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1.  e-Health, m-Health and healthier social media reform: the big scale view 
In the upcoming decade, digital platforms will be the backbone of a strategic revolution in the way medical services are provided, affecting both healthcare providers and patients. Digital-based patient-centered healthcare services allow patients to actively participate in managing their own care, in times of health as well as illness, using personally tailored interactive tools. Such empowerment is expected to increase patients’ willingness to adopt actions and lifestyles that promote health as well as improve follow-up and compliance with treatment in cases of chronic illness. Clalit Health Services (CHS) is the largest HMO in Israel and second largest world-wide. Through its 14 hospitals, 1300 primary and specialized clinics, and 650 pharmacies, CHS provides comprehensive medical care to the majority of Israel’s population (above 4 million members). CHS e-Health wing focuses on deepening patient involvement in managing health, through personalized digital interactive tools. Currently, CHS e-Health wing provides e-health services for 1.56 million unique patients monthly with 2.4 million interactions every month (August 2011). Successful implementation of e-Health solutions is not a sum of technology, innovation and health; rather it’s the expertise of tailoring knowledge and leadership capabilities in multidisciplinary areas: clinical, ethical, psychological, legal, comprehension of patient and medical team engagement etc. The Google Health case excellently demonstrates this point. On the other hand, our success with CHS is a demonstration that e-Health can be enrolled effectively and fast with huge benefits for both patients and medical teams, and with a robust business model.
CHS e-Health core components
They include:
1. The personal health record layer (what the patient can see) presents patients with their own medical history as well as the medical history of their preadult children, including diagnoses, allergies, vaccinations, laboratory results with interpretations in layman’s terms, medications with clear, straightforward explanations regarding dosing instructions, important side effects, contraindications, such as lactation etc., and other important medical information. All personal e-Health services require identification and authorization.
2. The personal knowledge layer (what the patient should know) presents patients with personally tailored recommendations for preventative medicine and health promotion. For example, diabetic patients are push notified regarding their yearly eye exam. The various health recommendations include: occult blood testing, mammography, lipid profile etc. Each recommendation contains textual, visual and interactive content components in order to promote engagement and motivate the patient to actually change his health behaviour.
3. The personal health services layer (what the patient can do) enables patients to schedule clinic visits, order chronic prescriptions, e-consult their physician via secured e-mail, set SMS medication reminders, e-consult a pharmacist regarding personal medications. Consultants’ answers are sent securely to the patients’ personal mobile device.
On December 2009 CHS launched secured, web based, synchronous medical consultation via video conference. Currently 11,780 e-visits are performed monthly (May 2011). The medical encounter includes e-prescription and referral capabilities which are biometrically signed by the physician. On December 2010 CHS launched a unique mobile health platform, which is one of the most comprehensive personal m-Health applications world-wide. An essential advantage of mobile devices is their potential to bridge the digital divide. Currently, CHS m-Health platform is used by more than 45,000 unique users, with 75,000 laboratory results views/month, 1100 m-consultations/month and 9000 physician visit scheduling/month.
4. The Bio-Sensing layer (what physiological data the patient can populate) includes diagnostic means that allow remote physical examination, bio-sensors that broadcast various physiological measurements, and smart homecare devices, such as e-Pill boxes that gives seniors, patients and their caregivers the ability to stay at home and live life to its fullest. Monitored data is automatically transmitted to the patient’s Personal Health Record and to relevant medical personnel.
The monitoring layer is embedded in the chronic disease management platform, and in the interactive health promotion and wellness platform. It includes tailoring of consumer-oriented medical devices and service provided by various professional personnel—physicians, nurses, pharmacists, dieticians and more.
5. The Social layer (what the patient can share). Social media networks triggered an essential change at the humanity ‘genome’ level, yet to be further defined in the upcoming years. Social media has huge potential in promoting health as it combines fun, simple yet extraordinary user experience, and bio-social-feedback. There are two major challenges in leveraging health care through social networks:
a. Our personal health information is the cornerstone for personalizing healthier lifestyle, disease management and preventative medicine. We naturally see our personal health data as a super-private territory. So, how do we bring the power of our private health information, currently locked within our Personal Health Record, into social media networks without offending basic privacy issues?
b. Disease management and preventive medicine are currently neither considered ‘cool’ nor ‘fun’ or ‘potentially highly viral’ activities; yet, health is a major issue of everybody’s life. It seems like we are missing a crucial element with a huge potential in health behavioural change—the Fun Theory. Social media platforms comprehends user experience tools that potentially could break current misconception, and engage people in the daily task of taking better care of themselves.
CHS e-Health innovation team characterized several break-through applications in this unexplored territory within social media networks, fusing personal health and social media platforms without offending privacy. One of the most crucial issues regarding adoption of e-health and m-health platforms is change management. Being a ‘hot’ innovative ‘gadget’ is far from sufficient for changing health behaviours at the individual and population levels.
CHS health behaviour change management methodology includes 4 core elements:
1. Engaging two completely different populations: patients, and medical teams. e-Health applications must present true added value for both medical teams and patients, engaging them through understanding and assimilating “what’s really in it for me”. Medical teams are further subdivided into physicians, nurses, pharmacists and administrative personnel—each with their own driving incentive. Resistance to change is an obstacle in many fields but it is particularly true in the conservative health industry. To successfully manage a large scale persuasive process, we treat intra-organizational human resources as “Change Agents”. Harnessing the persuasive power of ~40,000 employees requires engaging them as the primary target group. Successful recruitment has the potential of converting each patient-medical team interaction into an exposure opportunity to the new era of participatory medicine via e-health and m-health channels.
2. Implementation waves: every group of digital health products that are released at the same time are seen as one project. Each implementation wave leverages the focus of the organization and target populations to a defined time span. There are three major and three minor implementation waves a year.
3. Change-Support Arrow: a structured infrastructure for every implementation wave. The sub-stages in this strategy include:
Cross organizational mapping and identification of early adopters and stakeholders relevant to the implementation wave
Mapping positive or negative perceptions and designing specific marketing approaches for the distinct target groups
Intra and extra organizational marketing
Conducting intensive training and presentation sessions for groups of implementers
Running conflict-prevention activities, such as advanced tackling of potential union resistance
Training change-agents with resistance-management behavioural techniques, focused intervention for specific incidents and for key opinion leaders
Extensive presence in the clinics during the launch period, etc.
The entire process is monitored and managed continuously by a review team.
4. Closing Phase: each wave is analyzed and a “lessons-learned” session concludes the changes required in the modus operandi of the e-health project team.
PMCID: PMC3571141
e-Health; mobile health; personal health record; online visit; patient empowerment; knowledge prescription
2.  Quantifying the Impoverishing Effects of Purchasing Medicines: A Cross-Country Comparison of the Affordability of Medicines in the Developing World 
PLoS Medicine  2010;7(8):e1000333.
Laurens Niëns and colleagues estimate the impoverishing effects of four medicines in 16 low- and middle-income countries using the impoverishment method as a metric of affordability and show that medicine purchases could impoverish large numbers of people.
Increasing attention is being paid to the affordability of medicines in low- and middle-income countries (LICs and MICs) where medicines are often highly priced in relation to income levels. The impoverishing effect of medicine purchases can be estimated by determining pre- and postpayment incomes, which are then compared to a poverty line. Here we estimate the impoverishing effects of four medicines in 16 LICs and MICs using the impoverishment method as a metric of affordability.
Methods and Findings
Affordability was assessed in terms of the proportion of the population being pushed below US$1.25 or US$2 per day poverty levels because of the purchase of medicines. The prices of salbutamol 100 mcg/dose inhaler, glibenclamide 5 mg cap/tab, atenolol 50 mg cap/tab, and amoxicillin 250 mg cap/tab were obtained from facility-based surveys undertaken using a standard measurement methodology. The World Bank's World Development Indicators provided household expenditure data and information on income distributions. In the countries studied, purchasing these medicines would impoverish large portions of the population (up to 86%). Originator brand products were less affordable than the lowest-priced generic equivalents. In the Philippines, for example, originator brand atenolol would push an additional 22% of the population below US$1.25 per day, whereas for the lowest priced generic equivalent this demographic shift is 7%. Given related prevalence figures, substantial numbers of people are affected by the unaffordability of medicines.
Comparing medicine prices to available income in LICs and MICs shows that medicine purchases by individuals in those countries could lead to the impoverishment of large numbers of people. Action is needed to improve medicine affordability, such as promoting the use of quality assured, low-priced generics, and establishing health insurance systems.
Please see later in the article for the Editors' Summary
Editors' Summary
In recent years, the international community has prioritized access to essential medicines, which has required focusing on the accessibility, availability, quality, and affordability of life-saving medicines and the development of appropriate data and research agendas to measure these components. Determining the degree of affordability of medicines, especially in low- and middle-income countries, is a complex process as the term affordability is vague. However, the cost of medicines is a major public health issue, especially as the majority of people in developing countries do not have health insurance and medicines freely provided through the public sector are often unavailable. Therefore, although countries have a legal obligation to make essential medicines available to those who need them at an affordable cost, poor people often have to pay for the medicines that they need when they are ill. Consequently, where medicine prices are high, people may have to forego treatment or they may go into debt if they decide to buy the necessary medicines.
Why Was This Study Done?
