Annotations
Early ambulation following myocardial infarction Several workers ~-~have already shown that early ambulation and discharge following acute, uncomplicated myocardial infarction does not result in any increase in morbidity and mortality rate. Recently, in a prospective, randomized, controlled investigation in which ambulation after 5 days (with discharge after ! 2 days) was compared with ambulation and discharge on day 13 and day 19 respectively, it was shown that the morbidity and mortality rate was significantly reduced during the year of follow-up, in the early ambulation group and particularly in patients who already had complications of their acute myocardial infarction on admission2 It has also long been known that age has an adverse effect both on the short-term 5 and long-term ~ morbidity and mortality rate of patients with acute myocardial infarction. Thus, in patients with uncomplicated myocardial infarction who were kept at bed rest for 12 days after admission, there was a 32 per cent complication rate during the first year in those under the age of 60 as opposed to 71 per cent in patients over the age of 60 years. If patients who already had complications on admission were considered, the corresponding figures were 69 per cent and 91 per cent, respectively. On the other hand, if these patients were mobilized early (5 days), then the complication rate averaged 24 per cent, regardlessOf the age of the patient or his state on admissionY Thromboembolic complications seem to be particularly reduced. Of nine patients who suffered from thromboembolic phenomenon, eight were in the late ambulation group {pulmonary embolism four, arterial embolism or thrombosis four) and only one patient had an arterial thromboembolic complication in the group who were mobilized early? It is obvious, that no hard-and-fast rules can be laid down in the management of the individual patient with acute myocardial infarction, and certainly it would be most illogical to mobilize him during the acute phase of any complication that may develop. However, the above studies indicate that age, and the fact that complications had been present, are no contraindication to early mobilization and our policy, as in the studies reported, has been to count the 5 days of bed rest from the first day that the patient's immediate symptoms or complications were satisfactorily treated and under control.
Whether 5 days is the optimum period of bed rest is not known and indeed at least one study has shown no ill effects in patients with uncomplicated myocardial infarction who were mobilized 2 days after their~admission. 8
Abraham S. Abraham, M.D., F.R.C.P. Moshe Weinstein, M.D. Dept. of Medicine Shaare Zedek Hospital Jerusalem, Israel
REFERENCES
1. Harpur, J. E., Kellet, R. J., Conner, W. T., Galbraith, H. J. B., Hamilton, M., Murray, J. J., and Swallow, J. H.: Controlled trial of early mobilization and discharge from hospital in uncomplicated myocardial infarction, Lancet 2:1331, 1971. 2. Hutter, A. M., Sidel, V. W., Shine, K. I., and De Sanctis, R. W.: Early hospital discharge after myocardial infarction, N. Engl. J. Med. 288:1141, 1973. 3. Medical Division, Royal Infirmary, Glasgow: Early mobilization after uncomplicated myocardial infarction: prospective study of 538 patients, Lancet 2:346, 1973. 4. Abraham, A. S., Sever, Y., Weinstein, M., Dollberg, M., and Menczel, J.: Value of early ambulation in patients with and without complications after acute myocardial infarction, N. Engl. J. Med. 292:719, 1975. 5. Helmers, C." Short and long-term prognostic indices in acute myocardial infarction. A study of 606 patients initially treated in a coronary care unit, Acta Med. Scand. (Suppl.):555, 1974. 6. Cole, D. R., Singian, E. G., and Katz, L. N.: Long-term prognosis following myocardial infarction and some factors which affect it, Circulation 9:321, 1954. 7. Abraham, A. S., Sever, Y., Weinstein, M., Dollberg, M., and Menczel, J.: Early ambulation in acute myocardial infarction, Harefuah 89:503, 1975. 8. Hayes, M. J., Morris, G. K., and Hampton, J. R.: Comparison of mobilization after two and nine days in uncomplicated myocardial infarction, Br. Med. J. 3:10, 1974.
