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1.  Health 2.0 and Medicine 2.0: Tensions and Controversies in the Field 
Background
The term Web 2.0 became popular following the O’Reilly Media Web 2.0 conference in 2004; however, there are difficulties in its application to health and medicine. Principally, the definition published by O’Reilly is criticized for being too amorphous, where other authors claim that Web 2.0 does not really exist. Despite this skepticism, the online community using Web 2.0 tools for health continues to grow, and the term Medicine 2.0 has entered popular nomenclature.
Objective
This paper aims to establish a clear definition for Medicine 2.0 and delineate literature that is specific to the field. In addition, we propose a framework for categorizing the existing Medicine 2.0 literature and identify key research themes, underdeveloped research areas, as well as the underlying tensions or controversies in Medicine 2.0’s diverse interest groups.
Methods
In the first phase, we employ a thematic analysis of online definitions, that is, the most important linked papers, websites, or blogs in the Medicine 2.0 community itself. In a second phase, this definition is then applied across a series of academic papers to review Medicine 2.0’s core literature base, delineating it from a wider concept of eHealth.
Results
The terms Medicine 2.0 and Health 2.0 were found to be very similar and subsume five major salient themes: (1) the participants involved (doctors, patients, etc); (2) its impact on both traditional and collaborative practices in medicine; (3) its ability to provide personalized health care; (4) its ability to promote ongoing medical education; and (5) its associated method- and tool-related issues, such as potential inaccuracy in enduser-generated content. In comparing definitions of Medicine 2.0 to eHealth, key distinctions are made by the collaborative nature of Medicine 2.0 and its emphasis on personalized health care. However, other elements such as health or medical education remain common for both categories. In addition, this emphasis on personalized health care is not a salient theme within the academic literature. Of 2405 papers originally identified as potentially relevant, we found 56 articles that were exclusively focused on Medicine 2.0 as opposed to wider eHealth discussions. Four major tensions or debates between stakeholders were found in this literature, including (1) the lack of clear Medicine 2.0 definitions, (2) tension due to the loss of control over information as perceived by doctors, (3) the safety issues of inaccurate information, and (4) ownership and privacy issues with the growing body of information created by Medicine 2.0.
Conclusion
This paper is distinguished from previous reviews in that earlier studies mainly introduced specific Medicine 2.0 tools. In addressing the field’s definition via empirical online data, it establishes a literature base and delineates key topics for future research into Medicine 2.0, distinct to that of eHealth.
doi:10.2196/jmir.1056
PMCID: PMC2553249  PMID: 18682374
Web 2.0; Medicine 2.0; Health 2.0
2.  Conceptual and Analytical Considerations toward the Use of Patient-Reported Outcomes in Personalized Medicine 
American Health & Drug Benefits  2012;5(5):310-317.
Background
Patient-reported outcomes (PROs) can play an important role in personalized medicine. PROs can be viewed as an important fundamental tool to measure the extent of disease and the effect of treatment at the individual level, because they reflect the self-reported health state of the patient directly. However, their effective integration in personalized medicine requires addressing certain conceptual and methodological challenges, including instrument development and analytical issues.
Objectives
To evaluate methodological issues, such as multiple comparisons, missing data, and modeling approaches, associated with the analysis of data related to PRO and personalized medicine to further our understanding on the role of PRO data in personalized medicine.
Discussion
There is a growing recognition of the role of PROs in medical research, but their potential use in customizing healthcare is not widely appreciated. Emerging insights into the genetic basis of PROs could potentially lead to new pathways that may improve patient care. Knowledge of the biologic pathways through which the various genetic predispositions propel people toward negative or away from positive health experiences may ultimately transform healthcare. Understanding and addressing the conceptual and methodological issues in PROs and personalized medicine are expected to enhance the emerging area of personalized medicine and to improve patient care. This article addresses relevant concerns that need to be considered for effective integration of PROs in personalized medicine, with particular reference to conceptual and analytical issues that routinely arise with personalized medicine and PRO data. Some of these issues, including multiplicity problems, handling of missing values-and modeling approaches, are common to both areas. It is hoped that this article will help to stimulate further research to advance our understanding of the role of PRO data in personalized medicine.
Conclusion
A robust conceptual framework to incorporate PROs into personalized medicine can provide fertile opportunity to bring these two areas even closer and to enhance the way a specific treatment is attuned and delivered to address patient care and patient needs.
PMCID: PMC4046457  PMID: 24991329
3.  Regulation (EC) No 1901/2006 on medicinal products for paediatric use & clinical research in vulnerable populations 
Before any medicinal product is authorised for use in adults, it must undergo extensive pharmaceutical consistency and stability tests, toxicological tests and clinical trials to ensure that it is of high quality, safe and effective.
The same approach may not always be applied to medicinal products used to treat children.
Studies showed that over 50% of the medicinal products used in children may not have been tested for use in this age group. The absence of suitable authorised medicinal products to treat conditions in children results from the fact that pharmaceutical companies do not adapt medicinal products to the needs of the paediatric population. This leaves health care professionals with no alternative other than to use medicinal products "off-label" and to use unauthorised products with the associated risks of inefficacy and/or adverse reactions.
The Regulation (EC) No 1901/2006 sets up a system of requirements, rewards and incentives, together with horizontal measures, to ensure that medicinal products are researched, developed and authorised to meet the therapeutic needs of children.
The Regulation is addressed to:
1. The pharmaceutical industry by setting out the legal framework for receiving rewards and incentives by conducting clinical trials in the paediatric population.
2. The Member States to set out to support research into, and the development and availability of, medicinal products for paediatric use.
3. The Community as funds for research into medicinal products for the paediatric population shall be provided for in the Community budget in order to support studies relating to medicinal products or active substances not covered by a patent or a supplementary protection certificate.
The legal framework for conducting clinical trials, including children/minors, is set up in Directive 2001/20/EC, the Clinical Trials Directive (CTD), for the European Union (EU). The CTD establishes specific provisions regarding conduct of clinical trials, including multi-centre trials, on human subjects involving medicinal products and in particular relating to the implementation of good clinical practice. Compliance with this good practice provides assurance that the rights, safety and well-being of trial subjects are protected, and that the results of the clinical trials are credible. The CTD is addressed to all investigators conducting clinical trials including clinical trials in the paediatric population and had to be applied accordingly.
In the framework of the authorisation of medicinal products regulated by the Regulation (EC) No 726/2004 and Directive 2001/83/EC as amended and the CTD, and additional implementing Directives and guidelines, the new Regulation (EC) No 1901/2006 is an important new piece of legislation focusing on the requirements to improve the situation for the paediatric population.
All Regulations/Directives to be found:
doi:10.1186/1753-2000-2-37
PMCID: PMC2633263  PMID: 19063722
4.  Rural family medicine training in Canada. 
Canadian Family Physician  1995;41:993-1000.
OBJECTIVE: To examine the status of postgraduate family medicine training that occurs in rural family practice settings in Canada and to identify problems and how they are addressed. DESIGN: A retrospective questionnaire sent to all 18 Canadian family medicine training programs followed by a focus group discussion of results. SETTING: Canadian university family medicine training programs. PARTICIPANTS: Chairs or program directors of all 18 Canadian family medicine training programs and people attending a workshop at the Section of Teachers of Family Medicine annual meeting. MAIN OUTCOME MEASURES: Extent of training offered, educational models used, common problems for residents and teachers. RESULTS: Nine of 18 programs offer some family medicine training in a rural practice setting to some or all of their first-year family medicine residents, and 99 of 684 first-year family medicine residents did some training in a rural practice. All programs offer some training in a rural practice to some or all of the second-year residents, and 567 of 702 second-year residents did some training in a rural setting. In 12 of 18 programs, a rural family medicine block is compulsory. Education models for training for rural family practice vary widely. Isolation, accommodation, and supervision are common problems for rural family medicine residents. Isolation and faculty development are common problems for rural physician-teachers. Programs use various approaches to address these problems. CONCLUSIONS: The variety of postgraduate training models for rural family practice used in the 18 training programs reflects different regional health care needs and resources. There is no common rural family medicine curriculum. Networking through a rural physician-teachers group or a faculty of rural medicine could further the development of education for rural family practice.
