Clinical Trials and Novel Pathogens: Lessons Learned from SARS

During the recent global outbreak of severe acute respiratory syndrome (SARS), thousands of patients received treatments of uncertain efficacy and known toxicity such as ribavirin and corticosteroids. Despite this, no controlled clinical trials assessing the efficacy of these agents were conducted. If a second global SARS outbreak occurred, clinicians would not have controlled data on which to base therapeutic decisions. We discuss the unique methodologic and logistical challenges faced by researchers who attempt to conduct controlled trials of therapeutic agents during an outbreak of a novel or unknown infectious pathogen. We draw upon our own experience in attempting to conduct a randomized controlled trial (trial) of ribavirin therapy for SARS and discuss the lessons learned. Strategies to facilitate future clinical trials during outbreaks of unknown or novel pathogens are also presented

Perception of epidemic's related anxiety in the General French Population: a cross-sectional study in the Rhône-Alpes region

International audienceBackgroundTo efficiently plan appropriate public health interventions during possible epidemics, governments must take into consideration the following factors about the general population: their knowledge of epidemics, their fears of and psychological responses to them, their level of compliance with government measures and their communities' trusted sources of information. However, such surveys among the French general population are rare.MethodsA cross-sectional study was conducted in 2006 in a representative sample of 600 subjects living in the Rhône-Alpes region (south-east France) to investigate self-reported knowledge about infectious diseases and anxiety generated by epidemic risk with particular reference to avian influenza. Data on reactions to potentially new epidemics and the confidence level in various sources of information were also collected.ResultsRespondents were most knowledgeable about AIDS, followed by avian influenza. Overall, 75% of respondents had adequate knowledge of avian influenza. The percentage was even higher (88%) among inhabitants of the Ain district, where an avian influenza epidemic had previously been reported. However, 39% expressed anxiety about this disease. In total, 20% of respondents with knowledge about avian influenza stated that they had changed their behaviours during the epizooty. Epidemics were perceived as a real threat by 27% of respondents. In the event of a highly contagious outbreak, the majority of respondents said they would follow the advice given by authorities. The study population expressed a high level of confidence in physicians and scientists, but had strong reservations about politicians, deputies and the media.ConclusionsAlthough the survey was conducted only four months after the avian influenza outbreak, epidemics were not perceived as a major threat by the study population. The results showed that in the event of a highly infectious disease, the population would comply with advice given by public authorities

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

SARS Control and Psychological Effects of Quarantine, Toronto, Canada

Peer Reviewedhttp://deepblue.lib.umich.edu/bitstream/2027.42/40320/2/Hawryluck_SARS Control and Psychological Effects_2004.pd

Risk factors for posttraumatic stress reactions among chinese students following exposure to a snowstorm disaster

<p>Abstract</p> <p>Background</p> <p>It is important to understand which factors increase the risk of posttraumatic stress disorder (PTSD) in adolescents. Previous studies have shown that the most important risk factors for PTSD include the type, severity, and duration of exposure to the traumatic events.</p> <p>Methods</p> <p>A cross-sectional survey was used to investigate the psychological symptoms associated with the aftermath of a snowstorm disaster in the Hunan province of China in January 2008. Students living in Hunan were surveyed at a three<b>-</b>month follow-up after the disaster. The questionnaire battery included the Impact of Event Scale-Revised (IES-R, trauma and symptoms associated with PTSD), the Chinese version of the Life Orientation Test-Revised (LOT-R, optimism and pessimism), the Chinese version of the Eysenck Personality Questionnaire (EPQ, neuroticism and extraversion), the Chinese Trait Coping Style Questionnaire (TCSQ, positive and negative coping styles), and a range of questions addressing social demographic characteristics and factors relating to the snowstorm. The survey was administered in school, and 968 students completed and returned the questionnaires.</p> <p>Results</p> <p>The results showed that 14.5% of the students had a total IES-R score ≥20. Students with greater school-to-home distances showed higher levels of posttraumatic stress symptoms than students who lived shorter distances from school. Students with emotional support from their teachers reported higher levels of posttraumatic stress symptoms (21.20%) than students without a teacher's emotional support (11.07%). The IES-R total and subscale scores correlated with all variables except extraversion. The binary logistic regression analysis results showed that the teacher's emotional support [odds ratio (OR) = 1.72, 95% confidence interval (CI) = 1.13-2.62], school-to-home distance (OR = 1.01, 95% CI = 1.00-1.01), negative coping (OR = 1.05; 95% CI = 1.02-1.08), and neuroticism (OR = 1.04, 95% CI = 1.02-1.06) were risk factors that predicted PTSD frequency and severity (percentage correct = 85.5%).</p> <p>Conclusions</p> <p>The risk factors that significantly impacted the onset of posttraumatic stress reactions in students living in Hunan, China following a snowstorm disaster were the school-to-home distance, negative coping, neuroticism, and teacher's emotional support.</p

