla, J C

2017-01-01

To investigate sociodemographic characteristics, clinical and academic training, work setting and salary, clinical activities, and salary and job satisfaction among practicing neuropsychologists in four Nordic countries. 890 neuropsychologists from Denmark, Finland, Norway, and Sweden participated in an internet-based survey between December 2013 and June 2015. Three-fourths (76%) of the participants were women, with a mean age of 47 years (range 24-79). In the total sample, 11% earned a PhD and 42% were approved as specialists in neuropsychology (equivalent to board certification in the U.S.). Approximately 72% worked full-time, and only 1% were unemployed. Of the participants, 66% worked in a hospital setting, and 93% had conducted neuropsychological assessments during the last year. Attention deficit hyperactivity disorder, learning disability, and intellectual disability were the most common conditions seen by neuropsychologists. A mean income of 53,277 Euros was found. Neuropsychologists expressed greater job satisfaction than income satisfaction. Significant differences were found between the Nordic countries. Finnish neuropsychologists were younger and worked more hours every week. Fewer Swedish neuropsychologists had obtained specialist approval and fewer worked full-time in neuropsychology positions. Danish and Norwegian neuropsychologists earned more money than their Nordic colleagues. This is the first professional practice survey of Nordic neuropsychologists to provide information about sociodemographic characteristics and work setting factors. Despite the well-established guidelines for academic and clinical education, there are relevant differences between the Nordic countries. The results of the study offer guidance for refining the development of organized and highly functioning neuropsychological specialty practices in Nordic countries.

The clinical and cost effectiveness of bee honey dressing in the treatment of diabetic foot ulcers.

PubMed

Moghazy, A M; Shams, M E; Adly, O A; Abbas, A H; El-Badawy, M A; Elsakka, D M; Hassan, S A; Abdelmohsen, W S; Ali, O S; Mohamed, B A

2010-09-01

Honey is known, since antiquity, as an effective wound dressing. Emergence of resistant strains and the financial burden of modern dressings, have revived honey as cost-effective dressing particularly in developing countries. Its suitability for all stages of wound healing suggests its clinical effectiveness in diabetic foot wound infections. Thirty infected diabetic foot wounds were randomly selected from patients presenting to Surgery Department, Suez Canal University Hospital, Ismailia, Egypt. Honey dressing was applied to wounds for 3 months till healing, grafting or failure of treatment. Changes in grade and stage of wounds, using University of Texas Diabetic Wound Classification, as well as surface area were recorded weekly. Bacterial load was determined before and after honey dressing. Complete healing was significantly achieved in 43.3% of ulcers. Decrease in size and healthy granulation was significantly observed in another 43.3% of patients. Bacterial load of all ulcers was significantly reduced after the first week of honey dressing. Failure of treatment was observed in 6.7% of ulcers. This study proves that commercial clover honey is a clinical and cost-effective dressing for diabetic wound in developing countries. It is omnipresence and concordance with cultural beliefs makes it a typical environmentally based method for treating these conditions. Copyright (c) 2010 Elsevier Ireland Ltd. All rights reserved.

Is there a need for a focused health care service for children with autistic spectrum disorders? A keyhole look at this problem in Tripoli, Libya.

PubMed

Zeglam, Adel M; Maouna, Ameena

2012-07-01

Autism is a global disorder, but relatively little is known about its presentation and occurrence in many developing countries, including Libya. To estimate the prevalence of autistic spectrum disorders in children referred to Al-Khadra hospital (KH). To increase the awareness among pediatrician and primary health care providers of the importance of considering autism in children presenting with speech and language disorders. Prospective hospital-based study of all children referred to a neurodevelopment clinic between 2005 and 2009 with the diagnosis of either speech and language difficulties or behavioral difficulties. A total of 38,508 children were seen in the pediatric outpatient clinics of KH, Tripoli, between 2005 and 2009. Of these, 180 children were referred to the neurodevelopment clinic with history of delayed speech and language and or behavioral difficulties. A diagnosis of autism was made in 128 children, which gives a prevalence of approximately 1 in 300. The prevalence of autism in Libya is probably similar to that seen in the USA and the UK. No data were available for comparison from either Arab or other developing countries. Autism is an important differential diagnosis of any language disorder 'and behavioral difficulties'.

