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1.  Inclusion of Ethical Issues in Dementia Guidelines: A Thematic Text Analysis 
PLoS Medicine  2013;10(8):e1001498.
Clinical practice guidelines (CPGs) aim to improve professionalism in health care. However, current CPG development manuals fail to address how to include ethical issues in a systematic and transparent manner. The objective of this study was to assess the representation of ethical issues in general CPGs on dementia care.
Methods and Findings
To identify national CPGs on dementia care, five databases of guidelines were searched and national psychiatric associations were contacted in August 2011 and in June 2013. A framework for the assessment of the identified CPGs' ethical content was developed on the basis of a prior systematic review of ethical issues in dementia care. Thematic text analysis and a 4-point rating score were employed to assess how ethical issues were addressed in the identified CPGs. Twelve national CPGs were included. Thirty-one ethical issues in dementia care were identified by the prior systematic review. The proportion of these 31 ethical issues that were explicitly addressed by each CPG ranged from 22% to 77%, with a median of 49.5%. National guidelines differed substantially with respect to (a) which ethical issues were represented, (b) whether ethical recommendations were included, (c) whether justifications or citations were provided to support recommendations, and (d) to what extent the ethical issues were explained.
Ethical issues were inconsistently addressed in national dementia guidelines, with some guidelines including most and some including few ethical issues. Guidelines should address ethical issues and how to deal with them to help the medical profession understand how to approach care of patients with dementia, and for patients, their relatives, and the general public, all of whom might seek information and advice in national guidelines. There is a need for further research to specify how detailed ethical issues and their respective recommendations can and should be addressed in dementia guidelines.
Please see later in the article for the Editors' Summary
Editors’ Summary
In the past, doctors tended to rely on their own experience to choose the best treatment for their patients. Faced with a patient with dementia (a brain disorder that affects short-term memory and the ability tocarry out normal daily activities), for example, a doctor would use his/her own experience to help decide whether the patient should remain at home or would be better cared for in a nursing home. Similarly, the doctor might have to decide whether antipsychotic drugs might be necessary to reduce behavioral or psychological symptoms such as restlessness or shouting. However, over the past two decades, numerous evidence-based clinical practice guidelines (CPGs) have been produced by governmental bodies and medical associations that aim to improve standards of clinical competence and professionalism in health care. During the development of each guideline, experts search the medical literature for the current evidence about the diagnosis and treatment of a disease, evaluate the quality of that evidence, and then make recommendations based on the best evidence available.
Why Was This Study Done?
Currently, CPG development manuals do not address how to include ethical issues in CPGs. A health-care professional is ethical if he/she behaves in accordance with the accepted principles of right and wrong that govern the medical profession. More specifically, medical professionalism is based on a set of binding ethical principles—respect for patient autonomy, beneficence, non-malfeasance (the “do no harm” principle), and justice. In particular, CPG development manuals do not address disease-specific ethical issues (DSEIs), clinical ethical situations that are relevant to the management of a specific disease. So, for example, a DSEI that arises in dementia care is the conflict between the ethical principles of non-malfeasance and patient autonomy (freedom-to-move-at-will). Thus, healthcare professionals may have to decide to physically restrain a patient with dementia to prevent the patient doing harm to him- or herself or to someone else. Given the lack of guidance on how to address ethical issues in CPG development manuals, in this thematic text analysis, the researchers assess the representation of ethical issues in CPGs on general dementia care. Thematic text analysis uses a framework for the assessment of qualitative data (information that is word-based rather than number-based) that involves pinpointing, examining, and recording patterns (themes) among the available data.
What Did the Researchers Do and Find?
The researchers identified 12 national CPGs on dementia care by searching guideline databases and by contacting national psychiatric associations. They developed a framework for the assessment of the ethical content in these CPGs based on a previous systematic review of ethical issues in dementia care. Of the 31 DSEIs included by the researchers in their analysis, the proportion that were explicitly addressed by each CPG ranged from 22% (Switzerland) to 77% (USA); on average the CPGs explicitly addressed half of the DSEIs. Four DSEIs—adequate consideration of advanced directives in decision making, usage of GPS and other monitoring techniques, covert medication, and dealing with suicidal thinking—were not addressed in at least 11 of the CPGs. The inclusion of recommendations on how to deal with DSEIs ranged from 10% of DSEIs covered in the Swiss CPG to 71% covered in the US CPG. Overall, national guidelines differed substantially with respect to which ethical issues were included, whether ethical recommendations were included, whether justifications or citations were provided to support recommendations, and to what extent the ethical issues were clearly explained.
What Do These Findings Mean?
These findings show that national CPGs on dementia care already address clinical ethical issues but that the extent to which the spectrum of DSEIs is considered varies widely within and between CPGs. They also indicate that recommendations on how to deal with DSEIs often lack the evidence that health-care professionals use to justify their clinical decisions. The researchers suggest that this situation can and should be improved, although more research is needed to determine how ethical issues and recommendations should be addressed in dementia guidelines. A more systematic and transparent inclusion of DSEIs in CPGs for dementia (and for other conditions) would further support the concept of medical professionalism as a core element of CPGs, note the researchers, but is also important for patients and their relatives who might turn to national CPGs for information and guidance at a stressful time of life.
Additional Information
Please access these Web sites via the online version of this summary at
Wikipedia contains a page on clinical practice guidelines (note: Wikipedia is a free online encyclopedia that anyone can edit; available in several languages)
The US National Guideline Clearinghouse provides information on national guidelines, including CPGs for dementia
The Guidelines International Network promotes the systematic development and application of clinical practice guidelines
The American Medical Association provides information about medical ethics; the British Medical Association provides information on all aspects of ethics and includes an essential tool kit that introduces common ethical problems and practical ways to deal with them
The UK National Health Service Choices website provides information about dementia, including a personal story about dealing with dementia
MedlinePlus provides links to additional resources about dementia and about Alzheimers disease, a specific type of dementia (in English and Spanish)
The UK Nuffield Council on Bioethics provides the report Dementia: ethical issues and additional information on the public consultation on ethical issues in dementia care
PMCID: PMC3742442  PMID: 23966839
2.  Contemporary issues concerning informed consent in Japan based on a review of court decisions and characteristics of Japanese culture 
BMC Medical Ethics  2014;15:8.
Since Japan adopted the concept of informed consent from the West, its inappropriate acquisition from patients in the Japanese clinical setting has continued, due in part to cultural aspects. Here, we discuss the current status of and contemporary issues surrounding informed consent in Japan, and how these are influenced by Japanese culture.
Current legal norms towards informed consent and information disclosure are obscure in Japan. For instance, physicians in Japan do not have a legal duty to inform patients of a cancer diagnosis. To gain a better understanding of these issues, we present five court decisions related to informed consent and information disclosure. We then discuss Japanese culture through reviews of published opinions and commentaries regarding how culture affects decision making and obtaining informed consent. We focus on two contemporary problems involving informed consent and relevant issues in clinical settings: the misuse of informed consent and persistence in obtaining consent. For the former issue, the phrase "informed consent" is often used to express an opportunity to disclose medical conditions and recommended treatment choices. The casual use of the expression "informed consent" likely reflects deep-rooted cultural influences. For the latter issue, physicians may try to obtain a signature by doing whatever it takes, lacking a deep understanding of important ethical principles, such as protecting human dignity, serving the patient’s best interest, and doing no harm in decision-making for patients.
There is clearly a misunderstanding of the concept of informed consent and a lack of complete understanding of ethical principles among Japanese healthcare professionals. Although similar in some respects to informed consent as it originated in the United States, our review makes it clear that informed consent in Japan has clear distinguishing features.
Japanese healthcare professionals should aim to understand the basic nature of informed consent, irrespective of their attitudes about individualism, liberalism, and patient self-determination. If they believe that the concept of informed consent is important and essential in Japanese clinical settings, efforts should be made to obtain informed consent in an appropriate manner.
PMCID: PMC3923408  PMID: 24495473
Informed consent; Japanese culture; Ethical principles; Ethical issues; Misuse; Healthcare professionals
3.  The identification of the general practice registrar needing assistance 
The Australasian Medical Journal  2011;4(6):308-314.
Doctors undertaking vocational training in general practice in Australia may require assistance, in addition to the normal training offered as part of their training programme. Issues requiring assistance may go undetected for a period of time. Delay in the identification of issues leads to delay in the provision of the assistance. The aim of this study is to determine the most common reasons registrars require extra assistance, and how these issues are identified. The findings of this study will provide direction for 21 regionally based training providers (RTPs) to develop improved tools to ensure earlier detection of registrars requiring assistance.
This study is based on qualitative research methods, using semi-structured interviews with senior medical education staff of four regional general practice training providers in Victoria, Australia.
Issues identified included language and cultural issues, applied knowledge and skills, attitude and professionalism, and health and family issues.
The principal method that training providers identified issues was via the GP supervisor. This was predominantly by informal communication, rather than formal evaluation sheets. Other methods included the external clinical teaching visit and other training formative assessments. These more formalised procedures were more likely to identify issues later than desired. They were also used as a way of clarifying suspected problems. The selection process was not felt to be helpful, and the examinations provided information too late.
