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1.  SUPPORT Tools for evidence-informed health Policymaking (STP) 13: Preparing and using policy briefs to support evidence-informed policymaking 
Health Research Policy and Systems  2009;7(Suppl 1):S13.
This article is part of a series written for people responsible for making decisions about health policies and programmes and for those who support these decision makers.
Policy briefs are a relatively new approach to packaging research evidence for policymakers. The first step in a policy brief is to prioritise a policy issue. Once an issue is prioritised, the focus then turns to mobilising the full range of research evidence relevant to the various features of the issue. Drawing on available systematic reviews makes the process of mobilising evidence feasible in a way that would not otherwise be possible if individual relevant studies had to be identified and synthesised for every feature of the issue under consideration. In this article, we suggest questions that can be used to guide those preparing and using policy briefs to support evidence-informed policymaking. These are: 1. Does the policy brief address a high-priority issue and describe the relevant context of the issue being addressed? 2. Does the policy brief describe the problem, costs and consequences of options to address the problem, and the key implementation considerations? 3. Does the policy brief employ systematic and transparent methods to identify, select, and assess synthesised research evidence? 4. Does the policy brief take quality, local applicability, and equity considerations into account when discussing the synthesised research evidence? 5. Does the policy brief employ a graded-entry format? 6. Was the policy brief reviewed for both scientific quality and system relevance?
PMCID: PMC3271824  PMID: 20018103
2.  A diffusion of innovations model of physician order entry. 
OBJECTIVE: To interpret the results of a cross-site study of physician order entry (POE) in hospitals using a diffusion of innovations theory framework. METHODS: Qualitative study using observation, focus groups, and interviews. Data were analyzed by an interdisciplinary team of researchers using a grounded approach to identify themes. Themes were then interpreted using classical Diffusion of Innovations (DOI) theory as described by Rogers [1]. RESULTS: Four high level themes were identified: organizational issues; clinical and professional issues; technology implementation issues; and issues related to the organization of information and knowledge. Further analysis using the DOI framework indicated that POE is an especially complex information technology innovation when one considers communication, time, and social system issues in addition to attributes of the innovation itself. CONCLUSION: Implementation strategies for POE should be designed to account for its complex nature. The ideal would be a system that is both customizable and integrated with other parts of the information system, is implemented with maximum involvement of users and high levels of support, and is surrounded by an atmosphere of trust and collaboration.
PMCID: PMC2243456  PMID: 11825150
3.  Remembering and Voting: Theory and Evidence from Amnesic Patients 
One of the most prominent claims to emerge from the field of public opinion is that citizens can vote for candidates whose issue positions best reflect their own beliefs even when they cannot remember previously learned stances associated with the candidates. The current experiment provides a unique and powerful examination of this claim by determining whether individuals with profound amnesia, whose severe memory impairments prevent them from remembering specific issue information associated with any particular candidate, can vote for candidates whose issue positions come closest to their own political views. We report here that amnesic patients, despite not being able to remember any issue information, consistently voted for candidates with favored political positions. Thus, sound voting decisions do not require recall or recognition of previously learned associations between candidates and their issue positions. This result supports a multiple memory systems model of political decision making.
PMCID: PMC3917545  PMID: 24511170
voting; candidate evaluation; memory; emotion; on-line processing; citizen competence
4.  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
5.  Informed consent in human experimentation before the Nuremberg code. 
BMJ : British Medical Journal  1996;313(7070):1445-1449.
The issue of ethics with respect to medical experimentation in Germany during the 1930s and 1940s was crucial at the Nuremberg trials and related trials of doctors and public health officials. Those involved in horrible crimes attempted to excuse themselves by arguing that there were no explicit rules governing medical research on human beings in Germany during the period and that research practices in Germany were not different from those in allied countries. In this context the Nuremberg code of 1947 is generally regarded as the first document to set out ethical regulations in human experimentation based on informed consent. New research, however, indicates that ethical issues of informed consent in guidelines for human experimentation were recognised as early as the nineteenth century. These guidelines shed light on the still contentious issue of when the concepts of autonomy, informed consent, and therapeutic and non-therapeutic research first emerged. This issue assumes renewed importance in the context of current attempts to assess liability and responsibility for the abuse of people in various experiments conducted since the second world war in the United States, Canada, Russia, and other nations.