Fulbright project focuses on rehabilitation technician education and physiotherapy practice at the Kachere Rehabilitation Centre in Malawi.

PubMed

Glickman, Leslie B

2017-09-01

The aim of this project was to strengthen rehabilitation technician education and physiotherapy practice at the Kachere Rehabilitation Centre in the less-resourced country of Malawi by enlarging and reinforcing the skills of faculty, administrators, and adjunct clinicians, and fostering their continuing professional development. The project was developed through a partnership with the Kachere Rehabilitation Centre (KRC), the Medical Rehabilitation College (MRC), and a US-trained physical therapist (a Fulbright Program Scholar - FPS). The elements were education of staff, faculty, and students, and administrative consultation for rehabilitation managers, educational administrators, and faculty clinicians. Formal and informal participant feedback on the project was positive. It indicated a receptive audience who expanded their knowledge and willingly considered ideas to modify teaching, clinical, and management approaches for optimal patient care, enhanced clinician/student learning, meeting curricular accreditation standards, and solving day-to-day challenges. The project made a positive impact on the participants, fostering their goal to parallel clinical practice and educational initiatives used by recognized international standard bearers. Lessons learned emphasized the power of partnerships, networking, flexibility, and creative thinking. For international physiotherapists, it is an underutilized opportunity to extend global outreach, scholarship, clinical practice, and academic knowledge in a less-resourced country eager to upgrade the background and skills of rehabilitation providers.

The clinical nurse specialist in New Zealand: how is the role defined?

PubMed

Roberts, Jennifer; Floyd, Sue; Thompson, Shona

2011-07-01

New Zealand, like many countries, is developing new advanced nursing practice roles to meet emerging needs. While much has been written about the Nurse Practitioner (NP), the role of Clinical Nurse Specialist (CNS) remains relatively unexplored and lacks national definition. This paper reports the findings from research designed to investigate the role of the CNS and how it is defined by New Zealand District Health Boards (DHBs). The study sought to identify the current requirements and expectations for the CNS role and how it is defined in practice. In 2008, 15 CNS job descriptions were collected from eight DHBs throughout the country generating data that were treated both quantitatively and qualitatively. Overall, few areas of consensus were found regarding the essential requirements for the CNS role and there were inconsistencies in how the roles were defined, most notably concerning requirements for postgraduate qualifications and Professional Development Recognition Programmes. Thematic analysis of the documents generated four key areas relevant to the CNS role. These described the CNS as a leader, a clinical expert, a co-ordinator and an educator. The findings indicate that the CNS role is inconsistently defined in New Zealand, particularly with respect to the postgraduate qualifications required and what is meant by 'expertise'.

Cross border semantic interoperability for clinical research: the EHR4CR semantic resources and services

PubMed Central

Daniel, Christel; Ouagne, David; Sadou, Eric; Forsberg, Kerstin; Gilchrist, Mark Mc; Zapletal, Eric; Paris, Nicolas; Hussain, Sajjad; Jaulent, Marie-Christine; MD, Dipka Kalra

2016-01-01

With the development of platforms enabling the use of routinely collected clinical data in the context of international clinical research, scalable solutions for cross border semantic interoperability need to be developed. Within the context of the IMI EHR4CR project, we first defined the requirements and evaluation criteria of the EHR4CR semantic interoperability platform and then developed the semantic resources and supportive services and tooling to assist hospital sites in standardizing their data for allowing the execution of the project use cases. The experience gained from the evaluation of the EHR4CR platform accessing to semantically equivalent data elements across 11 European participating EHR systems from 5 countries demonstrated how far the mediation model and mapping efforts met the expected requirements of the project. Developers of semantic interoperability platforms are beginning to address a core set of requirements in order to reach the goal of developing cross border semantic integration of data. PMID:27570649

An evaluation of a computer based education program for the diagnosis and management of dementia in primary care. An international study of the transcultural adaptations necessary for European dissemination.