An increased awareness of the potential issues leading to a registrar to require assistance enables identification and subsequent action to occur in a more timely and more useful fashion. Informal communication between practices and training programme staff should be encouraged to enable these issues to be dealt with early in training.
PMCID: PMC3562948  PMID: 23386893
General practice; remediation; vocational training
4.  Clinical Ethics in Gabon: The Spectrum of Clinical Ethical Issues Based on Findings from In-Depth Interviews at Three Public Hospitals 
PLoS ONE  2015;10(7):e0132374.
Unlike issues in biomedical research ethics, ethical challenges arising in daily clinical care in Sub-Saharan African countries have not yet been studied in a systematic manner. However this has to be seen as a distinct entity as we argue in this paper. Our aim was to give an overview of the spectrum of clinical ethical issues and to understand what influences clinical ethics in the Sub-Saharan country of Gabon.
Materials and Methods
In-depth interviews with 18 health care professionals were conducted at three hospital sites in Gabon. Interview transcripts were analyzed using a grounded theory approach (open and axial coding), giving a qualitative spectrum of categories for clinical ethical issues. Validity was checked at a meeting with study participants and other health care experts in Gabon after analysis of the data.
Twelve main categories (with 28 further-specified subcategories) for clinical ethical issues were identified and grouped under three core categories: A) micro level: “confidentiality and information”, “interpersonal, relational and behavioral issues”, “psychological strain of individuals”, and “scarce resources”; B) meso level: “structural issues of medical institutions”, “issues with private clinics”, “challenges connected to the family”, and “issues of education, training and competence”; and C) macro level: “influence of society, culture, religion and superstition”, “applicability of western medicine”, “structural issues on the political level”, and “legal issues”.
Interviewees reported a broad spectrum of clinical ethical issues that go beyond challenges related to scarce financial and human resources. Specific socio-cultural, historical and educational backgrounds also played an important role. In fact these influences are central to an understanding of clinical ethics in the studied local context. Further research in the region is necessary to put our study into perspective. As many participants reported a lack of awareness of ethical issues amongst other health care professionals in daily clinical practice, we suggest that international organizations and national medical schools should consider infrastructure and tools to improve context-sensitive capacity building in clinical ethics for Sub-Saharan African countries like Gabon.
PMCID: PMC4498757  PMID: 26161655
5.  Evaluating a Web-Based Health Risk Assessment With Tailored Feedback: What Does an Expert Focus Group Yield Compared to a Web-Based End-User Survey? 
Increasingly, Web-based health applications are developed for the prevention and management of chronic diseases. However, their reach and utilization is often disappointing. Qualitative evaluations post-implementation can be used to inform the optimization process and ultimately enhance their adoption. In current practice, such evaluations are mainly performed with end-user surveys. However, a review approach by experts in a focus group may be easier to administer and might provide similar results.
The aim of this study was to assess whether industrial design engineers in a focus group would address the same issues as end users in a Web-based survey when evaluating a commercial Web-based health risk assessment (HRA) with tailored feedback.
Seven Dutch companies used the HRA as part of their corporate health management strategy. Employees using the HRA (N=2289) and 10 independent industrial designers were invited to participate in the study. The HRA consisted of four components: (1) an electronic health questionnaire, (2) biometric measurements, (3) laboratory evaluation, and (4) individually tailored feedback generated by decision support software. After participating in the HRA as end users, both end users and designers evaluated the program. End users completed an evaluation questionnaire that included a free-text field. Designers participated in a focus group discussion. Constructs from user satisfaction and technology acceptance theories were used to categorize and compare the remarks from both evaluations.
We assessed and qualitatively analyzed 294 remarks of 189 end users and 337 remarks of 6 industrial designers, pertaining to 295 issues in total. Of those, 137 issues were addressed in the end-user survey and 148 issues in the designer focus group. Only 7.3% (10/137) of the issues addressed in the survey were also addressed in the focus group. End users made more remarks about the usefulness of the HRA and prior expectations that were not met. Designers made more remarks about how the information was presented to end users, quality of the feedback provided by the HRA, recommendations on the marketing and on how to create more unity in the design of the HRA, and on how to improve the HRA based on these issues.
End-user surveys should not be substituted for expert focus groups. Issues identified by end users in the survey and designers in the focus group differed considerably, and the focus group produced a lot of new issues. The issues addressed in the focus group often focused on different aspects of user satisfaction and technology acceptance than those addressed by the survey participants; when they did focus on the same aspects, then the nature of issues differed considerably in content.
PMCID: PMC3906664  PMID: 24384408
health risk assessment; health information systems; qualitative research; evaluation; end users; professional review; designers; optimization
6.  Informal hospice caregiver pain management concerns: A qualitative study 
Palliative medicine  2013;27(7):673-682.
Informal, unpaid, family caregivers provide much hospice care in the United States. These caregivers suffer physically, psychologically, emotionally, and socially from the burden of caring. The most often identified area of caregiver burden is the management of end-of-life pain. However, little empirical evidence exists of effective interventions to help caregivers manage end-of-life pain, and issues surrounding caregiver pain management remain vague and undefined. Understanding these concerns will inform the design of effective caregiver interventions.
The purpose of this study was to describe and organize caregiver pain management challenges faced by home hospice caregivers of cancer patients.
A content analysis of secondary data, namely, recordings of caregiver interviews, was conducted to describe pain management issues. These interviews were part of a larger clinical trial.
Multiple sessions with 29 informal caregivers, of patients dying of cancer, were audio-recorded. Subjects were purposively selected from two hospice programs in the Northwestern United States. Caregivers of noncancer patients were excluded from the study sample.
A framework of six major themes with subordinate subthemes was developed through a literature review and peer review. The framework was used to organize the content of 87 caregiver interviews. The six major themes identified in the analysis included Caregiver-Centric Issues, Caregiver Medication Skills and Knowledge Issues, End-of-Life Symptom Knowledge Issues, Communication and Teamwork Issues, Organizational Skill Issues, and Patient-Centric Issues.
This analysis clearly articulated and classified caregiver issues surrounding pain management. Future hospice research may benefit from the use of this analysis and framework in the development of tools to alleviate this major cause of caregiver burden.
PMCID: PMC3950803  PMID: 23612959
Caregivers; hospice care; pain; pain management; palliative care; end-of-life
7.  Review Of Internet Health Information Quality Initiatives 
The massive growth of health information on the Internet; the global nature of the Internet; the seismic shift taking place in the relationships of various actors in this arena, and the absence of real protection from harm for citizens who use the Internet for health purposes are seen to be real problems. One response to many of these problems has been the burgeoning output of codes of conduct by numerous organizations trying to address quality of health information.
Review the major self-regulatory initiatives in the English-speaking world to develop quality and ethical standards for health information on the Internet. Compare and analyze the approaches taken by the different initiatives. Clarify the issues around the development and enforcement of standards.
Quality initiatives selected meet one or more of the following criteria: Self-regulatory. A reasonable constituency. Diversity (eg, of philosophy, approach and process)-to achieve balance and wide representation, and to illustrate and compare different approaches. Historic value. A wider reach than a national audience, except when its reach is a significant sector of the Internet health information industry.
The initiatives were compared in 3 ways: (1) Analysis and comparison of: key concepts, mechanism, or approach. Analysis of: the obligations that a provider has to meet to comply with the given initiative, the intended beneficiaries of that initiative, and the burdens imposed on different actors. These burdens are described in terms of their effect on the long-term sustainability and maintenance of the initiative by its developers. Analysis of the enforcement mechanisms. (2) Analysis and comparison by type of sponsoring organization, the reach of the initiative, and the sources of funding of the initiative or the sponsoring organization. (3) How the various initiatives fall under 1 of 3 key mechanisms and comparison of the advantages and disadvantages of these key mechanisms.
The issues that affect the initiatives and future work on the quality of health information on the Internet are identified and analyzed. These issues are:
(a) Three key mechanisms used in the quality initiatives (b) Sustainability issues that affect the initiatives: Burdens placed on health information providers, citizens and others. Currency and maintenance issues of the initiatives. Funding. Cost. Acceptance. Market conditions. User indifference or ambivalence. (c) Enforcement issues surrounding the initiatives (d) Adequacy of approach, scope, reach, and enforcement provisions of the various quality initiatives (e) Gaps that need to be addressed to achieve good quality of health information on the internet
Ten conclusions are presented. A framework of action to be undertaken by the World Health Organization in the field of quality of health information on the Internet is recommended.
PMCID: PMC1761913  PMID: 11772543
Internet/standards; Ethics, Professional; Social Control, Formal; Health Care Quality; Quality Assurance; Health Care/standards; Commerce/standards; Information Management/standards; Medical Informatics/standards; Quality control; Guidelines; Privacy; Informed Consent
8.  Qualitative Evaluation of a Text Messaging Intervention to Support Patients With Active Tuberculosis: Implementation Considerations 
JMIR mHealth and uHealth  2015;3(1):e21.
Tuberculosis (TB) remains a major global public health problem and mobile health (mHealth) interventions have been identified as a modality to improve TB outcomes. TextTB, an interactive text-based intervention to promote adherence with TB medication, was pilot-tested in Argentina with results supporting the implementation of trials at a larger scale.