PMCID: PMC2146570  PMID: 7780331
5.  Need to teach family medicine concepts even before establishing such practice in a country 
Background
The practice of family medicine is not well established in many developing countries including Sri Lanka. The Sri Lankan Government funds and runs the health facilities which cater to the health needs of a majority of the population. Services of a first contact doctor delivered by full time, vocationally trained, Family Physicians is generally overshadowed by outpatient departments of the government hospitals and after hours private practice by the government sector doctors and specialists. This process has changed the concept of the provision of comprehensive primary and continuing care for entire families, which in an ideal situation, should addresses psychosocial problems as well and deliver coordinated health care services in a society. Therefore there is a compelling need to teach Family Medicine concepts to undergraduates in all medical faculties.
Discussion
A similar situation prevails in many countries in the region. Faculty of Medicine Peradeniya embarked on teaching family medicine concepts even before a department of Family Medicine was established. The faculty has recognized CanMed Family Medicine concepts as the guiding principles where being an expert, communicator, collaborator, advocate, manager and professional is considered as core competencies of a doctor. These concepts created the basis to evaluate the existing family medicine curriculum , and the adequacy of teaching knowledge and skills, related to family medicine has been confirmed. However inadequacies of teaching related to communication, collaboration, management, advocacy and professionalism were recognized. Importance of inculcating patient centred attitudes and empathy in patient care was highlighted. Adopting evaluation tools like Patient Practitioner Orientation Scale and Jefferson’s Scale of Empathy was established. Consensus has been developed among all the departments to improve their teaching programmes in order to establish a system of teaching family medicine concepts among students which would lead them to be good Family Physicians in the future.
Summary
Teaching Family Medicine concepts could be initiated even before establishing departments of family medicine in medical faculties and establishing the practice of family medicine in society. Family medicine competencies could be inculcated among graduates while promoting the establishment of the proper practice of Family Medicine in the society.
doi:10.1186/1447-056X-13-1
PMCID: PMC3904475  PMID: 24397851
Family medicine concepts; Undergraduate curriculum; Communication; Patient; Centeredness; Empathy
6.  Public health concerns for anti-obesity medicines imported for personal use through the internet: a cross-sectional study 
BMJ Open  2012;2(3):e000854.
Objective
To explore the circulation of anti-obesity medicines via the internet and their quality.
Design
Cross-sectional study.
Setting
Internet pharmacies and pharmaceutical suppliers accessible from Japan.
Participants
Anti-obesity medicines were purchased using relevant keywords on Japanese Google search engine. Blogs and advertisement-only sites were excluded.
Primary and secondary outcome measures
The authenticity of the samples was investigated in collaboration with the manufacturers of the samples and medicine regulatory authorities. Quality of the samples was assessed by pharmacopoeial analyses using high-performance liquid chromatography.
Results
82 samples were purchased from 36 internet sites. Approximately half of the sites did not mention a physical address, and 45% of the samples did not contain a package insert. A variety of custom declarations were made for the shipments of the samples: personal health items, supplement, medicines, general merchandise, tea and others. Among 82 samples, 52 samples were analysed to check their pharmacopoeial quality. Authenticity responses were received from only five of 20 manufacturing companies. According to the pharmacopoeial analyses and authenticity investigation, three of the samples were identified as counterfeits and did not contain any active ingredients. Two of these samples were confirmed as counterfeits by the manufacturer of the authentic products. The manufacturer of the other sample did not respond to our request for an authenticity check even after several communication attempts. These counterfeit cases have been reported at the rapid alert system of Western Pacific Region of the WHO.
Conclusions
Many counterfeit and unapproved anti-obesity medicines may be easily bypassing regulatory checks during shipping and are widely circulated through the internet. Regulatory authorities should take measures to prevent these medicines from entering countries to safeguard their citizens.
Article summary
Article focus
Quality of online anti-obesity medicines.
Circulation of unapproved anti-obesity medicines via the internet.
Key messages
Counterfeit and substandard anti-obesity medicines, orlistat are identified.
False and vague custom declarations were made by some of the shipping companies to bypass regulatory checks of unapproved online medicines.
Strengths and limitations of this study
Small sample size and low authenticity response rate are limitations of this study.
However, the study provides valuable information for regulatory authorities on how unapproved and counterfeit medicines are being circulated through the internet.
Concerted efforts of authentic manufacturers and medicine regulatory authorities are a must to combat counterfeits and ensure access of quality medicines to online consumers.
doi:10.1136/bmjopen-2012-000854
PMCID: PMC3353131  PMID: 22581794
7.  Factors predicting the guideline compliant supply (or non‐supply) of non‐prescription medicines in the community pharmacy setting 
Background
The reclassification of prescription only medicines to pharmacy and general sales list medicines (also known as non‐prescription medicines) provides the public with greater access to medicines that they can purchase for self‐care. There is evidence that non‐prescription medicines may be associated with inappropriate supply. This study investigated factors predicting evidence‐based (guideline compliant) supply or non‐supply of non‐prescription medicines.
Method
Secondary analysis of results from a randomised controlled trial of educational interventions to promote the evidence based supply of non‐prescription medicines. Ten actors made simulated patient (customer) visits to 60 community pharmacies using seven scenarios reflecting different types of presentations. The dependent variable was appropriate (guideline compliant) supply of antifungal medication for treatment of vaginal candidiasis.
Results
No significant association was shown between guideline compliant behaviour and pharmacy type or location, or with the actor making the visit. The likelihood of guideline compliant outcome was significantly greater with symptom presentations than with condition or product presentations (p<0.001). The likelihood of a guideline compliant outcome increased (a) as more information was exchanged (p<0.001), (b) with the use of WWHAM (a mnemonic frequently used by medicine counter assistants during consultations for non‐prescription medicines) (p<0.001); (c) when specific WWHAM questions were used (including “description of symptoms” (p<0.001) and “whether other medication was currently being used” (p<0.001); and (d) in consultations involving solely pharmacists compared with those involving only medicine counter assistants (p = 0.017). After adjustment for presentation type, a significant association persisted between appropriate outcome and consultations with WWHAM scores of 2 and ⩾3, respectively.
Conclusions
The nature and extent of information exchange between pharmacy staff and customers has a strong influence on the guideline compliant supply of non‐prescription medicines. Future interventions to promote the safe and effective use of non‐prescription medicines should address the apparent deficit in communication between pharmacy staff in general, and medicine counter assistants in particular, which may reflect both pharmacy staff skills and customer expectations.
doi:10.1136/qshc.2005.014720
PMCID: PMC2564005  PMID: 16456211
communication; community pharmacy services; evidence based practice; non‐prescription medicines
8.  Challenges and Opportunities in Academic Hospital Medicine: Report from the Academic Hospital Medicine Summit 
ABSTRACT
BACKGROUND
The field of hospital medicine is growing rapidly in academic medical centers. However, few organizations have explicitly considered the opportunities and barriers posed to hospital medicine’s development as an academic field in internal medicine.
OBJECTIVE
To develop consensus around key areas limiting or facilitating hospital medicine’s development as an academic discipline.
DESIGN
Consensus format conference of key stakeholders in academic hospital medicine.