PubMed

Degryse, J; De Lepeleire, J; Southgate, L; Vernooij-Dassen, M; Gay, B; Heyrman, J

2009-05-01

The aim of this study is to make an inventory of the changes that are needed to make an interactive computer based training program (ICBT) with a specific educational content, acceptable to professional communities with different linguistic,cultural and health care backgrounds in different European countries. Existing educational software, written in two languages was reviewed by GPs and primary care professionals in three different countries. Reviewers worked through the program using a structured critical reading grid. A 'simple' translation of the program is not sufficient. Minor changes are needed to take account of linguistic differences and medical semantics. Major changes are needed in respect of the existing clinical guidelines in every country related to differences in the existing health care systems. ICTB programs cannot easily be used in different countries and cultures. The development of a structured educational program needs collaboration between educationalists, domain experts, information technology advisers and software engineers. Simple validation of the content by local expert groups will not guarantee the program's exportability. It is essential to involve different national expert groups at every phase of the development process in order to disseminate it in other countries.

Towards a new era in fetal medicine in the Nordic countries.

PubMed

Sitras, Vasilis

2016-08-01

Fetal medicine is a subspecialty of obstetrics investigating the development, growth and disease of the human fetus. The advances in fetal imaging (ultrasonography, MRI) and molecular diagnostic techniques, together with the possibility of intervention in utero, make fetal medicine an important, rapidly developing field within women's healthcare. Therefore, a variety of specialists, such as neonatologists, pediatric cardiologists, medical geneticists, radiologists and pediatric surgeons, are necessary to adjunct in the diagnosis and treatment of the fetus as a patient. In this commentary, we provide a description of some organizational and educational aspects of fetal medicine in the Nordic countries, using examples of the management of specific conditions such as aneuploidy screening, red cell allo-immunization and fetal interventions. Clearly, there are several cultural, legal, organizational and practical differences between the Nordic countries; these are not necessarily negative, given the high standards of care in all Nordic countries. The scope of the newly founded Nordic Network of Fetal Medicine is to enhance cooperation in clinical practice, education and research between the participant countries. Hopefully, this initiative will find the necessary political and economic support from the national authorities and bring a new era in the field of fetal medicine in the Nordic region. © 2016 Nordic Federation of Societies of Obstetrics and Gynecology.

The practice of clinical neuropsychology in Australia.

PubMed

Ponsford, Jennie

2016-11-01

This paper describes the development and practice of clinical neuropsychology in Australia. Clinical Neuropsychology has shown rapid growth in Australia over the past three decades. Comprehensive and specialized training programs are producing high quality graduates who are employed in a broad range of settings or private practice. Australia now has a substantial number of clinical neuropsychologists with specialist training. Whilst the majority of Australian clinical neuropsychologists still undertake assessment predominantly, there are growing opportunities for clinical neuropsychologists in rehabilitation and in a broad range of research contexts. Cultural issues relating to the assessment of Indigenous Australians and immigrants from many countries present significant challenges. Some major contributions have been made in the realms of test development and validation across various age groups. Australian clinical neuropsychologists are also contributing significantly to research in the fields of traumatic brain injury, aging and dementias, epilepsy, memory assessment, rehabilitation, substance abuse, and other psychiatric disorders. Expansion of roles of clinical neuropsychologists, in domains such as rehabilitation and research is seen as essential to underpin continuing growth of employment opportunities for the profession.

Clinical nursing and midwifery research: grey literature in African countries.

