Basic problems in controlled trials.

Burkhardt, Rainer; Kienle, G.

doi:10.1136/jme.9.2.80

Cited by 14 publications

(6 citation statements)

References 24 publications

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“…However, 'minimisation' does not tackle the problem of unknown confounders linked to different clinicians or patient variables which are not or cannot be enumerated but which never-theless impact on the clinician's psyche and skew allocation. Burkhardt and Kienle (1983) further pointed out that the RCT is inevitably flawed in that the sample is inevitably unrepresentative of the population. However, this could be said of any alternative research method and, while randomisation is not a perfect solution, it is perhaps the least bad scientific option for evaluations (Uberla, 1981).…”

Section: Societal Benefitsmentioning

confidence: 99%

“…Equipoise is more than indifference between treatments as it captures the uncertainty over which treatment is best, as opposed to confidence that they are the same. The exceptions failed to recognise that, since medicine is an inexact science, further constraints are necessary otherwise any RCT would be justified, irrespective of current evidence (Anonymous, 1979;Barry and Molyneux, 1992;Bracken, 1987;Burkhardt and Kienle, 1983;Buyse, 1991;Capron, 1978;Challah and Mays, 1986;Chalmers, 1968;Clayton, 1982;Collins et al, 1992;Curran, 1979;Dudley, 1983;Gillon, 1994;Hutchins, 1996;Lantos, 1995;Mike, 1989aMiller, 1993;Moore and Papp, 1996;Oakley, 1990;Peto et al, 1976;Pringle and Churchill, 1995;Raju, 1992;Schafer, 1982). The remainder discussed different forms of 'equipoise' which put varying constraints on the idea of clinical uncertainty.…”

Section: Uncertainty As Justification For Rctsmentioning

confidence: 99%

See 1 more Smart Citation

Ethical issues in the design and conduct of randomised controlled trials.

Edwards¹,

Lilford²,

Braunholtz³

et al. 1998

Health Technology Assessment

146

122

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Health Technology Assessment is indexed in Index Medicus/MEDLINE and Excerpta Medica/ EMBASE. Copies of the Executive Summaries are available from the NCCHTA web site (see overleaf). NHS R&D HTA Programme T he overall aim of the NHS R&D Health Technology Assessment (HTA) programme is to ensure that high-quality research information on the costs, effectiveness and broader impact of health technologies is produced in the most efficient way for those who use, manage and work in the NHS. Research is undertaken in those areas where the evidence will lead to the greatest benefits to patients, either through improved patient outcomes or the most efficient use of NHS resources. The Standing Group on Health Technology advises on national priorities for health technology assessment. Six advisory panels assist the Standing Group in identifying and prioritising projects. These priorities are then considered by the HTA Commissioning Board supported by the National Coordinating Centre for HTA (NCCHTA). This report is one of a series covering acute care, diagnostics and imaging, methodology, pharmaceuticals, population screening, and primary and community care. It was identified as a priority by the Methodology Panel and funded as project number 93/41/02. The views expressed in this publication are those of the authors and not necessarily those of the Standing Group, the Commissioning Board, the Panel members or the Department of Health. The editors wish to emphasise that funding and publication of this research by the NHS should not be taken as implicit support for the recommendations for policy contained herein. In particular, policy options in the area of screening will, in England, be considered by the National Screening Committee. This Committee, chaired by the Chief Medical Officer, will take into account the views expressed here, further available evidence and other relevant considerations. Reviews in Health Technology Assessment are termed 'systematic' when the account of the search, appraisal and synthesis methods (to minimise biases and random errors) would, in theory, permit the replication of the review by others.

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Section: Societal Benefitsmentioning

confidence: 99%

Section: Uncertainty As Justification For Rctsmentioning

confidence: 99%

Ethical issues in the design and conduct of randomised controlled trials.

Edwards¹,

Lilford²,

Braunholtz³

et al. 1998

Health Technology Assessment

146

122

View full text Add to dashboard Cite

show abstract

“…In this regard Faulder is again on the right lines in fastening on the ethics of randomnised trials as the area where the definition of responsible research still needs to be completed. The amount of attention they gain in the literature on medical ethics testifies to this fact (see REFER- ENCES 7,11,16,17,18). In randomnised trials there is still controversy over consent and over what counts as 'not harming patients.'…”

Section: Annals New York Academy Of Sciencesmentioning

confidence: 99%

Medical Research and the Human Subject

Byrne¹

1988

Annals of the New York Academy of Sciences

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“…Where no scientific evidence exists that a new treatment may be of benefit, the decision to begin a series of clinical trials rests mainly on inferential, theoretical, and often very subjective grounds. Burkhardt and Kienle (1981, 1983) have asserted that pursuing a clinical trial beyond the establishment of a clear trend in the data subverts the doctor-patient relationship. The utilitarian standpoint on this issue is represented by Vere (1983), who argued for the ethical necessity of conducting rigorous trials that lead to optimally valid scientific conclusions.…”

Section: The Issue Of the Controlled Clinical Trialmentioning

confidence: 99%

Ethical issues in psychotherapy research: Problems in a collaborative clinical trials study.

Imber¹,

Glanz²,

Elkin³

et al. 1986

American Psychologist

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This article reviews certain ethical issues that may be present in psychotherapy outcome research and discusses how they were addressed in the pilot-study phase of a large collaborative study of psychotherapy outcomes. The issues and how they were managed are presented in two categories, those that emanated from the use of a clinical trials design and those derived from the collaborative nature of the research. Ethical problems in the design and conduct of psychotherapy research are not frequently discussed, and the specific issues present in this research program illustrate some matters that must be dealt with by investigators sensitive to the ethical propriety of their work.

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Basic problems in controlled trials.

Cited by 14 publications

References 24 publications

Ethical issues in the design and conduct of randomised controlled trials.

Ethical issues in the design and conduct of randomised controlled trials.

Medical Research and the Human Subject

Ethical issues in psychotherapy research: Problems in a collaborative clinical trials study.

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