RESULTS
The Consensus Group identified several issues impeding the development of academic hospital medicine as a recognized entity in academic settings, including extraordinarily rapid growth, increasingly preponderate non-teaching roles, and demands to perform non-clinical duties (such as quality improvement) not generally viewed as academic pursuits. The Consensus Group developed recommendations for addressing these concerns, specifically 1) characterizing the ‘optimal’ job description for an academic hospitalist, 2) developing better local and at-a-distance opportunities for training academic hospitalists in key aspects of early career success, 3) advocacy for development of fellows and junior faculty researchers in hospital medicine.
SUMMARY
Fostering academic hospital medicine will help address these issues more effectively and will help the field while also attracting the next generation of generalists needed to care for an increasingly complex inpatient population.
doi:10.1007/s11606-009-0944-6
PMCID: PMC2669869  PMID: 19259748
internal medicine; Consensus Group; opportunities; academic hospital; hospital medicine; hospitalists
9.  The Impact of the Internal Medicine Sub-internship on Medical Student Career Choice 
Background
Medical student interest in internal medicine is decreasing. Whether the internal medicine sub-internship affects intent to pursue internal medicine is unknown.
Objective
Determine the immediate and longer-term effect of the medicine sub-internship on students’ decision to pursue internal medicine residency.
Design
Mixed method, single institution, prospective cohort study.
PARTICIPANTS
Ninety-two students completing an internal medicine sub-internship in 2006.
Measurements
Survey administered prior to and immediately after the sub-internship and prior to the match. Questions included likelihood of applying in internal medicine and perceived impact of the sub-internship on career choice.
Main Results
Seventy-seven percent of students (N = 63) completed the first two surveys; 63% (N = 58) completed the second and third. Immediately post sub-internship, 21% (N = 13) were less likely to apply in internal medicine and 11% (N = 7) were more likely to apply (net change in plans was not significant, p = 0.38). There was a significant relationship between the perceived impact of the sub-internship and likelihood of applying in medicine (ANOVA comparison across means, p <  0.001). Compared to the second survey, on the third survey more students (41%, N = 24) believed the sub-internship positively impacted their decision to apply in medicine, though overall shifting was not significant (p = 0.39). Key themes describing sub-internship impact included the intense workload, value of experiencing internship, rewards of assuming the physician role, and education received (30%, 25%, 20% and 16% of comments, respectively).
Conclusions
Overall, there was not a significant effect of the sub-internship on students’ decision to apply in internal medicine. Additional research about the relative impact of the sub-internship in relationship to other career choice predictors is needed to better address factors that may encourage or dissuade students from pursuing internal medicine.
doi:10.1007/s11606-010-1263-7
PMCID: PMC2854997  PMID: 20229140
undergraduate medical education; career choice; internal medicine; sub-internship
10.  Pharmacokinetic research in children: an analysis of registered records of clinical trials 
BMJ Open  2011;1(1):e000221.
Background
Reported off-label/unlicensed prescribing rates in children range from 11% to 80%. Research into pharmacokinetic profiles of children's medicines is essential in the creation of more knowledge on the safety and efficacy of medicines in children. This study investigated how often pharmacokinetic data are collected in clinical trials of medicines in children by analysing registered records of clinical trials.
Methods
The registered records of all clinical trials in children that were recruiting on 22 May 2009 were identified on the International Clinical Trials Registry Platform using a Clinical Trials in Children search filter. The records of trials in children below 12 years of age, in which the intervention was one or more medicines, were assessed for evidence that pharmacokinetic data would be collected.
Results
Of 1081 eligible trial records, 257 (24%) declared that pharmacokinetic data would be collected. Of these trials, 199 (77%) recruited in Northern America; recruitment in all other regions was below 20%. Trials recruited most often in children over 2 years of age (74%), and least often in newborn infants (32%). Most trials researched medicines in the field of cancer (29%). Trials investigated one-third of the medicines that were indicated as a priority for pharmacokinetic research by the European Medicines Agency.
Conclusions
There is a need for increased knowledge of the pharmacokinetic profiles of children's medicines. The amount of currently ongoing pharmacokinetic research does not seem to address adequately the lack of knowledge in this area. This study sets a baseline for monitoring of future progress on the amount of ongoing pharmacokinetic research in children.
Article summary
Article focus
The main aim of this study was to assess how many registered records of clinical trials of medicines that were recruiting children and were identifiable on the International Clinical Trials Registry Platform Search Portal contained evidence that pharmacokinetic data would be collected.
Secondary aims were to assess which pharmacokinetic data were collected and what types of trials were reporting pharmacokinetic data.
Key messages
This study quantifies, for the first time, the amount of currently ongoing research into pharmacokinetic profiles of medicines in children.
It shows how much and what kind of pharmacokinetic research is being carried out worldwide as registered at clinical trial registries and analyses the types of trials that perform this research.
It sets a baseline for future studies, to monitor progress in the amount of pharmacokinetic research that is performed in children.
Strengths and limitations of this study
Our study is one of the first studies of its kind, in that it has created a comprehensive oversight of the amount of ongoing research in one particular research area, by analysing information in registered records of clinical trials. Using information in clinical trial databases as such offers a unique, and currently underused, method for informing future research prioritisation efforts at a policy level (in our case of paediatric off-patent medicines by the European Medicines Agency).
This study is limited by the quality of information in the included registered records. Studying registered records of clinical trials is not the same as studying how clinical trials were in fact conducted. However, in the absence of open access to complete trial protocols we have no other choice than to use the information entered into a trial registry for this type of analysis.
doi:10.1136/bmjopen-2011-000221
PMCID: PMC3191584  PMID: 22021789
Public health; statistics &research methods; pharmacokinetics; clinical trials registration; paediatrics; pharmacology; clinical trial
11.  An ethnobotanical survey of medicinal plants used in the eastern highlands of Papua New Guinea 
Background
The Eastern Highlands area of Papua New Guinea (PNG) has a rich tradition of medicinal plant use. However, rapid modernization is resulting in the loss of independent language traditions and consequently a loss of individuals knowledgeable in medicinal plant use. This report represents a program to document and preserve traditional knowledge concerning medicinal plant use in PNG. This report documents and compares traditional plant use in the Eastern Highlands districts of Unggai-Bena, Okapa, and Obura-Wonenara, and puts these new records in context of previously documented PNG medicinal plant use.
Methods
This manuscript is an annotated combination of Traditional Medicines survey reports generated by UPNG trainees using a survey questionnaire titled “Information sheet on traditional herbal reparations and medicinal plants of PNG”. The Traditional Medicines survey project is supported by WHO, US NIH and PNG governmental health care initiatives and funding.
Results
Overall, after “poisoning” (synonymous with “magic”) the most commonly recorded ailments addressed by medicinal plant use were pain, gynecological disease, gastrointestinal maladies, anemia or malnutrition and malaria. However, the recorded indications for plant use varied widely amongst the different survey locations. Unlike many areas of PNG, mixing of ingredients was the most common mode of preparation recorded, except for two areas where the consumption of fresh plant material was more common. Throughout the Eastern Highlands oral administration was most common, with topical application second. Overall, leaves were most commonly used in the preparations of the healers interviewed, followed by bark and stems. Several new medicinal uses of plants were also documented.
Conclusions
Collaboration between the WHO, UPNG and the PNG Department of Health initiated Traditional Medicine survey program in order to preserve traditional knowledge concerning medicinal plant use in PNG. This effort promotes integration of effective and accessible traditional practices with Western protocols. The Traditional Medicine surveys are particularly important because, in the absence of the clinical validation, the documentation of the consistent use of a given plant for specific indication by a large number of herbalists, across a wide range of ethnic traditions, maybe considered as a positive criterion for the promulgation of said use amongst PNG’s recently formed traditional healer associations.
doi:10.1186/1746-4269-8-47
PMCID: PMC3549922  PMID: 23249544
Papua New Guinea; Eastern Highlands; Medicinal Plants; Obura-Wonenara; Unggai-Bena; Okapa
12.  Threats to Validity in the Design and Conduct of Preclinical Efficacy Studies: A Systematic Review of Guidelines for In Vivo Animal Experiments 
PLoS Medicine  2013;10(7):e1001489.