The objective of this research was to understand issues encountered during pilot-testing in order to inform future implementation in a larger-scale trial.
A descriptive, observational qualitative design guided by a sociotechnical framework was used. The setting was a clinic within a public pulmonary-specialized hospital in Argentina. Data were collected through workflow observation over 115 days, text messages (n=2286), review of the study log, and stakeholder input. Emerging issues were categorized as organizational, human, technical, or sociotechnical considerations.
Issues related to the intervention included workflow issues (eg, human, training, security), technical challenges (eg, data errors, platform shortcomings), and message delivery issues (eg, unintentional sending of multiple messages, auto-confirmation problems). System/contextual issues included variable mobile network coverage, electrical and Internet outages, and medication shortages.
Intervention challenges were largely manageable during pilot-testing, but need to be addressed systematically before proceeding with a larger-scale trial. Potential solutions are outlined. Findings may help others considering implementing an mHealth intervention to anticipate and mitigate certain challenges. Although some of the issues may be context dependent, other issues such as electrical/Internet outages and limited resources are not unique issues to our setting. Release of new software versions did not result in solutions for certain issues, as specific features used were removed. Therefore, other software options will need to be considered before expanding into a larger-scale endeavor. Improved automation of some features will be necessary, however, a goal will be to retain the intervention capability to be interactive, user friendly, and patient focused. Continued collaboration with stakeholders will be required to conduct further research and to understand how such an mHealth intervention can be effectively integrated into larger health systems.
PMCID: PMC4376194  PMID: 25802968
mHealth; tuberculosis; sociotechnical evaluation; text messaging
9.  Patient Perspectives on Online Health Information and Communication With Doctors: A Qualitative Study of Patients 50 Years Old and Over 
As health care systems around the world shift toward models that emphasize self-care management, there is increasing pressure for patients to obtain health information online. It is critical that patients are able to identify potential problems with using the Internet to diagnose and treat a health issue and that they feel comfortable communicating with their doctor about the health information they acquire from the Internet.
Our aim was to examine patient-identified (1) problems with using the Internet to identify and treat a health issue, (2) barriers to communication with a doctor about online health information seeking, and (3) facilitators of communication with a doctor about patient searches for health information on the Internet.
For this qualitative exploratory study, semistructured interviews were conducted with a sample of 56 adults age 50 years old and over. General concerns regarding use of the Internet to diagnose and treat a health issue were examined separately for participants based on whether they had ever discussed health information obtained through the Internet with a doctor. Discussions about barriers to and facilitators of communication about patient searches for health information on the Internet with a doctor were analyzed using thematic analysis.
Six higher-level general concerns emerged: (1) limitations in own ability, (2) credibility/limitations of online information, (3) anxiety, (4) time consumption, (5) conflict, and (6) non-physical harm. The most prevalent concern raised by participants who communicated with a doctor about their online health information seeking related to the credibility or limitations in online information. Participants who had never communicated with a doctor about their online health information seeking most commonly reported concerns about non-physical harm. Four barriers to communication emerged: (1) concerns about embarrassment, (2) concerns that the doctor doesn’t want to hear about it, (3) belief that there is no need to bring it up, and (4) forgetting to bring it up. Facilitators of communication included: (1) having a family member present at doctor visits, (2) doctor-initiated inquiries, and (3) encountering an advertisement that suggested talking with a doctor.
Overall, participants displayed awareness of potential problems related to online health information seeking. Findings from this study point to a set of barriers as well as facilitators of communication about online health information seeking between patients and doctors. This study highlights the need for enhanced patient communication skills, eHealth literacy assessments that are accompanied by targeted resources pointing individuals to high-quality credible online health information, and the need to remind patients of the importance of consulting a medical professional when they use online health resources to diagnose and treat a health issue.
PMCID: PMC4319073  PMID: 25586865
health communication; Internet; online health information seeking; barriers to patient-doctor communication; adults 50 years old and over; qualitative research
10.  How do medical journalists treat cancer-related issues? 
ecancermedicalscience  2015;9:502.
Cancer patients can obtain information about their illness through a variety of media sources. Therefore, it is important to know how medical journalists treat cancer-related issues; to that end, we sent self-administered questionnaires to 364 journalists in 82 organisations who had reported on medical issues for the Japanese media, asking for their reasons for reporting on cancer-related issues and the difficulties they had faced. The most common reason for reporting on health-related issues was their personal interest in a particular issue (n = 36). They mainly covered conventional therapies (n = 33), healthcare policy (n = 30), new therapies (n = 25), and diagnosis (n = 25). All of the journalists that were surveyed experienced some difficulties in reporting health issues. Significant concerns included the quality of information (n = 36), social impact (n = 35), lack of technical knowledge (n = 35), and difficulty in understanding technical terms (n = 35). Journalists commonly used personal networks, including physicians, as information sources (n = 42), as well as social media (e.g., e-mail, Twitter and Facebook) (n = 32). Topic selection was biased, with 35 of 48 journalists having never reported on topics concerning hospices. Physicians were the most trusted source of information about cancer, and journalists attached high importance to interviewing them. As medical knowledge is advancing rapidly, journalists may have increasing difficulty covering cancer-related issues.
PMCID: PMC4335961  PMID: 25729415
information seeking; information source; medical information; news reporting; patient behaviour
11.  The information needs and preferences of persons with longstanding inflammatory bowel disease 
Understanding the information needs and preferred vehicles of information delivery to patients with inflammatory bowel disease (IBD) will enhance their care.
To survey persons with longstanding IBD as to their information needs and preferred vehicles of information delivery.
The population-based Manitoba IBD Cohort (n=271, mean disease duration 11 years) was surveyed to assess its information needs across 23 issues, both retrospectively at the time of diagnosis and currently.
Most participants (64%) were initially diagnosed by a gastroenterologist, or otherwise by a family physician (19%) or surgeon (12%). Recalling time of diagnosis, at least 80% rated as very important information about common symptoms of IBD, possible complications, long-term prognosis, medication side effects, self management of symptoms and when to involve the doctor, yet only 10% to 36% believed they received the right amount of information about these issues. Dietary guidance was also regarded as important by 80% to 89%, yet only 8% to 16% received the correct amount of information. Regarding current needs, a large proportion believed it would be very helpful to have more information about long-term prognosis (66%) and diet considerations (60% to 68%). The following information sources were regarded as very acceptable: medical specialist (81%); brochure (79%); family doctor (64%); and website (64%), with 51% ranking the medical specialist as the first choice. In a comparison of the responses of this cohort to those of a recently diagnosed sample, there was remarkable consistency in the information needs and most desired sources of information.
In the present population-based cohort with longstanding disease, dietary information was regarded as the least adequately addressed. There was clear openness to receiving information through other routes than just the medical specialist, suggesting that optimizing brochures and websites would be an important adjunct source of information.
Approximately 10 years after diagnosis, only a small percentage of persons with IBD believed they received the correct amount of information about the issues they regarded as most important to have discussed at diagnosis.
PMCID: PMC3414474  PMID: 22891177
Crohn disease; Cohort study; Inflammatory bowel disease; Patient knowledge; Population based; Ulcerative colitis
12.  Analysis of US Food and Drug Administration Warning Letters 
Pharmaceutical medicine  2008;22(2):10.1007/BF03256691.
Recent studies have suggested that there has been an increase in the number of ‘warning letters’ issued by the US Food and Drug Administration (FDA) despite the publication of the FDA advertising guidelines. However, limited information is available on the description of warning letters. The objective of this study was to analyse the frequency and content of FDA warning letters in relation to promotional claims and discuss the influence of regulatory and industry constraints on promotion.
All warning letters published by the FDA between 5 May 1995 and 11 June 2007 were reviewed. Warning letters related to promotional issues were included and analysed. Information related to the identification number, date of the warning letter, FDA division that issued the letter, drug name, manufacturer, specific warning problem, type of promotional material and requested action was extracted. Two independent investigators reviewed and classified each PDF file, any differences were discussed until a consensus was reached.
Between May 1995 and June 2007 a total of 8692 warning letters were issued, of which 25% were related to drugs. Of these, 206 warning letters focused on drug promotion and were included in this study: 23% were issued in 2005, 15% in 2004 and 14% in 1998. In total, 47% of the warning letters were issued because of false or misleading unapproved doses and uses, 27% failed to disclose risks, 15% cited misleading promotion, 8% related to misleading labelling and 3% promoted false effectiveness claims.
There is an important variation in the number of warning letters issued in the last decade, probably because of the increasing number of drugs approved by the FDA, drug withdrawal scandals, and the publication of the FDA and the Pharmaceutical Research and Manufacturers of America (PhRMA) guidelines.
We found that benefit-related claims, such as unapproved uses or doses of drugs, and failure to disclose risks, are the main causes of FDA issued warning letters for promotional claims related to medications.
PMCID: PMC3864040  PMID: 24353430
13.  Ethical Issues in HIV Prevention Research with People Who Inject Drugs 
Clinical trials (London, England)  2013;11(2):239-245.
Injection drug use continues to significantly contribute to new infections with HIV. Moreover, conducting HIV prevention research with people who inject drugs (PWIDs) can be complicated for an array of practical, social, legal and ethical reasons. It is critical that these research efforts are sensitive to the particular vulnerabilities associated with injection drug use as well as those related to being at risk for acquiring HIV so as to minimize harm to participants in research.