Hypertension control, compliance and science Recognition of the toll of disability and untimely death resulting from high blood pressure and realization that its treatment does more good than harm have brought students of hypertension out of their wet labs and sub-specialty wards and into the marketplace; the Goldblatt kidney risks replacement by the Gimbel hypertension control program. 1
666
Although thoughtful evaluations of community programs for the detection and treatment of hypertension are few, they underscore two lessons: (1) Each of six requirements: detec-
tion, linkage to a clinician, appropriate work-up, adequate treatment, high medication compliance, and lifelong followup must be met before the patient benefits, and a failure to
November, 1977, Vol. 94, No. 5
Annota~ons
satisfy a latter requirement nullifies all prior efforts, however effective. (2) In abandoning the ivory tower for the shopping plaza, we must be careful not to abandon the scientific method for any collection of hopes, homilies, and unconfirmed conventional wisdom when designing programs to achieve the community control of hypertension. These strategies for hypertension control, though they invoke disciplines foreign to the laboratory or clinical investigator, are subject to the same rules of evidence and should no more be placed in general use without prior validation t h a n should unproven drugs or untested surgery. 2. 3 Both of these points have been underscored again in a series of randomized trials recently carried out in collaboration with industrial and community physicians in our town. 4, Screening of a random sample of employees at Dominion Foundries and Steel Limited yielded 245 men who had hypertension (when sitting quietly on three separate occasions, a standard series of fifth phase diastolic blood pressure readings were _> 95 mm. Hg), were free of remediable forms of hypertension, and were taking no daily medications. Because teaching patients about their disease and its t r e a t m e n t is a time-honored approach to gaining their cooperation and because the convenience of follow-up care had been suggested as an important determinant of compliance, we tested these two strategies in our first randomized clinical trial. These men were randomly assigned to receive or not receive instruction about hypertension, its effects on target organs, health, and life-expectancy, the benefits of therapy, the need for high compliance, and some simple reminders for pilltaking. Although subsequent tests showed t h a t they mastered this information, they were no more likely to take their medicine than men who received no instruction, and we could demonstrate no correlation between knowledge and compliance. For care and follow-up these men had been randomly allocated to see either their own family doctors outside working hours or industrial physicians at the mill during work shifts; the added convenience of follow-up at work had no effect upon medication compliance either. Thus, two commonly proposed strategies for improving medication compliance in hypertension, when subjected to the randomized experiment, could not be shown to be useful2 Our second clinicial trial was carried out to determine whether a more behaviorally-oriented set of strategies could "salvage" men who remained uncontrolled and non-compliant at the end of our first trial. Thirty-eight such men were allocated either to a control group or to an experimental group who were taught how to measure their own blood pressure, asked to keep records of their blood pressure and medication taking, shown how to tailorthe latter to the performance of daily habits and rituals,and seen fortnightlyby a high school graduate with no formal health professional training who rewarded them for improvements in compliance and blood pressure control. Six months later average compliance had fallen a further 1.5 per cent among controls but rose 21.3 per cent in the experimental group, 30 per cent of w h o m achieved goal blood pressures. This encouraging initial result, if confirmed by other investigators,could mean that effective compliance-improving strategies might be applied, maintained, and supervised by a layperson without demanding either more time from a busy clinicianor more reorganization from a beleaguered health service.~
A m e r i c a n Hea r t Jo u r n a l
However, adherence to the scientific method calls for caution in interpreting even the results of randomized trials such as these. For example, although the results of our second trial were statistically significant, they are based upon only 38 men. Furthermore, our compliance-improving .strategies influenced the treating clinicians (who often increased the "vigor" of the t r e a t m e n t regimen) as well as the hypertensive patients, and quantifying the contribution of the former to the net result requires further research. Finally, we do not yet know which of the individual components of the compound strategy tested in our second trial was responsible for the successful result; fortunately, a third trial addressing this issue is now being analyzed. Returning to the two lessons which began this invited annotation: First, only half of the hypertensive men we studied were taking enough medication at six m o n t h s to show systematic declines in their diastolic blood pressures; the other half were not realizing the benefits of blood pressure reduction and had nullified the previous effort and expense of their detection and evaluation. Second, the application of the scientificmethod to the problem of compliance with antihypertensive medications permitted us to distinguish those commonly recommended strategieswhich m a y be clinically useful from those which are not. Surely we need further trialsto confirm or refute the value of these and other strategiespurported to satisfyeach of the requirements for the control of hypertension. David L. Sackett R. Brian Haynes Edward S. Gibson D. Wayne Taylor Robin S. Roberts Arnold L. Johnson Dept. of Clinical Epidemiology and Biostatistics McMaster University Health Sciences Center and Dominion Foundries and Steel Ltd. Hamilton, Ontario Canada REFERENCES 1.