Background
The vast majority of medical interventions introduced into clinical development prove unsafe or ineffective. One prominent explanation for the dismal success rate is flawed preclinical research. We conducted a systematic review of preclinical research guidelines and organized recommendations according to the type of validity threat (internal, construct, or external) or programmatic research activity they primarily address.
Methods and Findings
We searched MEDLINE, Google Scholar, Google, and the EQUATOR Network website for all preclinical guideline documents published up to April 9, 2013 that addressed the design and conduct of in vivo animal experiments aimed at supporting clinical translation. To be eligible, documents had to provide guidance on the design or execution of preclinical animal experiments and represent the aggregated consensus of four or more investigators. Data from included guidelines were independently extracted by two individuals for discrete recommendations on the design and implementation of preclinical efficacy studies. These recommendations were then organized according to the type of validity threat they addressed. A total of 2,029 citations were identified through our search strategy. From these, we identified 26 guidelines that met our eligibility criteria—most of which were directed at neurological or cerebrovascular drug development. Together, these guidelines offered 55 different recommendations. Some of the most common recommendations included performance of a power calculation to determine sample size, randomized treatment allocation, and characterization of disease phenotype in the animal model prior to experimentation.
Conclusions
By identifying the most recurrent recommendations among preclinical guidelines, we provide a starting point for developing preclinical guidelines in other disease domains. We also provide a basis for the study and evaluation of preclinical research practice.
Please see later in the article for the Editors' Summary
Editors' Summary
Background
The development process for new drugs is lengthy and complex. It begins in the laboratory, where scientists investigate the causes of diseases and identify potential new treatments. Next, promising interventions undergo preclinical research in cells and in animals (in vivo animal experiments) to test whether the intervention has the expected effect and to support the generalization (extension) of this treatment–effect relationship to patients. Drugs that pass these tests then enter clinical trials, where their safety and efficacy is tested in selected groups of patients under strictly controlled conditions. Finally, the government bodies responsible for drug approval review the results of the clinical trials, and successful drugs receive a marketing license, usually a decade or more after the initial laboratory work. Notably, only 11% of agents that enter clinical testing (investigational drugs) are ultimately licensed.
Why Was This Study Done?
The frequent failure of investigational drugs during clinical translation is potentially harmful to trial participants. Moreover, the costs of these failures are passed onto healthcare systems in the form of higher drug prices. It would be good, therefore, to reduce the attrition rate of investigational drugs. One possible explanation for the dismal success rate of clinical translation is that preclinical research, the key resource for justifying clinical development, is flawed. To address this possibility, several groups of preclinical researchers have issued guidelines intended to improve the design and execution of in vivo animal studies. In this systematic review (a study that uses predefined criteria to identify all the research on a given topic), the authors identify the experimental practices that are commonly recommended in these guidelines and organize these recommendations according to the type of threat to validity (internal, construct, or external) that they address. Internal threats to validity are factors that confound reliable inferences about treatment–effect relationships in preclinical research. For example, experimenter expectation may bias outcome assessment. Construct threats to validity arise when researchers mischaracterize the relationship between an experimental system and the clinical disease it is intended to represent. For example, researchers may use an animal model for a complex multifaceted clinical disease that only includes one characteristic of the disease. External threats to validity are unseen factors that frustrate the transfer of treatment–effect relationships from animal models to patients.
What Did the Researchers Do and Find?
The researchers identified 26 preclinical guidelines that met their predefined eligibility criteria. Twelve guidelines addressed preclinical research for neurological and cerebrovascular drug development; other disorders covered by guidelines included cardiac and circulatory disorders, sepsis, pain, and arthritis. Together, the guidelines offered 55 different recommendations for the design and execution of preclinical in vivo animal studies. Nineteen recommendations addressed threats to internal validity. The most commonly included recommendations of this type called for the use of power calculations to ensure that sample sizes are large enough to yield statistically meaningful results, random allocation of animals to treatment groups, and “blinding” of researchers who assess outcomes to treatment allocation. Among the 25 recommendations that addressed threats to construct validity, the most commonly included recommendations called for characterization of the properties of the animal model before experimentation and matching of the animal model to the human manifestation of the disease. Finally, six recommendations addressed threats to external validity. The most commonly included of these recommendations suggested that preclinical research should be replicated in different models of the same disease and in different species, and should also be replicated independently.
What Do These Findings Mean?
This systematic review identifies a range of investigational recommendations that preclinical researchers believe address threats to the validity of preclinical efficacy studies. Many of these recommendations are not widely implemented in preclinical research at present. Whether the failure to implement them explains the frequent discordance between the results on drug safety and efficacy obtained in preclinical research and in clinical trials is currently unclear. These findings provide a starting point, however, for the improvement of existing preclinical research guidelines for specific diseases, and for the development of similar guidelines for other diseases. They also provide an evidence-based platform for the analysis of preclinical evidence and for the study and evaluation of preclinical research practice. These findings should, therefore, be considered by investigators, institutional review bodies, journals, and funding agents when designing, evaluating, and sponsoring translational research.
Additional Information
Please access these websites via the online version of this summary at http://dx.doi.org/10.1371/journal.pmed.1001489.
The US Food and Drug Administration provides information about drug approval in the US for consumers and for health professionals; its Patient Network provides a step-by-step description of the drug development process that includes information on preclinical research
The UK Medicines and Healthcare Products Regulatory Agency (MHRA) provides information about all aspects of the scientific evaluation and approval of new medicines in the UK; its My Medicine: From Laboratory to Pharmacy Shelf web pages describe the drug development process from scientific discovery, through preclinical and clinical research, to licensing and ongoing monitoring
The STREAM website provides ongoing information about policy, ethics, and practices used in clinical translation of new drugs
The CAMARADES collaboration offers a “supporting framework for groups involved in the systematic review of animal studies” in stroke and other neurological diseases
doi:10.1371/journal.pmed.1001489
PMCID: PMC3720257  PMID: 23935460
13.  A Systematic Review of Studies That Aim to Determine Which Outcomes to Measure in Clinical Trials in Children  
PLoS Medicine  2008;5(4):e96.
Background
In clinical trials the selection of appropriate outcomes is crucial to the assessment of whether one intervention is better than another. Selection of inappropriate outcomes can compromise the utility of a trial. However, the process of selecting the most suitable outcomes to include can be complex. Our aim was to systematically review studies that address the process of selecting outcomes or outcome domains to measure in clinical trials in children.
Methods and Findings
We searched Cochrane databases (no date restrictions) in December 2006; and MEDLINE (1950 to 2006), CINAHL (1982 to 2006), and SCOPUS (1966 to 2006) in January 2007 for studies of the selection of outcomes for use in clinical trials in children. We also asked a group of experts in paediatric clinical research to refer us to any other relevant studies. From these articles we extracted data on the clinical condition of interest, description of the method used to select outcomes, the people involved in the selection process, the outcomes selected, and limitations of the method as defined by the authors. The literature search identified 8,889 potentially relevant abstracts. Of these, 70 were retrieved, and 25 were included in the review. These studies described the work of 13 collaborations representing various paediatric specialties including critical care, gastroenterology, haematology, psychiatry, neurology, respiratory paediatrics, rheumatology, neonatal medicine, and dentistry. Two groups utilised the Delphi technique, one used the nominal group technique, and one used both methods to reach a consensus about which outcomes should be measured in clinical trials. Other groups used semistructured discussion, and one group used a questionnaire-based survey. The collaborations involved clinical experts, research experts, and industry representatives. Three groups involved parents of children affected by the particular condition.
