0
May 12, 1993, Vol 269, No. 18 >
ARTICLE | May 12, 1993

Pulmonary Artery Catheterization: Title and subTitle BreakCan There Be an Integrated Strategy for Guideline Development and Research Promotion? FREE

C. David Naylor, MD, DPhil; William J. Sibbald, MD; Charles L. Sprung, MD; S. Patricia Pinfold, BScN; James E. Calvin, MD; Frank B. Cerra, MD
[+] Author Affiliations

Reprint requests to the Institute for Clinical Evaluative Sciences, Sunnybrook Health Science Centre, Room G258, 2075 Bayview Ave, Toronto, Ontario, Canada M4N 3M5 (Dr Naylor).


JAMA. 1993;269(18):2407-2411. doi:10.1001/jama.1993.03500180099042
Text Size: A A A
Published online
Article
References

Objectives.  —To review the evidence regarding indications for pulmonary artery catheterization (PAC) in critically ill patients, and to propose a guideline-generating process that would encourage randomized controlled trials of PAC.

Data Sources.  —Computerized and manual search for randomized trials involving PAC as an integral part of the protocol, published as of October 1992. Manual search for guidelines endorsed by specialty societies and/or proposed by expert panels following an explicit group process.

Data Synthesis.  —Four trials suggest benefit from PAC for pre- or perioperative management of high-risk surgical patients. Two others indicate that PAC for low-risk aortic aneurysm surgery confers no advantages. Use of PAC to guide therapy aimed at improved mixed venous oxygen saturation was beneficial compared with usual care with PAC in two small trials among patients with septic shock and severe trauma. Other PAC indications are either untested or inadequately tested by small trials. Large trials are needed, but trials to date have been impeded by clinicians' uncertainty about PAC and unwillingness to randomize critically ill patients. No published guidelines for PAC have used a formal group process and/or a hierarchical review of evidence to demarcate proven from unproven indications.

Conclusions.  —We propose a research-promoting expert panel on indications for PAC. Aided by a critical literature review, experts would rate case scenarios on the need for routine PAC with or without a specified intervention strategy. Future trials should test indications where there is either consensus about the uncertainty of need for PAC, or interpanelist disagreement owing to inconclusive evidence. This process could facilitate practice guideline development, utilization management, and large trials of PAC and related interventions.(JAMA. 1993;269:2407-2411)