2.
3:
4.
5.
Alderman, M. H , and Schoenbaum, E. E.: Detection and t r e a t m e n t of hypertension at the work site, N. Engl. J. Med. 293:65, 1975. Sackett, D. L.: Hypertension in the real world: Public reaction, physician response and patient compliance, in: Genest, J., et al. eds., Hypertension: Physiopathology and treatment, New York, 1977, McGraw-Hill Book Company, Inc. Sackett, D. L.: Priorities and methods for future research, in: Sackett, D. L., and Haynes, R. B., eds, Compliance with therapeutic regimens, Baltimore, 1976, J o h n s Hopkins University Press. Sackett, D. L., Haynes, R. B., Gibson, E. S., Hackett, B. C., Taylor, D. W., Roberts, R. S., and Johnson, A. L.: Randomized clinical trial of strategies for improving medication compliance in primary hypertension, Lancet 1 : 1205, 1975. Haynes, R. B., Sackett, D. L., Gibson, E. S., Taylor, D. W., Hackett, B. C., Roberts, R. S., and Johnson, A. L.: Improvement of medication compliance in uncontrolled hypertension, Lancet 1:1265, 1976.
667
Early ambulation following myocardial infarction Several workers ~-~have already shown that early ambulation and discharge following acute, uncomplicated myocardial infarction does not result in any increase in morbidity and mortality rate. Recently, in a prospective, randomized, controlled investigation in which ambulation after 5 days (with discharge after ! 2 days) was compared with ambulation and discharge on day 13 and day 19 respectively, it was shown that the morbidity and mortality rate was significantly reduced during the year of follow-up, in the early ambulation group and particularly in patients who already had complications of their acute myocardial infarction on admission2 It has also long been known that age has an adverse effect both on the short-term 5 and long-term ~ morbidity and mortality rate of patients with acute myocardial infarction. Thus, in patients with uncomplicated myocardial infarction who were kept at bed rest for 12 days after admission, there was a 32 per cent complication rate during the first year in those under the age of 60 as opposed to 71 per cent in patients over the age of 60 years. If patients who already had complications on admission were considered, the corresponding figures were 69 per cent and 91 per cent, respectively. On the other hand, if these patients were mobilized early (5 days), then the complication rate averaged 24 per cent, regardlessOf the age of the patient or his state on admissionY Thromboembolic complications seem to be particularly reduced. Of nine patients who suffered from thromboembolic phenomenon, eight were in the late ambulation group {pulmonary embolism four, arterial embolism or thrombosis four) and only one patient had an arterial thromboembolic complication in the group who were mobilized early? It is obvious, that no hard-and-fast rules can be laid down in the management of the individual patient with acute myocardial infarction, and certainly it would be most illogical to mobilize him during the acute phase of any complication that may develop. However, the above studies indicate that age, and the fact that complications had been present, are no contraindication to early mobilization and our policy, as in the studies reported, has been to count the 5 days of bed rest from the first day that the patient's immediate symptoms or complications were satisfactorily treated and under control.
