Protecting Patient Rights Research Articles

Legal assessment of current situation on orphan patients in Lithuania

After Lithuania joined the European Union, the Regulation (EC) No. 141/2000 on orphan medicinal products and Commission Regulation (EC) No. 847/2000 came into force as part of national legislation. Member States must adopt specific measures to increase knowledge on rare diseases and to improve their detection, diagnosis, and treatment. The aim of this article was to present and to assess the current legal situation on orphan patients and their treatment in Lithuania, to identify legislation gaps, and to propose some ideas how to facilitate the solution of the existing problems in this field. For this purpose, European Union and Lithuanian legal documents on rare medicinal products are examined using a comparative method. With reference to inventory of Member States' incentives for rare diseases in national level, the most important issues, which orphan patients face to in Lithuania, are singled out. In Lithuania, the situation of orphan patients in terms of protection of patient rights is insufficiently determined. The access to effective health care services or approved therapies in some cases is restricted. Working relationships between genetic services and various clinical specialists as well as with those in primary care are not legally determined; the number of clinical trials aimed at orphan medicinal products is low. These results suggest a need for awareness raising among Lithuanian Government, health care specialists, patient organizations about the importance to improve practical implementation of European Union legislation and progressive experience of some European countries in this field.

Evaluation of the reliability and validity of the Medical Outcomes Study sleep scale in patients with painful diabetic peripheral neuropathy during an international clinical trial

BackgroundSleep is an important element of functioning and well-being. The Medical Outcomes Study Sleep Scale (MOS-Sleep) includes 12 items assessing sleep disturbance, sleep adequacy, somnolence, quantity of sleep, snoring, and awakening short of breath or with a headache. A sleep problems index, grouping items from each of the former domains, is also available. This study evaluates the psychometric properties of MOS-Sleep Scale in a painful diabetic peripheral neuropathic population based on a clinical trial conducted in six countries.MethodsClinical data and health-related quality of life data were collected at baseline and after 12 weeks of follow-up. Overall, 396 patients were included in the analysis. Psychometric properties of the MOS-Sleep were assessed in the overall population and per country when the sample size was sufficient. Internal consistency reliability was assessed by Cronbach's alpha; the structure of the instrument was assessed by verifying item convergent and discriminant criteria; construct validity was evaluated by examining the relationships between MOS-Sleep scores and sleep interference and pain scores, and SF-36 scores; effect-sizes were used to assess the MOS-Sleep responsiveness. The study was conducted in compliance with United States Food and Drug Administration regulations for informed consent and protection of patient rights.ResultsCronbach's alpha ranged from 0.71 to 0.81 for the multi-item dimensions and the sleep problems index. Item convergent and discriminant criteria were satisfied with item-scale correlations for hypothesized dimensions higher than 0.40 and tending to exceed the correlations of items with other dimensions, respectively. Taken individually, German, Polish and English language versions had good internal consistency reliability and dimension structure. Construct validity was supported with lower sleep adequacy score and greater sleep problems index scores associated with measures of sleep interference and pain scores. In addition, correlations between the SF-36 scores and the MOS-Sleep scores were low to moderate, ranging from -0.28 to -0.53. Responsiveness was supported by effect sizes > 0.80 for patients who improved according to the mean sleep interference and pain scores and clinician and patient global impression of change (p < 0.0001).ConclusionThe MOS-Sleep had good psychometric properties in this painful diabetic peripheral neuropathic population.Trial registrationAs this study was conducted from 2000 to 2002 (i.e., before the filing requirement came out), no trial registration number is available.

An Analysis of Patient Rights Violations in Psychiatric Hospitals in Japan After the Enactment of the Mental Health Act of 1987

The Mental Health Act in Japan was enacted in 1987. This study aims to determine whether the act has been effective in protecting patient rights by delineating the content and trends of patient rights violations at psychiatric hospitals through an analysis of newspaper reports. An analysis of 924 newspaper articles found 39 hospitals involved in patient rights violations. The results show that violations of patient rights have continued to occur after the implementation of the act. The reasons: for-profit policy of hospitals, a defective oversight system, and a lack of knowledge about the act by medical staff.

