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The chapter considers the ethical problems engendered by random assignment and privacy concerns in randomised controlled experiments and cluster randomised trials. The…
The chapter considers the ethical problems engendered by random assignment and privacy concerns in randomised controlled experiments and cluster randomised trials. The particular focus is on procedural, legislative and technical approaches to reducing or avoiding the problems. Examples are given from a variety of disciplines including health and education, though the main emphasis is on research in crime and delinquency.
This paper identifies and explores issues of medication, the elderly, and the problems in securing and using evidence from randomised control trials. Demographic and…
This paper identifies and explores issues of medication, the elderly, and the problems in securing and using evidence from randomised control trials. Demographic and health care data are presented. While the elderly are a significant set of consumers of medicines, there is a lack of published evidence, in control trial format, on which medications are better for elderly patients. Even if all the trial evidence on a new drug was published before the drug was put on the market, as recently recommended, there are serious issues to consider in securing and using evidence from clinical trials. This paper indicates ten problems in securing and using evidence from randomised control trials. Three examples of randomised control trials involving the elderly are given. While it is easier to call for improvements in the evidence base than to achieve improvements, this paper argues that improvements are fundamentally necessary. This is because if no significant improvement comes through on the evidence base, we will never know if we are providing the elderly with the cost‐effective care and attention that they deserve.
Diabetic foot ulcers are associated with considerable morbidity, mortality and costs to the NHS. This paper describes a review of publications reporting randomised…
Diabetic foot ulcers are associated with considerable morbidity, mortality and costs to the NHS. This paper describes a review of publications reporting randomised controlled trials examining the clinical effectiveness of interventions for diabetic foot ulcers for 1986–1996. Only 23 studies were identified that described randomised controlled trials and, of these, only 4 fulfilled three criteria shown to influence reliability of results: adequate description of randomisation, double blinding and description of withdrawals and drop‐outs. No cost‐effectiveness studies conducted alongside trials were identified from the searches. This shortage of rigorous trials highlights the need for more well designed research in the prevention and treatment of diabetic foot ulcers to determine clinical effectiveness as well as relative cost‐effectiveness.
Randomised controlled trials (RCTs) are considered the bedrock of evidence‐based practice. However, they raise important issues about participant recruitment and the…
Randomised controlled trials (RCTs) are considered the bedrock of evidence‐based practice. However, they raise important issues about participant recruitment and the ethics of group allocation. In this article we report relevant literature on how participants with learning disabilities and other stakeholders experience RCTs. Five quantitative studies have been published, one reporting on the views of people with learning disabilities and the remainder on carers' views. Despite the methodological limitations of the studies, carers appear to have a positive experience of RCT participation, and people with learning disabilities are able to understand certain aspects of research methods. We conclude that stakeholders are not hostile to RCTs, but the therapeutic misconception may affect their experiences. Further research is required to investigate interventions that might help promote RCTs in learning disabilities.
The randomised controlled trial, though highly valued, has been criticised as not helping to understand how results occur: Real-life complexity is not captured, i.e. what…
The randomised controlled trial, though highly valued, has been criticised as not helping to understand how results occur: Real-life complexity is not captured, i.e. what actually happens at trial sites (rather than what was intended). The purpose of this paper is to summarise and comment on two 2014 research papers addressing this challenge of randomised trials – concerning new therapeutic approaches for people diagnosed with psychotic disorders.
One paper is about what staff thought when adopting a new recovery-focused approach in two mental health services as part of a randomised trial. The other is the plan for a small pilot trial of a new treatment for psychosis called positive psychotherapy. It describes how the researchers planned to study the detail of what happens in their small trial, to help them improve the design of a future, larger trial.
The first paper recommends avoiding services undergoing too many changes and ensuring managers will visibly support the project. When training staff in a new approach, trainers should recognise staff's existing knowledge and skills and use practical methods like role-play. In the second paper, the plan for the small positive psychotherapy trial seems detailed enough to explain what really happens, except in one area: looking at how clinicians actually select service users for the trial.