The researchers wanted to show the impact of the cost of medicines on poorer populations by undertaking an analysis that quantified the proportion of people who would be pushed into poverty (an income level of US$1.25 or US$2 a day) because their only option is to pay out-of-pocket expenses for the life-saving medicines they need. The researchers referred to this consequence as the “impoverishing effect of a medicine.”
What Did the Researchers Do and Find?
The researchers generated “impoverishment rates” of four medicines in 16 low- and middle-income countries by comparing households' daily per capita income before and after (the hypothetical) purchase of one of the following: a salbutamol 100 mcg/dose inhaler, glibenclamide 5 mg cap/tab, atenolol 50 mg cap/tab, and amoxicillin 250 mg cap/tab. This selection of drugs covers the treatment/management of three chronic diseases and one acute illness. The cost of each medicine was taken from standardized surveys, which report median patient prices for a selection of commonly used medicines in the private sector (the availability of essential medicines in the public sector is much lower so many people will depend on the private sector for their medicines) for both originator brand and lowest priced generic products. If the prepayment income was above the US$1.25 (or US$2) poverty line and the postpayment income fell below these lines, purchasing these medicines at current prices impoverishes people.
According to the results of this analysis, a substantial proportion (up to 86%) of the population in the countries studied would be pushed into poverty as a result of purchasing one of the four selected medicines. Furthermore, the lowest priced generic versions of each medicine were generally substantially more affordable than originator brand products. For example, in the Philippines, purchasing originator brand atenolol would push an additional 22% of the population below US$1.25 per day compared to 7% if the lowest priced generic equivalent was bought instead. In effect, purchasing essential medicines for both chronic and acute conditions could impoverish large numbers of people, especially if originator brand products are bought.
What Do These Findings Mean?
Although the purchasing of medicines represents only part of the costs associated with the management of an illness, it is clear that the high cost of medicines have catastrophic effects on poor people. In addition, as the treatment of chronic conditions often requires a combination of medicines, the cost of treating and managing a chronic condition such as asthma, diabetes, and cardiovascular disease is likely to be even more unaffordable than what is reported in this study. Therefore concerted action is urgently required to improve medicine affordability and prevent poor populations from being pushed further into poverty. Such action could include: governments, civil society organizations, and others making access to essential medicines more of a priority and to consider this strategy as an integral part of reducing poverty; the development, implementation, and enforcement of sound national and international price policies; actively promoting the use of quality assured, low-cost generic drugs; ensuring the availability of essential medicines in the public sector at little or no charge to poor people; establishing health insurance systems with outpatient medicine benefits; encouraging pharmaceutical companies to differentially price medicines that are still subject to patent restrictions.
Additional Information
Please access these Web sites via the online version of this summary at
For a comprehensive resource for medicine prices, availability, and affordability, see Health Action International
Guidelines about access to essential medicines and pharmaceutical policies can be found at WHO
Transparency Alliance provides more information about medicines
Access to essential medicines has become a key campaign topic; for more information see Médecins Sans Frontières (Doctors without Borders)
PMCID: PMC2930876  PMID: 20824175
3.  Predicting outcome following psychological therapy in IAPT (PROMPT): a naturalistic project protocol 
BMC Psychiatry  2014;14:170.
Depression and anxiety are highly prevalent and represent a significant and well described public health burden. Whilst first line psychological treatments are effective for nearly half of attenders, there remain a substantial number of patients who do not benefit. The main objective of the present project is to establish an infrastructure platform for the identification of factors that predict lack of response to psychological treatment for depression and anxiety, in order to better target treatments as well as to support translational and experimental medicine research in mood and anxiety disorders.
Predicting outcome following psychological therapy in IAPT (PROMPT) is a naturalistic observational project that began patient recruitment in January 2014. The project is currently taking place in Southwark Psychological Therapies Service, an Improving Access to Psychological Therapies (IAPT) service currently provided by the South London and Maudsley NHS Foundation Trust (SLaM). However, the aim is to roll-out the project across other IAPT services. Participants are approached before beginning treatment and offered a baseline interview whilst they are waiting for therapy to begin. This allows us to test for relationships between predictor variables and patient outcome measures. At the baseline interview, participants complete a diagnostic interview; are asked to give blood and hair samples for relevant biomarkers, and complete psychological and social questionnaire measures. Participants then complete their psychological therapy as offered by Southwark Psychological Therapies Service. Response to psychological therapy will be measured using standard IAPT outcome data, which are routinely collected at each appointment.
This project addresses a need to understand treatment response rates in primary care psychological therapy services for those with depression and/or anxiety. Measurement of a range of predictor variables allows for the detection of bio-psycho-social factors which may be relevant for treatment outcome. This will enable future clinical decision making to be based on the individual needs of the patient in an evidence-based manner. Moreover, the identification of individuals who fail to improve following therapy delivered by IAPT services could be utilised for the development of novel interventions.
PMCID: PMC4057910  PMID: 24910361
4.  Number of Patients Studied Prior to Approval of New Medicines: A Database Analysis 
PLoS Medicine  2013;10(3):e1001407.
In an evaluation of medicines approved by the European Medicines Agency 2000 to 2010, Ruben Duijnhoven and colleagues find that the number of patients evaluated for medicines approved for chronic use are inadequate for evaluation of safety or long-term efficacy.
At the time of approval of a new medicine, there are few long-term data on the medicine's benefit–risk balance. Clinical trials are designed to demonstrate efficacy, but have major limitations with regard to safety in terms of patient exposure and length of follow-up. This study of the number of patients who had been administered medicines at the time of medicine approval by the European Medicines Agency aimed to determine the total number of patients studied, as well as the number of patients studied long term for chronic medication use, compared with the International Conference on Harmonisation's E1 guideline recommendations.
Methods and Findings
All medicines containing new molecular entities approved between 2000 and 2010 were included in the study, including orphan medicines as a separate category. The total number of patients studied before approval was extracted (main outcome). In addition, the number of patients with long-term use (6 or 12 mo) was determined for chronic medication. 200 unique new medicines were identified: 161 standard and 39 orphan medicines. The median total number of patients studied before approval was 1,708 (interquartile range [IQR] 968–3,195) for standard medicines and 438 (IQR 132–915) for orphan medicines. On average, chronic medication was studied in a larger number of patients (median 2,338, IQR 1,462–4,135) than medication for intermediate (878, IQR 513–1,559) or short-term use (1,315, IQR 609–2,420). Safety and efficacy of chronic use was studied in fewer than 1,000 patients for at least 6 and 12 mo in 46.4% and 58.3% of new medicines, respectively. Among the 84 medicines intended for chronic use, 68 (82.1%) met the guideline recommendations for 6-mo use (at least 300 participants studied for 6 mo and at least 1,000 participants studied for any length of time), whereas 67 (79.8%) of the medicines met the criteria for 12-mo patient exposure (at least 100 participants studied for 12 mo).
For medicines intended for chronic use, the number of patients studied before marketing is insufficient to evaluate safety and long-term efficacy. Both safety and efficacy require continued study after approval. New epidemiologic tools and legislative actions necessitate a review of the requirements for the number of patients studied prior to approval, particularly for chronic use, and adequate use of post-marketing studies.
Please see later in the article for the Editors' Summary
Editors' Summary
Before any new medicine is marketed for the treatment of a human disease, it has to go through extensive laboratory and clinical research. In the laboratory, scientists investigate the causes of diseases, identify potential new treatments, and test these interventions in disease models, some of which involve animals. The safety and efficacy of potential new interventions is then investigated in a series of clinical trials—studies in which the new treatment is tested in selected groups of patients under strictly controlled conditions, first to determine whether the drug is tolerated by humans and then to assess its efficacy. Finally, the results of these trials are reviewed by the government body responsible for drug approval; in the US, this body is the Food and Drug Administration, and in the European Union, the European Medicines Agency (EMA) is responsible for the scientific evaluation and approval of new medicines.
Why Was This Study Done?
Clinical trials are primarily designed to test the efficacy—the ability to produce the desired therapeutic effect—of new medicines. The number of patients needed to establish efficacy determines the size of a clinical trial, and the indications for which efficacy must be shown determine the trial's duration. However, identifying adverse effects of drugs generally requires the drug to be taken by more patients than are required to show efficacy, so the information about adverse effects is often relatively limited at the end of clinical testing. Consequently, when new medicines are approved, their benefit–risk ratios are often poorly defined, even though physicians need this information to decide which treatment to recommend to their patients. For the evaluation of risk or adverse effects of medicines being developed for chronic (long-term) treatment of non-life-threatening diseases, current guidelines recommend that at least 1,000–1,500 patients are exposed to the new drug and that 300 and 100 patients use the drug for six and twelve months, respectively, before approval. But are these guidelines being followed? In this database analysis, the researchers use data collected by the EMA to determine how many patients are exposed to new medicines before approval in the European Union and how many are exposed for extended periods of time to medicines intended for chronic use.
What Did the Researchers Do and Find?