REFERENCES

1 +
Swan HJ, Ganz W, Forrester J, et al.  Catheterization of the heart in man with use of a flow-directed balloon-tipped catheter. N Engl J Med . 1970;;283: 447-451.
2 +
Robin ED.  Death by pulmonary artery flow-directed catheter: time for a moratorium? Chest . 1987;; 92:727-731.
3 +
Robin ED.  The cult of the Swan-Ganz catheter: overuse and abuse of pulmonary flow catheters. Ann Intern Med . 1985;;103:445-449.
4 +
Matthay MA, Chatterjee K.  Bedside catheterization of the pulmonary artery: risks compared with benefits. Ann Intern Med . 1988;;109:826-834.
5 +
Spodick DH.  Flow-directed pulmonary artery catheterization. Chest . 1989;;95:489-490.
6 +
Dalen JE.  Does pulmonary artery catheterization benefit patients with acute myocardial infarction? Chest . 1990;;98:1313-1314.
7 +
Spodick DH.  Analysis of flow-directed pulmonary artery catheterization. JAMA . 1989;;261:1946-1947.
8 +
Sibbald WJ, Sprung CL.  The pulmonary artery catheter: the debate continues. Chest . 1988;;94:899-901.
9 +
Shoemaker WC.  Use and abuse of the balloon tip pulmonary artery (Swan-Ganz) catheter: are patients getting their money's worth? Crit Care Med . 1990;; 18:1294-1295.
10 +
Gore JM, Goldberg RJ, Spodick DH, et al.  A community-wide assessment of the use of pulmonary artery catheters in patients with acute myocardial infarction. Chest . 1987;;92:721-727.
11 +
Gore JM, Dalen JE.  Pulmonary artery catheters. Chest . 1988;;93:1115.
12 +
Robin ED.  Defenders of the pulmonary artery catheter. Chest . 1988;;93:1059-1062.
13 +
Robin ED.  Warning about pulmonary artery (Swan-Ganz) flow catheters. Ir Med J . 1987;;80:330-331.
14 +
Robin ED.  Hazards of the Swan-Ganz catheter. Ann Intern Med . 1988;;108:151.
15 +
Sprung CL.  Complications of pulmonary artery catheterization.  In: Sprung CL, ed. The Pulmonary Artery Catheter: Methodology and Clinical Applications . Baltimore, Md: Aspen; 1983;:73-101.
16 +
Sladen A.  Complications of invasive hemodynamic monitoring in the intensive care unit. Curr Probl Surg . 1988;;25:69-145.
17 +
Johnston WE.  Complications from the use of pulmonary artery catheters.  In: Lumb PD, Bryan Brown C, eds. Complications in Critical Care Medicine . Chicago, Ill: Year Book Medical Publishers Inc; 1988;;45-65.
18 +
Becker RC, Martin RG, Underwood DA.  Right-sided endocardial lesions and flow-directed pulmonary artery catheters. Cleve Clin J Med . 1987;;54: 384-388.
19 +
Norfleet EA, Watson CB.  Continuous mixed venous oxygen saturation measurement: a significant advance in hemodynamic monitoring? J Clin Monit . 1985;;1:245-258.
20 +
Iberti TJ, Fischer EP, Leibowitz AB, et al.  A multicenter study of physicians' knowledge of the pulmonary artery catheter. JAMA . 1990;;264:2928-2932.
21 +
Steingrub JS, Celoria G, Vickers-Lahti M, Teres D, Bria W.  Therapeutic impact of pulmonary artery catheterization in a medical/surgical ICU. Chest . 1991;; 99:1451-1455.
22 +
Fein AM, Goldberg SK, Walkenstein MD, Dershaw B, Braitman L, Lippmann ML.  Is pulmonary artery catheterization necessary for the diagnosis of pulmonary edema? Am Rev Respir Dis . 1984;;129: 1006-1009.
23 +
Connors AF Jr, McCaffree DR, Gray BA.  Evaluation of right-heart catheterization in the critically ill patient without acute myocardial infarction. N Engl J Med . 1983;;308:263-267.
