780 CONTROLLED TRIALS: PLANNED DECEPTION?
SIR,-I read with mixed feelings your editorial of March 10. objection to controlled trials cited is that the patient "is being deceived", yet you recogise that informed-consent procedures negate this objection. The patient should not be deceived and, in my experience, has never been deceived in this respect. The use of placebos is always discussed and plainly written out. (An alternative, for those wholly opposed to placebos, might be to compare very-low-dose therapy with fulldose therapy.) Against the objection that one group of patients "will receive inferior treatment"-apparently the excuse for the
One
German defection from mandated controlled trials-the answer is equally straightforward. With few exceptions, uncontrolled studies should never be done in human beings, so that there cannot be even an anecdotal suggestion that a drug is effective, this avoiding a falsely ethical compulsion not to do a controlled study. You selectively cite T. C. Chalmers but neglect his oft-repeated plea for randomisation of the first
patient. I agree that prudent management in some circumstances (reducing smoking, certain diets, for example) need not await fully conclusive trials. However, if we are to get a true result we need adequate standards of comparison, and it has been repeatedly shown that for most medical and surgical,procedures a well-designed prospective double-blind controlled trial with random allocation (and, where suitable, cross-over) is one of
the very best methods. The major assault on controlled trials of medical and surgical therapies has been mounted by traditionalists with great faith (no other word will do) in anecdotal observation. However, the policy of medical journals should be to insist inflexibly on proper clinical trials. While prudence and concern for the patient dictate that a placebo need not always be used, we should stick to this concept of soundly planned investigations. University of Massachusetts Medical School, and Division of Cardiology, St. Vincent Hospital, Worcester, Massachusetts 01604,
U.S.A.
DAVID H. SPODICK
SIR, With reference
to your editorial of March 10 (p. 534), be interested to know that our research ethics comyou may mittee insists on patients’ being informed when a placebo is included in a trial. In this unit we have recently completed a double-blind control trial of cestrogen therapy in which the inclusion of the placebo was fully explained to the patients and have been most impressed by the very small number of placebo reactors which this trial produced. M.R.C. Mineral Metabolism Unit, General Infirmary, Leeds LS1 3EX
B. E. C. NORDIN Chairman, Leeds Western District Ethics Committee
UNEMPLOYMENT AND HEALTH
SIR,—Isupport the
for research into the effects of unDraper and colleagues argued
case
by Dr employment on health as (Feb. 17,p. 373). If unemployment in contemporary welfare conditions does have adverse effects then the picture in the U.K. is very worrying. Although the official figures show around 1½million wholly unemployed, the total of persons without satisfactory jobs is very much higher, if we add those affected by underemployment. In 1964, in an article in the Sunday Times of March 1, William Allen asked "Is Britain a half-time country?". In the same newspaper on June 12, 1966, he pointed to a surplus of manpower numbering "several millions". This proposition has never been seriously challenged, and since that time the employment position in several major industries has worsened. New technology, increased competition, and trade recession
all recognised as causes, but the effect has been a continuing reduction in the demand for labour. Most surplus workers are in paid employment but with presumably little meaningful work to do. Such a state of affairs might well be the cause of stress, guilt feelings, lack of fulfil-
are
ment, and waste of potential among those affected. We do not need to look ahead to the effect of the use of microprocessors on employment; however serious that may be, for large-scale unemployment, both overt and covert, is a fact of life. Although disguised and concealed and with its economic impact on individuals mitigated by employment legislation and welfare provision, it could well cause widespread ill-health and much social malaise. A major research effort in this area seems overdue.