Using the European Commission's Community Register of Medicinal Products, the researchers identified 161 standard medicines and 39 orphan medicines (medicines to treat or prevent rare life-threatening diseases) that contained new active substances and that were approved in the European Union between 2000 and 2010. They extracted information on the total number of patients studied and on the number exposed to the medicines for six months and twelve months before approval of each medicine from EMA's European public assessment reports. The average number of patients studied before approval was 1,708 for standard medicines and 438 for orphan medicines (marketing approval is easier to obtain for orphan medicines than for standard medicines to encourage drug companies to develop medicines that might otherwise be unprofitable). On average, medicines for chronic use (for example, asthma medications) were studied in more patients (2,338) than those for intermediate use such as anticancer drugs (878), or short-term use such as antibiotics (1,315). The safety and efficacy of chronic use was studied in fewer than 1,000 patients for at least six and twelve months in 46.4% and 58.4% of new medicines, respectively. Finally, among the 84 medicines intended for chronic use, 72 were studied in at least 300 patients for six months, and 70 were studied in at least 100 patients for twelve months.
What Do These Findings Mean?
These findings suggest that although the number of patients studied before approval is sufficient to determine the short-term efficacy of new medicines, it is insufficient to determine safety or long-term efficacy. Any move by drug approval bodies to require pharmaceutical companies to increase the total number of patients exposed to a drug, or the number exposed for extended periods of time to drugs intended for chronic use, would inevitably delay the entry of new products into the market, which likely would be unacceptable to patients and healthcare providers. Nevertheless, the researchers suggest that a reevaluation of the study size and long-term data requirements that need to be met for the approval of new medicines, particularly those designed for long-term use, is merited. They also stress the need for continued study of both the safety and efficacy of new medicines after approval and the importance of post-marketing studies that actively examine safety issues.
Additional Information
Please access these websites via the online version of this summary at
The European Medicines Agency (EMA) provides information about all aspects of the scientific evaluation and approval of new medicines in the European Union; its European public assessment reports are publicly available
The European Commission's Community Register of Medicinal Products is a publicly searchable database of medicinal products approved for human use in the European Union
The US Food and Drug Administration provides information about drug approval in the US for consumers and for health professionals
The US National Institutes of Health provides information (including personal stories) about clinical trials
PMCID: PMC3601954  PMID: 23526887
5.  Psychosocial interventions for patients with chronic disease 
Treatment of patients with chronic diseases will be one of the main challenges of medicine in the future. This paper presents an overview of different origins, mechanism, and symptoms necessary for understanding new and different interventions that include a psychosomatic view.
In a psychosomatic therapeutic intervention there are very different targets, such as psychological symptoms, personality traits, attitudes toward disease and life, risk behaviour, and social isolation and as biological targets the change of autonomic imbalance and of the effects of the psycho-endocrinological or psycho-immunological stress responses. And there are also different psychosomatic measures that influence the individual biological, psychological and sociological targets. There is a need to give different answer to different questions in the field of psychosomatic and behavioral medicine. Comparative effectiveness research is an important strategy for solving some methodological issues. What is the target of treatment for different diseases: Symptom reduction, healing, or limiting progression to the worst case - the death of patients. We know that, the patient-physician relationship is important for every medical/therapeutic action for patients with chronic diseases.
This volume of BioPsychoSocial Medicine will present four different psychosomatic treatment studies from the clinical field in the sense of phase 2 studies: Reports of patients with obesity, anorexia nervosa, chronic somatoform pain and coronary artery disease were presented
PMCID: PMC3299618  PMID: 22293471
psycho social intervention; concepts; mechanism; efficiacy; eating disorders; pain; coronary artery disease
6.  Evaluating Drug Prices, Availability, Affordability, and Price Components: Implications for Access to Drugs in Malaysia 
PLoS Medicine  2007;4(3):e82.
Malaysia's stable health care system is facing challenges with increasing medicine costs. To investigate these issues a survey was carried out to evaluate medicine prices, availability, affordability, and the structure of price components.
Methods and Findings
The methodology developed by the World Health Organization (WHO) and Health Action International (HAI) was used. Price and availability data for 48 medicines was collected from 20 public sector facilities, 32 private sector retail pharmacies and 20 dispensing doctors in four geographical regions of West Malaysia. Medicine prices were compared with international reference prices (IRPs) to obtain a median price ratio. The daily wage of the lowest paid unskilled government worker was used to gauge the affordability of medicines. Price component data were collected throughout the supply chain, and markups, taxes, and other distribution costs were identified. In private pharmacies, innovator brand (IB) prices were 16 times higher than the IRPs, while generics were 6.6 times higher. In dispensing doctor clinics, the figures were 15 times higher for innovator brands and 7.5 for generics. Dispensing doctors applied high markups of 50%–76% for IBs, and up to 316% for generics. Retail pharmacy markups were also high—25%–38% and 100%–140% for IBs and generics, respectively. In the public sector, where medicines are free, availability was low even for medicines on the National Essential Drugs List. For a month's treatment for peptic ulcer disease and hypertension people have to pay about a week's wages in the private sector.
The free market by definition does not control medicine prices, necessitating price monitoring and control mechanisms. Markups for generic products are greater than for IBs. Reducing the base price without controlling markups may increase profits for retailers and dispensing doctors without reducing the price paid by end users. To increase access and affordability, promotion of generic medicines and improved availability of medicines in the public sector are required.
Drug price and availability data were collected from West Malaysian public sector facilities, private sector retail pharmacies, and dispensing doctors. Mark-ups were higher on generic drugs than on innovator brands.
Editors' Summary
The World Health Organization has said that one-third of the people of the world cannot access the medicines they need. An important reason for this problem is that prices are often too high for people or government-funded health systems to afford. In developing countries, most people who need medicines have to pay for them out of their own pockets. Where the cost of drugs is covered by health systems, spending on medicines is a major part of the total healthcare budget. Governments use a variety of approaches to try to control the cost of drugs and make sure that essential medicines are affordable and not overpriced. According to the theory of “free market economics,” the costs of goods and services are determined by interactions between buyers and sellers and not by government intervention. However, free market economics does not work well at containing the costs of medicines, particularly new medicines, because new medicines are protected by patent law, which legally prevents others from making, using, or selling the medicine for a particular period of time. Therefore, without government intervention, there is nothing to help to push down prices.
Why Was This Study Done?
Malaysia is a middle-income country with a relatively effective public health system, but it is facing a rapid rise in drug costs. In Malaysia, medicine prices are determined by free-market economics, without any control by government. Government hospitals are expected to provide drugs free, but a substantial proportion of medicines are paid for by patients who buy them directly from private pharmacies or prescribing doctors. There is evidence that Malaysian patients have difficulties accessing the drugs they need and that cost is an important factor. Therefore, the researchers who wrote this paper wanted to examine the cost of different medicines in Malaysia, and their availability and affordability from different sources.
What Did the Researchers Do and Find?
In this research project, 48 drugs were studied, of which 28 were part of a “core list” identified by the World Health Organization as “essential drugs” on the basis of the global burden of disease. The remaining 20 reflected health care needs in Malaysia itself. The costs of each medicine were collected from government hospitals, private pharmacies, and dispensing doctors in four different regions of Malaysia. Data were collected for the “innovator brand” (made by the original patent holder) and for “generic” brands (an equivalent drug to the innovator brand, produced by a different company once the innovator brand no longer has an exclusive patent). The medicine prices were compared against international reference prices (IRP), which are the average prices offered by not-for-profit drug companies to developing countries. Finally, the researchers also compared the cost of the drugs with daily wages, in order to work out their “affordability.”
The researchers found that, irrespective of the source of medicines, prices were on average very much higher than the international reference price, ranging from 2.4 times the IRP for innovator brands accessed through public hospitals, to 16 times the IRP for innovator brands accessed through private pharmacies. The availability of medicines was also very poor, with only 25% of generic medicines available on average through the public sector. The affordability of many of the medicines studied was again very poor. For example, one month's supply of ranitidine (a drug for stomach ulcers) was equivalent to around three days' wages for a low-paid government worker, and one month's supply of fluoxetine (an antidepressant) would cost around 26 days' wages.
What Do These Findings Mean?
These results show that essential drugs are very expensive in Malaysia and are not universally available. Many people would not be able to pay for essential medicines. The cost of medicines in Malaysia seems to be much higher than in areas of India and Sri Lanka, although the researchers did not attempt to collect data in order to carry out an international comparison. It is possible that the high cost and low availability in Malaysia are the result of a lack of government regulation. Overall, the findings suggest that the government should set up mechanisms to prevent drug manufacturers from increasing prices too much and thus ensure greater access to essential medicines.
Additional Information.
Please access these Web sites via the online version of this summary at
Read a related PLoS Medicine Perspective article by Suzanne Hill
Information is available from the World Health Organization on Improving Access to Medicines
Information on medicine prices is available from Health Action International
Wikipedia has an entry on Patent (a type of intellectual property that is normally used to prevent other companies from selling a newly invented medicine). (Wikipedia is an internet encyclopedia anyone can edit.)
The Drugs for Neglected Diseases Initiative is an international collaboration between public organizations that aims to develop drugs for people suffering from neglected diseases
PMCID: PMC1831730  PMID: 17388660
7.  Psychiatric Emergencies 
Canadian Family Physician  1972;18(6):49-53.
Dr. Bayrakal believes that the time has come for the family physician to deal with minor psychiatric disturbances in his office as well as psychiatric emergencies in the emergency department. The newly emerging medico-social philosophy of both the federal and provincial governments, he says, is giving greater responsibility and authority to the family physician in every area of medicine, including psychiatry.