To describe how we addressed some of these ethical challenges during the course of a large-scale multinational randomized HIV prevention trial involving PWIDs, which was successfully completed.
The ethical issues encountered during the life-cycle of the trial were catalogued by the principal investigator, study coordinator and ethicist working on the trial. Relevant study documents were then reviewed to provide pertinent details. The ethical issues unique to the trial were then described.
Before implementation, the trial faced particularly complex challenges related to the vulnerability of PWIDs where HIV seroincidence rates in the population were high and legal policies and stigma regarding injection drug use was severe. Accordingly, a rapid policy assessment was commissioned and a series of community engagement activities were conducted. During the trial, in addition to using careful standard operating procedures regarding all aspects of trial conduct and extensive staff training, the trial standardized informed consent procedures and assessed them. Further, social harms were monitored along with physical harms and adverse events. Following the decision to close the study, it was critical to develop an orderly and safe process for closing it. The issue of post-trial access to the study medication and a complex intervention also surfaced for consideration.
The issues described in this paper are necessarily limited to how they manifested themselves within the context of a particular trial that was conducted in two countries. In addition, other stakeholders may have divergent views on the ethical issues described and may also have identified additional ethical issues that would warrant examination.
Adopting similar approaches to addressing ethical issues in future research promises to facilitate this work so that needed strategies to prevent HIV infection among PWIDs can be safely and appropriately tested. Future trials enrolling PWID who are at risk of detainment should identify ways of mapping closely their experiences and perceptions in order to better apprehend some of the ethical issues at stake. In addition, scholarly and policy work needs to address the ethical issues related to post-trial access to multi-modal interventions that may be desired by participants, but are not shown to be effective in achieving the primary outcomes of the study.
PMCID: PMC3972281  PMID: 24127238
Research Ethics; Injection Drug Use; HIV Prevention; International
14.  Warm climates of the past—a lesson for the future? 
This Discussion Meeting Issue of the Philosophical Transactions A had its genesis in a Discussion Meeting of the Royal Society which took place on 10–11 October 2011. The Discussion Meeting, entitled ‘Warm climates of the past: a lesson for the future?’, brought together 16 eminent international speakers from the field of palaeoclimate, and was attended by over 280 scientists and members of the public. Many of the speakers have contributed to the papers compiled in this Discussion Meeting Issue. The papers summarize the talks at the meeting, and present further or related work. This Discussion Meeting Issue asks to what extent information gleaned from the study of past climates can aid our understanding of future climate change. Climate change is currently an issue at the forefront of environmental science, and also has important sociological and political implications. Most future predictions are carried out by complex numerical models; however, these models cannot be rigorously tested for scenarios outside of the modern, without making use of past climate data. Furthermore, past climate data can inform our understanding of how the Earth system operates, and can provide important contextual information related to environmental change. All past time periods can be useful in this context; here, we focus on past climates that were warmer than the modern climate, as these are likely to be the most similar to the future. This introductory paper is not meant as a comprehensive overview of all work in this field. Instead, it gives an introduction to the important issues therein, using the papers in this Discussion Meeting Issue, and other works from all the Discussion Meeting speakers, as exemplars of the various ways in which past climates can inform projections of future climate. Furthermore, we present new work that uses a palaeo constraint to quantitatively inform projections of future equilibrium ice sheet change.
PMCID: PMC3785815  PMID: 24043873
palaeoclimate; future climate; modelling; proxy data
15.  Information from Pharmaceutical Companies and the Quality, Quantity, and Cost of Physicians' Prescribing: A Systematic Review 
PLoS Medicine  2010;7(10):e1000352.
Geoff Spurling and colleagues report findings of a systematic review looking at the relationship between exposure to promotional material from pharmaceutical companies and the quality, quantity, and cost of prescribing. They fail to find evidence of improvements in prescribing after exposure, and find some evidence of an association with higher prescribing frequency, higher costs, or lower prescribing quality.
Pharmaceutical companies spent $57.5 billion on pharmaceutical promotion in the United States in 2004. The industry claims that promotion provides scientific and educational information to physicians. While some evidence indicates that promotion may adversely influence prescribing, physicians hold a wide range of views about pharmaceutical promotion. The objective of this review is to examine the relationship between exposure to information from pharmaceutical companies and the quality, quantity, and cost of physicians' prescribing.
Methods and Findings
We searched for studies of physicians with prescribing rights who were exposed to information from pharmaceutical companies (promotional or otherwise). Exposures included pharmaceutical sales representative visits, journal advertisements, attendance at pharmaceutical sponsored meetings, mailed information, prescribing software, and participation in sponsored clinical trials. The outcomes measured were quality, quantity, and cost of physicians' prescribing. We searched Medline (1966 to February 2008), International Pharmaceutical Abstracts (1970 to February 2008), Embase (1997 to February 2008), Current Contents (2001 to 2008), and Central (The Cochrane Library Issue 3, 2007) using the search terms developed with an expert librarian. Additionally, we reviewed reference lists and contacted experts and pharmaceutical companies for information. Randomized and observational studies evaluating information from pharmaceutical companies and measures of physicians' prescribing were independently appraised for methodological quality by two authors. Studies were excluded where insufficient study information precluded appraisal. The full text of 255 articles was retrieved from electronic databases (7,185 studies) and other sources (138 studies). Articles were then excluded because they did not fulfil inclusion criteria (179) or quality appraisal criteria (18), leaving 58 included studies with 87 distinct analyses. Data were extracted independently by two authors and a narrative synthesis performed following the MOOSE guidelines. Of the set of studies examining prescribing quality outcomes, five found associations between exposure to pharmaceutical company information and lower quality prescribing, four did not detect an association, and one found associations with lower and higher quality prescribing. 38 included studies found associations between exposure and higher frequency of prescribing and 13 did not detect an association. Five included studies found evidence for association with higher costs, four found no association, and one found an association with lower costs. The narrative synthesis finding of variable results was supported by a meta-analysis of studies of prescribing frequency that found significant heterogeneity. The observational nature of most included studies is the main limitation of this review.
With rare exceptions, studies of exposure to information provided directly by pharmaceutical companies have found associations with higher prescribing frequency, higher costs, or lower prescribing quality or have not found significant associations. We did not find evidence of net improvements in prescribing, but the available literature does not exclude the possibility that prescribing may sometimes be improved. Still, we recommend that practitioners follow the precautionary principle and thus avoid exposure to information from pharmaceutical companies.
Please see later in the article for the Editors' Summary
Editors' Summary
A prescription drug is a medication that can be supplied only with a written instruction (“prescription”) from a physician or other licensed healthcare professional. In 2009, 3.9 billion drug prescriptions were dispensed in the US alone and US pharmaceutical companies made US$300 billion in sales revenue. Every year, a large proportion of this revenue is spent on drug promotion. In 2004, for example, a quarter of US drug revenue was spent on pharmaceutical promotion. The pharmaceutical industry claims that drug promotion—visits from pharmaceutical sales representatives, advertisements in journals and prescribing software, sponsorship of meetings, mailed information—helps to inform and educate healthcare professionals about the risks and benefits of their products and thereby ensures that patients receive the best possible care. Physicians, however, hold a wide range of views about pharmaceutical promotion. Some see it as a useful and convenient source of information. Others deny that they are influenced by pharmaceutical company promotion but claim that it influences other physicians. Meanwhile, several professional organizations have called for tighter control of promotional activities because of fears that pharmaceutical promotion might encourage physicians to prescribe inappropriate or needlessly expensive drugs.
Why Was This Study Done?
But is there any evidence that pharmaceutical promotion adversely influences prescribing? Reviews of the research literature undertaken in 2000 and 2005 provide some evidence that drug promotion influences prescribing behavior. However, these reviews only partly assessed the relationship between information from pharmaceutical companies and prescribing costs and quality and are now out of date. In this study, therefore, the researchers undertake a systematic review (a study that uses predefined criteria to identify all the research on a given topic) to reexamine the relationship between exposure to information from pharmaceutical companies and the quality, quantity, and cost of physicians' prescribing.
What Did the Researchers Do and Find?
The researchers searched the literature for studies of licensed physicians who were exposed to promotional and other information from pharmaceutical companies. They identified 58 studies that included a measure of exposure to any type of information directly provided by pharmaceutical companies and a measure of physicians' prescribing behavior. They then undertook a “narrative synthesis,” a descriptive analysis of the data in these studies. Ten of the studies, they report, examined the relationship between exposure to pharmaceutical company information and prescribing quality (as judged, for example, by physician drug choices in response to clinical vignettes). All but one of these studies suggested that exposure to drug company information was associated with lower prescribing quality or no association was detected. In the 51 studies that examined the relationship between exposure to drug company information and prescribing frequency, exposure to information was associated with more frequent prescribing or no association was detected. Thus, for example, 17 out of 29 studies of the effect of pharmaceutical sales representatives' visits found an association between visits and increased prescribing; none found an association with less frequent prescribing. Finally, eight studies examined the relationship between exposure to pharmaceutical company information and prescribing costs. With one exception, these studies indicated that exposure to information was associated with a higher cost of prescribing or no association was detected. So, for example, one study found that physicians with low prescribing costs were more likely to have rarely or never read promotional mail or journal advertisements from pharmaceutical companies than physicians with high prescribing costs.
