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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.

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 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.

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 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 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.

This paper theoretically and empirically analyzes the effects of the elderly’s physical health status on their need for care and the choice of care models in China.

Empirically, the estimation results of a large-sample randomized intervention trial with chronic obstructive pulmonary disease (COPD) patients through the difference-in-difference method indicated the following: (1) After the COPD intervention trial, the physical health status of the elderly in the treatment group improved significantly, the need for care was substantially reduced and the health improvement led to a 35.5% reduction in the probability of using elderly care. (2) The reduction in the need for care regarding the treatment group occurred mainly in social care. The probability of using social care decreased by 67.8% due to the elderly’s health improvement, while that of home care remained unchanged generally. (3) Further heterogeneity tests suggested that families with fewer potential internal resources for caregiving had a more pronounced decline in the need for social care.

Theoretically, these empirical results support the existence of the “pecking order” theory in the family’s choice of elderly care model, that is, families tend to employ all internal resources for caregiving before resorting to social care, resulting in a higher sensitivity of social care to health.

The main policy implication of this paper is that ex ante preventive health intervention policies can significantly alleviate the burden of care, especially social care, on families. And preventive health intervention policies are particularly effective in reducing the burden of the families with relatively few resources for informal internal care.

The randomised control trial is regarded as the gold standard among the methods used in treatment outcome studies, whatever the treatment. This method imposes the highest level of control over other factors that may influence outcome so that the true effects of the treatment can be tested. In this paper the key features of an RCT are examined, along with potential challenges that emerge when applied to evaluations of psychotherapeutic interventions with people who have learning disabilities.

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.