The author discusses major psychiatric emergencies (suicide, suicidal attempt, homicide, social scandal, as well as other psychiatric emergencies) on the ward including adolescent psychiatry. (The descriptions and treatment procedures are given on a concrete clinical level without theoretical overload.)
In the family physician's work, psychological understanding is of profound importance. Giving him the added scope of psychiatric consideration to see the patient in bio-psycho-social totality will enable him to practice a more humanized form of medicine.
PMCID: PMC2370403  PMID: 20468779
8.  The faunal drugstore: Animal-based remedies used in traditional medicines in Latin America 
Zootherapy is the treatment of human ailments with remedies made from animals and their products. Despite its prevalence in traditional medical practices worldwide, research on this phenomenon has often been neglected in comparison to medicinal plant research. This review discusses some related aspects of the use of animal-based remedies in Latin America, identifies those species used as folk remedies, and discusses the implications of zootherapy for public health and biological conservation. The review of literature revealed that at least 584 animal species, distributed in 13 taxonomic categories, have been used in traditional medicine in region. The number of medicinal species catalogued was quite expansive and demonstrates the importance of zootherapy as an alternative mode of therapy in Latin America. Nevertheless, this number is certainly underestimated since the number of studies on the theme are very limited. Animals provide the raw materials for remedies prescribed clinically and are also used in the form of amulets and charms in magic-religious rituals and ceremonies. Zootherapeutic resources were used to treat different diseases. The medicinal fauna is largely based on wild animals, including some endangered species. Besides being influenced by cultural aspects, the relations between humans and biodiversity in the form of zootherapeutic practices are conditioned by the social and economic relations between humans themselves. Further ethnopharmacological studies are necessary to increase our understanding of the links between traditional uses of faunistic resources and conservation biology, public health policies, sustainable management of natural resources and bio-prospecting.
PMCID: PMC3060860  PMID: 21385357
9.  Ten years of integrated care for mental disorders in the Netherlands 
International Journal of Integrated Care  2011;11(Special 10th Anniversary Edition):e015.
Background and problem statement
Integrated care for mental disorders aims to encompass forms of collaboration between different health care settings for the treatment of mental disorders. To this end, it requires integration at several levels, i.e. integration of psychiatry in medicine, of the psychiatric discourse in the medical discourse; of localization of mental health care and general health care facilities; and of reimbursement systems.
Description of policy practice
Steps have been taken in the last decade to meet these requirements, enabling psychiatry to move on towards integrated treatment of mental disorder as such, by development of a collaborative care model that includes structural psychiatric consultation that was found to be applicable and effective in several Dutch health care settings. This collaborative care model is a feasible and effective model for integrated care in several health care settings. The Bio Psycho Social System has been developed as a feasible instrument for assessment in integrated care as well.
The discipline of psychiatry has moved from anti-psychiatry in the last century, towards an emancipated medical discipline. This enabled big advances towards integrated care for mental disorder, in collaboration with other medical disciplines, in the last decade.
Now is the time to further expand this concept of care towards other mental disorders, and towards integrated care for medical and mental co-morbidity. Integrated care for mental disorder should be readily available to the patient, according to his/her preference, taking somatic co-morbidity into account, and with a focus on rehabilitation of the patient in his or her social roles.
PMCID: PMC3111888  PMID: 21677846
mental disorder; integrated care; bio psycho social model; psychiatry; disease management; collaborative care
10.  Social support needs for equity in health and social care: a thematic analysis of experiences of people with chronic fatigue syndrome/myalgic encephalomyelitis 
Needs-based resource allocation is fundamental to equitable care provision, which can meet the often-complex, fluctuating needs of people with Chronic Fatigue Syndrome/Myalgic Encephalomyelitis (CFS/ME). This has posed challenges both for those providing and those seeking support providers, in building shared understanding of the condition and of actions to address it. This qualitative study reports on needs for equity in health and social care expressed by adults living with CFS/ME.
The participants were 35 adults with CFS/ME in England, purposively selected to provide variation in clinical presentations, social backgrounds and illness experiences. Accounts of experienced needs and needs-related encounters with health and social services were obtained through a focus group (n = 6) and semi-structured interviews (n = 35). These were transcribed and needs related topics identified through data-led thematic analysis.
Participants emphasised needs for personalised, timely and sustained support to alleviate CFS/ME impacts and regain life control, in three thematic areas: (1) Illness symptoms, functional limitations and illness management; (2) practical support and social care; (3) financial support. Access of people with CFS/ME to support from health and social services was seen to be constrained by barriers stemming from social, cultural, organisational and professional norms and practices, further heightened for disadvantaged groups including some ethnic minorities. These reduced opportunities for their illness to be explained or associated functional limitations and social disadvantages to be addressed through social support. Participants sought more understanding of bio-psycho-social aspects of CFS/ME, of felt needs of people with CFS/ME and of human rights and disability rights, for providing person-centred, equitable care.
Changes in attitudes of health practitioners, policy makers and general public and more flexibly organised health and social care provision are needed to address equity issues in support needs expressed by people with CFS/ME, to be underpinned by research-based knowledge and communication, for public and professional education. Policy development should include shared decision-making and coordinated action across organizations working for people with CFS/ME, human rights and disadvantaged groups. Experiences of people with CFS/ME can usefully inform an understanding of equity in their health and social care.
PMCID: PMC3229491  PMID: 22044797
Chronic Fatigue Syndrome/Myalgic Encephalomyelitis; thematic analysis; social support; experiences; recognition; social welfare
11.  The future of social medicine 
The future of social medicine is based on 150 years of history and the rapidly evolving context within which medicine functions in modern societies. There are two views of social medicine. One is based on the vision of Guerin and, particularly, Virchow 150 years ago that: ”Doctors are the natural advocates of the poor, and social problems are largely within their jurisdiction.” The New York Academy of Medicine's Institute on Social Medicine 50 years ago reflected this broad view. Medicine, however, enamored of the biomedical paradigm and the advances in knowledge through biomedical research, largely abandoned this broad perspective, even as the knowledge about the social, behavioral, and environmental determinants of health was advancing rapidly. A second view of social medicine, and one that has influenced many in the past 30 years, was defined by McKeown and Lowe: ‘Social medicine is concerned with a body of knowledge and methods of obtaining knowledge appropriate to a discipline. This discipline may be said to comprise (a) epidemiology, and (b) the study of the medical needs of society, or in the contemporary short hand medical care.” Social medicine, in my view, includes not only the definition of McKeown and Lowe, but the broader context within which medicine fits in society. The context is changing. The social contract as defined by Bismarck and Beveridge has to be redefined. Just as the New York Academy of Medicine provided the vision of social medicine 50 years ago, the Academy has given us a new vision with the publication ofMedicine and Public Health: the Power of Collaboration in 1997. Authored by Dr. Roz Lasker, director of the Academy's Division of Public Health, the book identifies the key changes required by medicine and public health to advance the goals of medicine and public health for the benefit of both individual patients and the population as a whole. The book points the way for the future of social medicine by identifying not only what needs to be done, but also how to do it.
PMCID: PMC3455984  PMID: 10924032
12.  Implementing the 2009 Institute of Medicine recommendations on resident physician work hours, supervision, and safety 
Long working hours and sleep deprivation have been a facet of physician training in the US since the advent of the modern residency system. However, the scientific evidence linking fatigue with deficits in human performance, accidents and errors in industries from aeronautics to medicine, nuclear power, and transportation has mounted over the last 40 years. This evidence has also spawned regulations to help ensure public safety across safety-sensitive industries, with the notable exception of medicine.
In late 2007, at the behest of the US Congress, the Institute of Medicine embarked on a year-long examination of the scientific evidence linking resident physician sleep deprivation with clinical performance deficits and medical errors. The Institute of Medicine’s report, entitled “Resident duty hours: Enhancing sleep, supervision and safety”, published in January 2009, recommended new limits on resident physician work hours and workload, increased supervision, a heightened focus on resident physician safety, training in structured handovers and quality improvement, more rigorous external oversight of work hours and other aspects of residency training, and the identification of expanded funding sources necessary to implement the recommended reforms successfully and protect the public and resident physicians themselves from preventable harm.
Given that resident physicians comprise almost a quarter of all physicians who work in hospitals, and that taxpayers, through Medicare and Medicaid, fund graduate medical education, the public has a deep investment in physician training. Patients expect to receive safe, high-quality care in the nation’s teaching hospitals. Because it is their safety that is at issue, their voices should be central in policy decisions affecting patient safety. It is likewise important to integrate the perspectives of resident physicians, policy makers, and other constituencies in designing new policies. However, since its release, discussion of the Institute of Medicine report has been largely confined to the medical education community, led by the Accreditation Council for Graduate Medical Education (ACGME).
To begin gathering these perspectives and developing a plan to implement safer work hours for resident physicians, a conference entitled “Enhancing sleep, supervision and safety: What will it take to implement the Institute of Medicine recommendations?” was held at Harvard Medical School on June 17–18, 2010. This White Paper is a product of a diverse group of 26 representative stakeholders bringing relevant new information and innovative practices to bear on a critical patient safety problem. Given that our conference included experts from across disciplines with diverse perspectives and interests, not every recommendation was endorsed by each invited conference participant. However, every recommendation made here was endorsed by the majority of the group, and many were endorsed unanimously. Conference members participated in the process, reviewed the final product, and provided input before publication. Participants provided their individual perspectives, which do not necessarily represent the formal views of any organization.