Conclusions
Very few studies address the appropriate choice of outcomes for clinical research with children, and in most paediatric specialties no research has been undertaken. Among the studies we did assess, very few involved parents or children in selecting outcomes that should be measured, and none directly involved children. Research should be undertaken to identify the best way to involve parents and children in assessing which outcomes should be measured in clinical trials.
Ian Sinha and colleagues show, in a systematic review of published studies, that there are very few studies that address the appropriate choice of outcomes for clinical research with children.
Editors' Summary
Background.
When adult patients are given a drug for a disease by their doctors, they can be sure that its benefits and harms will have been carefully studied in clinical trials. Clinical researchers will have asked how well the drug does when compared to other drugs by giving groups of patients the various treatments and determining several “outcomes.” These are measurements carefully chosen in advance by clinical experts that ensure that trials provide as much information as possible about how effectively a drug deals with a specific disease and whether it has any other effects on patients' health and daily life. The situation is very different, however, for pediatric (child) patients. About three-quarters of the drugs given to children are “off-label”—they have not been specifically tested in children. The assumption used to be that children are just small people who can safely take drugs tested in adults provided the dose is scaled down. However, it is now known that children's bodies handle many drugs differently from adult bodies and that a safe dose for an adult can sometimes kill a child even after scaling down for body size. Consequently, regulatory bodies in the US, Europe, and elsewhere now require clinical trials to be done in children and drugs for pediatric use to be specifically licensed.
Why Was This Study Done?
Because children are not small adults, the methodology used to design trials involving children needs to be adapted from that used to design trials in adult patients. In particular, the process of selecting the outcomes to include in pediatric trials needs to take into account the differences between adults and children. For example, because children's brains are still developing, it may be important to include outcome measures that will detect any effect that drugs have on intellectual development. In this study, therefore, the researchers undertook a systematic review of the medical literature to discover how much is known about the best way to select outcomes in clinical trials in children.
What Did the Researchers Do and Find?
The researchers used a predefined search strategy to identify all the studies published since 1950 that examined the selection of outcomes in clinical trials in children. They also asked experts in pediatric clinical research for details of relevant studies. Only 25 studies, which covered several pediatric specialties and were published by 13 collaborative groups, met the strict eligibility criteria laid down by the researchers for their systematic review. Several approaches previously used to choose outcomes in clinical trials in adults were used in these studies to select outcomes. Two groups used the “Delphi” technique, in which opinions are sought from individuals, collated, and fed back to the individuals to generate discussion and a final, consensus agreement. One group used the “nominal group technique,” which involves the use of structured face-to-face discussions to develop a solution to a problem followed by a vote. Another group used both methods. The remaining groups (except one that used a questionnaire) used semistructured discussion meetings or workshops to decide on outcomes. Although most of the groups included clinical experts, people doing research on the specific clinical condition under investigation, and industry representatives, only three groups asked parents about which outcomes should be included in the trials, and none asked children directly.
What Do These Findings Mean?
These findings indicate that very few studies have addressed the selection of appropriate outcomes for clinical research in children. Indeed, in many pediatric specialties no research has been done on this important topic. Importantly, some of the studies included in this systematic review clearly show that it is inappropriate to use the outcomes used in adult clinical trials in pediatric populations. Overall, although the studies identified in this review provide some useful information on the selection of outcomes in clinical trials in children, further research is urgently needed to ensure that this process is made easier and more uniform. In particular, much more research must be done to determine the best way to involve children and their parents in the selection of outcomes.
Additional Information.
Please access these Web sites via the online version of this summary at http://dx.doi.org/10.1371/journal.pmed.0050096.
A related PLoSMedicine Perspective article is available
The European Medicines Agency provides information about the regulation of medicines for children in Europe
The US Food and Drug Administration Office of Pediatric Therapeutics provides similar information for the US
The UK Medicines and Healthcare products Regulatory Agency also provides information on why medicines need to be tested in children
The UK Medicines for Children Research Network aims to facilitate the conduct of clinical trials of medicines for children
The James Lind Alliance has been established in the UK to increase patient involvement in medical research issues such as outcome selection in clinical trials
doi:10.1371/journal.pmed.0050096
PMCID: PMC2346505  PMID: 18447577
14.  Quality of generic medicines in South Africa: Perceptions versus Reality – A qualitative study 
Background
Generic Medicines are an important policy option allowing for access to affordable, essential medicines. Quality of generic medicines must be guaranteed through the activities of national medicines regulatory authorities. Existing negative perceptions surrounding the quality of generic medicines must be addressed to ensure that people use them with confidence. Campaigns to increase the uptake of generic medicines by consumers and providers of healthcare need to be informed by local norms and practices. This study sought to compare South African consumers’ and healthcare providers’ perceptions of quality of generics to the actual quality of selected products.
Methods
The study was conducted at the local level in three cities of South Africa: Johannesburg, Durban and Cape Town. Purposive sampling was used to recruit consumer participants (n = 73) and random sampling used to recruit healthcare providers from public and private sectors (n = 15). Data were obtained through twelve focus group discussions with consumers and semi-structured interviews (n = 15) with healthcare providers in order to gain familiarity with perceptions of quality. One hundred and thirty five products comprising paracetamol tablets (n = 47), amoxicillin capsules (n = 45) and hydrochlorothiazide tablets (n = 43) were sourced from public and private sector healthcare providers. These products were subjected to in vitro dissolution, uniformity of weight and identity (Fourier Transformed Infrared Spectroscopy) tests using prescribed methods from the British (2005) and United States Pharmacopeias (2006).
Results
Respondents described drug quality in relation to the effect on symptoms. Procurement and use behavior of healthcare providers was influenced by prior experience, manufacturers’ names and consumers’ ability to pay. All formulations passed the in vitro tests for quality.
Conclusions
This study showed clear differences between perceptions of quality and actual quality of medicines suggesting deficiencies in public engagement by government regarding the implementation of generic medicines policy. Implementation of generic medicines policy requires the involvement of consumers and healthcare providers to specifically address their information gaps and needs.
doi:10.1186/1472-6963-12-297
PMCID: PMC3479066  PMID: 22943592
15.  International Federation for Emergency Medicine model curriculum for medical student education in emergency medicine 
There is a critical and growing need for emergency physicians and emergency medicine resources worldwide. To meet this need, physicians must be trained to deliver time-sensitive interventions and life-saving emergency care. Currently, there is no internationally recognized, standard curriculum that defines the basic minimum standards for emergency medicine education. To address this lack, the International Federation for Emergency Medicine (IFEM) convened a committee of international physicians, health professionals, and other experts in emergency medicine and international emergency medicine development to outline a curriculum for foundation training of medical students in emergency medicine. This curriculum document represents the consensus of recommendations by this committee. The curriculum is designed with a focus on the basic minimum emergency medicine educational content that any medical school should be delivering to its students during their undergraduate years of training. It is not designed to be prescriptive, but to assist educators and emergency medicine leadership in advancing physician education in basic emergency medicine content. The content would be relevant, not just for communities with mature emergency medicine systems, but also for developing nations or for nations seeking to expand emergency medicine within current educational structures. We anticipate that there will be wide variability in how this curriculum is implemented and taught, reflecting the existing educational milieu, the resources available, and the goals of the institutions’ educational leadership.
doi:10.1007/s12245-009-0142-7
PMCID: PMC2850981  PMID: 20414375
Curriculum; International emergency medicine; Medical education; Medical students
16.  Driving a decade of change: HIV/AIDS, patents and access to medicines for all 
Since 2000, access to antiretroviral drugs to treat HIV infection has dramatically increased to reach more than five million people in developing countries. Essential to this achievement was the dramatic reduction in antiretroviral prices, a result of global political mobilization that cleared the way for competitive production of generic versions of widely patented medicines.