PubMed

Sun, C; Dohrn, J; Omoni, G; Malata, A; Klopper, H; Larson, E

2016-03-01

This study reviewed grey literature to assess clinical nursing and midwifery research conducted in southern and eastern African countries over the past decade. The shortage of published nursing research from African countries severely limits the ability of practicing nurses and midwives to base clinical decisions on solid evidence. However, little is known regarding unpublished or unindexed clinical research ('grey literature'), a potentially rich source of information. Identifying these sources may reveal resources to assist nurses in providing evidence-based care. This scoping review of grey literature on clinical nursing and midwifery research in southern and eastern African countries helped to identify gaps in research and assess whether these gaps differ from published research. Systematic searches of grey literature were performed. Research was included if it was conducted by nurses in 1 of 25 southern or eastern African countries, between 2004 and 2014 and included patient outcomes. Data were extracted on location, institution, research topic, institutional connections and author information. Chi-square tests were performed to compare differences between indexed and non-indexed literature. We found 262 studies by 287 authors from 17 southern and eastern African countries covering 13 topics. Although all topics were also found in indexed literature and there were statistically significant differences between the number of times, fewer topics were covered in grey literature vs. indexed. Patient satisfaction and experience and traditional health practices were more likely to be published, whereas chronic disease, assault and paediatric-related research were less often published. Generally, there is a paucity of clinical nursing research in this region. This could reflect the shortage of nurses prepared to conduct research in this region. Nurses may find additional resources for evidence in the grey literature. A complete understanding of the state of nursing science in southern and eastern African countries will help nurses and midwives to understand gaps in clinical research knowledge, potentially direct their research to more critical topics, and inform funding bodies and policy-makers of the situation of nursing science in southern and eastern African countries. © 2016 International Council of Nurses.

ESR teleradiology survey: results.

PubMed

2016-08-01

With recent developments of teleradiology technology and services, it has become necessary to better evaluate its extent and use among different countries in Europe. With this goal in mind, the ESR launched two specific surveys intended to gather the current state of adoption and implementation of teleradiology in clinical practice. A special focus on differentiating between insourcing teleradiology services among partners of the same organisation and outsourcing to external services was an essential part of the design of these surveys. The first survey was addressed to 44 national societies of different countries in Europe, while the second survey was intended for all practicing radiologist ESR members. While the results of these surveys reported here may provide a wealth of information to better understand the trends in adoption of teleradiology in Europe, they only represent a snapshot at a certain point in time. The rapid development of telecommunication tools as well as a fundamental change in practice and healthcare economics will certainly influence these observations in the upcoming years. These data, however, will provide objective and relevant parameters for supporting the efforts of experts and policy makers in promoting appropriate criteria and guidelines for adequate use of teleradiology in clinical practice. Main Messages • Understand concepts and challenges of teleradiology • Provide insight into current trends and solutions for teleradiology • Compare differences in teleradiolgy strategies between countries in Europe • Establish a reference on statistical data of usage of teleradiology in Europe.

Providing travel health care--the nurses' role: an international comparison.

PubMed

Bauer, Irmgard; Hall, Sheila; Sato, Nahoko

2013-01-01

In many countries, the responsibility for travel health lies with medical practitioners who delegate certain tasks to nursing staff. Elsewhere, nurses have taken a leading role and work independently in private or hospital-based clinics, occupational health departments and general practices. The purpose of this study was to examine the roles and challenges faced by nurses providing travel health care in Australia, Japan and the UK, and to compare educational and professional needs. Nurses involved in travel health care were invited to complete an online questionnaire with multiple choice, open-ended, and Likert Scale questions. SurveyMonkey's statistical facilities analysed quantitative data; thematic content analysis was applied to qualitative responses. Differences and similarities between the three countries were conveyed by 474 participants focusing on current positions, work arrangements, and educational and practical concerns. Clinical practice issues, including vaccination and medication regulations, were highlighted with the differences between countries explained by the respective history of travel health care development and the involvement within their nursing profession. The call for more educational opportunities, including more support from employers, and a refinement of the role as travel health nurse appears to be international. Nurses require support networks within the field, and the development of a specialist "travel health nurse" would give a stronger voice to their concerns and needs for specific education and training in travel health care. Copyright © 2013 Elsevier Ltd. All rights reserved.

