PMCC PMCC

Search tips
Search criteria

Advanced
Results 1-25 (86243)

Clipboard (0)
None

Related Articles

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?
doi:10.1186/1478-4505-7-S1-S13
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.  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.
Images
PMCID: PMC2352998  PMID: 8973233
4.  Pharmaceutical information systems and possible implementations of informed consent - developing an heuristic 
BMC Medical Ethics  2012;13:30.
Background
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.
Analysis
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.
doi:10.1186/1472-6939-13-30
PMCID: PMC3507876  PMID: 23157854
Autonomy; Control; Health information; Health information systems; Informed consent; Routinisation
5.  Health Care Financing In Iran; Is Privatization A Good Solution? 
Background:
This paper considers a range of issues related to the financing of health care system and relevant government policies in Iran.
Methods:
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.
Results:
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.
Conclusion:
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
6.  AboutKidsHealth: A Unique Initiative in Pediatric Consumer Health Informatics 
Summary
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
7.  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
8.  Optimizing the HIV/AIDS informed consent process in India 
BMC Medicine  2004;2:28.
Background
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.
Methods
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.
Results
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%.
Conclusions
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.
doi:10.1186/1741-7015-2-28
PMCID: PMC509426  PMID: 15287983
9.  Rapid appraisal of needs in reproductive health care in southern Sudan: qualitative study 
BMJ : British Medical Journal  1999;319(7212):743-748.
Objectives
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.
Design
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.
Setting
Communities affected by conflict in southern Sudan.
Participants
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.
Results
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.
Conclusion
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
10.  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
11.  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
12.  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.
doi:10.1007/BF03168632
PMCID: PMC3452436  PMID: 10461576
HL7; DICOM; PACS; radiology information systems; hospital information systems; communication protocol standards; interface
13.  Issues in mHealth: Findings From Key Informant Interviews 
Background
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.
Objective
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.
Methods
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.
Results
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.
Conclusions
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.
doi:10.2196/jmir.1989
PMCID: PMC3510768  PMID: 23032424
Cellular phone; mobile health; mobile phone
14.  Information Chaos in Primary Care: Implications for Physician Performance and Patient Safety 
Purpose
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.
Methods
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.
Results
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.
Conclusions
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.
doi:10.3122/jabfm.2011.06.100255
PMCID: PMC3286113  PMID: 22086819
Primary Health Care; Information Management/Informatics; Complexity Science; Medical Errors; Practice Management
15.  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.
doi:10.1186/cvm-1-1-055
PMCID: PMC59600  PMID: 11714410
clinical trial; developing countries; ethics; publishing; symposium
16.  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.
doi:10.1093/schbul/sbj027
PMCID: PMC2632186  PMID: 16293810
financial capacity; ethics; schizophrenia; SMI; representative payee
17.  Turning science into policy: challenges and experiences from the science–policy interface 
This paper discusses key issues in the science–policy interface. It stresses the importance of linking the conservation and sustainable use of biodiversity to the Millennium Development Goals and to issues of immediate concern to policy-makers such as the economy, security and human health. It briefly discusses the process of decision-making and how the scientific and policy communities have successfully worked together on global environmental issues such as stratospheric ozone depletion and climate change, and the critical role of international assessments in providing the scientific basis for informed policy at the national and international level. The paper also discusses the drivers of global environmental change, the importance of constructing plausible futures, indicators of change, the biodiversity 2010 target and how environmental issues such as loss of biodiversity, stratospheric ozone depletion, land degradation, water pollution and climate change cannot be addressed in isolation because they are strongly interconnected and there are synergies and trade-offs among the policies, practices and technologies that are used to address these issues individually.
doi:10.1098/rstb.2004.1601
PMCID: PMC1569452  PMID: 15814358
biodiversity; climate change; ozone; assessments; plausible futures; indicators
18.  Internet Communities for Recruitment of Cancer Patients into an Internet Survey: A Discussion Paper 