24 +
Bayliss J, Norell M, Ryan A, et al.  Bedside hemodynamic monitoring: experience in a general hospital. BMJ . 1983;;287:187-190.
25 +
Eisenberg PR, Jaffe AS, Schuster DP.  Clinical evaluation compared to pulmonary artery catheterization in the hemodynamic assessment of critically ill patients. Crit Care Med . 1984;;12:549-553.
26 +
Connors AF Jr, Dawson NV, Shaw PK, Montenegro HD, Nara AR, Martin L.  Hemodynamic status in critically ill patients with and without acute heart disease. Chest . 1990;;98:1200-1206.
27 +
Forrester JC, Diamond G, Swan HJ.  Correlative classification of clinical and hemodynamic function after acute myocardial infarction. Am J Cardiol . 1977;;39:137-145.
28 +
Celoria G, Steingrub JS, Vickers-Lahti M, et al.  Clinical assessment of hemodynamic values in two surgical intensive care units. Arch Surg . 1990;;125: 1036-1039.
29 +
Stevenson LW, Perloft JK.  The limited reliability of physical signs for estimating hemodynamics in chronic heart failure. JAMA . 1989;;261:884-888.
30 +
Tuchschmidt J, Sharma OP.  Impact of hemodynamic monitoring in a medical intensive care unit. Crit Care Med . 1987;;15:840-843.
31 +
 Ontario Intensive Care Study Group. Evaluation of right heart catheterization in critically ill patients. Crit Care Med . 1992;;20:928-933.
32 +
Chatterjee K, Matthay M.  Right-heart catheterization is a diagnostic procedure, not a therapeutic intervention. J Intensive Care Med . 1991;;6:101-104.
33 +
Schultz RJ, Whitfield GF, LaMura JJ, Raciti A, Krishnamurthy S.  The role of physiologic monitoring in patients with fractures of the hip. Trauma . 1985;;25:309-316.
34 +
Isaacson IJ, Lowdon JD, Berry AJ, et al.  the value of pulmonary artery and central venous monitoring in patients undergoing abdominal aortic reconstructive surgery. J Vasc Surg . 1990;;12:754-760.
35 +
Joyce WP, Provan JL, Amelo FM, McEwan MMP, Jelenich S, Jones DP.  The role of central haemodynamic monitoring in abdominal aortic surgery: a prospective randomised study. Eur J Vasc Surg . 1990;;4:633-636.
36 +
Pearson KS, Gomez MN, Moyers JR, Carter JG, Tinker JH.  A cost/benefit analysis of randomized invasive monitoring for patients undergoing cardiac surgery. Anesth Analg . 1989;;69:336-341.
37 +
Rajput MA, Richey HM, Bush BA, Glendening DL, Matthews JI.  A comparison between a conventional and a fiberoptic flow-directed thermal dilution pulmonary artery catheter in critically ill patients. Arch Intern Med . 1989;;149:83-85.
38 +
Guyatt G, Ontario Intensive Care Study Group.  A randomized control trial of right-heart catheterization in critically ill patients. J Intensive Care Med . 1991;;6:91-95.
39 +
Shoemaker WC, Appel PA, Kram HB, Waxman K, Lee T.  Prospective trial of supranormal values of survivors as therapeutic goals in high-risk surgical patients. Chest . 1988;;94:1176-1186.
40 +
Berlauk JF, Abrams JH, Gilmour IJ, O'Connor SR, Knighton DR, Cerra FB.  Preoperative optimization of cardiovascular hemodynamics improves outcome in peripheral vascular surgery: a prospective randomized clinical trial. Ann Surg . 1991;;214:289-299.
41 +
Tuchschmidt J, Fried J, Astiz M, Rackow E.  Elevation of cardiac output and oxygen delivery improves outcome in septic shock. Chest . 1992;;102: 216-220.
42 +