In September 2010 the ACGME issued new rules to go into effect on July 1, 2011. Unfortunately, they stop considerably short of the Institute of Medicine’s recommendations and those endorsed by this conference. In particular, the ACGME only applied the limitation of 16 hours to first-year resident physicans. Thus, it is clear that policymakers, hospital administrators, and residency program directors who wish to implement safer health care systems must go far beyond what the ACGME will require. We hope this White Paper will serve as a guide and provide encouragement for that effort.
Resident physician workload and supervision
By the end of training, a resident physician should be able to practice independently. Yet much of resident physicians’ time is dominated by tasks with little educational value. The caseload can be so great that inadequate reflective time is left for learning based on clinical experiences. In addition, supervision is often vaguely defined and discontinuous. Medical malpractice data indicate that resident physicians are frequently named in lawsuits, most often for lack of supervision. The recommendations are: The ACGME should adjust resident physicians workload requirements to optimize educational value. Resident physicians as well as faculty should be involved in work redesign that eliminates nonessential and noneducational activity from resident physician dutiesMechanisms should be developed for identifying in real time when a resident physician’s workload is excessive, and processes developed to activate additional providersTeamwork should be actively encouraged in delivery of patient care. Historically, much of medical training has focused on individual knowledge, skills, and responsibility. As health care delivery has become more complex, it will be essential to train resident and attending physicians in effective teamwork that emphasizes collective responsibility for patient care and recognizes the signs, both individual and systemic, of a schedule and working conditions that are too demanding to be safeHospitals should embrace the opportunities that resident physician training redesign offers. Hospitals should recognize and act on the potential benefits of work redesign, eg, increased efficiency, reduced costs, improved quality of care, and resident physician and attending job satisfactionAttending physicians should supervise all hospital admissions. Resident physicians should directly discuss all admissions with attending physicians. Attending physicians should be both cognizant of and have input into the care patients are to receive upon admission to the hospitalInhouse supervision should be required for all critical care services, including emergency rooms, intensive care units, and trauma services. Resident physicians should not be left unsupervised to care for critically ill patients. In settings in which the acuity is high, physicians who have completed residency should provide direct supervision for resident physicians. Supervising physicians should always be physically in the hospital for supervision of resident physicians who care for critically ill patientsThe ACGME should explicitly define “good” supervision by specialty and by year of training. Explicit requirements for intensity and level of training for supervision of specific clinical scenarios should be providedCenters for Medicare and Medicaid Services (CMS) should use graduate medical education funding to provide incentives to programs with proven, effective levels of supervision. Although this action would require federal legislation, reimbursement rules would help to ensure that hospitals pay attention to the importance of good supervision and require it from their training programs
Resident physician work hours
Although the IOM “Sleep, supervision and safety” report provides a comprehensive review and discussion of all aspects of graduate medical education training, the report’s focal point is its recommendations regarding the hours that resident physicians are currently required to work. A considerable body of scientific evidence, much of it cited by the Institute of Medicine report, describes deteriorating performance in fatigued humans, as well as specific studies on resident physician fatigue and preventable medical errors.
The question before this conference was what work redesign and cultural changes are needed to reform work hours as recommended by the Institute of Medicine’s evidence-based report? Extensive scientific data demonstrate that shifts exceeding 12–16 hours without sleep are unsafe. Several principles should be followed in efforts to reduce consecutive hours below this level and achieve safer work schedules. The recommendations are: Limit resident physician work hours to 12–16 hour maximum shiftsA minimum of 10 hours off duty should be scheduled between shiftsResident physician input into work redesign should be actively solicitedSchedules should be designed that adhere to principles of sleep and circadian science; this includes careful consideration of the effects of multiple consecutive night shifts, and provision of adequate time off after night work, as specified in the IOM reportResident physicians should not be scheduled up to the maximum permissible limits; emergencies frequently occur that require resident physicians to stay longer than their scheduled shifts, and this should be anticipated in scheduling resident physicians’ work shiftsHospitals should anticipate the need for iterative improvement as new schedules are initiated; be prepared to learn from the initial phase-in, and change the plan as neededAs resident physician work hours are redesigned, attending physicians should also be considered; a potential consequence of resident physician work hour reduction and increased supervisory requirements may be an increase in work for attending physicians; this should be carefully monitored, and adjustments to attending physician work schedules made as needed to prevent unsafe work hours or working conditions for this group“Home call” should be brought under the overall limits of working hours; work load and hours should be monitored in each residency program to ensure that resident physicians and fellows on home call are getting sufficient sleepMedicare funding for graduate medical education in each hospital should be linked with adherence to the Institute of Medicine limits on resident physician work hours
Moonlighting by resident physicians
The Institute of Medicine report recommended including external as well as internal moonlighting in working hour limits. The recommendation is: All moonlighting work hours should be included in the ACGME working hour limits and actively monitored. Hospitals should formalize a moonlighting policy and establish systems for actively monitoring resident physician moonlighting
Safety of resident physicians
The “Sleep, supervision and safety” report also addresses fatigue-related harm done to resident physicians themselves. The report focuses on two main sources of physical injury to resident physicians impaired by fatigue, ie, needle-stick exposure to blood-borne pathogens and motor vehicle crashes. Providing safe transportation home for resident physicians is a logistical and financial challenge for hospitals. Educating physicians at all levels on the dangers of fatigue is clearly required to change driving behavior so that safe hospital-funded transport home is used effectively. Fatigue-related injury prevention (including not driving while drowsy) should be taught in medical school and during residency, and reinforced with attending physicians; hospitals and residency programs must be informed that resident physicians’ ability to judge their own level of impairment is impaired when they are sleep deprived; hence, leaving decisions about the capacity to drive to impaired resident physicians is not recommendedHospitals should provide transportation to all resident physicians who report feeling too tired to drive safely; in addition, although consecutive work should not exceed 16 hours, hospitals should provide transportation for all resident physicians who, because of unforeseen reasons or emergencies, work for longer than consecutive 24 hours; transportation under these circumstances should be automatically provided to house staff, and should not rely on self-identification or request
Training in effective handovers and quality improvement
Handover practice for resident physicians, attendings, and other health care providers has long been identified as a weak link in patient safety throughout health care settings. Policies to improve handovers of care must be tailored to fit the appropriate clinical scenario, recognizing that information overload can also be a problem. At the heart of improving handovers is the organizational effort to improve quality, an effort in which resident physicians have typically been insufficiently engaged. The recommendations are: Hospitals should train attending and resident physicians in effective handovers of careHospitals should create uniform processes for handovers that are tailored to meet each clinical setting; all handovers should be done verbally and face-to-face, but should also utilize written toolsWhen possible, hospitals should integrate hand-over tools into their electronic medical records (EMR) systems; these systems should be standardized to the extent possible across residency programs in a hospital, but may be tailored to the needs of specific programs and services; federal government should help subsidize adoption of electronic medical records by hospitals to improve signoutWhen feasible, handovers should be a team effort including nurses, patients, and familiesHospitals should include residents in their quality improvement and patient safety efforts; the ACGME should specify in their core competency requirements that resident physicians work on quality improvement projects; likewise, the Joint Commission should require that resident physicians be included in quality improvement and patient safety programs at teaching hospitals; hospital administrators and residency program directors should create opportunities for resident physicians to become involved in ongoing quality improvement projects and root cause analysis teams; feedback on successful quality improvement interventions should be shared with resident physicians and broadly disseminatedQuality improvement/patient safety concepts should be integral to the medical school curriculum; medical school deans should elevate the topics of patient safety, quality improvement, and teamwork; these concepts should be integrated throughout the medical school curriculum and reinforced throughout residency; mastery of these concepts by medical students should be tested on the United States Medical Licensing Examination (USMLE) stepsFederal government should support involvement of resident physicians in quality improvement efforts; initiatives to improve quality by including resident physicians in quality improvement projects should be financially supported by the Department of Health and Human Services
Monitoring and oversight of the ACGME
While the ACGME is a key stakeholder in residency training, external voices are essential to ensure that public interests are heard in the development and monitoring of standards. Consequently, the Institute of Medicine report recommended external oversight and monitoring through the Joint Commission and Centers for Medicare and Medicaid Services (CMS). The recommendations are: Make comprehensive fatigue management a Joint Commission National Patient Safety Goal; fatigue is a safety concern not only for resident physicians, but also for nurses, attending physicians, and other health care workers; the Joint Commission should seek to ensure that all health care workers, not just resident physicians, are working as safely as possibleFederal government, including the Centers for Medicare and Medicaid Services and the Agency for Healthcare Research and Quality, should encourage development of comprehensive fatigue management programs which all health systems would eventually be required to implementMake ACGME compliance with working hours a “ condition of participation” for reimbursement of direct and indirect graduate medical education costs; financial incentives will greatly increase the adoption of and compliance with ACGME standards
Future financial support for implementation
The Institute of Medicine’s report estimates that $1.7 billion (in 2008 dollars) would be needed to implement its recommendations. Twenty-five percent of that amount ($376 million) will be required just to bring hospitals into compliance with the existing 2003 ACGME rules. Downstream savings to the health care system could potentially result from safer care, but these benefits typically do not accrue to hospitals and residency programs, who have been asked historically to bear the burden of residency reform costs. The recommendations are: The Institute of Medicine should convene a panel of stakeholders, including private and public funders of health care and graduate medical education, to lay down the concrete steps necessary to identify and allocate the resources needed to implement the recommendations contained in the IOM “Resident duty hours: Enhancing sleep, supervision and safety” report. Conference participants suggested several approaches to engage public and private support for this initiativeEfforts to find additional funding to implement the Institute of Medicine recommendations should focus more broadly on patient safety and health care delivery reform; policy efforts focused narrowly upon resident physician work hours are less likely to succeed than broad patient safety initiatives that include residency redesign as a key componentHospitals should view the Institute of Medicine recommendations as an opportunity to begin resident physician work redesign projects as the core of a business model that embraces safety and ultimately saves resourcesBoth the Secretary of Health and Human Services and the Director of the Centers for Medicare and Medicaid Services should take the Institute of Medicine recommendations into consideration when promulgating rules for innovation grantsThe National Health Care Workforce Commission should consider the Institute of Medicine recommendations when analyzing the nation’s physician workforce needs
Recommendations for future research
Conference participants concurred that convening the stakeholders and agreeing on a research agenda was key. Some observed that some sectors within the medical education community have been reluctant to act on the data. Several logical funders for future research were identified. But above all agencies, Centers for Medicare and Medicaid Services is the only stakeholder that funds graduate medical education upstream and will reap savings downstream if preventable medical errors are reduced as a result of reform of resident physician work hours.