PMCID: PMC2352998  PMID: 8973233
6.  Pharmaceutical information systems and possible implementations of informed consent - developing an heuristic 
BMC Medical Ethics  2012;13:30.
Denmark has implemented a comprehensive, nationwide pharmaceutical information system, and this system has been evaluated by the Danish Council of Ethics. The system can be seen as an exemplar of a comprehensive health information system for clinical use.
The paper analyses 1) how informed consent can be implemented in the system and how different implementations create different impacts on autonomy and control of information, and 2) arguments directed towards justifying not seeking informed consent in this context.
Results and Conclusion
Based on the analysis a heuristic is provided which enables a ranking and estimation of the impact on autonomy and control of information of different options for consent to entry of data into the system and use of data from the system.
The danger of routinisation of consent is identified.
The Danish pharmaceutical information system raises issues in relation to autonomy and control of information, issues that will also occur in relation to other similar comprehensive health information systems. Some of these issues are well understood and their impact can be judged using the heuristic which is provided. More research is, however needed in relation to routinisation of consent.
PMCID: PMC3507876  PMID: 23157854
Autonomy; Control; Health information; Health information systems; Informed consent; Routinisation
7.  Health Care Financing In Iran; Is Privatization A Good Solution? 
This paper considers a range of issues related to the financing of health care system and relevant government policies in Iran.
This study used mixed methods. A systematic literature review was undertaken to identify relevant publications. This was supplemented by hand searching in books and journals, including government publications. The issues and uncertainties identified in the literature were explored in detail through semi-structured interviews with key informants. These were triangulated with empirical evidence in the form of the literature, government statistics and independent expert opinions to validate the views expressed in the interviews.
The systematic review of published literature showed that no previous publication has addressed issues relating to the financing of healthcare services in Iran. However, a range of opinion pieces outlined issues to be explored further in the interviews. Such issues summarised into four main categories.
The health care market in Iran has faced a period in which financial issues have enhanced managerial complexity. Privatization of health care services would appear to be a step too far in assisting the system to confront its challenges at the current time. The most important step toward solving such challenges is to focus on a feasible, relevant and comprehensive policy, which optimises the use of health care resources in Iran.
PMCID: PMC3469022  PMID: 23113205
Healthcare; Financing; privatization; Iran
8.  Ethical issues in penile transplantation 
Asian Journal of Andrology  2010;12(6):795-800.
This article provides an overview of the ethical issues associated with penile transplantation, a form of composite tissue allografting. There is only one reported case of human penile transplantation, and, as such, this technique is considered to be experimental. The ethical issues at stake involve both the graft donor and the graft recipient. With regard to the recipient, there are significant concerns relating to surgical risks and benefits, informed consent, body image (including surgical expectations and outcomes) and compliance. Donor issues may include family consent and privacy, as well as graft harvesting (leaving the donor cadaver without a penis). Many of these ethical issues can be explored during the recipient's assessment and consent process. Because no medium-term or long-term outcome data for this procedure exist—only one such operation has ever been performed—the burdens and ethical issues concerning penile transplantation remain unknown.
PMCID: PMC3739079  PMID: 20835258
ethics; penis; transplantation
9.  AboutKidsHealth: A Unique Initiative in Pediatric Consumer Health Informatics 
Consumers of online health information are concerned with issues of quality and trust.
No sites presently offer comprehensive child health information and tools for families seeking solutions to complex questions that may involve disease, lifestyle, behavioral, and educational issues. Parents of children with complex health issues as well as parents of typically developing children, need a trusted, comprehensive online resource to inform and guide. To meet this need, The Hospital for Sick Children, with the support of founding sponsor TD Securities, launched a unique initiative, AboutKidsHealth in June2004. The project employs web technology combined with social marketing campaigns to promote and deliver evidence-based information and programmes in all major areas influencing child health and family quality of life. The web-based infrastructure will also be used to support selected research projects, and to provide enhanced communication and services for families of children with complex conditions and health professionals.
