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Confronting the conflict of interest crisis in medical research.

In the last couple of years, serious controversies have raised doubts over the reliability of research supporting the efficacy and safety of Selective Serotonin Reuptake Inhibitors, popular drugs used for the treatment of depression and a variety of related conditions. These controversies have also evoked concerns over the promotional tactics used by industry to promote these drugs. In another article in this volume, David Healy argues that the tactics highlighted by these and some other recent controversies in psychiatry have brought medical research itself to the level of commercial publicity. In the following article, I provide some additional first-hand information about controversies in which David Healy was involved. I then situate these controversies within the context of the increasing commercialization of medical research. I discuss how the controversies highlight the failure of existing regulatory regimes in curbing inappropriate industry influence over research. I critically analyse some of the measures recently promoted by the medical research community, such as the introduction of a clinical trial registry, and I indicate why these measures are insufficient. In conclusion, I highlight how a more radical reform of the clinical trials scene is needed.

Authorship↗

Quality control and reliability of reported doses.

Results of performance tests verifying the dosimetric properties of dosimetric systems are published in various reports (e.g. IAEA and EURADOS). However, there is hardly any information in the open literature relating to the uncertainty in a dose measurement or in the annual dose, which is increased by failure of the evaluation or data management system, damage of the dosemeter itself or by the loss of dosemeter. In this article, an attempt is made to estimate the importance of the above-mentioned conditions. This is achieved by sending questionnaires to about 200 approved dosimetric services in Europe. In total 88 questionnaires were returned and analysed. In the questionnaires, the frequency of occurrence of the various error conditions were investigated. Participants were also asked to evaluate the impact of the error condition from a dosimetric point of view and what countermeasures are taken. The article summarises all responses and compares different sources of errors according to their impact on the uncertainty of the resulting dose and gives a comprehensive overview on quality control actions and reliability on reported doses from European dosimetric services.

Body Burden↗

Results of the 1999-2000 collaborative exercise and proficiency testing program on mitochondrial DNA of the GEP-ISFG: an inter-laboratory study of the observed variability in the heteroplasmy level of hair from the same donor.

The Spanish and Portuguese working group (GEP) of international society for forensic genetics (ISFG) 1999-2000 collaborative exercise on mitochondrial DNA (mtDNA) included the analysis of four bloodstain samples and one hair shaft sample by 19 participating laboratories from Spain, Portugal and several Latin-American countries. A wide range of sequence results at position 16,093 of the HV1 (from T or C homoplasmy to different levels of heteroplasmy) were submitted by the different participating laboratories from the hair shaft sample during the first phase of this exercise. During the discussion of these results in the Annual GEP-ISFG 2000 Conference a second phase of this exercise was established with two main objectives: (i) to evaluate the incidence of the HV1 sequence heteroplasmy detected in Phase I across different sample types from the same donor including blood, saliva, and hair shafts, (ii) to perform a technical review of the electropherograms to evaluate the relative levels of heteroplasmies obtained by the different laboratories and also to examine the source of possible errors detected in Phase I. Anonymous review of the raw sequence data permitted the detection of three transcription errors and three errors due to methodological problems. Highly variable levels of heteroplasmy were found in the hair shaft and more stability in blood and saliva. Three laboratories found variable levels of heteroplasmy at position 16,093 across adjacent fragments from the same hair shaft. Two laboratories also described more than one heteroplasmic position from a single hair. The relevance of these findings for the interpretation of mtDNA data in the forensic context is also discussed.

Blood Stains↗

Improving serious mental illness through interprofessional education.

Current health policies emphasize partnership between professional groups, between agencies and with users, to ensure more integrated health and social care services. However, a number of reasons have been consistently identified as inhibiting interprofessional working. Among the many factors identified are poor communication, conflicting power relations and role confusion, and these present immense challenges to those who wish to offer interprofessional education and training opportunities. East Gloucestershire NHS Trust worked in partnership with the University of Gloucestershire (formerly the Cheltenham and Gloucester College of Higher Education) to overcome these problems and deliver an important postqualifying interprofessional training for those working with people with serious mental illness - the Thorn-based 'Diploma in Integrated Approaches to Serious Mental Illness'. This collaborative initiative represents a good model by which practitioners of all disciplines can be trained to a high standard and meet the requirements of the National Service Framework for Mental Health. This paper describes the initiative and identifies the extent to which the course has, by mirroring the practice it is seeking to generate, 'pulled together' to ensure interprofessional, intersectoral and professional/user collaboration. The key challenges associated with interprofessional working (with people with serious mental illness and with others) and with course implementation and how these were met are discussed and further opportunities are identified.

