Minimisation: the platinum standard for trials?

Treasure, Tom; MacRae, K D

doi:10.1136/bmj.317.7155.362

Cited by 299 publications

(123 citation statements)

References 6 publications

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“…Patients were prestratified both by these risk factors and by gender, country, age group (Ն or Ͻ65 years), aspirin use, and type of hypertension (diastolic or ISH) before dynamic treatment randomization, sometimes called a minimization process. 13,14 The study was approved by local ethics committees, and all subjects gave informed consent.…”

Section: Methodsmentioning

confidence: 99%

Influence of Diabetes and Type of Hypertension on Response to Antihypertensive Treatment

et al. 2000

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Section: Methodsmentioning

confidence: 99%

Influence of Diabetes and Type of Hypertension on Response to Antihypertensive Treatment

et al. 2000

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“…Minimisation is a more refined approach and allows multiple potential confounding factors to be taken into account; but a problem with minimisation is that the group size can be very small 356 .…”

Section: Methods Of Random Allocationmentioning

confidence: 99%

Preventing falls in older people

2014

The Pharmaceutical Journal

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Preventing falls in older peopleSimon Conroy Falls are a major cause of injury fear of falling and death affecting 24% of older people annually. Falls have a major impact on hospital services, and are an important cause of carer strain and admission to long term care.Multifactorial interventions delivered to fallers are effective in reducing falls rates by 25%. However, no UK studies have evaluated the role of screening older people living in the primary care setting and offering those at high risk a falls prevention programme. This work describes two studies -the evaluation of a postal falls risk screening tool, and a randomised controlled trial assessing the benefits of offering a falls prevention programme to those identified as being at high risk.335 older people were recruited into the screening study, using a modified version of the Falls Risk Assessment Tool. The sensitivity was 79%, specificity 58%, positive predictive value 50% and the negative predictive value 83%.In the RCT, 364 community-dwelling older people at high risk of falls were randomised into a pragmatic, multicentre trial evaluating falls prevention programmes. 181 were allocated to the control group and 183 to the intervention.The primary outcome was the rate of falls; the adjusted IRR was 0.73 (0.51-1.03), p=0.071. There were no significant differences between the groups in terms of the proportion of fallers, recurrent fallers, medically verified falls, injurious falls, time to first fall or time to second fall. Nor were there significant differences in terms of institutionalisation, mortality, basic or extended activities of daily living, or fear of falling.Further work on the acceptability and implementation of falls prevention interventions is required, but subject to these conditions being met and a supportive cost-effectiveness analysis, the totality of the evidence suggests that screening and intervening for individuals at high risk of fall may be effective. 4 ACKNOWLEDGMENTS

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“…By this technique the person responsible for randomisation examines every single patient admitted to the trial and can allocate that patient to one or other treatment group to ensure that the balance of all factors which could possibly in¯uence the outcome of the study is maintained between the different groups. 6 The necessity for and sometimes dif®culty in obtaining written informed consent has been mentioned above. Where a new compound is being compared to standard therapy, Zelen 7 has suggested that only for the patients allocated to the investigational agent is written consent necessary since without the trial patients would receive standard therapy anyway.…”

Section: Randomisation and Informed Consentmentioning

confidence: 99%

Clinical trials in prostatic cancer—interpretations and misinterpretations

Newling

1999

Prostate Cancer Prostatic Dis

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New agents and therapies in prostate cancer, as in other diseases, need to be accurately, comprehensively and logically developed. The golden standard, a prospective, randomised phase III study can only be carried out ef®ciently if phase I and phase II studies have been completed. The advent of new therapies which will be used in early stage disease, necessitates the development of new methods of measuring their activity and correlating it with an in¯uence on the natural history of the disease. Efforts to get results more quickly by using weaker endpoints and retrospectively carrying out metanalyses have their disadvantages and dangers.This review will attempt to investigate how clinical trials from phase I through to phase IV in prostate cancer might be improved and made more easily interpretable. It will cover such aspects as the recruitment to trials, the demands of good clinical practice, the use of surrogate endpoints and attempt to give some indications how the newer therapeutic options can be reliably and quickly investigated through clinical trials.

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Minimisation: the platinum standard for trials?

Cited by 299 publications

References 6 publications

Influence of Diabetes and Type of Hypertension on Response to Antihypertensive Treatment

Influence of Diabetes and Type of Hypertension on Response to Antihypertensive Treatment

Preventing falls in older people

Clinical trials in prostatic cancer—interpretations and misinterpretations

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