Biomedical subjects

Andrew J Stevens

Publications and source records attributed to Andrew J Stevens.

4 recordsLinked to original sources

PubMed2005

Recruitment of ethnic minority patients to a cardiac rehabilitation trial: the Birmingham Rehabilitation Uptake Maximisation (BRUM) study [ISRCTN72884263].

BACKGROUND: Concerns have been raised about low participation rates of people from minority ethnic groups in clinical trials. However, the evidence is unclear as many studies do not report the ethnicity of participants and there is insufficient information about the reasons for ineligibility by ethnic group. Where there are data, there remains the key question as to whether ethnic minorities more likely to be ineligible (e.g. due to language) or decline to participate. We have addressed these questions in relation to the Birmingham Rehabilitation Uptake Maximisation (BRUM) study, a randomized controlled trial (RCT) comparing a home-based with a hospital-based cardiac rehabilitation programme in a multi-ethnic population in the UK. METHODS: Analysis of the ethnicity, age and sex of presenting and recruited subjects for a trial of cardiac rehabilitation in the West-Midlands, UK. PARTICIPANTS: 1997 patients presenting post-myocardial infarction, percutaneous transluminal coronary angioplasty or coronary artery bypass graft surgery. DATA COLLECTED: Exclusion rates, reasons for exclusion and reasons for declining to participate in the trial by ethnic group. RESULTS: Significantly more patients of South Asian ethnicity were excluded (52% of 'South Asian' v 36% 'White European' and 36% 'Other', p < 0.001). This difference in eligibility was primarily due to exclusion on the basis of language (i.e. the inability to speak English or Punjabi). Of those eligible, similar proportions were recruited from the different ethnic groups (white, South Asian and other). There was a marked difference in eligibility between people of Indian, Pakistani or Bangladeshi origin. CONCLUSION: Once eligible for this trial, people from different ethnic groups were recruited in similar proportions. The reason for ineligibility in the BRUM study was the inability to support the range of minority languages.

Aged↗

PubMed2005

The ethics of placebo-controlled trials: a comparison of inert and active placebo controls.

Because of the recent and controversial example of sham surgery for the evaluation of fetal tissue transplants for Parkinson's disease, there is renewed interest in the ethics of using "active" placebos in surgical trials, where otherwise there are no inert procedures available, and in pharmacological trials, where there are inert substances, but where patients may guess to which arm they have been allocated. This paper seeks to clarify the ethical arguments surrounding the use of active placebos in trials, and to set up a notation for assessing the ethics of trials more generally. We first establish an framework by which ethics committees can analyze such trials. We examine (1) the scientific value of the research; (2) the expected risks and benefits to individual patients, and (3) the voluntary nature of consent. We then contrast the implications of this framework for inert and active placebo-controlled trials, respectively. In particular, we analyze their relative expected utility using three main utility factors, namely, treatment effects, placebo effects, and altruism. We conclude that, when the intervention is already widely available, active placebo trials rely more heavily on altruism than do inert placebo trials and, when the intervention is restricted, this excess reliance may not be needed. What our analysis provides is the explicit justification for the apparent caution of Institutional Review Boards or ethics committees when reviewing sham operations, especially when the expected harm is not trivial and the risk of exploitation is high.

Clinical Trials as Topic↗

PubMed2005

Can health technologies be assessed using routine data?

OBJECTIVES: The potential of routine data for health technology assessment (HTA) in the United Kingdom was assessed. METHODS: Compiled were a comprehensive list of routine databases, their classification according to data characteristics, literature review on their current use, and their comparison with key topics identified as priorities for HTA. RESULTS: Two hundred seventy health-care databases for England or the English regions were identified. Twenty-four included data on both health technology and patient health state. Eleven found some published use in effectiveness evaluation. Of 140 prioritized health technologies, only 22 could be identified in routine databases. CONCLUSIONS: Routine data are plentiful but of limited use in HTA. The data sets usually do not include the effect of treatments. Coding is inadequate, and confidentiality regulations will make matters worse. Both need urgent attention.

Humans↗

PubMed2004

The impact of describing clinical trial treatments as new or standard.

Concern has been expressed over a possible widespread belief amongst patients in trials, that a new treatment is better than the standard, despite the lack of evidence of such superiority. A sample of the general public (N = 130) read a leaflet describing a hypothetical trial comparing two similar treatments for either arthritis or back-pain. Half read that both treatments were standard and generally available; half that one was new and available only within the trial. Participants rated any preference for one or the other treatment, gave written reasons, and indicated their willingness to enter the randomized trial. Fifteen participants subsequently talked through their answers. Most participants expressed no preference for either treatment when both were described as standard. When one was new more people with the arthritis (but not the back-pain) scenario expressed a preference (chi2 = 5.44, P = 0.031). Importantly, this was not more likely to be for the new treatment. Rationally, those who preferred a freely available treatment were less likely to participate in the trial (chi2 = 23.3, P < 0.001). The mere description of a trial treatment as new was insufficient to engender a preference for it over a standard treatment, although it may contribute to preference under certain additional circumstances.

Adolescent↗