already
School of Management, Leicester Polytechnic, P.O. Box 143, Leicester
G. C. BATTYE
RECRUITMENT TO PSYCHIATRY
SIR,—Iwelcome Professor McGirr’s belated espousal (March 17, p. 614) of the importance of good recruitment into psychiatry, but I doubt if he has gone far enough into practical proposals. Just to sit back and wait for maturity to bring about spontaneous selection suggests that medical educators and trainers can afford to take a passive role. In my experience psychiatry is inadequately taught in the undergraduate curriculum. More time and better teachers will not make much difference: two factors certainly would. The first is a more informed and respectful attitude towards psychiatry on the part of undergraduate teaching colleagues. The second is more prolonged and intensive exposure to the clinical problems of psychiatry at house-officer level, for most if not all graduates. Autobiographically (indulged in by those of us now in retirement) I was destined for a course far removed from psychiatry, when, faut de mieux, I had to take a mental hospital job (for the money). After a few months my extreme immaturity metamorphosed and I saw psychiatric patients in a completely new light. So you do not need maturity-you need disturbing, creative exposure. This can be translated easily and into any and every postgraduate training programme. 1 Duke Street, Cromarty, Ross-shire
IV11 8TH
W. MALCOLM MILLAR
DISCHARGING THE ELDERLY PATIENT
SIR,—Iread your review (Jan. 27, p. 198) of the study by
Gay and Jill Pitkeathley and the subsequent letter from Jane Gibbins (March 3, p. 498) with great interest.
Pat
Voluntary help plays a greater role in patient care after discharge than before, though the contribution is limited in elderly patients because of the multiplicity of their requirements. Discharges from our geriatric research unit are now planned at least a week in advance. The rehabilitation team (physiotherapist and occupational therapist) visits the home, accompanied by the patient, and this allows the team to gather information about home circumstances and to arrange for alterations, such as widening doors for wheelchairs or Zimmer frames or fixing hand rails in the bathroom or toilet. The visit may highlight the sort of social services that may be required after discharge. Our experience of planned discharge has been very encouraging and there have been very few discharge failures. Home visits may be the answer to the problem of discharge failure; the establishment of close communication between hospital and community may obviate the need for informing general practitioners as an urgent measure as long as detailed notes be sent to them later. St. John’s Hospital, London SW11 1SP
M. A. NASAR
SIR,-I read with mixed feelings your editorial of March 10. objection to controlled trials cited is that the patient "is being deceived", yet you recogise that informed-consent procedures negate this objection. The patient should not be deceived and, in my experience, has never been deceived in this respect. The use of placebos is always discussed and plainly written out. (An alternative, for those wholly opposed to placebos, might be to compare very-low-dose therapy with fulldose therapy.) Against the objection that one group of patients "will receive inferior treatment"-apparently the excuse for the
One
German defection from mandated controlled trials-the answer is equally straightforward. With few exceptions, uncontrolled studies should never be done in human beings, so that there cannot be even an anecdotal suggestion that a drug is effective, this avoiding a falsely ethical compulsion not to do a controlled study. You selectively cite T. C. Chalmers but neglect his oft-repeated plea for randomisation of the first
patient. I agree that prudent management in some circumstances (reducing smoking, certain diets, for example) need not await fully conclusive trials. However, if we are to get a true result we need adequate standards of comparison, and it has been repeatedly shown that for most medical and surgical,procedures a well-designed prospective double-blind controlled trial with random allocation (and, where suitable, cross-over) is one of
the very best methods. The major assault on controlled trials of medical and surgical therapies has been mounted by traditionalists with great faith (no other word will do) in anecdotal observation. However, the policy of medical journals should be to insist inflexibly on proper clinical trials. While prudence and concern for the patient dictate that a placebo need not always be used, we should stick to this concept of soundly planned investigations. University of Massachusetts Medical School, and Division of Cardiology, St. Vincent Hospital, Worcester, Massachusetts 01604,
U.S.A.