What Do These Findings Mean?
With rare exceptions, these findings suggest that exposure to pharmaceutical company information is associated with either no effect on physicians' prescribing behavior or with adverse affects (reduced quality, increased frequency, or increased costs). Because most of the studies included in the review were observational studies—the physicians in the studies were not randomly selected to receive or not receive drug company information—it is not possible to conclude that exposure to information actually causes any changes in physician behavior. Furthermore, although these findings provide no evidence for any net improvement in prescribing after exposure to pharmaceutical company information, the researchers note that it would be wrong to conclude that improvements do not sometimes happen. The findings support the case for reforms to reduce negative influence to prescribing from pharmaceutical promotion.
Additional Information
Please access these Web sites via the online version of this summary at
Wikipedia has pages on prescription drugs and on pharmaceutical marketing (note that Wikipedia is a free online encyclopedia that anyone can edit; available in several languages)
The UK General Medical Council provides guidelines on good practice in prescribing medicines
The US Food and Drug Administration provides information on prescription drugs and on its Bad Ad Program
Healthy Skepticism is an international nonprofit membership association that aims to improve health by reducing harm from misleading health information
The Drug Promotion Database was developed by the World Health Organization Department of Essential Drugs & Medicines Policy and Health Action International Europe to address unethical and inappropriate drug promotion
PMCID: PMC2957394  PMID: 20976098
16.  Breast Cancer Survivorship: A Comprehensive Review of Long-Term Medical Issues and Lifestyle Recommendations 
The Permanente Journal  2015;19(2):48-79.
As breast cancer becomes a chronic condition rather than a life-threatening illness, survivors not only have the challenge of dealing with multiple long-term side effects of treatment protocols, but may also be forced to address the preexisting comorbidities of their therapies, which often include multiple other issues. It is imperative that the information available regarding survivorship issues be accessible in an organized and useful format. This article is a modest attempt to provide a comprehensive review of the long-term medical issues.
Long-term survival rates after a diagnosis of breast cancer are steadily rising. This is good news, but clinicians must also recognize that this brings new challenges to the medical community. As breast cancer becomes a chronic condition rather than a life-threatening illness owing to advances in early diagnosis and more effective treatments, health care practitioners must recognize and manage the long-term sequelae of the constellation of therapeutic modalities. Survivors of breast cancer represent a unique and extremely complex group of patients; not only do they have the challenge of dealing with multiple long-term side effects of treatment protocols, but many are also forced to address the preexisting comorbidities of their therapies, which often include multiple other issues. Therapies have additional and/or additive side effects that may interfere with treatments directed toward the new primary diagnosis of breast cancer. Our mandate is to establish a smooth transition from patient with breast cancer to survivor of breast cancer while providing ongoing and future guidance.
Certainly, the information and resources to accomplish this transition are readily available; however, they are scattered throughout the literature and therefore are not easily accessible or available to the primary care physician. It is imperative that the information available regarding survivorship issues be accessible in an organized and useful format. This article is a modest attempt to provide a comprehensive review of the long-term medical issues relevant to survivorship after the diagnosis and treatment of breast cancer. A predicted shortage of oncologists by 2020 is well-recognized. Therefore, the bulk of long-term care will become dependent on the primary care physician. This shift of care means that these physicians will need to be well educated in the long-term medical issues related to breast cancer treatment.
PMCID: PMC4403581  PMID: 25902343
17.  Corporate Social Responsibility and Access to Policy Élites: An Analysis of Tobacco Industry Documents 
PLoS Medicine  2011;8(8):e1001076.
Gary Fooks and colleagues undertook a review of tobacco industry documents and show that policies on corporate social responsibility can enable access to and dialogue with policymakers at the highest level.
Recent attempts by large tobacco companies to represent themselves as socially responsible have been widely dismissed as image management. Existing research supports such claims by pointing to the failings and misleading nature of corporate social responsibility (CSR) initiatives. However, few studies have focused in depth on what tobacco companies hoped to achieve through CSR or reflected on the extent to which these ambitions have been realised.
Methods and Findings
Iterative searching relating to CSR strategies was undertaken of internal British American Tobacco (BAT) documents, released through litigation in the US. Relevant documents (764) were indexed and qualitatively analysed. In the past decade, BAT has actively developed a wide-ranging CSR programme. Company documents indicate that one of the key aims of this programme was to help the company secure access to policymakers and, thereby, increase the company's chances of influencing policy decisions. Taking the UK as a case study, this paper demonstrates the way in which CSR can be used to renew and maintain dialogue with policymakers, even in ostensibly unreceptive political contexts. In practice, the impact of this political use of CSR is likely to be context specific; depending on factors such as policy élites' understanding of the credibility of companies as a reliable source of information.
The findings suggest that tobacco company CSR strategies can enable access to and dialogue with policymakers and provide opportunities for issue definition. CSR should therefore be seen as a form of corporate political activity. This underlines the need for broad implementation of Article 5.3 of the Framework Convention on Tobacco Control. Measures are needed to ensure transparency of interactions between all parts of government and the tobacco industry and for policy makers to be made more aware of what companies hope to achieve through CSR.
Please see later in the article for the Editors' Summary
Editors' Summary
In the past, companies and multinational corporations were judged on the profits they made. Nowadays, though, much is made of corporate social responsibility (CSR). CSR is the commitment by business to behave ethically and to contribute to economic development while improving the quality of life of the workforce, their families, the local community, and society at large. Put simply, companies and corporations now endeavor to show that they have a positive impact on the environment, consumers, employees, and society in addition to making money for their shareholders. Large tobacco companies are no exception. British American Tobacco (BAT, the world's second largest publicly traded tobacco company), for example, began working on a wide-ranging CSR program more than a decade ago. Given that tobacco is responsible for an estimated 5.4 million deaths worldwide annually, this program was initially met with hostility and dismissed as an image management exercise. However, large parts of the investment and CSR communities now approve of BAT's CSR program, which has won numerous awards.
Why Was This Study Done?
But what do BAT and other tobacco companies actually hope to achieve through their CSR initiatives and how successful have they been in achieving these aims? Few studies have addressed these important questions. In particular, there has been little research into the extent to which tobacco companies use CSR initiatives as a form of corporate political activity that can help them gain “access” to policymakers and define the legitimate concerns and optimal alternatives of public policy (“issue definition”). Access is defined as taking place when policymakers consider the views of policy advocates such as tobacco company employees and is a crucial component of issue definition, which refers to the strategies adopted by bodies such as multinational corporations to influence the policy agenda by defining what issues public policy should concern itself with and how it should approach them. In this case study, the researchers explore whether BAT's CSR program works as a form of corporate political activity by systematically examining internal BAT documents made publicly available as a result of US litigation. Specifically, the researchers examine BAT's efforts through its CSR program to reestablish access with the UK Department of Health following the department's decision in the late 1990s to restrict contact with major tobacco companies.
What Did the Researchers Do and Find?
Using iterative searching, the researchers identified 764 documents in the Legacy Tobacco Documents Library (a large collection of internal tobacco company documents released as a result of US litigation cases) that contain information relevant to BAT's CSR strategies. Their analysis of these documents indicates that one of the key aims of the CSR program actively developed over the past decade by BAT was to help secure access to policymakers and shows how BAT used CSR to renew and maintain dialogue with policymakers at a time when contact between government and tobacco companies was extremely restricted. The documents also show that BAT employees used CSR initiatives as a means of issue definition to both optimize the probability of subsequent discussions taking place and to frame their content. Finally, the documents illustrate how BAT used its CSR program to expand the number of access points across government, thereby providing BAT with more opportunities to meet and talk to officials.
What Do These Findings Mean?
These findings suggest that CSR is a form of corporate political activity that potentially has important implications for public health given the documented impact of the political activity of tobacco companies in delaying and blocking health-related tobacco control policies. In practice, the impact of the political use of CSR is likely to be context specific and will depend on factors such as whether senior policymakers regard companies as reliable sources of information. Importantly, these findings underline the need for broad implementation of Article 5.3 of the World Health Organization's Framework Convention on Tobacco Control (FCTC), an international treaty that calls for the introduction of multiple measures to reduce tobacco consumption, including tobacco advertizing bans and relevant taxation policies. Article 5.3 aims to protect public-health policies on tobacco control from tobacco industry influence. The findings of this study indicate that implementation of Article 5.3 will require measures that ensure transparency in interactions between all parts of government and the tobacco industry and will need an increased awareness across government of what tobacco companies hope to achieve through CSR.