Whether 5 days is the optimum period of bed rest is not known and indeed at least one study has shown no ill effects in patients with uncomplicated myocardial infarction who were mobilized 2 days after their~admission. 8
Abraham S. Abraham, M.D., F.R.C.P. Moshe Weinstein, M.D. Dept. of Medicine Shaare Zedek Hospital Jerusalem, Israel
REFERENCES
1. Harpur, J. E., Kellet, R. J., Conner, W. T., Galbraith, H. J. B., Hamilton, M., Murray, J. J., and Swallow, J. H.: Controlled trial of early mobilization and discharge from hospital in uncomplicated myocardial infarction, Lancet 2:1331, 1971. 2. Hutter, A. M., Sidel, V. W., Shine, K. I., and De Sanctis, R. W.: Early hospital discharge after myocardial infarction, N. Engl. J. Med. 288:1141, 1973. 3. Medical Division, Royal Infirmary, Glasgow: Early mobilization after uncomplicated myocardial infarction: prospective study of 538 patients, Lancet 2:346, 1973. 4. Abraham, A. S., Sever, Y., Weinstein, M., Dollberg, M., and Menczel, J.: Value of early ambulation in patients with and without complications after acute myocardial infarction, N. Engl. J. Med. 292:719, 1975. 5. Helmers, C." Short and long-term prognostic indices in acute myocardial infarction. A study of 606 patients initially treated in a coronary care unit, Acta Med. Scand. (Suppl.):555, 1974. 6. Cole, D. R., Singian, E. G., and Katz, L. N.: Long-term prognosis following myocardial infarction and some factors which affect it, Circulation 9:321, 1954. 7. Abraham, A. S., Sever, Y., Weinstein, M., Dollberg, M., and Menczel, J.: Early ambulation in acute myocardial infarction, Harefuah 89:503, 1975. 8. Hayes, M. J., Morris, G. K., and Hampton, J. R.: Comparison of mobilization after two and nine days in uncomplicated myocardial infarction, Br. Med. J. 3:10, 1974.
Hypertension control, compliance and science Recognition of the toll of disability and untimely death resulting from high blood pressure and realization that its treatment does more good than harm have brought students of hypertension out of their wet labs and sub-specialty wards and into the marketplace; the Goldblatt kidney risks replacement by the Gimbel hypertension control program. 1
666
Although thoughtful evaluations of community programs for the detection and treatment of hypertension are few, they underscore two lessons: (1) Each of six requirements: detec-
tion, linkage to a clinician, appropriate work-up, adequate treatment, high medication compliance, and lifelong followup must be met before the patient benefits, and a failure to
November, 1977, Vol. 94, No. 5
Annota~ons
satisfy a latter requirement nullifies all prior efforts, however effective. (2) In abandoning the ivory tower for the shopping plaza, we must be careful not to abandon the scientific method for any collection of hopes, homilies, and unconfirmed conventional wisdom when designing programs to achieve the community control of hypertension. These strategies for hypertension control, though they invoke disciplines foreign to the laboratory or clinical investigator, are subject to the same rules of evidence and should no more be placed in general use without prior validation t h a n should unproven drugs or untested surgery. 2. 3 Both of these points have been underscored again in a series of randomized trials recently carried out in collaboration with industrial and community physicians in our town. 4, Screening of a random sample of employees at Dominion Foundries and Steel Limited yielded 245 men who had hypertension (when sitting quietly on three separate occasions, a standard series of fifth phase diastolic blood pressure readings were _> 95 mm. Hg), were free of remediable forms of hypertension, and were taking no daily medications. Because teaching patients about their disease and its t r e a t m e n t is a time-honored approach to gaining their cooperation and because the convenience of follow-up care had been suggested as an important determinant of compliance, we tested these two strategies in our first randomized clinical trial. These men were randomly assigned to receive or not receive instruction about hypertension, its effects on target organs, health, and life-expectancy, the benefits of therapy, the need for high compliance, and some simple reminders for pilltaking. Although subsequent tests showed t h a t they mastered this information, they were no more likely to take their medicine than men who received no instruction, and we could demonstrate no correlation between