Education, Professional↗

An integrated medical and psychosocial treatment program for psychotic disorders: patient characteristics and outcome.

OBJECTIVES: To provide an overview of a comprehensive and integrated case-management program that incorporates principles of assertive community treatment and combines effective medical and psychosocial interventions and to present the results of a process and outcome evaluation of the program, with particular emphasis on its impact on service utilization and consumer satisfaction. METHOD: Data on demographic, clinical, and several outcome measures were collected on all patients who received care in the program for a minimum of 6 months. For process evaluation we assessed the extent to which the program adhered to its goals and satisfied the patients, their families, and community-service agencies. Outcome-evaluation data on the number and length of hospital admissions were compared for each subject with individual historical data for a period equal to the time spent in the program. In addition, relapses of psychotic symptoms that did not result in hospital admissions were calculated for each patient while in the program. RESULTS: Demographic, clinical, and treatment characteristics of clients show that the program has succeeded in maintaining its focus on providing services to relatively chronically ill patients with psychotic disorders over a mean period of 3 years. The process-evaluation data indicated a high level of satisfaction by patients, families, and other service agencies with the services received. Information on outcome variable showed that the program achieved significantly lower rates of hospital admissions and relapse of psychosis than expected. There was a highly significant reduction achieved in the utilization of inpatient hospital resources for patients receiving care in the program. Most of the inpatient service utilization was attributed to patients either who were resistant to treatment with antipsychotic agents or who refused to accept or comply with medication. CONCLUSIONS: It is possible to provide effective continuity of care from inpatient treatment to community adjustment for most individuals with psychotic disorders across the spectrum by blending hospital and community resources within an integrated case-management model of care.

Adult↗

Enhancing nursing students' clinical placement experiences: a quality improvement project.

Clinical experience is recognised as the core of nursing education. Quality clinical placements across a variety of venues are vital to the development of capable and competent professionals. However there is evidence, both anecdotal and empirical, suggesting that students' clinical placement experiences are fraught with problems. The quality improvement project described in this paper aimed to improve the clinical learning experience of nursing students by strengthening communication and partnerships between the university and the two local health services. To achieve this goal, clinicians' perceptions of the problems related to clinical placements and their recommendations for improvement were explored. Focus groups, brainstorming sessions, personal interviews and surveys were used to collect qualitative and quantitative data. Problems and priority issues were identified as more than five hundred clinicians expressed their concerns, claims and issues. Key findings from the project are described under five themes: communication breakdown between the university and clinicians; mentorship; preparation for clinical placements; clinical competence; and graduates' readiness for practice. Utilising a quality improvement framework this project promoted vigorous debate and dialogue between university and health service partners. The nature and extent of the problems surrounding clinical placements were examined, high priority issues targeted for improvement, and the subsequent results measured through feedback from clinicians and students. The success of this project, although impressive in the early stages, will depend upon ongoing communication and evaluation to ensure sustainability of the improvements made.

Attitude of Health Personnel↗

[External partnerships and prevention relative to psychoactive substances: what should be the position of the school and its partners?].

School health education is one of the primary missions of the educational system which is characterised by the involvement of numerous professional institutions, associations, and others, at the heart of academic establishments. The need for partnership within this complex domain has been recognised and affirmed by the official publications of the national Ministry of Education as it has been in actions. In so far as the move towards the recourse of external intervention, should this be considered as the result of a true partnership or an act of simple delegation (or subcontracting)? Firstly, this article proposes to define the concept of partnership. Secondly, it presents the results of a study on the implementation of drug-use prevention in high schools who underline the importance of the problems associated with partnership in this field and attempt to put into perspective the respective points of view of the educational teams and external actors. On the basis of these results, it proposes a typology of the networks from which the activities are built, then analyses the conditions necessary in order that health education be implemented within a framework of partnership established on the competencies, differences and contributions of each partner.

Adolescent↗

Functional fiefdom, poverty model or individualism? Development of intergovernmental relations in health planning.

