Access and use of human tissues from the developing world: ethical challenges and a way forward using a tissue trust

<p>Abstract</p> <p>Background</p> <p>Scientists engaged in global health research are increasingly faced with barriers to access and use of human tissues from the developing world communities where much of their research is targeted. In part, the problem can be traced to distrust of researchers from affluent countries, given the history of 'scientific-imperialism' and 'biocolonialism' reflected in past well publicized cases of exploitation of research participants from low to middle income countries.</p> <p>Discussion</p> <p>To a considerable extent, the failure to adequately engage host communities, the opacity of informed consent, and the lack of fair benefit-sharing have played a significant role in eroding trust. These ethical considerations are central to biomedical research in low to middle income countries and failure to attend to them can inadvertently contribute to exploitation and erode trust. A 'tissue trust' may be a plausible means for enabling access to human tissues for research in a manner that is responsive to the ethical challenges considered.</p> <p>Summary</p> <p>Preventing exploitation and restoring trust while simultaneously promoting global health research calls for innovative approaches to human tissues research. A tissue trust can reduce the risk of exploitation and promote host capacity as a key benefit.</p

Pandemic influenza preparedness: an ethical framework to guide decision-making

BACKGROUND: Planning for the next pandemic influenza outbreak is underway in hospitals across the world. The global SARS experience has taught us that ethical frameworks to guide decision-making may help to reduce collateral damage and increase trust and solidarity within and between health care organisations. Good pandemic planning requires reflection on values because science alone cannot tell us how to prepare for a public health crisis. DISCUSSION: In this paper, we present an ethical framework for pandemic influenza planning. The ethical framework was developed with expertise from clinical, organisational and public health ethics and validated through a stakeholder engagement process. The ethical framework includes both substantive and procedural elements for ethical pandemic influenza planning. The incorporation of ethics into pandemic planning can be helped by senior hospital administrators sponsoring its use, by having stakeholders vet the framework, and by designing or identifying decision review processes. We discuss the merits and limits of an applied ethical framework for hospital decision-making, as well as the robustness of the framework. SUMMARY: The need for reflection on the ethical issues raised by the spectre of a pandemic influenza outbreak is great. Our efforts to address the normative aspects of pandemic planning in hospitals have generated interest from other hospitals and from the governmental sector. The framework will require re-evaluation and refinement and we hope that this paper will generate feedback on how to make it even more robust

Traumatic deep vein thrombosis in a soccer player: A case study

A 42 year-old male former semi-professional soccer player sustained a right lower extremity popliteal contusion during a soccer game. He was clinically diagnosed with a possible traumatic deep vein thrombosis (DVT), and sent for confirmatory tests. A duplex doppler ultrasound was positive for DVT, and the patient was admitted to hospital for anticoagulation (unfractionated heparin, warfarin). Upon discharge from hospital the patient continued oral warfarin anticoagulation (six months), and the use of compression stockings (nine months). He followed up with his family doctor at regular intervals for serial coagulation measurements, and ultrasound examinations. The patient's only identified major thrombotic risk factor was the traumatic injury. One year after the initial deep vein thrombosis (DVT) the patient returned to contact sport, however he continued to have intermittent symptoms of right lower leg pain and right knee effusion. Athletes can develop vascular injuries in a variety of contact and non-contact sports. Trauma is one of the most common causes of lower extremity deep vein thrombosis (DVT), however athletic injuries involving lower extremity traumatic DVT are seldom reported. This diagnosis and the associated risk factors must be considered during the initial physical examination. The primary method of radiological diagnosis of lower extremity DVT is a complete bilateral duplex sonography, which can be augmented by other methods such as evidence-based risk factor analysis. Antithrombotic medication is the current standard of treatment for DVT. Acute thrombolytic treatment has demonstrated an improved therapeutic efficacy, and a decrease in post-DVT symptoms. There is a lack of scientific literature concerning the return to sport protocol following a DVT event. Athletic individuals who desire to return to sport after a DVT need to be fully informed about their treatment and risk of reoccurrence, so that appropriate decisions can be made

On pandemics and the duty to care: whose duty? who cares?

