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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 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 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 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.

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.

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.

The authors tested the hypothesis that having a high availability of different types of alcoholic drinks (beer, wine or spirits) as compared to being confined to one type only associate with a higher alcohol intake and worse next-day hangover.

This randomized controlled pilot trial took place over one evening and included 35 individuals randomized into two groups. Individuals in the mixed-type group could consume any type of alcoholic drink (beer, wine, cocktails), whereas individuals in the single-type group were to adhere to one type of own choice. Information on number of drinks was obtained continuously during the trial. Hangover symptoms were reported by participants using the Acute Hangover Severity Scale (AHSS) at 8:00, 12:00 and 16:30 the following day. Median regression was used to assess number of drinks and maximum AHSS in two groups.

Participants in the mixed-type group consumed significantly more drinks compared to the single-type group (10.9 vs 5.7, p < 0.001). The maximal AHSS score the day after drinking was higher in the mixed-type group as compared to the single-type group (median 4.3 vs 2.6, p < 0.0001).

This study suggests that having a variety of alcoholic drinks available associates to a higher alcohol intake and more severe hangover as compared to having to adhere to one type only. Larger studies are warranted to validate findings.

To examine the availability and quality of clinical guidelines on perioperative diabetes care in hospital units before and after a randomised clinical trial (RCT) and international accreditation.

Interventional “before‐after” study in 51 units (38 surgical and 13 anaesthetic) in nine hospitals participating in a RCT in the greater Copenhagen area; 27 of the units also underwent international accreditation.

The proportion of units with guidelines increased from 24/51 (47 percent) units before to 38/51 (75 percent) units after the trial. Among the 27 units without guidelines before the trial, significantly more accredited units compared to non‐accredited units had a guideline after the trial (9/10 (90 percent) compared to 5/17 (29 percent). The quality of the systematic development scale and the clinical scales improved significantly after the trial in both accredited units (both p<0.001) and in non‐accredited units (both p<0.02). The improvement of the systematic development scale was significantly higher in accredited than in non‐accredited units (p<0.01).

The combination of conducting both the DIPOM Trial and international accreditation led to a significant improvement of both dissemination and quality of guidelines on perioperative diabetic care.

The purpose of this paper is to review the efficacy of atypical antipsychotics in combination with clozapine. Previous meta-analyses have assessed the use of both typical and atypical antipsychotics in combination with clozapine, combination treatment being withheld only for those patients deemed treatment resistant.

Outcomes assessed included: positive, negative and overall symptom score. The total numbers of participants (n=588) were scored using the Positive and Negative Symptom Scale/the Brief Psychiatric Rating Scale and effect sizes were used to judge the efficacy of the combination treatments. Data gained from the ten randomized, double blind, placebo controlled trials were analysed using the R statistical software.

The effect sizes gained from analysis showed a small benefit of combination therapy over clozapine monotherapy. Therefore, it is the recommendation of this analysis that alternative avenues be sought in order to treat patients who have a sub-optimal response to clozapine with a combination other than two second generation antipsychotics.

The initial trials search unveiled 1,412 studies. After the inclusion and exclusion criteria were applied, ten trials were used in this meta-analysis.

The recommendation of this analysis that alternative medications be sought in order to treat patients who have a sub-optimal response to clozapine with a combination other than two second generation antipsychotics. This route should only be used once all other treatment options have been exhausted.

This meta-analytical study looks specifically at the combination of atypical antipsychotics with clozapine in comparison to clozapine monotherapy. This work extends existing meta-analysis by incorporating data from more recent trials.