Trend of HIV/AIDS Prevalence and Related Interventions Administered in Prisons of Iran -13 Years’ Experience

PubMed Central

SHAHBAZI, Mohammad; FARNIA, Marzieh; RAHMANI, Khaled; MORADI, Ghobad

2014-01-01

Abstract Background HIV/AIDS epidemic is concentrated among injecting drug users in Iran. Like many other countries with HIV/AIDS concentrated epidemic, prisons are high risk areas for spreading HIV/AIDS. The aim of this paper was to study the trend of HIV/AIDS prevalence and related interventions administered in prisons of Iran during a 13 years period Methods This cross sectional study was conducted using the data collected from the sentinel sites in all prisons in the country and it also used the data about Harm Reduction interventions which has been implemented by Iran Prisons Organization. To evaluate the correlation between the prevalence and each of administered interventions in prisons the Correlation Coefficient Test was used for the second half of the mentioned time period Results The prevalence of HIV/AIDS in prisons had increased rapidly in the early stages of epidemic, so that in 2002 the prevalence raised to 3.83%. Followed by the expansion of Methadone Maintenance Therapy and development of Triangular Clinics, HIV/AIDS prevalence in prisons declined. There was a relationship between interventions and the prevalence of HIV/AIDS. Conclusion In regions and countries where the epidemic is highly prevalent among injecting drug users and prisoners, Methadone Maintenance Therapy and development of Triangular Clinics can be utilized to control HIV/AIDS epidemic quickly. PMID:26005657

Research, empiricism and clinical practice in low-income countries.

PubMed

Isaac, Mohan; Chand, Prabhat; Murthy, Pratima

2007-10-01

Mental health problems are relevant for every country. They are particularly important for low-income countries which face a high burden of illness due to infectious disease, greater socio-economic disparities, and have limited resources for mental health care. There is a great mismatch in the areas of mental health research, practice, policy and services in comparison to developed countries. There have been a few studies that have investigated major mental health problems prevailing in these countries but missed out significant health problems. Studies have tended to be more donor driven and conducted in tertiary centres. The low priority accorded to mental health by the policy makers, scarcity of human resources, lack of culture-specific study instruments, lack of support from scientific journals have been some of the impediments to mental health research in these countries. In addition, lack of community participation and absence of sound mental health policies have deprived the vast majority of the benefit of modern psychiatric treatments. Recently, with increase in collaboration in research, availability of treatment including low-priced psychotropics, and a growing emphasis on the need for mental health policy in some low-income countries, the bleak scenario is expected to change.

Naturally occurring NS3 resistance-associated variants in hepatitis C virus genotype 1: Their relevance for developing countries.

PubMed

Echeverría, Natalia; Betancour, Gabriela; Gámbaro, Fabiana; Hernández, Nelia; López, Pablo; Chiodi, Daniela; Sánchez, Adriana; Boschi, Susana; Fajardo, Alvaro; Sóñora, Martín; Moratorio, Gonzalo; Cristina, Juan; Moreno, Pilar

2016-09-02

Hepatitis C virus (HCV) is a major cause of global morbidity and mortality, with an estimated 130-150 million infected individuals worldwide. HCV is a leading cause of chronic liver diseases including cirrhosis and hepatocellular carcinoma. Current treatment options in developing countries involve pegylated interferon-α and ribavirin as dual therapy or in combination with one or more direct-acting antiviral agents (DAA). The emergence of resistance-associated variants (RAVs) after treatment reveals the great variability of this virus leading to a great difficulty in developing effective antiviral strategies. Baseline RAVs detected in DAA treatment-naïve HCV-infected patients could be of great importance for clinical management and outcome prediction. Although the frequency of naturally occurring HCV NS3 protease inhibitor mutations has been addressed in many countries, there are only a few reports on their prevalence in South America. In this study, we investigated the presence of RAVs in the HCV NS3 serine protease region by analysing a cohort of Uruguayan patients with chronic hepatitis C who had not been treated with any DAAs and compare them with the results found for other South American countries. The results of these studies revealed that naturally occurring mutations conferring resistance to NS3 inhibitors exist in a substantial proportion of Uruguayan treatment-naïve patients infected with HCV genotype 1 enrolled in these studies. The identification of these baseline RAVs could be of great importance for patients' management and outcome prediction in developing countries. Copyright © 2016 Elsevier B.V. All rights reserved.

