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Explore indexed PubMed citations for clinical trials, systematic reviews and public health research. Read source abstracts and follow each citation to its original PubMed record.

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At least 829 records · Page 46Linked to original sources
PubMed1997

Undercover careseekers: simulated clients in the study of health provider behavior in developing countries.

The simulated client method (SCM) has been used for over 20 years to study health care provider behavior in a first-hand way while minimizing observation bias. In developing countries, it has proven useful in the study of physicians, drug retailers, and family planning services. In SCM, research assistants with fictitious case scenarios (or with stable conditions or a genuine interest in the services) visit providers and request their assistance. Providers are not aware that these clients are involved in research. Simulated clients later report on the events of their visit and these data are analyzed. This paper reviews 23 developing country studies of physician, drug retail, and family planning services in order to draw conclusions about (1) the advantages and limitations of the methods; (2) considerations for design and implementation of a simulated client study; (3) validity and reliability; and (4) ethical concerns. Examples are also drawn from industrialized countries, related methodologies, and non-health fields to illustrate the issues surrounding SCM. Based on this review, we conclude that the information gathered through the use of simulated clients is unique and valuable for managers, intervention planners and evaluators, social scientist, regulators, and others. Areas that need to be explored in future work with this method include: ways to ensure data validity and reliability; research on additional types of providers and health care needs; and adaptation of the technique for routine use.

Attitude of Health Personnel↗
PubMed2002

Palliative care: an international necessity.

Palliative care is the care of patients whose disease is incurable and whose life expectancy is limited to weeks or months. This commentary describes the development of modern palliative care, some of the elements and underlying philosophical constructs of such care, and calls for expansion and improvement in end of life care throughout the world.

Caregivers↗
PubMed1999

Acres of Skin.

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Attitude↗
PubMed2002

Patent immorality?

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Developing Countries↗
PubMed1995

HIV preventive vaccines. Progress to date.

The major conceptual problem for HIV vaccine development has been the lack of information on immune responses known to correlate with protection against HIV infection in humans. In this regard, studies on the natural history of HIV infection and AIDS, especially of people with apparent resistance to HIV infection and of patients with HIV infection who have long term survival without disease progression, may provide important information for vaccine development. In addition, a major concern for the development of broadly effective vaccines has been the extensive genetic variability which is characteristic of HIV. In spite of these unknowns, the first generation of HIV candidate vaccines has been developed and evaluated. HIV candidate vaccines based on the subunit recombinant envelope concept (gp120 or gp160) have been shown to protect chimpanzees from HIV infection on challenge, and have now been evaluated in humans in phase I and phase II trials. These products are well tolerated, and capable of inducing neutralising antibodies, but not cytotoxic T lymphocytes. A second vaccine concept, currently in phase I trials, is based on live recombinant vectors, especially using poxvirus vectors followed by boosting with subunit recombinant envelope vaccines. This concept is theoretically very attractive because preliminary data suggest that these vaccines induce both humoral and cell-mediated immunity. However, no published information is available on the ability of live recombinant vector vaccines to protect chimpanzees from HIV infection. The next step in HIV vaccine development is to proceed carefully to expanded phase II and phase III trials to assess the protective efficacy of these candidate vaccines in humans. These trials will be extremely complex from the logistical, scientific and ethical points of view, and will require close collaboration between clinical, basic science and behavioural researchers, national and international organisations, and the pharmaceutical industry.

AIDS Vaccines↗
PubMed2006

Inclusion of patients with severe mental illness in clinical trials: issues and recommendations surrounding informed consent.

Modern medicine would be unthinkable without the possibility of administering pharmaceuticals and other evidence-based interventions. The development of these interventions requires scientific research, ultimately with human subjects. This venture raises ethical, legal and human rights issues, which are addressed in numerous national and international declarations and regulations. In these documents, special attention is usually directed towards research involving vulnerable groups, such as children, pregnant women, unemployed persons, refugees, patients with psychiatric disorders, dementia or mental retardation, and those who are dying. In relation to patients with psychiatric disorders, two important and mutually connected ethical questions can be posed. Firstly, is research with persons who have severe psychiatric illnesses permissible? And, secondly, how can the mental capacity of prospective research subjects be assessed? We investigate these questions using the Dutch legal system as an example. Regarding the first question, the Dutch Medical-Scientific Research on Human Subjects Act (1998) presents a detailed regulation that is in line with relevant international documents, such as the Convention on Human Rights and Biomedicine (1997). In the Dutch statute, the possibilities for research involving subjects who lack mental capacity are limited, but not completely excluded. Under certain conditions, two types of research are exempted from the general prohibition of research with such subjects that is included in article 4 of the statute. These two types are (i) therapeutic research and (ii) non-therapeutic research that could not take place without the participation of subjects from the category to which the mentally incapacitated person belongs. The conditions pertain to ethical and scientific review, insurance, written proxy consent and respect for resistance by the subject. An extra condition for the permissibility of non-therapeutic research is that the risks for the prospective subject are negligible and the burdens minimal. Although the Dutch regulation obviously does not solve all problems, it is relatively clear when compared with the situation in other European countries, such as Belgium, France, Germany, and England and Wales. Regarding the second question, two basic factors need to be considered when defining 'mental capacity'. These relate to the assumption of competence and to the task-specificity of capacity. The crucial issue in assessing mental capacity is not whether a psychiatric diagnosis is present, but whether the patient has the mental abilities required to make the decision at hand in a meaningful way. In establishing an appropriate standard for capacity assessment, several interests have to be weighed. The ethical demands of protection of subjects and stimulation of scientific research may be balanced by attempting to enhance patients' mental capacity. The procedure of 'experienced consent' seems promising in this regard, although this approach entails its own ethical problems.

Clinical Trials as Topic↗