The purpose of this paper is to provide future directions for the usage of Internet communities (ICs) for recruitment of research participants based on issues raised in an Internet survey among 132 cancer patients. 317 general and 233 ethnic-specific Internet Cancer Support Groups and 1,588 ethnic-specific ICs were contacted to recruit cancer patients. Research staff recorded issues and wrote memos during the recruitment process. The written memos and records were later analyzed using content analysis. The issues included: (a) difficulty in identifying appropriate ICs and potential participants, (b) meta-tags, (c) dominant white and women groups, (d) dynamics inside ICs, (e) difficulty in trust building, and (f) potential selection bias. The findings suggest that researchers thoroughly review the ICs’ information, be recognizant of potential gender and ethnic issues and current trends in Internet interaction, and consider potential selection bias.
doi:10.1016/j.ijnurstu.2006.07.003
PMCID: PMC2235818  PMID: 16962122
Internet Communities; Cancer Patients; Recruitment; Internet Research
19.  People and Organizational Issues in Research Systems Implementation 
Knowledge about people and organizational issues pertinent to implementation and maintenance of clinical systems has grown steadily over the past fifteen years. Less is known about implementation of systems used for clinical and biomedical research. In conjunction with current National Institutes of Health Roadmap efforts that promote translational research, these issues should now be identified and addressed. During the 2007 American College of Medical Informatics Symposium, members discussed behavioral aspects of translational informatics. This article summarizes that discussion, which covered organizational issues, implications of how knowledge about clinical systems implementation can inform research systems implementation, and those issues unique to each kind of system.
doi:10.1197/jamia.M2582
PMCID: PMC2410012  PMID: 18308986
20.  A Cross-site Qualitative Study of Physician Order Entry 
Objective: To describe the perceptions of diverse professionals involved in computerized physician order entry (POE) at sites where POE has been successfully implemented and to identify differences between teaching and nonteaching hospitals.
Design: A multidisciplinary team used observation, focus groups, and interviews with clinical, administrative, and information technology staff to gather data at three sites. Field notes and transcripts were coded using an inductive approach to identify patterns and themes in the data.
Measurements: Patterns and themes concerning perceptions of POE were identified.
Results: Four high-level themes were identified: (1) organizational issues such as collaboration, pride, culture, power, politics, and control; (2) clinical and professional issues involving adaptation to local practices, preferences, and policies; (3) technical/implementation issues, including usability, time, training and support; and (4) issues related to the organization of information and knowledge, such as system rigidity and integration. Relevant differences between teaching and nonteaching hospitals include extent of collaboration, staff longevity, and organizational missions.
Conclusion: An organizational culture characterized by collaboration and trust and an ongoing process that includes active clinician engagement in adaptation of the technology were important elements in successful implementation of physician order entry at the institutions that we studied.
doi:10.1197/jamia.M770
PMCID: PMC150372  PMID: 12595408
21.  Framing health and foreign policy: lessons for global health diplomacy 
Global health financing has increased dramatically in recent years, indicative of a rise in health as a foreign policy issue. Several governments have issued specific foreign policy statements on global health and a new term, global health diplomacy, has been coined to describe the processes by which state and non-state actors engage to position health issues more prominently in foreign policy decision-making. Their ability to do so is important to advancing international cooperation in health. In this paper we review the arguments for health in foreign policy that inform global health diplomacy. These are organized into six policy frames: security, development, global public goods, trade, human rights and ethical/moral reasoning. Each of these frames has implications for how global health as a foreign policy issue is conceptualized. Differing arguments within and between these policy frames, while overlapping, can also be contradictory. This raises an important question about which arguments prevail in actual state decision-making. This question is addressed through an analysis of policy or policy-related documents and academic literature pertinent to each policy framing with some assessment of policy practice. The reference point for this analysis is the explicit goal of improving global health equity. This goal has increasing national traction within national public health discourse and decision-making and, through the Millennium Development Goals and other multilateral reports and declarations, is entering global health policy discussion. Initial findings support conventional international relations theory that most states, even when committed to health as a foreign policy goal, still make decisions primarily on the basis of the 'high politics' of national security and economic material interests. Development, human rights and ethical/moral arguments for global health assistance, the traditional 'low politics' of foreign policy, are present in discourse but do not appear to dominate practice. While political momentum for health as a foreign policy goal persists, the framing of this goal remains a contested issue. The analysis offered in this article may prove helpful to those engaged in global health diplomacy or in efforts to have global governance across a range of sectoral interests pay more attention to health equity impacts.
doi:10.1186/1744-8603-6-14
PMCID: PMC2936293  PMID: 20727211
22.  Frequency and reasons for outcome reporting bias in clinical trials: interviews with trialists 
Objectives To provide information on the frequency and reasons for outcome reporting bias in clinical trials.