Additional Information
Please access these Web sites via the online version of this summary at
The Corporate Responsibility (CORE) coalition, an alliance of voluntary organizations, trade unions, and companies, maintains a Web site that contains useful material on corporate social responsibility
The European Coalition for Corporate Justice (ECCJ) promotes corporate accountability by bringing together national platforms of civil society organizations (including NGOs, trade unions, consumer advocacy groups, and academic institutions) from all over Europe
The Legacy Tobacco Documents Library is a public, searchable database of tobacco company internal documents detailing their advertising, manufacturing, marketing, sales, and scientific activities
The World Health Organization provides information about the dangers of tobacco (in several languages), details of the Framework Convention on Tobacco Control (in several languages), and guidelines for the implementation of Article 5.3 of the FCTC
The Framework Convention Alliance provides more information about the FCTC
For information about tobacco industry influence on policy, see the 2009 World Health Organization report Tobacco interference with tobacco control
PMCID: PMC3160341  PMID: 21886485
18.  Rational Prescribing in Primary Care (RaPP): A Cluster Randomized Trial of a Tailored Intervention 
PLoS Medicine  2006;3(6):e134.
A gap exists between evidence and practice regarding the management of cardiovascular risk factors. This gap could be narrowed if systematically developed clinical practice guidelines were effectively implemented in clinical practice. We evaluated the effects of a tailored intervention to support the implementation of systematically developed guidelines for the use of antihypertensive and cholesterol-lowering drugs for the primary prevention of cardiovascular disease.
Methods and Findings
We conducted a cluster-randomized trial comparing a tailored intervention to passive dissemination of guidelines in 146 general practices in two geographical areas in Norway. Each practice was randomized to either the tailored intervention (70 practices; 257 physicians) or control group (69 practices; 244 physicians). Patients started on medication for hypertension or hypercholesterolemia during the study period and all patients already on treatment that consulted their physician during the trial were included. A multifaceted intervention was tailored to address identified barriers to change. Key components were an educational outreach visit with audit and feedback, and computerized reminders linked to the medical record system. Pharmacists conducted the visits. Outcomes were measured for all eligible patients seen in the participating practices during 1 y before and after the intervention. The main outcomes were the proportions of (1) first-time prescriptions for hypertension where thiazides were prescribed, (2) patients assessed for cardiovascular risk before prescribing antihypertensive or cholesterol-lowering drugs, and (3) patients treated for hypertension or hypercholesterolemia for 3 mo or more who had achieved recommended treatment goals.
The intervention led to an increase in adherence to guideline recommendations on choice of antihypertensive drug. Thiazides were prescribed to 17% of patients in the intervention group versus 11% in the control group (relative risk 1.94; 95% confidence interval 1.49–2.49, adjusted for baseline differences and clustering effect). Little or no differences were found for risk assessment prior to prescribing and for achievement of treatment goals.
Our tailored intervention had a significant impact on prescribing of antihypertensive drugs, but was ineffective in improving the quality of other aspects of managing hypertension and hypercholesterolemia in primary care.
Editors' Summary
An important issue in health care is “getting research into practice,” in other words, making sure that, when evidence from research has established the best way to treat a disease, doctors actually use that approach with their patients. In reality, there is often a gap between evidence and practice.
  An example concerns the treatment of people who have high blood pressure (hypertension) and/or high cholesterol. These are common conditions, and both increase the risk of having a heart attack or a stroke. Research has shown that the risks can be lowered if patients with these conditions are given drugs that lower blood pressure (antihypertensives) and drugs that lower cholesterol. There are many types of these drugs now available. In many countries, the health authorities want family doctors (general practitioners) to make better use of these drugs. They want doctors to prescribe them to everyone who would benefit, using the type of drugs found to be most effective. When there is a choice of drugs that are equally effective, they want doctors to use the cheapest type. (In the case of antihypertensives, an older type, known as thiazides, is very effective and also very cheap, but many doctors prefer to give their patients newer, more expensive alternatives.) Health authorities have issued guidelines to doctors that address these issues. However, it is not easy to change prescribing practices, and research in several countries has shown that issuing guidelines has only limited effects.
Why Was This Study Done?
The researchers wanted—in two parts of Norway—to compare the effects on prescribing practices of what they called the “passive dissemination of guidelines” with a more active approach, where the use of the guidelines was strongly promoted and encouraged.
What Did the Researchers Do and Find?
They worked with 146 general practices. In half of them the guidelines were actively promoted. The remaining were regarded as a control group; they were given the guidelines but no special efforts were made to encourage their use. It was decided at random which practices would be in which group; this approach is called a randomized controlled trial. The methods used to actively promote use of the guidelines included personal visits to the practices by pharmacists and use of a computerized reminder system. Information was then collected on the number of patients who, when first treated for hypertension, were prescribed a thiazide. Other information collected included whether patients had been properly assessed for their level of risk (for strokes and heart attacks) before antihypertensive or cholesterol-lowering drugs were given. In addition, the researchers recorded whether the recommended targets for improvement in blood pressure and cholesterol level had been reached.
Only 11% of those patients visiting the control group of practices who should have been prescribed thiazides, according to the guidelines, actually received them. Of those seen by doctors in the practices where the guidelines were actively promoted, 17% received thiazides. According to statistical analysis, the increase achieved by active promotion is significant. Little or no differences were found for risk assessment prior to prescribing and for achievement of treatment goals.
What Do These Findings Mean?
Even in the active promotion group, the great majority of patients (83%) were still not receiving treatment according to the guidelines. However, active promotion of guidelines is more effective than simply issuing the guidelines by themselves. The study also demonstrates that it is very hard to change prescribing practices. The efforts made here to encourage the doctors to change were considerable, and although the results were significant, they were still disappointing. Also disappointing is the fact that achievement of treatment goals was no better in the active-promotion group. These issues are discussed further in a Perspective about this study (DOI: 10.1371/journal.pmed.0030229).
Additional Information.
Please access these Web sites via the online version of this summary at
• The Web site of the American Academy of Family Physicians has a page on heart disease
• The MedlinePlus Medical Encyclopedia's pages on heart diseases and vascular diseases
• Information from NHS Direct (UK National Health Service) about heart attack and stroke
• Another PLoS Medicine article has also addressed trends in thiazide prescribing
Passive dissemination of management guidelines for hypertension and hypercholesterolaemia was compared with active promotion. Active promotion led to significant improvement in antihypertensive prescribing but not other aspects of management.
PMCID: PMC1472695  PMID: 16737346
19.  Informed recruitment in partner studies of HIV transmission: an ethical issue in couples research 
BMC Medical Ethics  2009;10:14.
Much attention has been devoted to ethical issues related to randomized controlled trials for HIV treatment and prevention. However, there has been less discussion of ethical issues surrounding families involved in observational studies of HIV transmission. This paper describes the process of ethical deliberation about how best to obtain informed consent from sex partners of injection drug users (IDUs) tested for HIV, within a recent HIV study in Eastern Europe. The study aimed to assess the amount of HIV serodiscordance among IDUs and their sexual partners, identify barriers to harm reduction, and explore ways to optimize intervention programs. Including IDUs, either HIV-positive or at high risk for HIV, and their sexual partners would help to gain a more complete understanding of barriers to and opportunities for intervention.
This paper focuses on the ethical dilemma regarding informed recruitment: whether researchers should disclose to sexual partners of IDUs that they were recruited because their partner injects drugs (i.e., their heightened risk for HIV). Disclosing risks to partners upholds the ethical value of respect for persons through informed consent. However, disclosure compromises the IDU's confidentiality, and potentially, the scientific validity of the research. Following a brief literature review, we summarize the researchers' systematic evaluation of this issue from ethical, scientific, and logistical perspectives. While the cultural context may be somewhat unique to Eastern Europe and Central Asia, the issues raised and solutions proposed here inform epidemiological research designs and their underlying ethical tensions.
We present ethical arguments in favor of disclosure, discuss how cultural context shapes the ethical issues, and recommend refinement of guidance for couples research of communicable diseases to assist investigators encountering these ethical issues in the future.
PMCID: PMC2751767  PMID: 19709442
20.  Supporting Cancer Patients in Illness Management: Usability Evaluation of a Mobile App 
JMIR mHealth and uHealth  2014;2(3):e33.
Mobile phones and tablets currently represent a significant presence in people’s everyday lives. They enable access to different information and services independent of current place and time. Such widespread connectivity offers significant potential in different app areas including health care.
Our goal was to evaluate the usability of the Connect Mobile app. The mobile app enables mobile access to the Connect system, an online system that supports cancer patients in managing health-related issues. Along with symptom management, the system promotes better patient-provider communication, collaboration, and shared decision making. The Connect Mobile app enables access to the Connect system over both mobile phones and tablets.
The study consisted of usability tests of a high fidelity prototype with 7 cancer patients where the objectives were to identify existing design and functionality issues and to provide patients with a real look-and-feel of the mobile system. In addition, we conducted semistructured interviews to obtain participants’ feedback about app usefulness, identify the need for new system features and design requirements, and measure the acceptance of the mobile app and its features within everyday health management.
The study revealed a total of 27 design issues (13 for mobile apps and 14 for tablet apps), which were mapped to source events (ie, errors, requests for help, participants' concurrent feedback, and moderator observation). We also applied usability heuristics to identify violations of usability principles. The majority of violations were related to enabling ease of input, screen readability, and glanceability (15 issues), as well as supporting an appropriate match between systems and the real world (7 issues) and consistent mapping of system functions and interactions (4 issues). Feedback from participants also showed the cancer patients’ requirements for support systems and how these needs are influenced by different context-related factors, such as type of access terminal (eg, desktop computer, tablet, mobile phone) and phases of illness. Based on the observed results, we proposed design and functionality recommendations that can be used for the development of mobile apps for cancer patients to support their health management process.