Global trade rules agreed upon in 1994 required many developing countries to begin offering patents on medicines for the first time. Government and civil society reaction to expected increases in drug prices precipitated a series of events challenging these rules, culminating in the 2001 World Trade Organization's Doha Declaration on the Agreement on Trade-Related Aspects of Intellectual Property Rights and Public Health. The Declaration affirmed that patent rules should be interpreted and implemented to protect public health and to promote access to medicines for all. Since Doha, more than 60 low- and middle-income countries have procured generic versions of patented medicines on a large scale.
Despite these changes, however, a "treatment timebomb" awaits. First, increasing numbers of people need access to newer antiretrovirals, but treatment costs are rising since new ARVs are likely to be more widely patented in developing countries. Second, policy space to produce or import generic versions of patented medicines is shrinking in some developing countries. Third, funding for medicines is falling far short of needs. Expanded use of the existing flexibilities in patent law and new models to address the second wave of the access to medicines crisis are required.
One promising new mechanism is the UNITAID-supported Medicines Patent Pool, which seeks to facilitate access to patents to enable competitive generic medicines production and the development of improved products. Such innovative approaches are possible today due to the previous decade of AIDS activism. However, the Pool is just one of a broad set of policies needed to ensure access to medicines for all; other key measures include sufficient and reliable financing, research and development of new products targeted for use in resource-poor settings, and use of patent law flexibilities. Governments must live up to their obligations to protect access to medicines as a fundamental component of the human right to health.
doi:10.1186/1758-2652-14-15
PMCID: PMC3078828  PMID: 21439089
17.  Quality use of medicines within universal health coverage: challenges and opportunities 
Background
Medicines are a major driver of quality, safety, equity, and cost of care in low and middle-income country health systems. Universal health coverage implementers must explicitly address appropriate use of medicines to realize the health benefits of medicines, avoid wasting scarce resources, and sustain the financial viability of universal health coverage schemes.
Discussion
Medicines are major contributors to the health and well-being of individuals and populations when used appropriately, and they waste resources and endanger health when used unnecessarily or incorrectly. Stakeholders need to balance inherently competing objectives in the pharmaceutical sector. Emerging and expanding UHC schemes provide potential levers to balance competing system objectives.
To use these levers, sustainable universal coverage programs will require a) information systems that can track medicines utilization, expenditures, and quality of medicines use; b) routine monitoring of indicators of medicines availability, access, affordability, and use; c) policies and programs that facilitate appropriate medicines use by prescribers, dispensers, and patients; d) transparency in setting priorities for medicines coverage under resource constraints; and e) a system perspective to engage diverse actors.
As they operationalize paths toward universal health coverage and include targeted medicines coverage policies and programs, systems can build on, and innovate, pharmaceutical policy frameworks and management tools from different countries’ settings.
Summary
Ensuring that medicines which achieve important health outcomes are available, accessible to all, used appropriately, and sustainably affordable is essential for realizing universal health coverage. Stakeholder cooperation and use of information and financing system levers provide opportunities to work toward this goal.
doi:10.1186/1472-6963-14-357
PMCID: PMC4158132  PMID: 25164588
Universal health coverage; Medicines; Pharmaceutical benefit; Financial incentives; Health systems; Quality of care
18.  Traditional use of medicinal plants in the boreal forest of Canada: review and perspectives 
Background
The boreal forest of Canada is home to several hundred thousands Aboriginal people who have been using medicinal plants in traditional health care systems for thousands of years. This knowledge, transmitted by oral tradition from generation to generation, has been eroding in recent decades due to rapid cultural change. Until now, published reviews about traditional uses of medicinal plants in boreal Canada have focused either on particular Aboriginal groups or on restricted regions. Here, we present a review of traditional uses of medicinal plants by the Aboriginal people of the entire Canadian boreal forest in order to provide comprehensive documentation, identify research gaps, and suggest perspectives for future research.
Methods
A review of the literature published in scientific journals, books, theses and reports.
Results
A total of 546 medicinal plant taxa used by the Aboriginal people of the Canadian boreal forest were reported in the reviewed literature. These plants were used to treat 28 disease and disorder categories, with the highest number of species being used for gastro-intestinal disorders, followed by musculoskeletal disorders. Herbs were the primary source of medicinal plants, followed by shrubs. The medicinal knowledge of Aboriginal peoples of the western Canadian boreal forest has been given considerably less attention by researchers. Canada is lacking comprehensive policy on harvesting, conservation and use of medicinal plants. This could be explained by the illusion of an infinite boreal forest, or by the fact that many boreal medicinal plant species are widely distributed.
Conclusion
To our knowledge, this review is the most comprehensive to date to reveal the rich traditional medicinal knowledge of Aboriginal peoples of the Canadian boreal forest. Future ethnobotanical research endeavours should focus on documenting the knowledge held by Aboriginal groups that have so far received less attention, particularly those of the western boreal forest. In addition, several critical issues need to be addressed regarding the legal, ethical and cultural aspects of the conservation of medicinal plant species and the protection of the associated traditional knowledge.
doi:10.1186/1746-4269-8-7
PMCID: PMC3316145  PMID: 22289509
Medicinal plants; traditional knowledge; boreal forest; Aboriginal people; Algonquian; Athapaskan; conservation; management; policy
19.  Prevalence and patterns of prenatal use of traditional medicine among women at selected harare clinics: a cross-sectional study 
Background
Prenatal use of traditional medicine or complementary and alternative medicine is widespread globally despite the lack of evidence of the effectiveness of these therapeutic options. Documentation on the prevalence and patterns of this maternal practice in the Zimbabwean setting was also lacking.
Methods
A cross sectional survey of 248 women at selected health centres in Harare was carried out to address the need for such data using an interviewer-administered questionnaire.
Results
Fifty-two (52%) (95% C.I. 44%-60%) of the participants reported to have used at least one traditional medicine intervention during the third trimester of their most recent pregnancy to induce labour, avoid perineal tearing and improve the safety of their delivery process. The study found prenatal use of traditional medicine to be significantly associated with nulliparity and nulligravidity. Such practice was also significant among participants residing in a particular high density suburb located in close proximity to informal traders of traditional medicines. Prenatal traditional medicine use was not significantly linked to experiencing an obstetrics-related adverse event. Instead, participants who reported not using any traditional medicine during pregnancy reported experiencing significantly more adverse events, mainly perineal tearing during delivery.
Conclusions
The practice of prenatal use of traditional medicine was significant in the study setting, with a prevalence of 52%. A variety of products were used in various dosage forms for differing indications. Nulliparity, nulligavidity and possible accessibility of these products were the factors significantly associated with prenatal use of traditional medicine. Prenatal use of traditional medicine was not significantly associated with any obstetric adverse event.
doi:10.1186/1472-6882-12-164
PMCID: PMC3533916  PMID: 23016608
Traditional medicine; Prenatal; Prevalence
20.  Heart Palpitation From Traditional and Modern Medicine Perspectives 
Background:
Palpitation is a sign of a disease and is very common in general population. For this purpose we decided to explain it in this study.
Objectives:
The purpose of this study was to describe the palpitation in both modern and traditional medicine aspect. It may help us to diagnose and cure better because the traditional medicine view is holistic and different from modern medicine.
Materials and Methods:
We addressed some descriptions to the articles of traditional medicine subjects which have published recently. Palpitation in modern medicine was extracted from medical books such as Braunwald, Harrison and Guyton physiology and some related articles obtained from authentic journals in PubMed and Ovid and Google scholar between1990 to 2013.
Results:
According to modern medicine, there are many causes for palpitation and in some cases it is cured symptomatically. In traditional medicine view, palpitation has been explained completely and many causes have been described. Its aspect is holistic and it cures causatively. The traditional medicine scientists evaluated the body based on Humors and temperament. Temperament can be changed to dis-temperament in diseases. Humors are divided in 4 items: sanguine, humid or phlegm, melancholy and bile. Palpitation is a disease, it is heart vibration and is caused by an abnormal substance in the heart itself or its membrane or other adjacent organs that would result in the heart suffering.