PMCID: PMC1839327
10.  What are the chances? Evaluating risk and benefit information in consumer health materials 
Much consumer health information addresses issues of disease risk or treatment risks and benefits, addressing questions such as “How effective is this treatment?” or “What is the likelihood that this test will give a false positive result?” Insofar as it addresses outcome likelihood, this information is essentially quantitative in nature, which is of critical importance, because quantitative information tends to be difficult to understand and therefore inaccessible to consumers. Information professionals typically examine reading level to determine the accessibility of consumer health information, but this measure does not adequately reflect the difficulty of quantitative information, including materials addressing issues of risk and benefit. As a result, different methods must be used to evaluate this type of consumer health material. There are no standard guidelines or assessment tools for this task, but research in cognitive psychology provides insight into the best ways to present risk and benefit information to promote understanding and minimize interpretation bias. This paper offers an interdisciplinary bridge that brings these results to the attention of information professionals, who can then use them to evaluate consumer health materials addressing risks and benefits.
PMCID: PMC385301  PMID: 15098049
11.  Optimizing the HIV/AIDS informed consent process in India 
BMC Medicine  2004;2:28.
While the basic ethical issues regarding consent may be universal to all countries, the consent procedures required by international review boards which include detailed scientific and legal information, may not be optimal when administered within certain populations. The time and the technicalities of the process itself intimidate individuals in societies where literacy and awareness about medical and legal rights is low.
In this study, we examined pregnant women's understanding of group education and counseling (GEC) about HIV/AIDS provided within an antenatal clinic in Maharashtra, India. We then enhanced the GEC process with the use of culturally appropriate visual aids and assessed the subsequent changes in women's understanding of informed consent issues.
We found the use of visual aids during group counseling sessions increased women's overall understanding of key issues regarding informed consent from 38% to 72%. Moreover, if these same visuals were reinforced during individual counseling, improvements in women's overall comprehension rose to 96%.
This study demonstrates that complex constructs such as informed consent can be conveyed in populations with little education and within busy government hospital settings, and that the standard model may not be sufficient to ensure true informed consent.
PMCID: PMC509426  PMID: 15287983
12.  Rapid appraisal of needs in reproductive health care in southern Sudan: qualitative study 
BMJ : British Medical Journal  1999;319(7212):743-748.
To identify the need for reproductive health care among a community affected by conflict, and to ascertain the priority given by the community to reproductive health issues.
Rapid appraisal. This comprised interviews with key informants, in-depth interviews, and group discussions. Secondary data were collated. Freelisting, ranking, and scenarios were used to obtain information.
Communities affected by conflict in southern Sudan.
Interviews and group discussions were chosen purposively. Twenty interviews with key informants were undertaken, in-depth interviews were held with 14 women, and 23 group discussions were held.
Main outcome measures
Need for reproductive health care. Perceived priority afforded to reproductive health issues in comparison with other health problems.
Reproductive health in general and sexually transmitted diseases in particular were important issues for these communities. Problems in reproductive health were ranked differently depending on the age and sex of the respondents. Perceptions about reproductive health issues in communities varied between service providers, and community leaders. Settled and displaced communities had different priorities and differing experiences of reproductive health problems and their treatment.
Rapid appraisal could be used as the first step to involving communities in assessing needs and planning service provision.
Key messagesCommunity members are not routinely involved in assessing their needs or identifying priorities for humanitarian aidReproductive health needs were important to this population affected by conflictCommunity leaders and health service providers will not necessarily hold the same view of need as community membersPeople of different age, sex, and circumstance are likely to perceive community needs differentlyRapid appraisal may be a useful tool to involve communities living in these contexts to identify their needs and priorities
PMCID: PMC28227  PMID: 10488000
13.  Duplicate Medical Records: A Survey of Twin Cities Healthcare Organizations 
Duplicate medical records occur when a single patient is associated with more than one medical record number. This causes a dangerous and expensive issue for hospitals and health information technology. A survey was constructed to gather qualitative information from Twin Cities healthcare organizations. The goal was to determine baseline information regarding the recognition of the problems surrounding duplicate medical record creation and organizational strategies for resolutions. The survey demonstrated that all organizations acknowledged the importance and patient safety issue regarding the creation of duplicates but the strategies and solutions are varied. As defined in the Minnesota Alliance for Patient Safety5, the ultimate goal of this survey was to favorably impact patient safety. The deidentified results were disseminated to all participating organizations along with recommendations for system improvements in order to raise awareness of the issue and promote patient safety.