Bishop M, Shoemaker W, Appel P, Kram H.  Prospective trial of supranormal values in severely traumatized patients. Crit Care Med . 1992;;20 ( (suppl) ):S93. Abstract.
43 +
Shoemaker WC, Kram HB, Appel PL, Fleming AW.  The efficacy of central venous and pulmonary artery catheters and therapy based upon them in reducing mortality and morbidity. Arch Surg . 1990;; 125:1332-1338.
44 +
Lowenstein E, Teplic R.  To (PA) catheterize or not to (PA) catheterize—that is the question. Anesthesiology . 1980;;53:361-363.
45 +
Streisand JB, Clark NJ, Pace NL.  Placement of the pulmonary arterial catheter before anesthesia for cardiac surgery: safe, intelligent, and appropriate use of invasive hemodynamic monitoring. J Clin Monit . 1985;;1:193-197.
46 +
Dzelzkans R, Stanley TH.  Placement of the pulmonary arterial catheter before anesthesia for cardiac surgery: a stressful, painful, unnecessary crutch. J Clin Monit . 1985;;1:197-200.
47 +
Bashein G, Johnson PW, Davis KB, Ivey TD.  Elective coronary bypass surgery without pulmonary artery catheter monitoring. Anesthesiology . 1985;;63:451-454.
48 +
Tuman KJ, McCarthy RJ, Speiss BD, et al.  Effect of pulmonary artery catheterization on outcome in patients undergoing coronary artery surgery. Anesthesiology . 1989;;70:199-206.
49 +
Friesinger GC, Williams SV, the American College of Physicians, the American College of Cardiology, and the American Heart Association Task Force on Clinical Privileges in Cardiology.  Clinical competence in hemodynamic monitoring: a statement for physicians from the ACP/ACC/AHA task force on clinical privileges in cardiology. J Am Coll Cardiol . 1990;;15:1460-1464.
50 +
Matthay MA, Chatterjee K.  Bedside catheterization of the pulmonary artery: risks compared with benefits. Ann Intern Med . 1988;;109:826-834.
51 +
Voyce SJ, Rippe JM.  Pulmonary artery catheters: an update. J Intensive Care Med . 1990;;5:175-192.
52 +
Vincent J-L, Bennett D, Boldt J, et al.  Expert panel: the use of the pulmonary artery catheter. Intensive Care Med . 1991;;17( (3) ):I-VIII.
53 +
Brook RH, Chassin MR, Fink A, Solomon DH, Kosecoff J, Park RE.  A method for detailed assessment of the appropriateness of medical technologies. Int J Technol Assess Health Care . 1986;;2:53-64.
54 +
Park RE, Fink A, Brook RH, et al.  Physician ratings of appropriate indications for six medical and surgical procedures. Am J Public Health . 1986;;76: 766-772.
55 +
Merrick NJ, Fink A, Park RE, et al.  Derivation of clinical indications for carotid endarterectomy by an expert panel. Am J Public Health . 1987;;77:187-190.
56 +
 Indications for cesarean section: final statement of the panel of the National Consensus Conference on Aspects of Cesarean Birth. Can Med Assoc J . 1986;;134:1348-1352.
57 +
Naylor CD, Baigrie RS, Goldman BS, et al.  Assessment of priority for coronary revascularization procedures. Lancet . 1990;;335:1070-1073.
58 +
Chassin M, Kosecoff J, Park RE, et al.  Does inappropriate use explain geographic variations in the use of health care services? JAMA . 1987;;258: 2533-2537.
59 +
Gray D, Hampton JR, Bernstein SJ, Kosecoff JB, Brook RH.  An audit of coronary angiography and coronary artery bypass surgery in the Trent region based on ratings of appropriateness. Lancet . 1990;;335:1317-1320.