Understanding and addressing users’ requirements is one of the main prerequisites for developing useful and effective technology-based health interventions. The results of this study outline different user requirements related to the design of the mobile patient support app for cancer patients. The results will be used in the iterative development of the Connect Mobile app and can also inform other developers and researchers in development, integration, and evaluation of mobile health apps and services that support cancer patients in managing their health-related issues.
PMCID: PMC4147703  PMID: 25119490
mobile applications; patients; cell phone; smartphone; symptom assessment; self-care; user-computer interface
21.  Interactions between Non-Physician Clinicians and Industry: A Systematic Review 
PLoS Medicine  2013;10(11):e1001561.
In a systematic review of studies of interactions between non-physician clinicians and industry, Quinn Grundy and colleagues found that many of the issues identified for physicians' industry interactions exist for non-physician clinicians.
Please see later in the article for the Editors' Summary
With increasing restrictions placed on physician–industry interactions, industry marketing may target other health professionals. Recent health policy developments confer even greater importance on the decision making of non-physician clinicians. The purpose of this systematic review is to examine the types and implications of non-physician clinician–industry interactions in clinical practice.
Methods and Findings
We searched MEDLINE and Web of Science from January 1, 1946, through June 24, 2013, according to PRISMA guidelines. Non-physician clinicians eligible for inclusion were: Registered Nurses, nurse prescribers, Physician Assistants, pharmacists, dieticians, and physical or occupational therapists; trainee samples were excluded. Fifteen studies met inclusion criteria. Data were synthesized qualitatively into eight outcome domains: nature and frequency of industry interactions; attitudes toward industry; perceived ethical acceptability of interactions; perceived marketing influence; perceived reliability of industry information; preparation for industry interactions; reactions to industry relations policy; and management of industry interactions. Non-physician clinicians reported interacting with the pharmaceutical and infant formula industries. Clinicians across disciplines met with pharmaceutical representatives regularly and relied on them for practice information. Clinicians frequently received industry “information,” attended sponsored “education,” and acted as distributors for similar materials targeted at patients. Clinicians generally regarded this as an ethical use of industry resources, and felt they could detect “promotion” while benefiting from industry “information.” Free samples were among the most approved and common ways that clinicians interacted with industry. Included studies were observational and of varying methodological rigor; thus, these findings may not be generalizable. This review is, however, the first to our knowledge to provide a descriptive analysis of this literature.
Non-physician clinicians' generally positive attitudes toward industry interactions, despite their recognition of issues related to bias, suggest that industry interactions are normalized in clinical practice across non-physician disciplines. Industry relations policy should address all disciplines and be implemented consistently in order to mitigate conflicts of interest and address such interactions' potential to affect patient care.
Please see later in the article for the Editors' Summary
Editors' Summary
Making and selling health care goods (including drugs and devices) and services is big business. To maximize the profits they make for their shareholders, companies involved in health care build relationships with physicians by providing information on new drugs, organizing educational meetings, providing samples of their products, giving gifts, and holding sponsored events. These relationships help to keep physicians informed about new developments in health care but also create the potential for causing harm to patients and health care systems. These relationships may, for example, result in increased prescription rates of new, heavily marketed medications, which are often more expensive than their generic counterparts (similar unbranded drugs) and that are more likely to be recalled for safety reasons than long-established drugs. They may also affect the provision of health care services. Industry is providing an increasingly large proportion of routine health care services in many countries, so relationships built up with physicians have the potential to influence the commissioning of the services that are central to the treatment and well-being of patients.
Why Was This Study Done?
As a result of concerns about the tension between industry's need to make profits and the ethics underlying professional practice, restrictions are increasingly being placed on physician–industry interactions. In the US, for example, the Physician Payments Sunshine Act now requires US manufacturers of drugs, devices, and medical supplies that participate in federal health care programs to disclose all payments and gifts made to physicians and teaching hospitals. However, other health professionals, including those with authority to prescribe drugs such as pharmacists, Physician Assistants, and nurse practitioners are not covered by this legislation or by similar legislation in other settings, even though the restructuring of health care to prioritize primary care and multidisciplinary care models means that “non-physician clinicians” are becoming more numerous and more involved in decision-making and medication management. In this systematic review (a study that uses predefined criteria to identify all the research on a given topic), the researchers examine the nature and implications of the interactions between non-physician clinicians and industry.
What Did the Researchers Do and Find?
The researchers identified 15 published studies that examined interactions between non-physician clinicians (Registered Nurses, nurse prescribers, midwives, pharmacists, Physician Assistants, and dieticians) and industry (corporations that produce health care goods and services). They extracted the data from 16 publications (representing 15 different studies) and synthesized them qualitatively (combined the data and reached word-based, rather than numerical, conclusions) into eight outcome domains, including the nature and frequency of interactions, non-physician clinicians' attitudes toward industry, and the perceived ethical acceptability of interactions. In the research the authors identified, non-physician clinicians reported frequent interactions with the pharmaceutical and infant formula industries. Most non-physician clinicians met industry representatives regularly, received gifts and samples, and attended educational events or received educational materials (some of which they distributed to patients). In these studies, non-physician clinicians generally regarded these interactions positively and felt they were an ethical and appropriate use of industry resources. Only a minority of non-physician clinicians felt that marketing influenced their own practice, although a larger percentage felt that their colleagues would be influenced. A sizeable proportion of non-physician clinicians questioned the reliability of industry information, but most were confident that they could detect biased information and therefore rated this information as reliable, valuable, or useful.
What Do These Findings Mean?
These and other findings suggest that non-physician clinicians generally have positive attitudes toward industry interactions but recognize issues related to bias and conflict of interest. Because these findings are based on a small number of studies, most of which were undertaken in the US, they may not be generalizable to other countries. Moreover, they provide no quantitative assessment of the interaction between non-physician clinicians and industry and no information about whether industry interactions affect patient care outcomes. Nevertheless, these findings suggest that industry interactions are normalized (seen as standard) in clinical practice across non-physician disciplines. This normalization creates the potential for serious risks to patients and health care systems. The researchers suggest that it may be unrealistic to expect that non-physician clinicians can be taught individually how to interact with industry ethically or how to detect and avert bias, particularly given the ubiquitous nature of marketing and promotional materials. Instead, they suggest, the environment in which non-physician clinicians practice should be structured to mitigate the potentially harmful effects of interactions with industry.
Additional Information
Please access these websites via the online version of this summary at
This study is further discussed in a PLOS Medicine Perspective by James S. Yeh and Aaron S. Kesselheim
The American Medical Association provides guidance for physicians on interactions with pharmaceutical industry representatives, information about the Physician Payments Sunshine Act, and a toolkit for preparing Physician Payments Sunshine Act reports
The International Council of Nurses provides some guidance on industry interactions in its position statement on nurse-industry relations
The UK General Medical Council provides guidance on financial and commercial arrangements and conflicts of interest as part of its good medical practice website, which describes what is required of all registered doctors in the UK
Understanding and Responding to Pharmaceutical Promotion: A Practical Guide is a manual prepared by Health Action International and the World Health Organization that schools of medicine and pharmacy can use to train students how to recognize and respond to pharmaceutical promotion.
The Institute of Medicine's Report on Conflict of Interest in Medical Research, Education, and Practice recommends steps to identify, limit, and manage conflicts of interest
The University of California, San Francisco, Office of Continuing Medical Education offers a course called Marketing of Medicines
PMCID: PMC3841103  PMID: 24302892
22.  Clinically relevant safety issues associated with St. John's wort product labels 
St. John's wort (SJW), used to treat depression, is popular in the USA, Canada, and parts of Europe. However, there are documented interactions between SJW and prescription medications including warfarin, cyclosporine, indinavir, and oral contraceptives. One source of information about these safety considerations is the product label. The aim of this study was to evaluate the clinically relevant safety information included on labeling in a nationally representative sample of SJW products from the USA.
Eight clinically relevant safety issues were identified: drug interactions (SJW-HIV medications, SJW-immunosupressants, SJW-oral contraceptives, and SJW-warfarin), contraindications (bipolar disorder), therapeutic duplication (antidepressants), and general considerations (phototoxicity and advice to consult a healthcare professional (HCP)). A list of SJW products was identified to assess their labels. Percentages and totals were used to present findings.
Of the seventy-four products evaluated, no product label provided information for all 8 evaluation criteria. Three products (4.1%) provided information on 7 of the 8 criteria. Four products provided no safety information whatsoever. Percentage of products with label information was: SJW-HIV (8.1%), SJW-immunosupressants (5.4%), SJW-OCPs (8.1%), SJW-warfarin (5.4%), bipolar (1.4%), antidepressants (23.0%), phototoxicity (51.4%), and consult HCP (87.8%). Other safety-related information on labels included warnings about pregnancy (74.3%), lactation (64.9%), discontinue if adverse reaction (23.0%), and not for use in patients under 18 years old (13.5%). The average number of a priori safety issues included on a product label was 1.91 (range 0–8) for 23.9% completeness.
