A Surrogate System for Informed Consent

Fost, Norman

doi:10.1001/jama.1975.03260070058024

Cited by 23 publications

(9 citation statements)

References 6 publications

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“…Numerous empirical studies have shown that many patients who have given their 'informed consent' have little idea of what they have consented to (Epstein et al, 1969;Robinson et al, 1976;Schultz et al, 1976;Muss et al, 1979), and that trust in the doctor and fear of the illness remain primary reasons for participating in clinical trials (Penman et al, 1984;Saurbrey et al, 1984). Fost (1975) suggested that one of the major barriers to communication is the emotional state of the patient which, in the context of a serious illness, may preclude rational consideration of any proposed study. He has therefore argued for the use of lay surrogates to evaluate clinical trials.…”

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confidence: 99%

“…He has therefore argued for the use of lay surrogates to evaluate clinical trials. The essence of this process is to obtain a response from individuals who are not candidates for investigations or therapeutic procedures but who are asked to behave as if they were (Fost, 1975 clearer mind than the patient and his decision will not be influenced by his dependence on the doctor.…”

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confidence: 99%

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The use of expert surrogates to evaluate clinical trials in non-small cell lung cancer

Mackillop¹,

Ward²,

O’Sullivan³

1987

Br J Cancer

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One hundred and eighteen doctors who treat pulmonary neoplasms in Ontario were asked how they would wish to be treated if they had non-small cell lung cancer. Four different scenarios were given. The physicians were then asked if they would consent to take part as subjects in one or more clinical trials for which they would be eligible in those situations. The proportion of respondents who would consent to each study ranged from 11% to 64%. Reasons given for refusing to participate as subjects in each trial were varied, but many felt that the trials offered unacceptable options for treatment. Medical oncologists consented to each study more frequently than radiation oncologists, respirologists or thoracic surgeons but all disciplines ranked the 6 studies in the same order of acceptability. It is concluded that some patients with non-oat cell lung cancer currently receive experimental therapies with high risk/benefits ratios which experts in the field would not accept for themselves. It is suggested that the expert surrogate system may be useful as an adjunct to the institutional review board in evaluating new trials before they are activated.

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confidence: 99%

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confidence: 99%

The use of expert surrogates to evaluate clinical trials in non-small cell lung cancer

Mackillop¹,

Ward²,

O’Sullivan³

1987

Br J Cancer

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“…This enabled us to use the nurses as patient surrogates. Although the answers given by surrogate patients are hypothetical and imaginary situations lack the emotional dimensions present in real illness, Fost [4] argued that the surrogate is able to reflect more carefully on his/her predicaments than the patient, who may be too frightened to think and cannot be expected to carry out a difficult cost-benefit analysis. To our knowledge, the present study is the first comparative longitudinal study on attitudes to chemotherapy in newly employed health professionals.…”

Section: Discussionmentioning

confidence: 99%

Experience with and attitudes to chemotherapy among newly employed nurses in oncological and surgical departments

Bremnes

1999

Supportive Care in Cancer

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Based on questionnaires, attitudes to chemotherapy were compared between newly employed nurses in oncology departments and surgical departments. Comparisons were made as they started in their new jobs and after 6 and 12 months. In total, 76 nurses were included in the study; 41 were employed in oncology departments and 35 in surgical departments. The questionnaires presented a hypothetical situation involving a toxic chemotherapy regimen. The subjects were asked to indicate the minimal benefit with respect to percentage chance of cure, length of life prolongation, and percentage symptom relief they would demand before accepting the toxic chemotherapy. The groups were well matched. On starting in their new jobs, both groups demanded identical chances of cure (23%) for the hypothetical treatment to be acceptable. Nurses < or =30 years demanded less chance of cure than those >30 years. There were no differences in wishes about life prolongation and symptom relief. The groups reported equivalent job satisfaction during the first year. At 6 months, 60% of the oncology nurses and 11% of the surgical nurses reported altered attitudes to chemotherapy, and approximately 70% of these in both groups had become more positive. At 6 months surgical nurses demanded less chance of symptom relief than the oncology nurses to accept the chemotherapy regimen. Otherwise, there were no differences between the groups during the first year. Attitudes to chemotherapy showed no differences between newly employed nurses in oncology and in surgical departments, and there were no changes in either group during the first year in their new jobs.

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“…Although the individuals surveyed do not represent a cross-section of society, it is improbable that the average lay person would prove to be more discriminating than the members of this unusually well educated group. The surrogate patients also had the opportunity to reflect on the possible costs and benefits of treatment without the emotional stress of a real illness (Fost, 1975). It is, therefore, improbable that the average cancer patient would, in reality, exercise better judgement than these surrogate patients.…”

Section: Discussionmentioning

confidence: 99%

“…It has been suggested that one of the barriers to communication is the mental state of the patient with a major illness who may be so emotionally disturbed as to preclude any rational consideration of a proposed clinical trial (Fost, 1975 individuals who do not have the education or experience to understand its significance (Ingelfinger, 1972). We have recently shown that although cancer patients in Canada today usually know their diagnosis, they are often unaware of their prognosis and frequently overestimate the potential benefit of treatment which they are receiving (Mackillop et al, 1988b).…”

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confidence: 99%

Clinical trials in cancer: the role of surrogate patients in defining what constitutes an ethically acceptable clinical experiment

Mackillop

Palmer²,

O’Sullivan³

et al. 1989

Br J Cancer

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Summary Doctors who treat lung cancer in Ontario were previously asked how they would wish to be managed if they developed non-small cell lung cancer and whether they would consent to participate in six clinical trials for which they might be eligible. The proportion of these expert surrogate patients who would consent to each clinical trial ranged from 11 to 64%. The results of this study were transmitted to the same group of doctors who were asked to comment on the ethical acceptability of each trial in the light of this information. The majority of physicians said that those trials to which less than 50% of expert surrogates consented should not have been opened to patients. Sixty-nine per cent of doctors thought that new trials should be evaluated in this way. We also present the results of a survey of 400 lay people in Ontario who were asked to imagine that they had lung cancer and whether they would consent to participate in two of these same clinical trials. Fifty per cent of lay people consented to a randomised trial of lobectomy versus segmentectomy in early, operable disease (LCSC-821) compared to 64% of expert surrogates, and 48% of lay people consented to a randomised trial of five different forms of chemotherapy in metastatic disease (SWOG-8241) compared to 19% of doctors. It was concluded that the lay people were unable to discern differences in the acceptability of clinical trials which were clear to experts in the field. Subsequently, respondents were told about the decisions which doctors would make in the same circumstances and asked if this information would modify their previous decisions. There is no net change in the proportion of patients consenting to the surgery trial but the proportion of people consenting to the chemotherapy trial decreased by 40%. The majority of lay people said that they would wish to have access to this type of information before consenting to participate in a clinical trial.

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A Surrogate System for Informed Consent

Cited by 23 publications

References 6 publications

The use of expert surrogates to evaluate clinical trials in non-small cell lung cancer

The use of expert surrogates to evaluate clinical trials in non-small cell lung cancer

Experience with and attitudes to chemotherapy among newly employed nurses in oncological and surgical departments

Clinical trials in cancer: the role of surrogate patients in defining what constitutes an ethically acceptable clinical experiment

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