PMCID: PMC3630963  PMID: 23616719
resident; hospital; working hours; safety
13.  UK medical teaching about ageing is improving but there is still work to be done: the Second National Survey of Undergraduate Teaching in Ageing and Geriatric Medicine 
Age and Ageing  2013;43(2):293-297.
Introduction: in 2008, a UK national survey of undergraduate teaching about ageing and geriatric medicine identified deficiencies, including failure to adequately teach about elder abuse, pressure ulcers and bio- and social gerontology. We repeated the survey in 2013 to consider whether the situation had improved.
Method: the deans of all 31 UK medical schools were invited to nominate a respondent with an overview of their undergraduate curriculum. Nominees were invited by email and letter to complete an online questionnaire quantifying topics taught, type of teaching and assessment undertaken, and the amount of time spent on teaching.
Results: one school only taught pre-clinical medicine and declined to participate. Of the 30 remaining schools, 20 responded and 19 provided analysable data. The majority of the schools (95–100%) provided teaching in delirium, dementia, stroke, falls, osteoporosis, extra-pyramidal disorders, polypharmacy, incontinence, ethics and mental capacity. Only 68% of the schools taught about elder abuse. Thirty-seven per cent taught a recognised classification of the domains of health used in Comprehensive Geriatric Assessment (CGA). The median (range) total time spent on teaching in ageing and geriatric medicine was 55.5 (26–192) h. There was less reliance on informal teaching and improved assessment:teaching ratios compared with the 2008 survey.
Conclusions: there was an improvement in teaching and assessment of learning outcomes in ageing and geriatric medicine for UK undergraduates between 2008 and 2013. However, further work is needed to increase the amount of teaching time devoted to ageing and to improve teaching around elder abuse and the domains of health used in CGA.
PMCID: PMC3927775  PMID: 24375323
undergraduate medical education; geriatrics; medical education; curriculum; elder abuse; older people
14.  Responsiveness of five condition-specific and generic outcome assessment instruments for chronic pain 
Changes of health and quality-of-life in chronic conditions are mostly small and require specific and sensitive instruments. The aim of this study was to determine and compare responsiveness, i.e. the sensitivity to change of five outcome instruments for effect measurement in chronic pain.
In a prospective cohort study, 273 chronic pain patients were assessed on the Numeric Rating Scale (NRS) for pain, the Short Form 36 (SF-36), the Multidimensional Pain Inventory (MPI), the Hospital Anxiety and Depression Scale (HADS), and the Coping Strategies Questionnaire (CSQ). Responsiveness was quantified by effect size (ES) and standardized response mean (SRM) before and after a four week in-patient interdisciplinary pain program and compared by the modified Jacknife test.
The MPI measured pain more responsively than the SF-36 (ES: 0.85 vs 0.72, p = 0.053; SRM: 0.72 vs 0.60, p = 0.027) and the pain NRS (ES: 0.85 vs 0.62, p < 0.001; SRM: 0.72 vs 0.57, p = 0.001). Similar results were found for the dimensions of role and social interference with pain. Comparison in function was limited due to divergent constructs. The responsiveness of the MPI and the SF-36 was equal for affective health but both were better than the HADS (e.g. MPI vs HADS depression: ES: 0.61 vs 0.43, p = 0.001; SF-36 vs HADS depression: ES: 0.54 vs 0.43, p = 0.004). In the "ability to control pain" coping dimension, the MPI was more responsive than the CSQ (ES: 0.46 vs 0.30, p = 0.011).
The MPI was most responsive in all comparable domains followed by the SF-36. The pain-specific MPI and the generic SF-36 can be recommended for comprehensive and specific bio-psycho-social effect measurement of health and quality-of-life in chronic pain.
PMCID: PMC2386498  PMID: 18439285
15.  Substance misuse teaching in undergraduate medical education 
BMC Medical Education  2014;14:34.
Over 12,000 hospital admissions in the UK result from substance misuse, therefore issues surrounding this need to be addressed early on in a doctor’s training to facilitate their interaction with this client group. Currently, undergraduate medical education includes teaching substance misuse issues, yet how this is formally integrated into the curriculum remains unclear.
Semi-structured interviews with 17 key members of staff responsible for the whole or part of the undergraduate medical curriculum were conducted to identify the methods used to teach substance misuse. Using a previously devised toolkit, 19 curriculum co-ordinators then mapped the actual teaching sessions that addressed substance misuse learning objectives.
Substance misuse teaching was delivered primarily in psychiatry modules but learning objectives were also found in other areas such as primary care placements and problem-based learning. On average, 53 teaching sessions per medical school focused on bio-psycho-social models of addiction whereas only 23 sessions per medical school focused on professionalism, fitness to practice and students’ own health in relation to substance misuse. Many sessions addressed specific learning objectives relating to the clinical features of substance dependence whereas few focused on iatrogenic addiction.
Substance misuse teaching is now inter-disciplinary and the frequent focus on clinical, psychological and social effects of substance misuse emphasises the bio-psycho-social approach underlying clinical practice. Some areas however are not frequently taught in the formal curriculum and these need to be addressed in future changes to medical education.
PMCID: PMC3932109  PMID: 24533849
16.  Shrug Ambivalence and Disagreement; Search Commonalities in Psychiatric Phenomena** 
Mens Sana Monographs  2014;12(1):92-103.
Holistic understanding is necessary to study intimate nuances of psychological/psychopathological processes; also, individual manifestations and individual approach are laudable goals in treatment and approach. But we cannot forget that major therapeutic advances result when we are able to delineate commonalities and stable symptom clusters that cut across geo-cultural boundaries and are amenable to study and intervention. Even though the purpose and approach of psychiatry, as of all medicine, has to be humane and caring, major therapeutic advancements and aetiologic understandings result only from a scientific methodology that stresses and figures out the commonalities of psychopathological phenomena.
It is a mistake to stress individuality so much that commonalities are obliterated. Although stress on the individual's needs has helped psychiatry at times become more humane, it has hurt the task enormously by making some very bright minds question the very scientific basis of psychiatry and its status as a medical discipline.
Hence, even as it is necessary to promote holistic and individualistic caring, it is equally necessary to shrug ambivalence and crippling disagreements that can result if individualism in therapy is carried beyond limits.
Psychiatry's tradition, and field, will always allow for diversity in its practice, even in its theorising. For, psychopathology has both a personal, deep inner dimension — due to biogenetic and personality factors - and social, manifest/unmanifest, outer dimension — due to the environment. And the practice, and theory, of both are likely to be different, although we do try to amalgamate them in our ‘bio-psycho-social’ model. Such differences are only manifestations of an intricate network of influences that make for the human condition in health and disease.
Psychiatry is the one branch which realises this diversity the most, but equally important for it is to stress its unity:
Of purpose – that of reducing individual and social psychopathology;Of goals – that of unravelling the aetiopathology of psychiatric disorders; finding precision in diagnostics and investigative tests; finding biomarkers; and finding precise therapies for precise disorders that control such disorders; and not just control, but finally cure them; finding methods of primary prevention; of moving from mental disorder to mental health; and, further, of progress to individual actualisation and personal and collective well-being with longevity;Of practice – a) in therapy: By synergising psychopharmacology/somatic therapies with psychotherapy/therapies, social therapies and pharmacogenetics; b) in diagnostics: By identifying the phenotype-genotype-endophenotype axis; and (c) by promoting such therapy and diagnostics as brings about control, and finally, cure/primary prevention of psychiatric disorders.The future course for psychiatry involves a goal oriented forward movement - while allowing for diversity in practice and theory, stressing on unity of purpose, goals, and practice.
