The role of corruption and unethical behaviour in precluding the placement of industry sponsored clinical trials in sub-Saharan Africa: stakeholder views

Clinical trials still represent the gold standard in testing the safety and efficacy of new and existing treatments. However, developing regions including sub-Saharan Africa remain underrepresented in pharmaceutical industry sponsored trials for a number of reasons including fear of corruption and unethical behaviour. This fear exists both on the part of pharmaceutical companies, and investigators carrying out research in the region. The objective of this research was to understand the ethical considerations associated with the conduct of pharmaceutical industry sponsored clinical trials in sub-Saharan Africa. Corruption was identified as a significant issue by a number of stakeholders who participated in semi-structured interviews and completed questionnaires. Additionally, fear of being perceived as corrupt or unethical even when conducting ethically sound research was raised as a concern. Thus corruption, whether actual or perceived, is one of a number of issues which have precluded the placement of a greater number of pharmaceutical sponsored clinical trials in this region. More discussion around corruption with all relevant stakeholders is required in order for progress to be made and to enable greater involvement of sub-Saharan African countries in the conduct of industry sponsored clinical trials

Patients' advocacy: the development of a service at the State Hospital, Carstairs, Scotland

Advocacy is part of the process of empowering patients and involving them in the development of services. This paper describes the development of an advocacy service in the State Hospital at Carstairs and explores the issues involved in advocacy in a maximum secure environment. Using a model of citizen advocacy the service was started in September 1997. Patient involvement throughout the hospital was high with approximately 88% of patients having some contact with the service by January 2000. Most of the issues raised by patients are similar to those in any mental health advocacy project. Entrapment is a particular issue for some patients. Safety and security issues influence every aspect of the service. This ranges from advocates having to do more for patients rather than enable them to do things for themselves (e.g. make telephone calls) to the principle of the patients' wishes being paramount being tempered by security demands

Balancing autonomy and risk: the Scottish approach

The impact of compulsory measures of medical treatment for mental disorders have for some time interested medical and legal commentators, possibly because of the complex ethical issues these raise. In a context where stigma and discrimination are realities for many of those who use mental health services some people argue that holistic legislation, which places treatment for mental disorder within amore general framework of incapacity law, could reduce the stigma of mental ill health. Szmukler, Daw and Dawson have made an interesting attempt to show how such a law might look inpractice. They have built on and reflected the work of the Bamford Committee in Northern Ireland, which, while recommending a single legislative basis for mental health and incapacity law, fell short ofproducing a draft bill.In looking at these proposals from a Scottish perspective, we have resisted the temptation to focus on points of detail and have attempted to discuss certain themes. In particular, we have looked at how Scotland has introduced a capacity-based threshold for mental health law and how this compares with Szmukler et al’s proposed approach

Comparison of drug use and psychiatric morbidity between prostitute and non-prostitute female drug users in Glasgow, Scotland

Aims: To compare psychiatric morbidity between 176 female drug users with lifetime involvement in prostitution (prostitutes) and 89 female drug users with no involvement (non-prostitutes) in Glasgow, Scotland. Method: The Revised Clinical Interview Schedule (CIS-R) measured current neurotic symptoms. Results: Prostitutes were more likely to report adult physical (OR 1.8) or sexual abuse (OR 2.4), to have attempted suicide (OR 1.7) and to meet criteria for current depressive ideas (OR 1.8) than non-prostitutes. Seventy-two percent of prostitutes and sixty-seven percent of non-prostitutes met criteria for a level of current neurotic symptoms likely to need treatment (CIS-R ≥18). Being in foster care (OR 8.9), being prescribed medication for emotional problems in the last 30 days (OR 7.7), adult sexual abuse (OR 4.5), poly drug use in the last 30 days (OR 3.6) and adult physical abuse (OR 2.6) were significantly associated with a CIS-R score of ≥18 for prostitutes using multiple logistic regression. Conclusions: Higher rates of adulthood abuse among prostitutes may explain the greater proportion of prostitutes than non-prostitutes meeting criteria for current depressive ideas and lifetime suicide attempts

Intimate Partner Violence Documentation and Awareness in an Urban Emergency Department.