The United States national government has the power under the National Health Planning and Development Act of 1974 to establish and exercise legal control over a system of Health System Agencies, State Health Planning and Development Agencies, and State Health Coordinating Councils. Although the national government appears to have the legal powers necessary to direct and control the health planning process, a federal system has difficulties in the implementation of planning which has centralized goals or direction. The states and regions have the potential power to weaken the strength of the national government. Three trends in the developing relationship between the national, state, and regional units in health planning are discussed. The first, the functional fiefdom, consists of self-perpetuating, narrow purpose agencies which are not responsible to local or state-wide elected officials. These are professional bureaucracies which create and reinforce cozy relationships with supportive interest groups. The second trend, the poverty model, includes the lack of control by local elected officials, a large role to nongovernmental actors, and a direct relationship between Washington and the regional planning agencies. The last trend appears to be an individualistic one with every unit fending for itself. A case study of Massachusetts along with supplemental materials from other states is presented to illustrate the trends.

Government↗

A successful university-school-district partnership to help San Francisco's K-12 students learn about science and medicine.

The Science and Health Education Partnership (SEP) is a program at the University of California, San Francisco, established in 1987 to support the San Francisco School District ("the District") in its efforts to improve science education in grades K-12. A large cadre of active biomedical scientists and health professionals and a core program staff provide support to 90-95% of the District's schools. The District's students are from a variety of racial and ethnic groups, including a large percentage from underrepresented minorities (URMs). The SEP program has numerous components, some designed to help teachers (e.g., a clinician or scientist forms an ongoing partnership with a teacher to enrich classroom instruction) and some involving direct work with students (e.g., a contest where teams of students design and present lessons on science or health to their peers; activities related specifically to the encouragement of URM students). The SEP's perspective has evolved from an emphasis on assisting individual teachers and students to one of supporting systemic change throughout the District (e.g., supporting full implementation of hands-on, inquiry-based science instruction throughout the District via professional development). During this evolution, the kinds of issues facing program staff have changed and a great deal has been learned about fostering successful partnership activities. For example, (1) having a coordinator is crucial to make such a program work well; (2) it is easier to find start-up funding than to find continuing funding for ongoing activities that are working; and (3) it is important to work with the volunteering scientists and the teachers to help them understand what each has to offer the partnership and to encourage explicit dialogue about roles and expectations. The author concludes with advice for starting a new partnership: think big but start small, and work toward a long-term association based on communication and trust.

Adolescent↗

Individual monitoring for internal exposure in Europe and the integration of dosimetric data.

The European Radiation Dosimetry Group, EURADOS, established a working group consisting of experts whose aim is to assist in the process of harmonisation of individual monitoring as part of the protection of occupationally exposed workers. A catalogue of facilities and internal dosimetric techniques related to individual monitoring in Europe has been completed as a result of this EURADOS study. A questionnaire was sent in 2002 to services requesting information on various topics including type of exposures, techniques used for direct and indirect measurements including calibration and sensitivity data and the methods employed for the assessment of internal doses. Information relating to Quality Control procedures for direct and indirect measurements, Quality Assurance Programmes in the facilities and legal requirements for "approved dosimetric services" were also considered. A total of 71 completed questionnaires were returned by internal dosimetry facilities in 26 countries. This results in an overview of the actual status of the processes used in internal exposure estimation in Europe. In many ways harmonisation is a reality in internal dose assessments, especially when taking into account the measurements of the activity retained or excreted from the body. However, a future study detailing the estimation of minimum detectable activity in the laboratories is highly recommended. Points to focus on in future harmonisation activities are as follows: the process of calculation of doses from measured activity, establishment of guidelines, similar dosimetric tools and application of the same ICRP recommendations. This would lead to a better and more harmonised approach to the estimation of internal exposures in all European facilities.

Body Burden↗

Involving private voluntary health care providers in 'Better Health for Africa'.

In Sub-Saharan Africa private voluntary health care providers are mostly Church-related or social not for profit organizations. They provide between 40% and 60% of health care services. In the context of Health Care Reforms, the World Bank and others have (re)discovered these non governmental providers. The World Bank document 'Better Health for Africa', promotes prominent roles for them in the execution of basic package of services and public health tasks. Unfortunately, the World Bank does not outline clearly how these roles should be achieved. The danger exists that governments, under pressure to economize, will only take the privatization angle which is in contradiction with the aims and objectives of the not for profit private providers. Thus their potential to contribute to Public Health care will be left unused and the reforms harder to achieve. My argument is that the collaboration between government and NGOs should be approached in the perspective of delegation of public duties and partnership. Thus the autonomy of NGO providers can be respected while their technical capabilities can be used optimally.