PMCID: PMC4037905  PMID: 24891800
Caring approach; Commonalities and stable symptom clusters; Holistic understanding; Idiographic-nomothetic orientation; Scientific methodology; Therapeutic advances
17.  Pathways of neighbourhood-level socio-economic determinants of adverse birth outcomes 
Although socio-economic factors have been identified as one of the most important groups of neighbourhood-level risks affecting birth outcomes, uncertainties still exist concerning the pathways through which they are transferred to individual risk factors. This poses a challenge for setting priorities and developing appropriate community-oriented public health interventions and planning guidelines to reduce the level of adverse birth outcomes.
This study examines potential direct and mediated pathways through which neighbourhood-level socio-economic determinants exert their impacts on adverse birth outcomes. Two hypothesized models, namely the materialist and psycho-social models, and their corresponding pathways are tested using a binary-outcome multilevel mediation analysis. Live birth data, including adverse birth outcomes and person-level exposure variables, were obtained from three public health units in the province of Ontario, Canada. Corresponding neighbourhood-level socio-economic, psycho-social and living condition variables were extracted or constructed from the 2001 Canadian Census and the first three cycles (2001, 2003, and 2005) of the Canadian Community Health Surveys.
Neighbourhood-level socio-economic-related risks are found to have direct effects on low birth weight and preterm birth. In addition, 20-30% of the total effects are contributed by indirect effects mediated through person-level risks. There is evidence of four person-level pathways, namely through individual socio-economic status, psycho-social stress, maternal health, and health behaviours, with all being simultaneously at work. Psycho-social pathways and buffering social capital-related variables are found to have more impact on low birth weight than on preterm birth.
The evidence supports both the materialist and psycho-social conceptualizations and the pathways that describe them, although the magnitude of the former is greater than the latter.
PMCID: PMC3706273  PMID: 23786633
Mediation analysis; Pathways of adverse birth outcomes; Neighbourhood-level socio-economic determinants; Preterm birth; Low birth weight
18.  Natural products as starting points for future anti-malarial therapies: going back to our roots? 
Malaria Journal  2011;10(Suppl 1):S3.
The discovery and development of new anti-malarials are at a crossroads. Fixed dose artemisinin combination therapy is now being used to treat a hundred million children each year, with a cost as low as 30 cents per child, with cure rates of over 95%. However, as with all anti-infective strategies, this triumph brings with it the seeds of its own downfall, the emergence of resistance. It takes ten years to develop a new medicine. New classes of medicines to combat malaria, as a result of infection by Plasmodium falciparum and Plasmodium vivax are urgently needed.
Natural product scaffolds have been the basis of the majority of current anti-malarial medicines. Molecules such as quinine, lapachol and artemisinin were originally isolated from herbal medicinal products. After improvement with medicinal chemistry and formulation technologies, and combination with other active ingredients, they now make up the current armamentarium of medicines. In recent years advances in screening technologies have allowed testing of millions of compounds from pharmaceutical diversity for anti-malarial activity in cellular assays. These initiatives have resulted in thousands of new sub-micromolar active compounds – starting points for new drug discovery programmes. Against this backdrop, the paucity of potent natural products identified has been disappointing. Now is a good time to reflect on the current approach to screening herbal medicinal products and suggest revisions. Nearly sixty years ago, the Chinese doctor Chen Guofu, suggested natural products should be approached by dao-xing-ni-shi or ‘acting in the reversed order’, starting with observational clinical studies. Natural products based on herbal remedies are in use in the community, and have the potential unique advantage that clinical observational data exist, or can be generated. The first step should be the confirmation and definition of the clinical activity of herbal medicinal products already used by the community. This first step forms a solid basis of observations, before moving to in vivo pharmacological characterization and ultimately identifying the active ingredient. A large part of the population uses herbal medicinal products despite limited numbers of well-controlled clinical studies. Increased awareness by the regulators and public health bodies of the need for safety information on herbal medicinal products also lends support to obtaining more clinical data on such products.
The relative paucity of new herbal medicinal product scaffolds active against malaria results discovered in recent years suggest it is time to re-evaluate the ‘smash and grab’ approach of randomly testing purified natural products and replace it with a patient-data led approach. This will require a change of perspective form many in the field. It will require an investment in standardisation in several areas, including: the ethnopharmacology and design and reporting of clinical observation studies, systems for characterizing anti-malarial activity of patient plasma samples ex vivo followed by chemical and pharmacological characterisation of extracts from promising sources. Such work falls outside of the core mandate of the product development partnerships, such as MMV, and so will require additional support. This call is timely, given the strong interest from researchers in disease endemic countries to support the research arm of a malaria eradication agenda. Para-national institutions such as the African Network for Drugs and Diagnostics Innovation (ANDi) will play a major role in facilitating the development of their natural products patrimony and possibly clinical best practice to bring forward new therapeutics. As in the past, with quinine, lapinone and artemisinin, once the activity of herbal medicinal products in humans is characterised, it can be used to identify new molecular scaffolds which will form the basis of the next generation of anti-malarial therapies.
PMCID: PMC3059461  PMID: 21411014
19.  Crowdsourced Health Research Studies: An Important Emerging Complement to Clinical Trials in the Public Health Research Ecosystem 
Crowdsourced health research studies are the nexus of three contemporary trends: 1) citizen science (non-professionally trained individuals conducting science-related activities); 2) crowdsourcing (use of web-based technologies to recruit project participants); and 3) medicine 2.0 / health 2.0 (active participation of individuals in their health care particularly using web 2.0 technologies). Crowdsourced health research studies have arisen as a natural extension of the activities of health social networks (online health interest communities), and can be researcher-organized or participant-organized. In the last few years, professional researchers have been crowdsourcing cohorts from health social networks for the conduct of traditional studies. Participants have also begun to organize their own research studies through health social networks and health collaboration communities created especially for the purpose of self-experimentation and the investigation of health-related concerns.
The objective of this analysis is to undertake a comprehensive narrative review of crowdsourced health research studies. This review will assess the status, impact, and prospects of crowdsourced health research studies.
Crowdsourced health research studies were identified through a search of literature published from 2000 to 2011 and informal interviews conducted 2008-2011. Keyword terms related to crowdsourcing were sought in Medline/PubMed. Papers that presented results from human health studies that included crowdsourced populations were selected for inclusion. Crowdsourced health research studies not published in the scientific literature were identified by attending industry conferences and events, interviewing attendees, and reviewing related websites.
Participatory health is a growing area with individuals using health social networks, crowdsourced studies, smartphone health applications, and personal health records to achieve positive outcomes for a variety of health conditions. PatientsLikeMe and 23andMe are the leading operators of researcher-organized, crowdsourced health research studies. These operators have published findings in the areas of disease research, drug response, user experience in crowdsourced studies, and genetic association. Quantified Self, Genomera, and DIYgenomics are communities of participant-organized health research studies where individuals conduct self-experimentation and group studies. Crowdsourced health research studies have a diversity of intended outcomes and levels of scientific rigor.
Participatory health initiatives are becoming part of the public health ecosystem and their rapid growth is facilitated by Internet and social networking influences. Large-scale parameter-stratified cohorts have potential to facilitate a next-generation understanding of disease and drug response. Not only is the large size of crowdsourced cohorts an asset to medical discovery, too is the near-immediate speed at which medical findings might be tested and applied. Participatory health initiatives are expanding the scope of medicine from a traditional focus on disease cure to a personalized preventive approach. Crowdsourced health research studies are a promising complement and extension to traditional clinical trials as a model for the conduct of health research.
PMCID: PMC3376509  PMID: 22397809
Community-Based Participatory Research; Preventive Medicine; Personalized Medicine; Individualized Medicine; Consumer Participation; Health Services Research; Health Care Research; Public Health; Genomics; Medicine
20.  P24 - Geriatric Medicine: An Innovative Care Strategy in Orthopaedics and Traumatology 
For many years, the administration of the Careggi University Hospital (CUH), in agreement with the Faculty of Medicine and Surgery of the University of Florence, has pressed for the creation of a department of general medicine within its othopaedic traumatology centre. In its decision n.243 of May 5, 2009, the administration of the CUH, along the lines of similar experiences already in place, set up a simple departmental unit (SDU) of geriatric medicine (GM) within the hospital’s department of orthopaedics.
The aim of this unit is to guarantee continuity of care to orthopaedics inpatients, through the identification of a specific care pathway for clinically unstable patients. The clinical activity carried out, mainly in the context of the provision of continuity of care, takes the form of daily consultancy. The SDU has a series of objectives, organisational (less postponement of surgery due to medical problems, better integration of healthcare through a multidisciplinary team, provision of internal medicine and geriatric consultancy to guarantee continuity of care), clinical (reduction of peri-operative medical complications and adverse events) and strategic (improvement of the quality of geriatric and internal medicine care, better communication with patients and families). The unit strives to exploit to the full the multi-professional (doctors, rehabilitation therapists, registered nurses, social workers) and interdisciplinary (internal medicine, geriatrics, orthopaedics, physical medicine, anaesthesiology, cardiology, angiology etc.) intervention and, in the fragile elderly, applies a multi-dimensional geriatric assessment instrument.
Clinical activity:
The physicians working in the GM SDU provide daily consultancy, including Saturday mornings. Constant telephone contact is available, also on Sundays and holidays.