Sedation in palliative care – a critical analysis of 7 years experience

BACKGROUND: The administration of sedatives in terminally ill patients becomes an increasingly feasible medical option in end-of-life care. However, sedation for intractable distress has raised considerable medical and ethical concerns. In our study we provide a critical analysis of seven years experience with the application of sedation in the final phase of life in our palliative care unit. METHODS: Medical records of 548 patients, who died in the Palliative Care Unit of GK Havelhoehe between 1995–2002, were retrospectively analysed with regard to sedation in the last 48 hrs of life. The parameters of investigation included indication, choice and kind of sedation, prevalence of intolerable symptoms, patients' requests for sedation, state of consciousness and communication abilities during sedation. Critical evaluation included a comparison of the period between 1995–1999 and 2000–2002. RESULTS: 14.6% (n = 80) of the patients in palliative care had sedation given by the intravenous route in the last 48 hrs of their life according to internal guidelines. The annual frequency to apply sedation increased continuously from 7% in 1995 to 19% in 2002. Main indications shifted from refractory control of physical symptoms (dyspnoea, gastrointestinal, pain, bleeding and agitated delirium) to more psychological distress (panic-stricken fear, severe depression, refractory insomnia and other forms of affective decompensation). Patients' and relatives' requests for sedation in the final phase were significantly more frequent during the period 2000–2002. CONCLUSION: Sedation in the terminal or final phase of life plays an increasing role in the management of intractable physical and psychological distress. Ethical concerns are raised by patients' requests and needs on the one hand, and the physicians' self-understanding on the other hand. Hence, ethically acceptable criteria and guidelines for the decision making are needed with special regard to the nature of refractory and intolerable symptoms, patients' informed consent and personal needs, the goals and aims of medical sedation in end-of-life care

Macrosocial determinants of population health in the context of globalization

Peer Reviewedhttp://deepblue.lib.umich.edu/bitstream/2027.42/55738/1/florey_globalization_2007.pd

Neuromuscular blockers—a means of palliation?

As we die, our respiratory pattern is altered and we seem to gasp and struggle for each breath. Such gasping is commonly seen as a clear sign of dyspnoea and suffering by families and loved ones, however, it is unclear whether it is perceived at all by the dying person. Narcotics and sedatives do not seem to affect these gasping respirations. In this issue of the Journal of Medical Ethics, we are asked to consider whether the last gasp of a dying patient could be or, perhaps, even should be avoided by administering neuromuscular blockers to palliate dying patients. For many reasons, such as our current failure to alleviate pain and distress, stories of inadequate analgesia and sedation in critically ill paralysed patients and the inability to know the intent—whether to palliate or to euthanise—it would seem that administering neuromuscular blockers should not be ethically permissible

Consensus guidelines on analgesia and sedation in dying ICU patients

grantor: University of Toronto'Background'. Intensivists must provide palliative care to dying patients but risk prosecution for assisted death if they administer too much analgesia and sedation. 'Purpose'. To develop consensus guidelines on analgesia and sedation in dying ICU patients, and help distinguish palliative care from euthanasia. 'Methods'. 'Design': Delphi technique. ' Sample': Three panels: (1) Academic Adult Intensive Care program directors and ICU directors in academic centres without a fellowship program (2) Deputy chief provincial coroners; (3) Validation panel of Intensivists from the 1999 'Canadian Critical Care End-of-Life' meeting. ' Intervention': Statements about analgesia and sedation. 'Outcome measures': A Likert scale indicating agreement with the statements, and indications of what modifications would increase agreement. 'Analysis ': A median value of 5.6 (80% agreement) was stipulated a priori to indicate consensus. 'Results'. Consensus was achieved on 16 statements. 'Conclusions'. We developed consensus guidelines on palliation in the ICU that will help distinguish palliative care from assisted death.M.Sc