BACKGROUND: As a number of commentators have noted, SARS exposed the vulnerabilities of our health care systems and governance structures. Health care professionals (HCPs) and hospital systems that bore the brunt of the SARS outbreak continue to struggle with the aftermath of the crisis. Indeed, HCPs – both in clinical care and in public health – were severely tested by SARS. Unprecedented demands were placed on their skills and expertise, and their personal commitment to their profession was severely tried. Many were exposed to serious risk of morbidity and mortality, as evidenced by the World Health Organization figures showing that approximately 30% of reported cases were among HCPs, some of whom died from the infection. Despite this challenge, professional codes of ethics are silent on the issue of duty to care during communicable disease outbreaks, thus providing no guidance on what is expected of HCPs or how they ought to approach their duty to care in the face of risk. DISCUSSION: In the aftermath of SARS and with the spectre of a pandemic avian influenza, it is imperative that we (re)consider the obligations of HCPs for patients with severe infectious diseases, particularly diseases that pose risks to those providing care. It is of pressing importance that organizations representing HCPs give clear indication of what standard of care is expected of their members in the event of a pandemic. In this paper, we address the issue of special obligations of HCPs during an infectious disease outbreak. We argue that there is a pressing need to clarify the rights and responsibilities of HCPs in the current context of pandemic flu preparedness, and that these rights and responsibilities ought to be codified in professional codes of ethics. Finally, we present a brief historical accounting of the treatment of the duty to care in professional health care codes of ethics. SUMMARY: An honest and critical examination of the role of HCPs during communicable disease outbreaks is needed in order to provide guidelines regarding professional rights and responsibilities, as well as ethical duties and obligations. With this paper, we hope to open the social dialogue and advance the public debate on this increasingly urgent issue

Seasonality of primary care utilization for respiratory diseases in Ontario: A time-series analysis

<p>Abstract</p> <p>Background</p> <p>Respiratory diseases represent a significant burden in primary care. Determining the temporal variation of the overall burden of respiratory diseases on the health care system and their potential causes are keys to understanding disease dynamics in populations and can contribute to the rational management of health care resources.</p> <p>Methods</p> <p>A retrospective, cross-sectional time series analysis was used to assess the presence and strength of seasonal and temporal patterns in primary care visits for respiratory diseases in Ontario, Canada, for a 10-year period from January 1, 1992 to December 31, 2002. Data were extracted from the Ontario Health Insurance Plan database for people who had diagnosis codes for chronic obstructive pulmonary disease, asthma, pneumonia, or upper respiratory tract infections.</p> <p>Results</p> <p>The results illustrate a clear seasonal pattern in visits to primary care physicians for all respiratory conditions, with a threefold increase in visits during the winter. Age and sex-specific rates show marked increases in visits of young children and in female adults. Multivariate time series methods quantified the interactions among primary care visits, and Granger causality criterion test showed that the respiratory syncytial virus (RSV) and influenza virus influenced asthma (p = 0.0060), COPD (p = 0.0038), pneumonia (p = 0.0001), and respiratory diseases (p = 0.0001).</p> <p>Conclusion</p> <p>Primary care visits for respiratory diseases have clear predictable seasonal patterns, driven primarily by viral circulations. Winter visits are threefold higher than summer troughs, indicating a short-term surge on primary health service demands. These findings can aid in effective allocation of resources and services based on seasonal and specific population demands.</p

Canadian national surveys on pandemic influenza preparations: pre-pandemic and peri-pandemic findings

BACKGROUND: Prior to the 2009 H1N1 Influenza pandemic, public health authorities in Canada and elsewhere prepared for the future outbreak, partly guided by an ethical framework developed within the Canadian Program of Research on Ethics in a Pandemic (CanPREP). We developed a telephone-based survey based on that framework, which was delivered across Canada in late 2008. In June, 2009, the WHO declared pandemic Phase 6 status and from the subsequent October (2009) until May 2010, the CanPREP team fielded a second (revised) survey, collecting another 1,000 opinions from Canadians during a period of pre-pandemic anticipation and peri-pandemic experience. METHODS: Surveys were administered by telephone with random sampling achieved via random digit dialing. Eligible participants were adults, 18 years or older, with per province stratification approximating provincial percentages of national population. Descriptive results were tabulated and logistic regression analyses used to assess whether demographic factors were significantly associated with outcomes, and to identify divergences (between the pre-pandemic and intra-pandemic surveys). RESULTS: N = 1,029 interviews were completed from 1,986 households, yielding a gross response rate of 52% (AAPOR Standard Definition 3). Over 90% of subjects indicated the most important goal of pandemic influenza preparations was saving lives, with 41% indicating that saving lives solely in Canada was the highest priority and 50% indicating saving lives globally was the highest priority. About 90% of respondents supported the obligation of health care workers to report to work and face influenza pandemic risks excepting those with serious health conditions which that increased risks. Strong majorities favoured stocking adequate protective antiviral dosages for all Canadians (92%) and, if effective, influenza vaccinations (95%). Over 70% agreed Canada should provide international assistance to poorer countries for pandemic preparation, even if resources for Canadians were reduced. CONCLUSIONS: Results suggest Canadians trust public health officials to make difficult decisions, providing emphasis is maintained on reciprocity and respect for individual rights. Canadians also support international obligations to help poorer countries and associated efforts to save lives outside the country, even if intra-national efforts are reduced

Is there a clinically significant seasonal component to hospital admissions for atrial fibrillation?