In the period from 1/9/2009 to 31/7/2010, a total of 1867 consultancies were provided, spread over 268 days, which corresponds to a mean of 6.97 examinations/day. Of these, 652 (34.92%) were first visits and 1215 (65.08%) were follow ups. The assessments were always conducted in a spirit of multi-professional and multidisciplinary collaboration.
The assessments were carried out in the following departments: general orthopaedics II (25.98%), general orthopaedics I (21.26%), general orthopaedics III (18.26%), traumatology-orthopaedics (13.55%), orthopaedic oncology and reconstruction (11.25%) as well as, in smaller percentages, in all the other SDUs of the orthopaedics department, in the neurosurgery department, the plastic surgery department and the spinal unit.
In particular, internal and geriatric medicine consultancy for patients was requested in connection with high levels of co-morbidity, polypharmacy regimens, acute confusional state, dehydration, hydro-electrolytic disorders, uncompensated type 2 diabetes mellitus, pulmonary embolism, chronic liver disease and cirrhosis, pneumonia and bronchitis causing respiratory insufficiency, decompensated congestive heart failure, targeted antibiotic therapy, chronic renal insufficiency, and management of anti-aggregant and anticoagulant therapies.
Positive aspects: the clinical assessments were made using a multidisciplinary approach, based on the fundamental collaboration of specialists in orthopaedics, anaesthesiology-resuscitation, angiology, cardiology, radiology and physical medicine; excellent collaboration with services (radiology, neuroradiology, angiology, cardiology, etc.).
Negative aspects: constant difficulties transferring clinically unstable patients to the hospital’s medical specialty SDUs due to lack of beds; lack of intermediate care beds as a sort of “buffer” between the intensive care and inpatient departments; scope for improving the internal medicine skills of the nursing staff.
Research projects:
In synergy the hospital’s other SDUs, the GM SDU takes part in projects aiming to improve care and clinical management. It currently has collaborations with the geriatrics clinic, regional centre of reference for haemostasis and thrombosis, the bone metabolism clinic, the orthopaedics clinics, the geriatrics agency, the radiology service, the continuity-of-care agency, the clinical management, and the general affairs unit. Furthermore, on the instigation of the regional health council, a working group has recently been set up on the reorganisation of the “Care pathway of elderly patients with proximal femur fracture (orthogeriatrics)”.
Prospects for implementation and improvement:
The aims of the “Project to reorganise and upgrade the orthopaedics and traumatology centre of the Careggi University Hospital” include: the institution of a medical geriatrics department providing medium and high intensity of care; the presence, 24 hours/day, of a specialist from the medical area in the traumatology open space; the involvement of the internal medicine specialist in pre-hospitalisation procedures.
PMCID: PMC3213796
21.  Concepts of functioning and health important to people with systemic sclerosis: a qualitative study in four European countries 
Annals of the Rheumatic Diseases  2011;70(6):1074-1079.
To describe the experiences of people with systemic sclerosis (SSc) in different European countries of functioning and health and to link these experiences to the WHO International Classification of Functioning, Disability and Health (ICF) to develop a common understanding from a bio-psycho-social perspective.
A qualitative multicentre study with focus-group interviews was performed in four European countries: Austria, Romania, Sweden and Switzerland. The qualitative data analysis followed a modified form of ‘meaning condensation’ and the concepts that emerged in the analysis were linked to the ICF.
63 people with SSc participated in 13 focus groups. In total, 86 concepts were identified. 32 (37%) of these were linked to the ICF component body functions and structures, 21 (24%) to activities and participation, 26 (30%) to environmental factors, 6 (7%) to personal factors and 1 (1%) to the health condition itself. 19 concepts (22%) were identified in all four countries and included impaired hand function, household activities, paid work, drugs, climate and coldness, support from others and experiences with healthcare institutions, non-pharmacological treatment, social security and benefits.
Concepts identified in all four countries could be used for guiding clinical assessment, as well as interdisciplinary team care and rheumatological rehabilitation for patients with SSc. For a full understanding of the aspects of the disease that were most relevant to people with SSc, people with SSc from multiple countries needed to be involved.
PMCID: PMC3086051  PMID: 21540204
22.  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.
PMCID: PMC2809376  PMID: 20098629
Personalized Genomic Medicine; Personalized Medicine; Ethics; Genomics; Policy
23.  Liaison psychiatry and Indian research 
Indian Journal of Psychiatry  2010;52(Suppl1):S386-S388.
Liaison in Psychiatry refers to the branch of Psychiatry involving assessment and treatment in the general hospital of referred patients, like in the casualty, or patients of deliberate self farm. The Indian scene also reveals major reference from medicine, surgery, surgical super specialty and orthopedics with psychiatric disorders like anxiety, depression and / or organic brain syndromes seen in about 40 to 50 % of the medical or surgical patients. Though the Indian published data is limited, most tertiary hospitals in India carry out liaison work with various departments like Neurology, Organ transplant, Intensive Care Units and Cosmetic Surgery, so as to give comprehensive health services to patients. Liaison in Psychiatry has thus brought the emphasis on the teaching of psycho-social aspects of medicine and also increased research possibilities.
PMCID: PMC3146176  PMID: 21836711
Liaison psychiatry; GHPU; CLP
24.  A systematic review of measures of shoulder pain and functioning using the International classification of functioning, disability and health (ICF) 
Shoulder pain is a common condition with prevalence estimates of 7–26% and the associated disability is multi-faceted. For functional assessments in clinic and research, a number of condition-specific and generic measures are available. With the approval of the ICF, a system is now available for the analysis of health status measures. The aims of this systematic literature review were to identify the most frequently addressed aspects of functioning in assessments of shoulder pain and provide an overview of the content of frequently used measures.
Meaningful concepts of the identified measures were extracted and linked to the most precise ICF categories. Second-level categories with a relative frequency above 1% and the content of measures with at least 5 citations were reported.
A set of 40 second-level ICF categories were identified in 370 single-item measures and 105 multi-item measures, of these, 28 belonged to activities and participation, 11 to body functions and structures and 1 to environmental factors. The most frequently addressed concepts were: pain; movement-related body functions and structures; sleep, hand and arm use, self-care, household tasks, work and employment, and leisure. Concepts of psycho-social functions and environmental factors were less frequently included. The content overview of commonly used condition-specific and generic measures displayed large variations in the number of included concepts. The most wide-ranging measures, the DASH and ASES were linked to 23 and 16 second-level ICF categories, respectively, whereas the Constant were linked to 7 categories and the SST and the SPADI to 6 categories each.
This systematic review displayed that measures used for shoulder pain included more than twice as many concepts of activities and participation than concepts of body functions and structures. Environmental factors were scarcely addressed. The huge differences in the content of the condition-specific multi-item measures demonstrates the importance of clarifying the content to select the most appropriate measure both in research and in clinical work. For clinical situations, we propose use of a wide-ranging condition-specific measure that conceptualizes assessments of shoulder pain from a bio-psycho-social perspective. Further research is needed to assess how patient-reported problems in functioning are captured in the commonly used measures.
PMCID: PMC3668165  PMID: 23445557
ICF; Outcome assessment (health care); Shoulder pain; Shoulder; Health; Cross-sectional studies; *Disability evaluation; World health organization; Recovery of function; *Rehabilitation
25.  East-West gradient in cardio-vascular mortality in Austria: how much can we explain by following the pattern of risk factors? 
Various studies show major regional differences in the prevalence of cardio-vascular disease morbidity and mortality, both in Europe and within European countries. In Austria, these differences are documented by an East-West gradient with declining morbidity and mortality rates when moving from the East to the West of the country. It was the aim of this study to analyse if, and to what extent, socio-demographic and socio-economic determinants, social resources and health behaviour can contribute to the clarification of this East-West gradient by conducting secondary analyses of an existing Austrian health dataset.
The data were analysed using bivariate analyses, as well as univariate and multivariate logistic regression models. These analyses revealed significant East-West gradients for various risk factors, as well as socio-demographic and socio-economic health determinants. There was a gradual decrease of hypertension, diabetes mellitus, obesity, and psycho-social discomfort in both sexes, with the highest prevalences in those Austrian regions with the highest cardio-vascular mortality and a stepwise decrease to the regions with the lowest cardio-vascular mortality. Controlling for educational level significantly raised the odds for diabetes, hypertension and obesity. In the results of the multivariate analyses, factors that significantly and independently predicted diabetes mellitus were geographic location, psycho-social discomfort, lack of physical exercise, and age in both sexes. For women these factors additionally included a low educational level, lack of social support, and being born abroad.
Our study shows a clear gradual decline of cardio-vascular mortality and some of its risk factors from East to West in Austria. Concerning these risk factors, the geographic region and psycho-social discomfort showed the greatest association with diabetes mellitus, hypertension, and obesity. Hence, they contribute to the explanation of the variance in spatial cardio-vascular disease mortality. Yet, a large proportion of this variance remains unexplained. It would be of great importance to public health and preventive measures to take a closer look at spatial differences in cardio-vascular disease morbidity and mortality to better tailor programmes to the regional environments and settings. Our results also call for a greater importance of preventative measures for psycho-social discomfort and increase of social support.
PMCID: PMC3231809  PMID: 22082341

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