Africa South of the Sahara↗

The Mumbai experience in building field level partnerships for DOTS implementation.

In February 1999, the Revised National Tuberculosis (TB) Control Programme (RNTCP) was implemented in the city of Mumbai after a pilot phase of 5 years. The city has a population of more than 12 million people and an estimated annual TB incidence of 21,000 cases, 8000 of these being infectious. This paper describes a partnership between the TB programme and a Non Governmental Organization (NGO), which began with a methodological analysis of the problems faced by the programme to help identify other key organizations, who might usefully be involved. The work focussed on "networking" to ensure the optimum use of existing resources. The problems encountered affected all levels of TB control from access to drug supply and treatment. The major issues related to an inadequate public health infrastructure resulting in poor technical and administrative support to field staff. There was confusion over roles of the health personnel in the TB programme and the public health facility, as well as poor technical performance. Partnerships were found to be useful in addressing the following areas: (1) the implementation of an external quality assurance scheme for sputum microscopy through involvement of microbiologists from large hospitals and research organizations; (2) training and capacity strengthening of programme and public health facility staff through innovative training and team building exercises organized by the programme, NGOs and the private sector; (3) development of Information, Education and Communication (IEC) material through partnerships with NGOs, and (4) the involvement of local NGOs and private doctors to increase case finding and to improve access to direct observation of treatment (DOT). The paper discusses the lessons learnt in this process and identifies some of the key issues in urban TB control, for consideration by policy makers.

Communicable Disease Control↗

The 20th Kellersberger Memorial Lecture, 1994. Leprosy and tuberculosis combined programmes: an uneasy partnership?

One of the purposes of this memorial lecture is to relate progress and difficulties in the field of leprosy to work in other fields. Tuberculosis is a disease closely related to leprosy and in 1982 the Kellersberger lecture was given by Dr. Styblo, someone whose name is synonymous with the development of effective Tuberculosis Control Programme in Africa. His title was "Tuberculosis and its control: lessons to be learned from past experience, and implications for leprosy control programme" (1). Many countries in Africa, including Ethiopia, have adopted the strategy of a combined leprosy and TB control programme. In this lecture then, I will examine more closely the strategy of combining the two programmes. I want to look at some of the problems that may arise and then draw out the ways in which each side of the partnership can contribute to the other, so that the combination can be more effective than either programme could hope to be on its own. This lecture will focus mainly on management issues, which are currently the most important barriers to effective control of both diseases, but the socio-economic aspects of disease, so much a part of Dr. Kellersberger's working life, will also be prominent.

Cost-Benefit Analysis↗

Carving a niche: establishing bioinformatics collaborations.

OBJECTIVES: The paper describes collaborations and partnerships developed between library bioinformatics programs and other bioinformatics-related units at four academic institutions. METHODS: A call for information on bioinformatics partnerships was made via email to librarians who have participated in the National Center for Biotechnology Information's Advanced Workshop for Bioinformatics Information Specialists. Librarians from Harvard University, the University of Florida, the University of Minnesota, and Vanderbilt University responded and expressed willingness to contribute information on their institutions, programs, services, and collaborating partners. Similarities and differences in programs and collaborations were identified. RESULTS: The four librarians have developed partnerships with other units on their campuses that can be categorized into the following areas: knowledge management, instruction, and electronic resource support. All primarily support freely accessible electronic resources, while other campus units deal with fee-based ones. These demarcations are apparent in resource provision as well as in subsequent support and instruction. CONCLUSIONS AND RECOMMENDATIONS: Through environmental scanning and networking with colleagues, librarians who provide bioinformatics support can develop fruitful collaborations. Visibility is key to building collaborations, as is broad-based thinking in terms of potential partners.

Computational Biology↗

Preparedness on the frontline: what's law got to do with it?