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Country-Specific Mortality and Growth Failure in Infancy and Yound Children and Association With Material Stature

Use interactive graphics and maps to view and sort country-specific infant and early dhildhood mortality and growth failure data and their association with maternal

1 +
Swan HJ, Ganz W, Forrester J, et al.  Catheterization of the heart in man with use of a flow-directed balloon-tipped catheter. N Engl J Med . 1970;;283: 447-451.
2 +
Robin ED.  Death by pulmonary artery flow-directed catheter: time for a moratorium? Chest . 1987;; 92:727-731.
3 +
Robin ED.  The cult of the Swan-Ganz catheter: overuse and abuse of pulmonary flow catheters. Ann Intern Med . 1985;;103:445-449.
4 +
Matthay MA, Chatterjee K.  Bedside catheterization of the pulmonary artery: risks compared with benefits. Ann Intern Med . 1988;;109:826-834.
5 +
Spodick DH.  Flow-directed pulmonary artery catheterization. Chest . 1989;;95:489-490.
6 +
Dalen JE.  Does pulmonary artery catheterization benefit patients with acute myocardial infarction? Chest . 1990;;98:1313-1314.
7 +
Spodick DH.  Analysis of flow-directed pulmonary artery catheterization. JAMA . 1989;;261:1946-1947.
8 +
Sibbald WJ, Sprung CL.  The pulmonary artery catheter: the debate continues. Chest . 1988;;94:899-901.
9 +
Shoemaker WC.  Use and abuse of the balloon tip pulmonary artery (Swan-Ganz) catheter: are patients getting their money's worth? Crit Care Med . 1990;; 18:1294-1295.
10 +
Gore JM, Goldberg RJ, Spodick DH, et al.  A community-wide assessment of the use of pulmonary artery catheters in patients with acute myocardial infarction. Chest . 1987;;92:721-727.
11 +
Gore JM, Dalen JE.  Pulmonary artery catheters. Chest . 1988;;93:1115.
12 +
Robin ED.  Defenders of the pulmonary artery catheter. Chest . 1988;;93:1059-1062.
13 +
Robin ED.  Warning about pulmonary artery (Swan-Ganz) flow catheters. Ir Med J . 1987;;80:330-331.
14 +
Robin ED.  Hazards of the Swan-Ganz catheter. Ann Intern Med . 1988;;108:151.
15 +
Sprung CL.  Complications of pulmonary artery catheterization.  In: Sprung CL, ed. The Pulmonary Artery Catheter: Methodology and Clinical Applications . Baltimore, Md: Aspen; 1983;:73-101.
16 +
Sladen A.  Complications of invasive hemodynamic monitoring in the intensive care unit. Curr Probl Surg . 1988;;25:69-145.
17 +
Johnston WE.  Complications from the use of pulmonary artery catheters.  In: Lumb PD, Bryan Brown C, eds. Complications in Critical Care Medicine . Chicago, Ill: Year Book Medical Publishers Inc; 1988;;45-65.
18 +
Becker RC, Martin RG, Underwood DA.  Right-sided endocardial lesions and flow-directed pulmonary artery catheters. Cleve Clin J Med . 1987;;54: 384-388.
19 +
Norfleet EA, Watson CB.  Continuous mixed venous oxygen saturation measurement: a significant advance in hemodynamic monitoring? J Clin Monit . 1985;;1:245-258.
20 +
Iberti TJ, Fischer EP, Leibowitz AB, et al.  A multicenter study of physicians' knowledge of the pulmonary artery catheter. JAMA . 1990;;264:2928-2932.
21 +
Steingrub JS, Celoria G, Vickers-Lahti M, Teres D, Bria W.  Therapeutic impact of pulmonary artery catheterization in a medical/surgical ICU. Chest . 1991;; 99:1451-1455.
22 +
Fein AM, Goldberg SK, Walkenstein MD, Dershaw B, Braitman L, Lippmann ML.  Is pulmonary artery catheterization necessary for the diagnosis of pulmonary edema? Am Rev Respir Dis . 1984;;129: 1006-1009.
23 +
Connors AF Jr, McCaffree DR, Gray BA.  Evaluation of right-heart catheterization in the critically ill patient without acute myocardial infarction. N Engl J Med . 1983;;308:263-267.
24 +
Bayliss J, Norell M, Ryan A, et al.  Bedside hemodynamic monitoring: experience in a general hospital. BMJ . 1983;;287:187-190.
25 +
Eisenberg PR, Jaffe AS, Schuster DP.  Clinical evaluation compared to pulmonary artery catheterization in the hemodynamic assessment of critically ill patients. Crit Care Med . 1984;;12:549-553.
26 +
Connors AF Jr, Dawson NV, Shaw PK, Montenegro HD, Nara AR, Martin L.  Hemodynamic status in critically ill patients with and without acute heart disease. Chest . 1990;;98:1200-1206.
27 +
Forrester JC, Diamond G, Swan HJ.  Correlative classification of clinical and hemodynamic function after acute myocardial infarction. Am J Cardiol . 1977;;39:137-145.
28 +
Celoria G, Steingrub JS, Vickers-Lahti M, et al.  Clinical assessment of hemodynamic values in two surgical intensive care units. Arch Surg . 1990;;125: 1036-1039.
29 +
Stevenson LW, Perloft JK.  The limited reliability of physical signs for estimating hemodynamics in chronic heart failure. JAMA . 1989;;261:884-888.
30 +
Tuchschmidt J, Sharma OP.  Impact of hemodynamic monitoring in a medical intensive care unit. Crit Care Med . 1987;;15:840-843.