These papers concern pioneering therapeutic approaches in psychosis. With randomised trials highly influential, both these papers recognise their potential problems, and seem to represent good attempts to understand what really happens.
– The purpose of this paper is to investigate the possible impact of a randomised controlled trial on the therapeutic environment of participating therapeutic communities (TCs).
The purpose of this paper is to investigate the possible impact of a randomised controlled trial on the therapeutic environment of participating therapeutic communities (TCs).
The authors compared the environment in four democratic day TCs involved in a randomised trial (experimental TCs) with a similar democratic day TC not involved in the trial (the control TC) by administering the Community Oriented Environment Scale (COPES) to 28 TC members.
TC members’ views of the real psychosocial environment at the experimental TC and control TC showed similar high levels for spontaneity, autonomy and personal problem orientation and similar intermediate levels for practical orientation and staff control. The TC members at the experimental TC rated significantly higher levels for order and organisation and clarity, while members at the control TC rated a significantly higher level for involvement.
The study provided no evidence of a significant adverse impact on the culture of democratic day TCs due to participation in a randomised trial. This finding answers one of the most common arguments in the debate on the ethics of RCTs in TCs.
The aim of this randomised intervention study was to test the use of two counselling styles in reducing alcohol consumption in offenders who were hazardous drinkers and…
The aim of this randomised intervention study was to test the use of two counselling styles in reducing alcohol consumption in offenders who were hazardous drinkers and who had been charged with alcohol‐related offences. An additional aim was to evaluate the research process itself before embarking on a larger trial. Participants were recruited from a police custody suite in the south east of England and randomised to receive either a motivational interviewing brief intervention (MIBI) or a standard brief intervention (BI). The Alcohol Use Disorder Identification Test (AUDIT) was used to screen offenders for hazardous drinking. Participants were asked to complete a second AUDIT 12 weeks later. Two hundred offenders with alcohol‐related offences were screened over a 10‐month period. Of these, 182 were alcohol dependent and were therefore excluded from the study. Of the 18 who were eligible to enter the study, six refused to participate. Five were randomised to the MIBI group and seven into the BI group (BI). The mean age of the MIBI group was 25 (SD±3.86) years and the mean age of the BI group was 32.4 (SD±7.9). Audit scores were significantly lower at time 2 compared to time 1 for both intervention groups (t(11) = 17.60; p < 0.05). There was no significant difference between the different intervention groups.
In the past decade, microfinance institutions (MFIs) have experienced a boom in innovations of lending products, partly fueled by donors who see microfinance as the next…
In the past decade, microfinance institutions (MFIs) have experienced a boom in innovations of lending products, partly fueled by donors who see microfinance as the next promise to alleviate poverty. Examples of these new products are the combination of credit with health or life insurance, business and health education, savings products, and the adoption of (or conversion to) individual loan liability. The add-on features generally aim at reducing the vulnerability of clients while contributing to asset creation, hence improving repayment rates and the sustainability of the service. The product innovations typically result from organizations striving to extend outreach, increase impact, and promote sustainability. As in other industries, MFIs typically decide whether to adopt new strategies based on other MFIs’ success with the innovations. Many new microlending products and approaches continue to be developed. However, MFIs must generally rely on qualitative and descriptive case studies and anecdotal evidence on the effectiveness of these innovations to decide whether to implement the new strategies. The usual case study approach does not provide tangible evidence that can enable other organizations to know what changes can be expected if they were to adopt similar product changes.
Realism is emerging as a paradigm for research and explanation in the natural and social sciences. A realist framework is elaborated and applied to the four possible…
Realism is emerging as a paradigm for research and explanation in the natural and social sciences. A realist framework is elaborated and applied to the four possible situations that may generate the observations of randomised, controlled trials. It is demonstrated that by using two realist concepts “mechanism” and “context” a number of misinterpretations of such trials from within the dominant empiricist paradigm may be rectified. Evidence based medicine should adopt realism to temper a misleading empiricism, this will involve relegating statistical arguments to their proper subsidiary place and adopting an adequate theory of causation.