BACKGROUND: Atrial fibrillation is a common cardiac dysrhythmia, particularly in the elderly. Recent studies have indicated a statistically significant seasonal component to atrial fibrillation hospitalizations. METHODS: We conducted a retrospective population cohort study using time series analysis to evaluate seasonal patterns of atrial fibrillation hospitalizations for the province of Ontario for the years 1988 to 2001. Five different series methods were used to analyze the data, including spectral analysis, X11, R-Squared, autocorrelation function and monthly aggregation. RESULTS: This study found evidence of weak seasonality, most apparent at aggregate levels including both ages and sexes. There was dramatic increase in hospitalizations for atrial fibrillation over the years studied and an age dependent increase in rates per 100,000. Overall, the magnitude of seasonal difference between peak and trough months is in the order of 1.4 admissions per 100,000 population. The peaks for hospitalizations were predominantly in April, and the troughs in August. CONCLUSIONS: Our study confirms statistical evidence of seasonality for atrial fibrillation hospitalizations. This effect is small in absolute terms and likely not significant for policy or etiological research purposes

Sources of evidence in HIV/AIDS care: pilot study comparing family physicians and AIDS service organization staff

BACKGROUND: The improvement of the quality of the evidence used in treatment decision-making is especially important in the case of patients with complicated disease processes such as HIV/AIDS for which multiple treatment strategies exist with conflicting reports of efficacy. Little is known about the perceptions of distinct groups of health care workers regarding various sources of evidence and how these influence the clinical decision-making process. Our objective was to investigate how two groups of treatment information providers for people living with HIV/AIDS perceive the importance of various sources of treatment information. METHODS: Surveys were distributed to staff at two local AIDS service organizations and to family physicians at three community health centres treating people living with HIV/AIDS. Participants were asked to rate the importance of 10 different sources of evidence for HIV/AIDS treatment information on a 5-point Likert-type scale. Mean rating scores and relative rankings were compared. RESULTS: Findings suggest that a discordance exists between the two health information provider groups in terms of their perceptions of the various sources of evidence. Furthermore, AIDS service organization staff ranked health care professionals as the most important source of information whereas physicians deemed AIDS service organizations to be relatively unimportant. The two groups appear to share a common mistrust for information from pharmaceutical industries. CONCLUSIONS: Discordance exists between medical "experts" from different backgrounds relating to their perceptions of evidence. Further investigation is warranted in order to reveal any effects on the quality of treatment information and implications in the decision-making process. Possible effects on collaboration and working relationships also warrant further exploration

Simplicity within complexity: Seasonality and predictability of hospital admissions in the province of Ontario 1988–2001, a population-based analysis

BACKGROUND: Seasonality is a common feature of communicable diseases. Less well understood is whether seasonal patterns occur for non-communicable diseases. The overall effect of seasonal fluctuations on hospital admissions has not been systematically evaluated. METHODS: This study employed time series methods on a population based retrospective cohort of for the fifty two most common causes of hospital admissions in the province of Ontario from 1988–2001. Seasonal patterns were assessed by spectral analysis and autoregressive methods. Predictive models were fit with regression techniques. RESULTS: The results show that 33 of the 52 most common admission diagnoses are moderately or strongly seasonal in occurrence; 96.5% of the predicted values were within the 95% confidence interval, with 37 series having all values within the 95% confidence interval. CONCLUSION: The study shows that hospital admissions have systematic patterns that can be understood and predicted with reasonable accuracy. These findings have implications for understanding disease etiology and health care policy and planning

Public perceptions of quarantine: community-based telephone survey following an infectious disease outbreak

<p>Abstract</p> <p>Background</p> <p>The use of restrictive measures such as quarantine draws into sharp relief the dynamic interplay between the individual rights of the citizen on the one hand and the collective rights of the community on the other. Concerns regarding infectious disease outbreaks (SARS, pandemic influenza) have intensified the need to understand public perceptions of quarantine and other social distancing measures.</p> <p>Methods</p> <p>We conducted a telephone survey of the general population in the Greater Toronto Area in Ontario, Canada. Computer-assisted telephone interviewing (CATI) technology was used. A final sample of 500 individuals was achieved through standard random-digit dialing.</p> <p>Results</p> <p>Our data indicate strong public support for the use of quarantine when required and for serious legal sanctions against those who fail to comply. This support is contingent both on the implementation of legal safeguards to protect against inappropriate use and on the provision of psychosocial supports for those affected.</p> <p>Conclusion</p> <p>To engender strong public support for quarantine and other restrictive measures, government officials and public health policy-makers would do well to implement a comprehensive system of supports and safeguards, to educate and inform frontline public health workers, and to engage the public at large in an open dialogue on the ethical use of restrictive measures during infectious disease outbreaks.</p