DAVID H. SPODICK
SIR, With reference
to your editorial of March 10 (p. 534), be interested to know that our research ethics comyou may mittee insists on patients’ being informed when a placebo is included in a trial. In this unit we have recently completed a double-blind control trial of cestrogen therapy in which the inclusion of the placebo was fully explained to the patients and have been most impressed by the very small number of placebo reactors which this trial produced. M.R.C. Mineral Metabolism Unit, General Infirmary, Leeds LS1 3EX
B. E. C. NORDIN Chairman, Leeds Western District Ethics Committee
UNEMPLOYMENT AND HEALTH
SIR,—Isupport the
for research into the effects of unDraper and colleagues argued
case
by Dr employment on health as (Feb. 17,p. 373). If unemployment in contemporary welfare conditions does have adverse effects then the picture in the U.K. is very worrying. Although the official figures show around 1½million wholly unemployed, the total of persons without satisfactory jobs is very much higher, if we add those affected by underemployment. In 1964, in an article in the Sunday Times of March 1, William Allen asked "Is Britain a half-time country?". In the same newspaper on June 12, 1966, he pointed to a surplus of manpower numbering "several millions". This proposition has never been seriously challenged, and since that time the employment position in several major industries has worsened. New technology, increased competition, and trade recession
all recognised as causes, but the effect has been a continuing reduction in the demand for labour. Most surplus workers are in paid employment but with presumably little meaningful work to do. Such a state of affairs might well be the cause of stress, guilt feelings, lack of fulfil-
are
ment, and waste of potential among those affected. We do not need to look ahead to the effect of the use of microprocessors on employment; however serious that may be, for large-scale unemployment, both overt and covert, is a fact of life. Although disguised and concealed and with its economic impact on individuals mitigated by employment legislation and welfare provision, it could well cause widespread ill-health and much social malaise. A major research effort in this area seems overdue.
already
School of Management, Leicester Polytechnic, P.O. Box 143, Leicester
G. C. BATTYE
RECRUITMENT TO PSYCHIATRY
SIR,—Iwelcome Professor McGirr’s belated espousal (March 17, p. 614) of the importance of good recruitment into psychiatry, but I doubt if he has gone far enough into practical proposals. Just to sit back and wait for maturity to bring about spontaneous selection suggests that medical educators and trainers can afford to take a passive role. In my experience psychiatry is inadequately taught in the undergraduate curriculum. More time and better teachers will not make much difference: two factors certainly would. The first is a more informed and respectful attitude towards psychiatry on the part of undergraduate teaching colleagues. The second is more prolonged and intensive exposure to the clinical problems of psychiatry at house-officer level, for most if not all graduates. Autobiographically (indulged in by those of us now in retirement) I was destined for a course far removed from psychiatry, when, faut de mieux, I had to take a mental hospital job (for the money). After a few months my extreme immaturity metamorphosed and I saw psychiatric patients in a completely new light. So you do not need maturity-you need disturbing, creative exposure. This can be translated easily and into any and every postgraduate training programme. 1 Duke Street, Cromarty, Ross-shire
IV11 8TH
W. MALCOLM MILLAR
DISCHARGING THE ELDERLY PATIENT
SIR,—Iread your review (Jan. 27, p. 198) of the study by
Gay and Jill Pitkeathley and the subsequent letter from Jane Gibbins (March 3, p. 498) with great interest.
Pat
Voluntary help plays a greater role in patient care after discharge than before, though the contribution is limited in elderly patients because of the multiplicity of their requirements. Discharges from our geriatric research unit are now planned at least a week in advance. The rehabilitation team (physiotherapist and occupational therapist) visits the home, accompanied by the patient, and this allows the team to gather information about home circumstances and to arrange for alterations, such as widening doors for wheelchairs or Zimmer frames or fixing hand rails in the bathroom or toilet. The visit may highlight the sort of social services that may be required after discharge. Our experience of planned discharge has been very encouraging and there have been very few discharge failures. Home visits may be the answer to the problem of discharge failure; the establishment of close communication between hospital and community may obviate the need for informing general practitioners as an urgent measure as long as detailed notes be sent to them later. St. John’s Hospital, London SW11 1SP
M. A. NASAR