The vast majority of SJW products fail to adequately address clinically relevant safety issues on their labeling. A few products do provide an acceptable amount of information on clinically relevant safety issues which could enhance the quality of counseling by HCPs and health store clerks. HCPs and consumers may benefit if the FDA re-examined labeling requirements for dietary supplements.
PMCID: PMC2483264  PMID: 18637192
23.  Issues in mHealth: Findings From Key Informant Interviews 
mHealth is enjoying considerable interest and private investment in the United States. A small but growing body of evidence indicates some promise in supporting healthy behavior change and self-management of long-term conditions. The unique benefits mobile phones bring to health initiatives, such as direct access to health information regardless of time or location, may create specific issues for the implementation of such initiatives. Other issues may be shared with general health information technology developments.
To determine the important issues facing the implementation of mHealth from the perspective of those within the US health system and those working in mHealth in the United States.
Semistructured interviews were conducted with 27 key informants from across the health and mHealth sectors in the United States. Interviewees were approached directly following an environmental scan of mHealth in the United States or recommendation by those working in mHealth.
The most common issues were privacy and data security, funding, a lack of good examples of the efficacy and cost effectiveness of mHealth in practice, and the need for more high-quality research. The issues are outlined and categorized according to the environment within which they predominantly occur: policy and regulatory environments; the wireless industry; the health system; existing mHealth practice; and research.
Many of these issues could be addressed by making the most of the current US health reform environment, developing a strategic and coordinated approach, and seeking to improve mHealth practice.
PMCID: PMC3510768  PMID: 23032424
Cellular phone; mobile health; mobile phone
24.  Complexity in Non-Pharmacological Caregiving Activities at the End of Life: An International Qualitative Study 
PLoS Medicine  2012;9(2):e1001173.
In a qualitative study reported by Olav Lindqvist and colleagues, the range of nonpharmacological caregiving activities used in the last days of a patient's life are described.
In late-stage palliative cancer care, relief of distress and optimized well-being become primary treatment goals. Great strides have been made in improving and researching pharmacological treatments for symptom relief; however, little systematic knowledge exists about the range of non-pharmacological caregiving activities (NPCAs) staff use in the last days of a patient's life.
Methods and Findings
Within a European Commission Seventh Framework Programme project to optimize research and clinical care in the last days of life for patients with cancer, OPCARE9, we used a free-listing technique to identify the variety of NPCAs performed in the last days of life. Palliative care staff at 16 units in nine countries listed in detail NPCAs they performed over several weeks. In total, 914 statements were analyzed in relation to (a) the character of the statement and (b) the recipient of the NPCA. A substantial portion of NPCAs addressed bodily care and contact with patients and family members, with refraining from bodily care also described as a purposeful caregiving activity. Several forms for communication were described; information and advice was at one end of a continuum, and communicating through nonverbal presence and bodily contact at the other. Rituals surrounding death and dying included not only spiritual/religious issues, but also more subtle existential, legal, and professional rituals. An unexpected and hitherto under-researched area of focus was on creating an aesthetic, safe, and pleasing environment, both at home and in institutional care settings.
Based on these data, we argue that palliative care in the last days of life is multifaceted, with physical, psychological, social, spiritual, and existential care interwoven in caregiving activities. Providing for fundamental human needs close to death appears complex and sophisticated; it is necessary to better distinguish nuances in such caregiving to acknowledge, respect, and further develop end-of-life care.
Please see later in the article for the Editors' Summary
Editors' Summary
End-of-life care is a major public health issue, yet despite the inevitability of death, issues related to death and dying are often taboo, and, if mentioned, are often referred to as “palliative care.” There are detailed definitions of palliative care, but in essence, the purpose of palliative care is to relieve any suffering in patients who are dying from progressive illness and to provide the best possible quality of life for both the patient and his or her family. In order to achieve this aim, both pharmacological and non-pharmacological management is necessary, with the latter taking a central role. Recently, a European Commission Seventh Framework Programme project, OPCARE9, aimed to improve the care of dying patients in Europe and beyond by optimizing research and clinical care for patients with cancer in the last days of their life, especially regarding well-being and comfort as death becomes imminent.
Why Was This Study Done?
There is now a growing literature base in non-pharmacological management at the end of an individual's life, particularly in relation to psychological, ethical, and communication issues as well as family-focused and culturally appropriate care. Despite this progress, there is currently little systematic knowledge in how health workers use such non-pharmacological approaches in their efforts to maximize well-being and comfort in patients experiencing their very last days of life. Therefore, in order to advance knowledge in this important clinical area, in this study the researchers reviewed and identified the variety of non-pharmacological caregiving activities performed by different professionals in the last days and hours of life for patients with cancer (and their families) in palliative care settings in the countries that participated in OPCARE9.
What Did the Researchers Do and Find?
The researchers modified an anthropological approach to collect relevant information in participating European countries—Germany, Italy, the Netherlands, Slovenia, Sweden, Switzerland, and the UK—and Argentina and New Zealand. Staff in palliative care settings generated a list of non-pharmacological caregiving activities after discussion about which interventions and activities they carried out with patients and families during the last days of life. This preliminary list of statements was added to if staff performed a new activity when in contact with patients or the patients' family during the last days of life. The researchers then used computer-assisted qualitative data analysis to code the statements.
Using this methodology, the researchers analyzed 914 statements of caregiving activities from 16 different facilities in nine countries. The greatest number of activities described some type of caregiving for an individual carried out through contact with his or her body, such as attending to diverse bodily needs (such as cleaning and moisturizing) while maintaining comfort and dignity. Listening, talking with, and understanding (particularly between professionals and the family) was the next most frequent activity, followed by creating an esthetical, safe, and pleasing environment for the dying person and his or her family, and necessary “backstage” activities, such as organizing paperwork or care plans. Other common activities included observing and assessing, which were often described as being carried out simultaneously with other interventions; just being present (described as increasingly important close to death); performing rituals surrounding death and dying (usually directed to families); guiding and facilitating (encompassing support in a compassionate manner); and finally, giving oral and written information and advice (usually to families).
What Do These Findings Mean?
These findings show that providing for fundamental human needs close to death is complex and sophisticated but ultimately integrated into a common theme of caregiving. This study also identifies a number of areas needing further investigation, such as enhancing the sensory and general environment for the patient and family. Finally, this study suggests that developing a greater level of detail, such as improved terminology for end-of-life care, would enhance appreciation of the nuances and complexity present in non-pharmacological care provision during the last days of life, with potential benefit for clinical practice, teaching, and research.
Additional Information
Please access these websites via the online version of this summary at
The OPCARE9 website details more information about this end-of-life care initiative
The World Health Organization website defines palliative care, and Wikipedia gives more information (note that Wikipedia is a free online encyclopedia that anyone can edit; available in several languages)
NHS Choices also provides information about end-of-life care
PMCID: PMC3279347  PMID: 22347815
25.  Information disclosure in clinical informed consent: “reasonable” patient’s perception of norm in high-context communication culture 
BMC Medical Ethics  2014;15:3.
The current doctrine of informed consent for clinical care has been developed in cultures characterized by low-context communication and monitoring-style coping. There are scarce empirical data on patients’ norm perception of information disclosure in other cultures.
We surveyed 470 adults who were planning to undergo or had recently undergone a written informed consent-requiring procedure in a tertiary healthcare hospital in Saudi Arabia. Perceptions of norm and current practice were explored using a 5-point Likert scale (1 = strongly agree with disclosure) and 30 information items in 7 domains: practitioners’ details, benefits, risks, complications’ management, available alternatives, procedure’s description, and post-procedure’s issues.
Respondents’ mean (SD) age was 38.4 (12.5); 50.2% were males, 57.2% had ≥ college education, and 37.9% had undergone a procedure. According to norm perception, strongly agree/agree responses ranged from 98.0% (major benefits) to 50.5% (assistant/trainee’s name). Overall, items related to benefits and post-procedure’s issues were ranked better (more agreeable) than items related to risks and available alternatives. Ranking scores were better in post-procedure respondents for 4 (13.3%) items (p < 0.001 to 0.001) and in males for 8 (26.7%) items (p = 0.008 to <0.001). Older age was associated with better ranking scores for 3 (10.0%) items and worse for one (p < 0.001 to 0.006). According to current practice perception, strongly agree/agree responses ranged from 93.3% (disclosure of procedure’s name) to 13.9% (lead practitioner’s training place), ranking scores were worse for all items compared to norm perception (p < 0.001), and post-procedure status, younger age, and lower educational level were associated with better ranking scores for 15 (50.0%), 12 (40.0%), and 4 (13.3%) items, respectively (p < 0.001 to 0.009).
1) even in an overall high-context communication culture, extensive and more information than is currently disclosed is perceived as norm, 2) the focus of the desired information is closer to benefits and post-procedure’s issues than risks and available alternatives, 3) male, post-procedure, and older patients are in favor of more information disclosure, 4) male, older, and more educated patients may be particularly dissatisfied with current information disclosure. The focus and extent of information disclosure for clinical informed consent may need to be adjusted if a “reasonable” patient’s standard is to be met.
PMCID: PMC3930349  PMID: 24406055
Clinical informed consent; Middle East; Information disclosure; Norm perception; Current practice; Gender; Age; High-context communication; Blunting-style coping; Reasonable patient’s standard

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