Conclusions:
Our data of this article suggests that causes of palpitation in the aspect of traditional medicine are completely different from modern medicine. It can help us to approach and treat this symptom better and with lower side effects than chemical drugs. According to this article we are able to detect a new approach in palpitation.
doi:10.5812/ircmj.14301
PMCID: PMC3965874  PMID: 24719741
Palpitation, Medicine, Traditional; Iran; Temperament
21.  Diet and Physical Activity for the Prevention of Noncommunicable Diseases in Low- and Middle-Income Countries: A Systematic Policy Review 
PLoS Medicine  2013;10(6):e1001465.
Carl Lachat and colleagues evaluate policies in low- and middle-income countries addressing salt and fat consumption, fruit and vegetable intake, and physical activity, key risk factors for non-communicable diseases.
Please see later in the article for the Editors' Summary
Background
Diet-related noncommunicable diseases (NCDs) are increasing rapidly in low- and middle-income countries (LMICs) and constitute a leading cause of mortality. Although a call for global action has been resonating for years, the progress in national policy development in LMICs has not been assessed. This review of strategies to prevent NCDs in LMICs provides a benchmark against which policy response can be tracked over time.
Methods and Findings
We reviewed how government policies in LMICs outline actions that address salt consumption, fat consumption, fruit and vegetable intake, or physical activity. A structured content analysis of national nutrition, NCDs, and health policies published between 1 January 2004 and 1 January 2013 by 140 LMIC members of the World Health Organization (WHO) was carried out. We assessed availability of policies in 83% (116/140) of the countries. NCD strategies were found in 47% (54/116) of LMICs reviewed, but only a minority proposed actions to promote healthier diets and physical activity. The coverage of policies that specifically targeted at least one of the risk factors reviewed was lower in Africa, Europe, the Americas, and the Eastern Mediterranean compared to the other two World Health Organization regions, South-East Asia and Western Pacific. Of the countries reviewed, only 12% (14/116) proposed a policy that addressed all four risk factors, and 25% (29/116) addressed only one of the risk factors reviewed. Strategies targeting the private sector were less frequently encountered than strategies targeting the general public or policy makers.
Conclusions
This review indicates the disconnection between the burden of NCDs and national policy responses in LMICs. Policy makers urgently need to develop comprehensive and multi-stakeholder policies to improve dietary quality and physical activity.
Please see later in the article for the Editors' Summary
Editors' Summary
Background
Noncommunicable diseases (NCDs)—chronic medical conditions including cardiovascular diseases (heart disease and stroke), diabetes, cancer, and chronic respiratory diseases (chronic obstructive pulmonary disease and asthma)—are responsible for two-thirds of the world's deaths. Nearly 80% of NCD deaths, close to 30 million per year, occur in low- and middle-income countries (LMICs), where they are also rising most rapidly. Diet and lifestyle (including smoking, lack of exercise, and harmful alcohol consumption) influence a person's risk of developing an NCD and of dying from it. Because they can be modified, these risk factors have been at the center of strategies to combat NCDs. In 2004, the World Health Organization (WHO) adopted the Global Strategy on Diet, Physical Activity and Health. For diet, it recommended that individuals achieve energy balance and a healthy weight; limit energy intake from total fats and shift fat consumption away from saturated fats to unsaturated fats and towards the elimination of trans-fatty acids; increase consumption of fruits, vegetables, legumes, whole grains, and nuts; limit the intake of free sugars; and limit salt consumption from all sources and ensure that salt is iodized. For physical activity, it recommended at least 30 minutes of regular, moderate-intensity physical activity on most days throughout a person's life.
Why Was This Study Done?
By signing onto the Global Strategy in 2004, WHO member countries agreed to implement it with high priority. A first step of implementation is usually the development of local policies. Consequently, one of the four objectives of the WHO Global Strategy is “to encourage the development, strengthening and implementation of global, regional, national and community policies and action plans to improve diets and increase physical activity.” Along the same lines, in 2011 the United Nations held a high-level meeting in which the need to accelerate the policy response to the NCD epidemic was emphasized. This study was done to assess the existing national policies on NCD prevention in LMICs. Specifically, the researchers examined how well those policies matched the WHO recommendations for intake of salt, fat, and fruits and vegetables, as well as the recommendations for physical activity.
What Did the Researchers Do and Find?
The researchers searched the Internet (including websites of relevant ministries and departments) for all publicly available national policies related to diet, nutrition, NCDs, and health from all 140 WHO member countries classified as LMICs by the World Bank in 2011. For countries for which the search did not turn up policies, the researchers sent e-mail requests to the relevant national authorities, to the regional WHO offices, and to personal contacts. All documents dated from 1 January 2004 to 1 January 2013 that included national objectives and guidelines for action regarding diet, physical exercise, NCD prevention, or a combination of the three, were analyzed in detail.
Most of the policies obtained were not easy to find and access. For 24 countries, particularly in the Eastern Mediterranean, the researchers eventually gave up, unable to establish whether relevant national policies existed. Of the remaining 116 countries, 29 countries had no relevant policies, and another 30 had policies that failed to mention specifically any of the diet-related risk factors included in the analysis. Fifty-four of the 116 countries had NCD policies that addressed at least one of the risk factors. Thirty-six national policy documents contained strategies to increase fruit and vegetable intake, 20 addressed dietary fat consumption, 23 aimed to limit salt intake, and 35 had specific actions to promote physical activity. Only 14 countries, including Jamaica, the Philippines, Iran, and Mongolia, had policies that addressed all four risk factors. The policies of 27 countries mentioned only one of the four risk factors.
Policies primarily targeted consumers and government agencies and failed to address the roles of the business community or civil society. Consistent with this, most were missing plans, mechanisms, and incentives to drive collaborations between the different stakeholders.
What Do These Findings Mean?
More than eight years after the WHO Global Strategy was agreed upon, only a minority of the LMICs included in this analysis have comprehensive policies in place. Developing policies and making them widely accessible is a likely early step toward specific implementation and actions to prevent NCDs. These results therefore suggest that not enough emphasis is placed on NCD prevention in these countries through actions that have been proven to reduce known risk factors. That said, the more important question is what countries are actually doing to combat NCDs, something not directly addressed by this analysis.
In richer countries, NCDs have for decades been the leading cause of sickness and death, and the fact that public health strategies need to emphasize NCD prevention is now widely recognized. LMICs not only have more limited resources, they also continue to carry a large burden from infectious diseases. It is therefore not surprising that shifting resources towards NCD prevention is a difficult process, even if the human cost of these diseases is massive and increasing. That only about 3% of global health aid is aimed at NCD prevention does not help the situation.
The authors argue that one step toward improving the situation is better sharing of best practices and what works and what doesn't in policy development. They suggest that an open-access repository like one that exists for Europe could improve the situation. They offer to organize, host, and curate such a resource under the auspices of WHO, starting with the policies retrieved for this study, and they invite submission of additional policies and updates.
Additional Information
Please access these websites via the online version of this summary at http://dx.doi.org/10.1371/journal.pmed.1001465.
This study is further discussed in a PLOS Medicine Perspective by Stuckler and Basu
The WHO website on diet and physical activity contains links to various documents, including a diet and physical activity implementation toolbox that contains links to the 2004 Global Strategy document and a Framework to Monitor and Evaluate Implementation
There is a 2011 WHO primer on NCDs entitled Prioritizing a Preventable Epidemic
A recent PLOS Medicine editorial and call for papers addressing the global disparities in the burden from NCDs
A PLOS Blogs post entitled Politics and Global HealthAre We Missing the Obvious? and associated comments discuss the state of the fight against NCDs in early 2013
The NCD Alliance was founded by the Union for International Cancer Control, the International Diabetes Federation, the World Heart Federation, and the International Union Against Tuberculosis and Lung Disease; its mission is to combat the NCD epidemic by putting health at the center of all policies
The WHO European Database on Nutrition, Obesity and Physical Activity (NOPA) contains national and subnational surveillance data, policy documents, actions to implement policy, and examples of good practice in programs and interventions for the WHO European member states
doi:10.1371/journal.pmed.1001465
PMCID: PMC3679005  PMID: 23776415
22.  Mapping Postgraduate Research at the University of Zambia: a review of dissertations for the Master of Medicine Programme 
Medical journal of Zambia  2010;37(2):52-57.