PMCID: PMC2815491  PMID: 20351892
14.  Poster Proposal: Access Patterns to a Website on Healthcare IT Failure 
Organizational and human factors issues associated with healthcare IT have led to project difficulties and failures. Detailed case accounts might improve knowledge sharing between healthcare organizations on lessons learned and best implementation practices. We conducted a study of access patterns to a website created by our first author that explicitly addresses the issue of health IT failure via highly detailed case accounts in an ‘anonymized’ format. We found that our website is one of few relevant sites that is retrieved via major search engine queries on “healthcare IT failure” or related concepts, and we hypothesize that “hits” on our website may reflect a significant portion of the demand for information on this issue. We then studied the demographics and queries used by viewers of our website via a public website-tracking utility (no personally-identifiable information was obtained). We found that demand for information on healthcare IT difficulty and failure via the Web is ongoing by searchers of a variety of demographics, and we believe the demand is largely unmet. The medical informatics community can contribute to filling this gap.
PMCID: PMC1839251  PMID: 17238714
15.  A literature review on communication between picture archiving and communication systems and radiology information systems and/or hospital information systems 
Journal of Digital Imaging  1999;12(3):138-143.
The purpose of this literature review is to present the concepts surrounding the issue of communication between imaging systems and information systems in radiology and the literature about them. Picture archiving and communication systems (PACS) were developed to combine viewing of modality images, archiving, and distribution of images. When PACS is integrated/interfaced with radiology information systems (RIS) or hospital information systems (HIS), it can merge patient demographics, medical records, and images. To address several issues surrounding communication between PACS and HIS/RIS and to make interface development easier and faster, various organizations have developed standards for the formatting and transfer of clinical data. Additional work continues to better handle these issues. Communication protocol Health Level 7 (HL7) is a standard application protocol used for electronic text data exchange in health care by most HIS/RIS. The imaging communication protocol for PACS is the Digital Imaging and Communications in Medicine (DICOM) standard specification protocol that describes the means of formatting and exchanging images and associated information.
PMCID: PMC3452436  PMID: 10461576
HL7; DICOM; PACS; radiology information systems; hospital information systems; communication protocol standards; interface
16.  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
17.  An Inexpensive Family Index of Risk for Mood Issues Improves Identification of Pediatric Bipolar Disorder 
Psychological assessment  2012;25(1):12-22.
Family history of mental illness provides important information when evaluating pediatric bipolar disorder (PBD). However, such information is often challenging to gather within clinical settings. This study investigates the feasibility and utility of gathering family history information using an inexpensive method practical for outpatient settings. Families (N=273) completed family history, rating scales, MINI and KSADS interviews about youths 5–18 (median=11) years presenting to an outpatient clinic. Primary caregivers completed a half page Family Index of Risk for Mood issues (FIRM). All families completed the FIRM quickly and easily. Most (78%) reported 1+ relatives having history of mood or substance issues, M=3.7 (SD=3.3). A simple sum of familial mood issues discriminated cases with PBD from all other cases, AUROC=.63, p=.006. FIRM scores were specific to youth mood disorder and not ADHD or disruptive behavior disorder. FIRM scores significantly improved the detection of PBD even controlling for rating scales. No subset of family risk items performed better than the total. Family history information showed clinically meaningful discrimination of PBD. Two different approaches to clinical interpretation showed validity in these clinically realistic data. Inexpensive and clinically practical methods of gathering family history can help to improve the detection of PBD.
PMCID: PMC3752418  PMID: 22800090
pediatric bipolar disorder; family history; community mental health; assessment; screening; sensitivity and specificity
18.  Information Chaos in Primary Care: Implications for Physician Performance and Patient Safety 
The purpose of this paper is to explore the concept of information chaos as it applies to the issues of patient safety and physician workload in primary care and to propose a research agenda.
We use a human factors engineering perspective to discuss the concept of information chaos in primary care and explore implications for its impact on physician performance and patient safety.