In search of a perfect ombudsman

Appropriately, this book has a question mark in its title. It is concerned with the role of the ombudsman in protecting patient rights and describes the systems that have evolved in seven countries with different cultures and history - Austria, Finland, Greece, Hungary, Israel, Norway and the UK.

Data Mining Strategies for Shaping Nursing and Health Policy Agendas

Data mining of electronic databases is becoming more popular as a method for researchers to study issues in the health policy arena. The advantages of using electronic databases, such as the decreased investments in time and costs associated with subject recruitment and data collection, contribute to its appeal. Despite these features, the use of electronic databases to address health policy issues in nursing has been limited. This article discusses potential uses of secondary analysis for nursing research and outlines the steps involved in the process of data mining. Examples of health services research using samples generated from electronic databases support the discussion. The growing popularity of secondary analyses has given rise to concerns regarding the protection of patient rights and confidentiality. The authors discuss steps taken by federal agencies and institutional review boards to ensure that data are protected while preserving the research potential of this method of analysis.

Protecting Patient Rights: A Nursing Responsibility

This article addresses the issues that practicing nurses should be aware of surrounding access to personal health information. In the age of technology, electronic transmission of medical records has created a new array of challenges for informing and protecting patients’ rights. The Health Insurance Portability Act of 1996 addresses critical issues and poses some actions necessary for nurses to understand to (a) facilitate patients in decision making and (b) advocate for the protection of information, which may be used against patients inappropriately. This article is a general overview of the specific right of autonomy for the patient, which may be in jeopardy of violation without the proper understanding of the issues we face.

Ethical issues arising in pharmacoepidemiologic research in a community hospital in Crete, Greece.

This paper presents the various issues encountered in planning, designing, performing, and reporting pharmacoepidemiologic research. Five hundred and fifty-one indigent patients insured by Social Care visited the Hospital Pharmacy of Chania General Hospital, and were compared with 551 patients insured under Social Security funds who visited three community pharmacies. The study had no external funding. Before we started the study, we officially sought approval from the Scientific Committee of our Hospital and from the local Pharmaceutical Association. We asked also for approval from the Medical School of the University of Crete. Patient privacy was of great concern in the design and performance of the study. The law in Greece, according to the directives of European Union, affects the way we use records in hospitals and protect patient rights. After these studies were completed, we made proposals to the authorities concerning continuous health education for both patients and health workers. Pharmacoepidemiologic research is difficult in hospitals outside universities or institutions, because of the lack of adequate funding and grants to support research staff.

Perianesthesia standards for ethical practice

Perianesthesia standards for ethical practice

Doctor Does Not Know Best: Why in the New Century Physicians Must Stop Trying to Benefit Patients

While twentieth-century medical ethics has focused on the duty of physicians to benefit their patients, the next century will see that duty challenged in three ways. First, we will increasingly recognize that it is unrealistic to expect physicians to be able to determine what will benefit their patients. Either they limit their attention to medical well-being when total well-being is the proper end of the patient or they strive for total well-being, which takes them beyond their expertise. Even within the medical sphere, they have no basis for choosing among the proper medical goals for medicine. Also, there are many plausible strategies for relating predicted benefits to harms, and physicians cannot be expert in picking among these strategies. Second, increasingly plausible ethical systems recognize that in some cases, patient benefit must be sacrificed to protect patient rights including the right to the truth, to have promises kept, to have autonomy respected, and to not be killed. Third, ethics of the next century will increasingly recognize that some patient benefits must be sacrificed to fulfill duties to others - either the duty to serve the interests of others or other duties such as keeping promises, telling the truth, and, particularly, promoting justice. Physicians in the twenty-first century will be seen as having a new, more limited duty to assist the patient in pursuing the patient's understanding of the patient's interest within the constraints of deontological ethical principles and externally imposed duties to promote justice. The result will be a duty to be loyal to the consumer of health care with the recognition that often this will mean that the physician is not permitted to pursue the physician's understanding of the patient's well-being.

The economics of clinical ethics programs: a quantitative justification.