Background Domestic violence rates in smaller cities have been reported to be some of the highest in Canada. It is highly likely that the staff at emergency departments (ED) will come in contact with victims of intimate partner violence in their daily practice. The purpose of this study is to better understand current practices for detecting intimate partner violence, staff awareness and knowledge regarding intimate partner violence, and barriers to questioning about intimate partner violence in the ED. Methods A standardized retrospective chart review captured domestic violence documentation rates in patients presenting to the ED, and a cross-sectional online survey was distributed to the ED staff. Results We found documentation about intimate partner violence in 4.64% of all included patient charts. No documentation was noted in the domestic violence field. Significantly, 16.4% of the ED staff reported never questioning female patients about intimate partner violence; 83.6% enquired when they thought it appropriate, and none asked routinely. None of the staff used a structured screening tool, and 81.8% of the ED staff had not received any formal training. Partner presence was the most common barrier to asking about intimate partner violence, followed by a lack of access to domestic violence management information, and a lack of knowledge regarding intimate partner violence. Conclusions Our findings suggest that the current documentation tools are not being properly utilized. Low rates of intimate partner violence documentation in high-risk patients and lack of education indicate that there is a need to improve current practices. In order to improve identification of this important problem, appropriate training and education about intimate partner/domestic violence are required to increase staff comfort as well as knowledge about available community resources for the victims

Social fragmentation, deprivation and urbanicity: relation to first-admission rates for psychoses

<i>Declaration</i> <i>of</i> <i>interest</i>: None. <i>Background</i>: Social disorganisation, fragmentation and isolation have long been posited as influencing the rate of psychoses at area level. Measuring such societal constructsis difficult. A census-based index measuring social fragmentation has been proposed. <i>Aims</i>: To investigate the association between first-admission rates for psychosis and area-based measures of social fragmentation, deprivation and urban/rural index. <i>Method</i>: We used indirect standardisation methods and logistic regression models to examine associations of social fragmentation, deprivation and urban/rural categories with first admissions for psychoses in Scotland for the 5-year period 1989–1993. <i>Results</i>: Areas characterised by high social fragmentation had higher first-ever admission rates for psychosis independent of deprivation and urban/rural status. There was a dose–response relationship between social fragmentation category and first-ever admission rates for psychosis. There was no statistically significant interaction between social fragmentation, deprivation and urban/rural index. <i>Conclusions</i>: First-admission rates are strongly associated with measures of social fragmentation, independent of material deprivation and urban/rural category

An insight into light as a chronobiological therapy in affective disorders

The field of chronobiology has vastly expanded over the past few decades, bringing together research from the fields of circadian rhythms and sleep. The importance of the environmental day–night cycle on our health is becoming increasingly evident as we evolve into a 24-hour society. Reducing or changing sleep times against our natural instincts to rest at night has a detrimental impact on our well-being. The mammalian circadian clock, termed "the suprachiasmatic nucleus", is responsible for synchronizing our behavioral and physiological outputs to the environment. It utilizes light transcoded by specialized retinal photoreceptors as its cue to set internal rhythms to be in phase with the light–dark cycle. Misalignment of these outputs results in symptoms such as altered/disturbed sleep patterns, changes in mood, and physical and mental exhaustion – symptoms shared by many affective clinical disorders. Key links to circadian abnormalities have been found in a number of disorders, such as seasonal affective disorder, nonseasonal depression, and bipolar affective disorder. Furthermore, therapies developed through chronobiological research have been shown to be beneficial in the treatment of these conditions. In this article, we discuss the impact of circadian research on the management of affective disorders, giving evidence of how a misaligned circadian system may be a contributor to the symptoms of depression and how moderating circadian rhythms with light therapy benefits patients

The Care Programme Approach and the end of indefinitely renewable Leave of Absence in Scotland

ObjectiveTo consider the relationship between the restriction of leave of absence (LOA) to 12 months, the introduction of community care orders (CCOs) and the implementation of the Care Programme Approach (CPA).DesignMultiple methods were employed: scrutiny of Mental Welfare Commission for Scotland (MWC) records; questionnaire to consultant psychiatrists and mental health officers (MHOs) regarding attitudes; survey of psychiatrists in respect of outcomes for named patients.SettingScotlandSubjectsTwo hundred and sixty six patients who were affected by the changes introduced by the Mental Health (Patients in the Community) Act 1995.ResultsInformation was available for 195 (73%) patients in relation to CPA. Of these 113 (58%) were included on CPA and for 63/113 (56%) (63/195 (32%)) CPA was considered to have enhanced patient care.Where CPA was considered useful it was because it was seen as bringing people together, enhancing the patient’s role in treatment and managing difficult situations. Negative comments regarding CPA were that it was unnecessary as the patient’s needs were straightforward, it duplicated current practices or it was too bureaucratic.ConclusionsDespite concerns expressed by professionals about the restriction to LOA and the guidance that patients should be on CPA, for only a minority of patients was CPA described as enhancing care. Questions are raised about the low use of CCOs and CPA by psychiatrists for patients who reached the new limits of LOA