Gender's Effects to the Early Symptoms of Alzheimer's Disease in 5 Asian Countries.

PubMed

Yang, Yuan-Han; Meguro, Kenichi; Dominguez, Jacqueline; Chen, Christopher Li-Hsian; Wang, Huali; Ong, Paulus Anam

2017-06-01

Asia has the greatest population and more patients with dementia in the world. Early recognition of clinical symptoms of Alzheimer's disease (AD) is crucial for dementia care. In order to foster collaboration in AD care, a uniformed manner to report the early clinical symptoms of AD is necessary. We have recruited clinically diagnosed patients with AD at their very mild stage with Clinical Dementia Rating (CDR) 0.5 in Taiwan, Japan, China, Philippines, and Singapore. Demographic characteristics and psychometrics including Ascertain of Dementia-8 (AD8) questionnaire were administrated to collect and report the clinical presentation in these countries. In total, 713 clinically diagnosed patients with AD at very mild stage, CDR 0.5, have been recruited from these 5 countries. "Repeats questions, stories, or statements" were consistently the frequently reported symptom across these countries. Taiwan, China, and Singapore have the higher AD8 total score compared to that in Japan and Philippines. Japan and Philippines have the gender-related differences in clinical presentation of early AD. Difficulties in using small trouble appliance and in handling complicated financial affairs were frequently reported in Japan female, compared to male, patients with AD. Identifying the clinical symptom of AD and the gender-related issues would be crucial in the dementia care in Asia.

Global respiratory syncytial virus-associated mortality in young children (RSV GOLD): a retrospective case series.

PubMed

Scheltema, Nienke M; Gentile, Angela; Lucion, Florencia; Nokes, D James; Munywoki, Patrick K; Madhi, Shabir A; Groome, Michelle J; Cohen, Cheryl; Moyes, Jocelyn; Thorburn, Kentigern; Thamthitiwat, Somsak; Oshitani, Hitoshi; Lupisan, Socorro P; Gordon, Aubree; Sánchez, José F; O'Brien, Katherine L; Gessner, Bradford D; Sutanto, Agustinus; Mejias, Asuncion; Ramilo, Octavio; Khuri-Bulos, Najwa; Halasa, Natasha; de-Paris, Fernanda; Pires, Márcia Rosane; Spaeder, Michael C; Paes, Bosco A; Simões, Eric A F; Leung, Ting F; da Costa Oliveira, Maria Tereza; de Freitas Lázaro Emediato, Carla Cecília; Bassat, Quique; Butt, Warwick; Chi, Hsin; Aamir, Uzma Bashir; Ali, Asad; Lucero, Marilla G; Fasce, Rodrigo A; Lopez, Olga; Rath, Barbara A; Polack, Fernando P; Papenburg, Jesse; Roglić, Srđan; Ito, Hisato; Goka, Edward A; Grobbee, Diederick E; Nair, Harish; Bont, Louis J