Information chaos is comprised of various combinations of information overload, information underload, information scatter, information conflict, and erroneous information. We provide a framework for understanding information chaos, its impact on physician mental workload and situation awareness, its consequences, discuss possible solutions and suggest a research agenda which may lead to methods to reduce the problem.
Information chaos is experienced routinely by primary care physicians. This is not just inconvenient, annoying and frustrating; it has implications for physician performance and patient safety. Additional research is needed to define methods to measure and eventually reduce information chaos.
PMCID: PMC3286113  PMID: 22086819
Primary Health Care; Information Management/Informatics; Complexity Science; Medical Errors; Practice Management
19.  Information on antidepressants for psychiatric inpatients: the divide between patient needs and professional practice 
Pharmacy Practice  2013;11(2):81-89.
Medicine information is an integral part of patient care and a patient right. In particular, patients with a mental health diagnosis have a need for information on medicines.
This study aims to describe the current practice on information provision on antidepressants to inpatients in psychiatric hospitals.
A qualitative study was conducted consisting of semi-structured interviews with health care professionals (n=46) and patients (n=17) in 11 Flemish psychiatric hospitals. Two topic guides were designed for conducting the interviews with these respective stakeholders. The issues addressed in the topic guides related to: organization of information provision in the hospital, information on demand of the patient, information provision by health care professionals, information for relatives, evaluation of provided information, interdisciplinary contacts on information provision and satisfaction on current practice of information provision. The interviews were analysed according to the five stages of the framework analysis.
Psychiatrists and nurses are the key players to provide information on antidepressants. Their approach depends on patient characteristics and mental state. Information is provided mainly orally. Health care professionals consider non-verbal cues of patients to verify if information has been understood. Health care professionals reported lack of time and lack of interdisciplinary contacts as negative aspects. Patients indicated that health care professionals take too little initiative to provide medicine information.
Patients are informed about their antidepressants through various pathways. Although the awareness is present of the importance of the individual approach and efforts are done to tailor information to the individual patient, improvement is still possible. Tailoring communication; assessing patient needs and preferences; matching of health care professional style and patient needs; and achieving concordance, is a complex and challenging task for health care professionals in mental health care.
PMCID: PMC3798178  PMID: 24155854
Drug Information Services; Antidepressive Agents; Depressive Disorder; Inpatients; Qualitative Research; Belgium
20.  Surgeons Underestimate Their Patients’ Desire for Preoperative Information 
World Journal of Surgery  2008;32(6):964-970.
Provision of adequate patient information may contribute to a “satisfying” surgical treatment. The patient’s views on successful transfer of information concerning operative characteristics may not be in concert with the surgeon’s. The aim of the present study was to determine opinions of both surgeons and patients about issues of surgical information.
A group of surgeons (n = 24) and surgical patients (n = 125) responded to a questionnaire that included 80 topics involving domains of information on disease, physical examination, preoperative period, anesthesia, operation, postoperative period, self care, and general hospital issues. Both groups were asked for their opinion on what they considered important and useful preoperative information for patients. Questions were scored with a visual analog scale. The reliability of the questionnaire was calculated with Cronbach’s alpha. Differences in opinions between surgeons and patients were analyzed with Student’s t-test.
The Cronbach’s alpha of the questionnaire was high (0.91), indicating its high reliability. Patients scored significantly higher (p < 0.001) in most domains, including preoperative period, anaesthesia, operation, postoperative period, self care, and general hospital information. Women demonstrated a significantly higher need for information than men did. These findings were independent of patient age or complexity of operation. In contrast, surgeons thought that their patients desired more extensive information on cause, effect, and prognosis of the disease itself (p < 0.001).
Surgeons generally underestimate their patients’ desire for receiving extensive information prior to a surgical procedure of any complexity. Surgeons should develop strategies to bridge this informational mismatch.
PMCID: PMC2386849  PMID: 18408963
21.  A Conceptual Model of the Information Requirements of Nursing Organizations 
Three related issues play a role in the identification of the information requirements of nursing organizations. These issues are the current state of computer systems in health care organizations, the lack of a well-defined data set for nursing, and the absence of models representing data and information relevant to clinical and administrative nursing practice. This paper will examine current methods of data collection, processing, and storage in clinical and administrative nursing practice for the purpose of identifying the information requirements of nursing organizations. To satisfy these information requirements, database technology can be used; however, a model for database design is needed that reflects the conceptual framework of nursing and the professional concerns of nurses. A conceptual model of the types of data necessary to produce the desired information will be presented and the relationships among data will be delineated.