The article provides an overview of current work toward identifying core competencies for public health emergency and bio-terrorism response, including law-related competencies. It demonstrates how competency sets are interrelated and how they provide a framework for developing preparedness training for public health leaders, public health and health care professionals, law enforcement, public health attorneys, and others. The health and safety of America's communities hinge on the nation's public health workforce--the estimated 448,254 public health professionals and 3 million related workforce professionals who form the expanded public health system that protects us during times of national crisis and in our daily lives. The response capacity of our health agencies and communities and their ability to respond effectively will be unpredictable without adequate training. Education in the core competencies in emergency preparedness and bio-terrorism response is essential. Preparedness at the front-line means that public health leaders and administrators must be able to communicate information, roles, capacities, and legal authorities to all emergency response partners during planning, drills, and actual emergencies. Each public health worker must be able to describe his or her communication role in emergency response within the agency, with the media, and with the general public. Law enforcement and state government representatives must understand the legal powers of their agencies and of public health agencies for coordinated response, mitigation, and recovery efforts in a public health emergency event.

Biological Warfare↗

Bridging the "med-ed gap" for students with special health care needs: a model school liaison program.

A successful school experience is critical to the development of all children, particularly in the areas of academic achievement, regular school attendance, and social competency. Vulnerabilities in achieving each of these three goals have been documented among students with special health care needs (SSHCN), and ascribed to the influence of their health-related disabilities. Despite recognition of these vulnerabilities, barriers still exist to successful integration of SSHCN into educational settings. A key barrier to successful integration involves poor linkages between the health and education systems. This article describes a model linkage system--the School Liaison Program at Texas Children's Hospital, developed as a U.S. Dept. of Health and Human Services Maternal and Child Health Bureau Special Project of Regional and National Significance. The program provides educational liaison services between the largest pediatric hospital in the United States and school districts in the fourth largest city. A description of the linkage system emphasizes interdisciplinary staffing by both special educators and health providers. The model for educational liaison service delivery presented includes the elements of eligibility, assessment of the educational implications of illness, plan development and referral, involvement in educational placement, and monitoring. Resources for integrating SSHCN into educational settings are suggested.

Adolescent↗

Sentinel monitoring of general community health during the 1998 World Football Cup.

BACKGROUND: Present knowledge of the consequences of mass gatherings for the health of the community is scant. Our objective was to determine the impact of the 1998 World Football Cup on general community health. METHODS: We set up an electronic sentinel disease surveillance, before, during and after the World Football Cup tournament held in France from June 10 to July 12, 1998. Medical activity, and the daily number of cases of communicable, environmental, and societal diseases relating to mass gatherings were surveyed. The incidence of the pathologies surveyed in real time during and after the World Cup versus the pre-Cup reference period was the main outcome measure. Five sentinel networks participated, comprising 553 general practitioners, 60 hospital adult emergency departments, 19 private emergency community services, 4 community health centres, and the medical centre of the Paris airports. RESULTS: Throughout the 66-day study period, physicians reported 558,829 medical encounters via 21,532 connections to the computer. Compared to the reference period, the level of medical activity reflected by the pathological items surveyed remained stable during the study period. CONCLUSION: The 1998 World Football Cup had no epidemiological impact on general community health, as observed by sentinel networks located downstream of the specific health services provided by the French authorities to ensure high standards of safety.

Adult↗

The impact of the new biology on radiation risks in space.

Radiation is considered to be one of three or four major hazards for personnel in space and has emerged as the most critical issue to be resolved for long-term missions, both orbital and interplanetary. Space habitats are stressful and dangerous environments. Health and medical consequences arising from microgravity, stress, and trauma include weakened immune systems, increased viral activity, and loss of bone mass. The greatest risks from radiation are generally assumed to be cancers and possibly damage to the central nervous system. Synergistic effects arising from the other environmental hazards along with abscopal and exogenic factors are likely. Space programs represent an exceptional opportunity for examining the biological consequences of low-dose exposures of humans to radiation at every level of progression. Although astronauts are a relatively small population, they are healthy, physically active volunteers who undergo extensive testing and medical examinations before, during, and after protracted exposures with periodic follow-up examinations. The radiation environments along with other hazards are likewise monitored and documented. Extensive international research programs are in progress. Seven years ago the U.S. National Aeronautics and Space Administration established the National Space Biomedical Research Institute through a cooperative agreement with a consortium of research and academic institutions in order to address radiation issues through a concerted, programmatic effort. Advanced technologies are rapidly being incorporated into these programs to determine the significance of new biological data and to evaluate the interplay among the different medical hazards. Programmatic in vivo and in vitro studies of the processes leading to carcinogenesis are in progress. Drugs and dietary supplements are being examined at the cellular and in vivo levels to assess their potential as dose-modifying agents. The infrastructure of this new approach, recent results, and research in progress are reviewed and discussed.

Academies and Institutes↗