Background
The publication of a dissertation is an integral part of the four-year postgraduate degree of Master of Medicine (in clinical disciplines) within the School of Medicine at the University of Zambia. The governing research policy states that the subject matter of the dissertation is expected to cover a topic relevant to health care in the Zambian context, that it be conducted in a way that is consistent with international ethical guidelines for biomedical research involving human subjects, and that research outcomes should be maximally utilized. The aim of the study is to explore the characteristics of the Masters of Medicine research at the University of Zambia.
Methodology
This descriptive study explores the subject matter and research methodology by type of clinical specialty of all dissertations from 1986 to 2009.
Results
The 132 dissertations included 36 (27.3%) in Surgery, 35 (26.5%) in Paediatrics, 32 (24.2%) in Internal Medicine, 24 (18.2%) in Obstetrics and Gynaecology, and 5 (3.8%) in Orthopaedic Surgery. Only 7 (5.3%) were interventional/experimental studies (4 of which were randomized controlled trials). Cross-sectional studies were the predominant type of the 125 observational studies (n=112, 84.8%). Thirty-three dissertations (25.0%) predominantly addressed HIV (16 Internal Medicine, 10 Paediatrics, 6 Surgery and 1 Obstetrics and Gynaecology); and 18 (13.6%) predominantly addressed infections, excluding TB (11 in Paediatrics). Other subjects included malignancy (n=6), TB (n=5), and diabetes mellitus (n=4). Over half of the dissertations (76, 57.6%) addressed the determinants of the cause, risk and development of diseases; and a third dealt with management and evaluation of diseases (26 and 18, respectively).
Conclusions
Few dissertations were based on experimental designs and most addressed determinants of the cause of diseases through cross-sectional studies. HIV and infections predominate as diseases reflecting the prevailing disease patterns in Lusaka in particular, and Zambia in general.
PMCID: PMC3604980  PMID: 23526859
23.  Paving the Way to Personalized Genomic Medicine: Steps to Successful Implementation 
Over the last decade there has been vast interest in and focus on the implementation of personalized genomic medicine. Although there is general agreement that personalized genomic medicine involves utilizing genome technology to assess individual risk and ensure the delivery of the “right treatment, for the right patient, at the right time,” different categories of stakeholders focus on different aspects of personalized genomic medicine and operationalize it in diverse ways. In order to move toward a clearer, more holistic understanding of the concept, this article begins by identifying and defining three major elements of personalized genomic medicine commonly discussed by stakeholders: molecular medicine, pharmacogenomics, and health information technology. The integration of these three elements has the potential to improve health and reduce health care costs, but it also raises many challenges. This article endeavors to address these challenges by identifying five strategic areas that will require significant investment for the successful integration of personalized genomics into clinical care: (1) health technology assessment; (2) health outcomes research; (3) education (of both health professionals and the public); (4) communication among stakeholders; and (5) the development of best practices and guidelines. While different countries and global regions display marked heterogeneity in funding of health care in the form of public, private, or blended payor systems, previous analyses of personalized genomic medicine and attendant technological innovations have been performed without due attention to this complexity. Hence, this article focuses on personalized genomic medicine in the United States as a model case study wherein a significant portion of health care payors represent private, nongovernment resources. Lessons learned from the present analysis of personalized genomic medicine could usefully inform health care systems in other global regions where payment for personalized genomic medicine will be enabled through private or hybrid public-private funding systems.
doi:10.2174/187569209788653998
PMCID: PMC2809376  PMID: 20098629
Personalized Genomic Medicine; Personalized Medicine; Ethics; Genomics; Policy
24.  Medicine in the 21st Century: Recommended Essential Geriatrics Competencies for Internal Medicine and Family Medicine Residents 
Background
Physician workforce projections by the Institute of Medicine require enhanced training in geriatrics for all primary care and subspecialty physicians. Defining essential geriatrics competencies for internal medicine and family medicine residents would improve training for primary care and subspecialty physicians. The objectives of this study were to (1) define essential geriatrics competencies common to internal medicine and family medicine residents that build on established national geriatrics competencies for medical students, are feasible within current residency programs, are assessable, and address the Accreditation Council for Graduate Medical Education competencies; and (2) involve key stakeholder organizations in their development and implementation.
Methods
Initial candidate competencies were defined through small group meetings and a survey of more than 100 experts, followed by detailed item review by 26 program directors and residency clinical educators from key professional organizations. Throughout, an 8-member working group made revisions to maintain consistency and compatibility among the competencies. Support and participation by key stakeholder organizations were secured throughout the project.
Results
The process identified 26 competencies in 7 domains: Medication Management; Cognitive, Affective, and Behavioral Health; Complex or Chronic Illness(es) in Older Adults; Palliative and End-of-Life Care; Hospital Patient Safety; Transitions of Care; and Ambulatory Care. The competencies map directly onto the medical student geriatric competencies and the 6 Accreditation Council for Graduate Medical Education Competencies.
Conclusions
Through a consensus-building process that included leadership and members of key stakeholder organizations, a concise set of essential geriatrics competencies for internal medicine and family medicine residencies has been developed. These competencies are well aligned with concerns for residency training raised in a recent Medicare Payment Advisory Commission report to Congress. Work is underway through stakeholder organizations to disseminate and assess the competencies among internal medicine and family medicine residency programs.
doi:10.4300/JGME-D-10-00065.1
PMCID: PMC2951777  PMID: 21976086
25.  Ethical quandaries in spiritual healing and herbal medicine: A critical analysis of the morality of traditional medicine advertising in southern African urban societies 
This paper critically examines the morality of advertising by practitioners in spiritual healing and herbal medicine heretofore referred to as traditional medicine, in southern African urban societies. While the subject of traditional medicine has been heavily contested in medical studies in the last few decades, the monumental studies on the subject have emphasised the place of traditional medicine in basic health services. Insignificant attention has been devoted to examine the ethical problems associated with traditional medicine advertising. Critical look at the worthiness of some advertising strategies used by practitioners in traditional medicine in launching their products and services on market thus has been largely ignored. Yet, though advertising is key to helping traditional medicine practitioners’ products and services known by prospective customers, this research registers a number of morally negative effects that seem to outweigh the merits that the activity brings to prospective customers. The paper adopts southern African urban societies, and in particular Mozambique, South Africa and Zimbabwe as particular references. The choice of the trio is not accidental, but based on the fact that these countries have in the last few decades been flooded with traditional medicine practitioners/traditional healers from within the continent and from abroad. Most of these practitioners use immoral advertising strategies in communicating to the public the products and services they offer. It is against this background that this paper examines the morality of advertising strategies deployed by practitioners in launching their products and services. To examine the moral worthiness of the advertising strategies used by traditional medical practitioners, I used qualitative analysis of street adverts as well as electronic and print media. From the results obtained through thematic content analysis, the paper concludes that most of the practitioners in traditional medicine lack both business and medical ethics. That said, the paper urges practitioners to seriously consider the morality of their adverts as in most cases they (adverts) do more harm than good. Further to that, the piece recommends the governments of the affected countries to put in place stringent measures to address this mounting problem.
PMCID: PMC3282931  PMID: 22187588
Keyword Advertising; herbal; spiritual; healing; traditional medicine; morality; southern Africa

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