2017-10-01

Respiratory syncytial virus (RSV) infection is an important cause of pneumonia mortality in young children. However, clinical data for fatal RSV infection are scarce. We aimed to identify clinical and socioeconomic characteristics of children aged younger than 5 years with RSV-related mortality using individual patient data. In this retrospective case series, we developed an online questionnaire to obtain individual patient data for clinical and socioeconomic characteristics of children aged younger than 5 years who died with community-acquired RSV infection between Jan 1, 1995, and Oct 31, 2015, through leading research groups for child pneumonia identified through a comprehensive literature search and existing research networks. For the literature search, we searched PubMed for articles published up to Feb 3, 2015, using the key terms "RSV", "respiratory syncytial virus", or "respiratory syncytial viral" combined with "mortality", "fatality", "death", "died", "deaths", or "CFR" for articles published in English. We invited researchers and clinicians identified to participate between Nov 1, 2014, and Oct 31, 2015. We calculated descriptive statistics for all variables. We studied 358 children with RSV-related in-hospital death from 23 countries across the world, with data contributed from 31 research groups. 117 (33%) children were from low-income or lower middle-income countries, 77 (22%) were from upper middle-income countries, and 164 (46%) were from high-income countries. 190 (53%) were male. Data for comorbidities were missing for some children in low-income and middle-income countries. Available data showed that comorbidities were present in at least 33 (28%) children from low-income or lower middle-income countries, 36 (47%) from upper middle-income countries, and 114 (70%) from high-income countries. Median age for RSV-related deaths was 5·0 months (IQR 2·3-11·0) in low-income or lower middle-income countries, 4·0 years (2·0-10·0) in upper middle-income countries, and 7·0 years (3·6-16·8) in high-income countries. This study is the first large case series of children who died with community-acquired RSV infection. A substantial proportion of children with RSV-related death had comorbidities. Our results show that perinatal immunisation strategies for children aged younger than 6 months could have a substantial impact on RSV-related child mortality in low-income and middle-income countries. Bill & Melinda Gates Foundation. Copyright © 2017 The Author(s). Published by Elsevier Ltd. This is an Open Access article under the CC BY 4.0 license. Published by Elsevier Ltd.. All rights reserved.

Probiotics, antibiotics and the immune responses to vaccines

PubMed Central

Praharaj, Ira; John, Sushil M.; Bandyopadhyay, Rini; Kang, Gagandeep

2015-01-01

Orally delivered vaccines have been shown to perform poorly in developing countries. There are marked differences in the structure and the luminal environment of the gut in developing countries resulting in changes in immune and barrier function. Recent studies using newly developed technology and analytic methods have made it increasingly clear that the intestinal microbiota activate a multitude of pathways that control innate and adaptive immunity in the gut. Several hypotheses have been proposed for the underperformance of oral vaccines in developing countries, and modulation of the intestinal microbiota is now being tested in human clinical trials. Supplementation with specific strains of probiotics has been shown to have modulatory effects on intestinal and systemic immune responses in animal models and forms the basis for human studies with vaccines. However, most studies published so far that have evaluated the immune response to vaccines in children and adults have been small and results have varied by age, antigen, type of antibody response and probiotic strain. Use of anthelminthic drugs in children has been shown to possibly increase immunogenicity following oral cholera vaccination, lending further support to the rationale for modulation of the immune response to oral vaccination through the intestinal microbiome. PMID:25964456

"More bang for the buck": exploring optimal approaches for guideline implementation through interviews with international developers.

PubMed

Gagliardi, Anna R

2012-11-15

Population based studies show that guidelines are underused. Surveys of international guideline developers found that many do not implement their guidelines. The purpose of this research was to interview guideline developers about implementation approaches and resources. Semi-structured telephone interviews were conducted with representatives of guideline development agencies identified in the National Guideline Clearinghouse and sampled by country, type of developer, and guideline clinical indication. Participants were asked to comment on the benefits and resource implications of three approaches for guideline implementation that varied by responsibility: developers, intermediaries, or users. Thirty individuals from seven countries were interviewed, representing government (n = 12) and professional (n = 18) organizations that produced guidelines for a variety of clinical indications. Organizations with an implementation mandate featured widely inconsistent funding and staffing models, variable approaches for choosing promotional strategies, and an array of dissemination activities. When asked to choose a preferred approach, most participants selected the option of including information within guidelines that would help users to implement them. Given variable mandate and resources for implementation, it was considered the most feasible approach, and therefore most likely to have impact due to potentially broad use. While implementation approaches and strategies need not be standardized across organizations, the findings may be used by health care policy makers and managers, and guideline developers to generate strategic and operational plans that optimize implementation capacity. Further research is needed to examine how to optimize implementation capacity by guideline developers, intermediaries and users.