Design Trial protocols were compared with subsequent publication(s) to identify any discrepancies in the outcomes reported, and telephone interviews were conducted with the respective trialists to investigate more extensively the reporting of the research and the issue of unreported outcomes.
Participants Chief investigators, or lead or coauthors of trials, were identified from two sources: trials published since 2002 covered in Cochrane systematic reviews where at least one trial analysed was suspected of being at risk of outcome reporting bias (issue 4, 2006; issue 1, 2007, and issue 2, 2007 of the Cochrane library); and a random sample of trial reports indexed on PubMed between August 2007 and July 2008.
Setting Australia, Canada, Germany, the Netherlands, New Zealand, the United Kingdom, and the United States.
Main outcome measures Frequency of incomplete outcome reporting—signified by outcomes that were specified in a trial’s protocol but not fully reported in subsequent publications—and trialists’ reasons for incomplete reporting of outcomes.
Results 268 trials were identified for inclusion (183 from the cohort of Cochrane systematic reviews and 85 from PubMed). Initially, 161 respective investigators responded to our requests for interview, 130 (81%) of whom agreed to be interviewed. However, failure to achieve subsequent contact, obtain a copy of the study protocol, or both meant that final interviews were conducted with 59 (37%) of the 161 trialists. Sixteen trial investigators failed to report analysed outcomes at the time of the primary publication, 17 trialists collected outcome data that were subsequently not analysed, and five trialists did not measure a prespecified outcome over the course of the trial. In almost all trials in which prespecified outcomes had been analysed but not reported (15/16, 94%), this under-reporting resulted in bias. In nearly a quarter of trials in which prespecified outcomes had been measured but not analysed (4/17, 24%), the “direction” of the main findings influenced the investigators’ decision not to analyse the remaining data collected. In 14 (67%) of the 21 randomly selected PubMed trials, there was at least one unreported efficacy or harm outcome. More than a quarter (6/21, 29%) of these trials were found to have displayed outcome reporting bias.
Conclusion The prevalence of incomplete outcome reporting is high. Trialists seemed generally unaware of the implications for the evidence base of not reporting all outcomes and protocol changes. A general lack of consensus regarding the choice of outcomes in particular clinical settings was evident and affects trial design, conduct, analysis, and reporting.
doi:10.1136/bmj.c7153
PMCID: PMC3016816  PMID: 21212122
23.  Legal and Ethical Issues Regarding Social Media and Pharmacy Education 
Widespread use of social media applications like Facebook, YouTube, and Twitter has introduced new complexities to the legal and ethical environment of higher education. Social communications have traditionally been considered private; however, now that much of this information is published online to the public, more insight is available to students' attitudes, opinions, and character. Pharmacy educators and administrators may struggle with the myriad of ethical and legal issues pertaining to social media communications and relationships with and among students. This article seeks to clarify some of these issues with a review of the legal facets and pertinent court cases related to social media. In addition, 5 core ethical issues are identified and discussed. The article concludes with recommendations for pharmacy educators with regard to preparing for and addressing potential legal issues pertaining to social media.
PMCID: PMC3058471  PMID: 21436925
social media; law; ethics; eprofessionalism; technology
24.  The Value of Using Top-Down and Bottom-Up Approaches for Building Trust and Transparency in Biobanking 
Public Health Genomics  2010;13(4):207-214.
With the domestic and international proliferation of biobanks and their associated connections to health information databases, scholarly attention has been turning from the ethical issues arising from the construction of biobanks to the ethical issues that emerge in their operation and management. Calls for greater transparency in governance structures, coupled with stern reminders of the value of maintaining public trust, are seen as critical components in the success of these resources. Two different approaches have been adopted for addressing these types of ethical issues: the first is a ‘top-down’ approach which focuses on developing policy, procedures, regulations and guidelines to aid decision-makers. The second is a ‘bottom-up’ approach, which begins with those who are most affected by the issues and attempts to inductively develop consensus recommendations and policy. While both approaches have merit, I argue that more work needs to be done on ‘bottom-up’ strategies if trust and transparency are to be more than mere slogans. Using 2 case examples from Indiana, the paper summarizes data from a set of surveys we recently conducted that address issues arising from biobanks that provide some insight into issues associated with trust and transparency.
doi:10.1159/000279622
PMCID: PMC2865393  PMID: 20395689
Biobanks; Ethics; Governance; Public trust; Transparency
25.  Ethical issues in dementia 
The growing number of individuals affected by dementia will intensify the ethical issues that emerge in clinical practice and research, issues early in disease relate to genetic testing, use of medications in mildly affected persons, and diagnostic disclosure. Research issues relate to appropriate informed consent processes, conflict of interests, and research design issues, such as the use of placebos and the use of biological tissues, in the later stages of disease concern about appropriate therapeutic goals and end-of-life care is appropriate.
PMCID: PMC3181593  PMID: 22033828
ethics; dementia; Alzheimer's disease; clinical practice; research; informed consent; end-of-life care; genetic testing; use of placebo

Results 1-25 (86243)