knowledge and compliance. For care and follow-up these men had been randomly allocated to see either their own family doctors outside working hours or industrial physicians at the mill during work shifts; the added convenience of follow-up at work had no effect upon medication compliance either. Thus, two commonly proposed strategies for improving medication compliance in hypertension, when subjected to the randomized experiment, could not be shown to be useful2 Our second clinicial trial was carried out to determine whether a more behaviorally-oriented set of strategies could "salvage" men who remained uncontrolled and non-compliant at the end of our first trial. Thirty-eight such men were allocated either to a control group or to an experimental group who were taught how to measure their own blood pressure, asked to keep records of their blood pressure and medication taking, shown how to tailorthe latter to the performance of daily habits and rituals,and seen fortnightlyby a high school graduate with no formal health professional training who rewarded them for improvements in compliance and blood pressure control. Six months later average compliance had fallen a further 1.5 per cent among controls but rose 21.3 per cent in the experimental group, 30 per cent of w h o m achieved goal blood pressures. This encouraging initial result, if confirmed by other investigators,could mean that effective compliance-improving strategies might be applied, maintained, and supervised by a layperson without demanding either more time from a busy clinicianor more reorganization from a beleaguered health service.~
A m e r i c a n Hea r t Jo u r n a l
However, adherence to the scientific method calls for caution in interpreting even the results of randomized trials such as these. For example, although the results of our second trial were statistically significant, they are based upon only 38 men. Furthermore, our compliance-improving .strategies influenced the treating clinicians (who often increased the "vigor" of the t r e a t m e n t regimen) as well as the hypertensive patients, and quantifying the contribution of the former to the net result requires further research. Finally, we do not yet know which of the individual components of the compound strategy tested in our second trial was responsible for the successful result; fortunately, a third trial addressing this issue is now being analyzed. Returning to the two lessons which began this invited annotation: First, only half of the hypertensive men we studied were taking enough medication at six m o n t h s to show systematic declines in their diastolic blood pressures; the other half were not realizing the benefits of blood pressure reduction and had nullified the previous effort and expense of their detection and evaluation. Second, the application of the scientificmethod to the problem of compliance with antihypertensive medications permitted us to distinguish those commonly recommended strategieswhich m a y be clinically useful from those which are not. Surely we need further trialsto confirm or refute the value of these and other strategiespurported to satisfyeach of the requirements for the control of hypertension. David L. Sackett R. Brian Haynes Edward S. Gibson D. Wayne Taylor Robin S. Roberts Arnold L. Johnson Dept. of Clinical Epidemiology and Biostatistics McMaster University Health Sciences Center and Dominion Foundries and Steel Ltd. Hamilton, Ontario Canada REFERENCES 1.
2.
3:
4.
5.
Alderman, M. H , and Schoenbaum, E. E.: Detection and t r e a t m e n t of hypertension at the work site, N. Engl. J. Med. 293:65, 1975. Sackett, D. L.: Hypertension in the real world: Public reaction, physician response and patient compliance, in: Genest, J., et al. eds., Hypertension: Physiopathology and treatment, New York, 1977, McGraw-Hill Book Company, Inc. Sackett, D. L.: Priorities and methods for future research, in: Sackett, D. L., and Haynes, R. B., eds, Compliance with therapeutic regimens, Baltimore, 1976, J o h n s Hopkins University Press. Sackett, D. L., Haynes, R. B., Gibson, E. S., Hackett, B. C., Taylor, D. W., Roberts, R. S., and Johnson, A. L.: Randomized clinical trial of strategies for improving medication compliance in primary hypertension, Lancet 1 : 1205, 1975. Haynes, R. B., Sackett, D. L., Gibson, E. S., Taylor, D. W., Hackett, B. C., Roberts, R. S., and Johnson, A. L.: Improvement of medication compliance in uncontrolled hypertension, Lancet 1:1265, 1976.
667