PMCID: PMC2245776
22.  Implementation of organizational practices to protect information in health organizations. 
In March of 1997, the National Research Council (NRC) of the National Academy of Sciences issued the report, "For the Record: Protecting Electronic Health Information." In its report, the Council recommended both technical and organizational practices to protect electronic health information. At the time the report was issued, Vanderbilt University Medical Center was deeply immersed in the development of organizational practices consistent with the Council's recommendations. We agreed that the recommended technical and organizational practices are important for protecting other information types in addition to health information, and that they suggest appropriate practices for non-electronic information, as well. In this paper, we focus on our process for developing and implementing the seven organizational practices recommended for immediate implementation.
PMCID: PMC2232171  PMID: 9929244
23.  Public health informatics: a CDC course for public health program managers. 
Information science and technology are critical to the modern practice of public health. Yet today's public health professionals generally have no formal training in public health informatics--the application of information science and technology to public health practice and research. Responding to this need, the U.S. Centers for Disease Control and Prevention (CDC) recently developed, tested, and delivered a new training course in public health informatics. The course was designed for experienced public health program managers and included sessions on general informatics principles and concepts; key information systems issues and information technologies; and management issues as they relate to information technology projects. This course has been enthusiastically received both at the state and federal levels. We plan to develop an abbreviated version for health officers, administrators, and other public health executives.
PMCID: PMC2232102  PMID: 9929264
24.  Clinical trials in developing countries: Discussions at the '9th International Symposium on Long Term Clinical Trials', London, UK, 19-20 June 2000 
This symposium provided a useful forum for the discussion of issues relating to the design and conduct of clinical trials. There is a need for greater awareness of the complexity of modern day trials, in which a host of statistical, logistical, regulatory and ethical issues are involved. Issues discussed ranged from the effect of sample size on the outcome, and subgroup analysis, to defining and maintaining discrete endpoints. Some useful debate centred on the use of meta-analysis and the current limitations of combining information from different data sets. This brought up the subjects of trial registries and raw data repositories for all clinical trials. Progress and relevance of the Cochrane collaboration were reviewed. The economics of clinical trials was another important topic. Regulatory issues such as the role of data and safety monitoring boards (DSMB) and the guidelines in place for effective data monitoring and progress analysis were discussed. Representatives of government organisations and industry gave both European and American perspectives. This report however focuses specifically on the section devoted to the subject of clinical trials in developing countries.
PMCID: PMC59600  PMID: 11714410
clinical trial; developing countries; ethics; publishing; symposium
25.  Financial Capacity in Persons with Schizophrenia and Serious Mental Illness: Clinical and Research Ethics Aspects 
Schizophrenia Bulletin  2005;32(1):81-91.
In contrast with issues of consent capacity, financial capacity has received surprisingly little clinical or ethical attention in the psychiatric literature. Issues of financial capacity emerge frequently regarding clients with serious mental illness (SMI), and their resolution has practical and ethical significance for clients, their families, and mental health professionals. These issues include whether a client has sufficient financial skills and judgment to live independently, whether a client requires a representative payee, and what goals for community reintegration should be established with a client. Similar to informed consent, issues of financial capacity raise ethical challenges for clinicians, caseworkers, and agencies. The present article addresses clinical and research ethics questions related to financial capacity in clients with schizophrenia and SMI. Clinical questions concern evaluation of financial capacity in clients with SMI, whether to seek assignment of a mandatory representative payee, whether to leverage treatment compliance through a representative payee arrangement, and whether a mental health professional should also serve as a client's representative payee. The research ethics question addresses implications of providing financial compensation for research participation to individuals with SMI and limited financial capacity and means. The ultimate goal of this article is to focus clinical and ethical attention on a neglected decisional capacity in SMI that is of fundamental importance for clients, families, clinicians, and researchers.
PMCID: PMC2632186  PMID: 16293810
financial capacity; ethics; schizophrenia; SMI; representative payee

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