The restructuring of the healthcare marketplace has exerted pressure directly and indirectly on clinical ethics programs. The fiscal orientation and emphasis on efficiency, outcome measures, and cost control have made it increasingly difficult to communicate arguments in support of the existence or growth of ethics programs. In the current marketplace, arguments that rely on the claim that ethics programs protect patient rights or assist in the professional formation of practitioners often result in minimal levels of funding and preclude program growth. Where ethics programs could once sustain themselves on goodwill alone and values arguments in an expanding healthcare market they are now encountering—at least by anecdotal reports—cutbacks and even elimination. To respond to these challenges, we offer an economic model that can be used to demonstrate the “value” of an institutionally based ethics program.

To the Editor

In their paper “Assisted Suicide Is Not Voluntary Active Euthanasia,” Watts and Howell1 engage the debate regarding physician assisted suicide. As the authors noted, we previously had written “Voluntary Active Euthanasia: The Individual Case and Public Policy.“2 Our intent in writing that article was to focus on the more general issue of voluntary active euthanasia (VAE) and not specifically on assisted suicide, since our article was a companion to the American Geriatric Society position paper on VAE.3 We now take the opportunity to explain our views about policy regarding physician assisted suicide. A central premise of our argument against legalizing VAE is that policy must comprehensively assess the benefits and the risks, both to the individual and to society. In this framework, we argued that potential pitfalls from legalized VAE outweighed the perceived benefits. How should we judge physician assisted suicide in this framework? The authors justify assisted suicide by citing the compelling case of those with intractable pain. How many patients cannot get adequate symptom relief once enrolled in hospice programs? The limited research that has been done suggests that this number is small.4,5 Obviously, more research is needed regarding the degree to which adequate palliation is not achieved, especially if it is not achieved despite vigorous efforts. However, the debate is not decided if a small number have intractable pain. There may be a few tragic cases whose only relief is found in continuous near-anesthetic analgesia. Our society must grapple with seriously inequitable access to supportive health care services, including hospice. Many will not get even first-line efforts to relieve pain and suffering. Our grave concern is that patient requests for assisted suicide will largely be prompted by lack of access to supportive services for the dying. Those at greatest risk for lack of access are the impoverished and those at risk of impoverishment with survival. A policy that encourages patients to choose to end life because of a lack of adequate supportive services is “inhumane,” to use Watts and Howell's term. As we previously noted,2 the most difficult cases will not be those with intractable pain but those with a “weariness with life.” Van der Maas and colleagues' work6 suggests that patients give this reason in just over one-fifth of the cases. No one yet knows how often these requests are firm and thoughtful requests, not arising dominantly from depression or social isolation. We find these cases quite troubling. The care that Dr. Quill gave his patient before the patient's decision to implement suicide would seem to be exemplary.7 Will we be able to secure similar standards for medical practice as a whole? Certainly, we have far to go. In The Netherlands, where VAE is not prosecuted, evidence to date indicates that the regulatory process falls far short of protecting patient rights.8 Although “ultimately” the patient is responsible for physician-assisted suicide, manipulation and coercion can be subtle. Having no attractive alternatives because of shortcomings of the health care system is quite coercive. Policy changes must be informed by carefully conducted empirical research and public debate. Virtually no such research exists, and the public debate is therefore clouded. Educational efforts to train health care providers to palliate pain and psychological distress during dying are obviously justified. Likewise, those who are dying must have appropriate access to palliative care. When this society has secured these services for all and has engendered reliable research, then we should debate whether killing the remaining sufferers can sometimes be justified. The reverse order would be a serious error.

Protection of patient rights and welfare in the VA cooperative studies program

Four VA Cooperative Studies Program Coordinating Centers have been established by the Cooperative Studies Program of the Medical Research Service of the Veterans Administration. Affiliated with each Coordinating Center is a Human Rights Committee (HRC). These HRCs function similarly to the Institutional Review Board but differ from it in many significant ways. This paper presents the organizational structures, the responsibilities, and the inherent dynamics of the HRCs. With clear and defined objectives and guidelines, the HRCs monitor the multicenter cooperative studies conducted within the VA health care system. The HRCs strive to balance the need for protecting patients' rights and welfare with the need for research. Its specific role is to ensure that multicenter trials are planned, implemented, and evaluated such that the rights and welfare of study subjects are protected. This is accomplished by reviewing the content and the procedures of the informed consent during the planning stage as well as by the site visits and continuing reviews during the ongoing phase of each cooperative study.