31 +
 Ontario Intensive Care Study Group. Evaluation of right heart catheterization in critically ill patients. Crit Care Med . 1992;;20:928-933.
32 +
Chatterjee K, Matthay M.  Right-heart catheterization is a diagnostic procedure, not a therapeutic intervention. J Intensive Care Med . 1991;;6:101-104.
33 +
Schultz RJ, Whitfield GF, LaMura JJ, Raciti A, Krishnamurthy S.  The role of physiologic monitoring in patients with fractures of the hip. Trauma . 1985;;25:309-316.
34 +
Isaacson IJ, Lowdon JD, Berry AJ, et al.  the value of pulmonary artery and central venous monitoring in patients undergoing abdominal aortic reconstructive surgery. J Vasc Surg . 1990;;12:754-760.
35 +
Joyce WP, Provan JL, Amelo FM, McEwan MMP, Jelenich S, Jones DP.  The role of central haemodynamic monitoring in abdominal aortic surgery: a prospective randomised study. Eur J Vasc Surg . 1990;;4:633-636.
36 +
Pearson KS, Gomez MN, Moyers JR, Carter JG, Tinker JH.  A cost/benefit analysis of randomized invasive monitoring for patients undergoing cardiac surgery. Anesth Analg . 1989;;69:336-341.
37 +
Rajput MA, Richey HM, Bush BA, Glendening DL, Matthews JI.  A comparison between a conventional and a fiberoptic flow-directed thermal dilution pulmonary artery catheter in critically ill patients. Arch Intern Med . 1989;;149:83-85.
38 +
Guyatt G, Ontario Intensive Care Study Group.  A randomized control trial of right-heart catheterization in critically ill patients. J Intensive Care Med . 1991;;6:91-95.
39 +
Shoemaker WC, Appel PA, Kram HB, Waxman K, Lee T.  Prospective trial of supranormal values of survivors as therapeutic goals in high-risk surgical patients. Chest . 1988;;94:1176-1186.
40 +
Berlauk JF, Abrams JH, Gilmour IJ, O'Connor SR, Knighton DR, Cerra FB.  Preoperative optimization of cardiovascular hemodynamics improves outcome in peripheral vascular surgery: a prospective randomized clinical trial. Ann Surg . 1991;;214:289-299.
41 +
Tuchschmidt J, Fried J, Astiz M, Rackow E.  Elevation of cardiac output and oxygen delivery improves outcome in septic shock. Chest . 1992;;102: 216-220.
42 +
Bishop M, Shoemaker W, Appel P, Kram H.  Prospective trial of supranormal values in severely traumatized patients. Crit Care Med . 1992;;20 ( (suppl) ):S93. Abstract.
43 +
Shoemaker WC, Kram HB, Appel PL, Fleming AW.  The efficacy of central venous and pulmonary artery catheters and therapy based upon them in reducing mortality and morbidity. Arch Surg . 1990;; 125:1332-1338.
44 +
Lowenstein E, Teplic R.  To (PA) catheterize or not to (PA) catheterize—that is the question. Anesthesiology . 1980;;53:361-363.
45 +
Streisand JB, Clark NJ, Pace NL.  Placement of the pulmonary arterial catheter before anesthesia for cardiac surgery: safe, intelligent, and appropriate use of invasive hemodynamic monitoring. J Clin Monit . 1985;;1:193-197.
46 +
Dzelzkans R, Stanley TH.  Placement of the pulmonary arterial catheter before anesthesia for cardiac surgery: a stressful, painful, unnecessary crutch. J Clin Monit . 1985;;1:197-200.
47 +
Bashein G, Johnson PW, Davis KB, Ivey TD.  Elective coronary bypass surgery without pulmonary artery catheter monitoring. Anesthesiology . 1985;;63:451-454.
48 +
Tuman KJ, McCarthy RJ, Speiss BD, et al.  Effect of pulmonary artery catheterization on outcome in patients undergoing coronary artery surgery. Anesthesiology . 1989;;70:199-206.
49 +
Friesinger GC, Williams SV, the American College of Physicians, the American College of Cardiology, and the American Heart Association Task Force on Clinical Privileges in Cardiology.  Clinical competence in hemodynamic monitoring: a statement for physicians from the ACP/ACC/AHA task force on clinical privileges in cardiology. J Am Coll Cardiol . 1990;;15:1460-1464.
50 +
Matthay MA, Chatterjee K.  Bedside catheterization of the pulmonary artery: risks compared with benefits. Ann Intern Med . 1988;;109:826-834.
51 +
Voyce SJ, Rippe JM.  Pulmonary artery catheters: an update. J Intensive Care Med . 1990;;5:175-192.
52 +
Vincent J-L, Bennett D, Boldt J, et al.  Expert panel: the use of the pulmonary artery catheter. Intensive Care Med . 1991;;17( (3) ):I-VIII.
53 +
Brook RH, Chassin MR, Fink A, Solomon DH, Kosecoff J, Park RE.  A method for detailed assessment of the appropriateness of medical technologies. Int J Technol Assess Health Care . 1986;;2:53-64.
54 +
Park RE, Fink A, Brook RH, et al.  Physician ratings of appropriate indications for six medical and surgical procedures. Am J Public Health . 1986;;76: 766-772.
55 +
Merrick NJ, Fink A, Park RE, et al.  Derivation of clinical indications for carotid endarterectomy by an expert panel. Am J Public Health . 1987;;77:187-190.
56 +
 Indications for cesarean section: final statement of the panel of the National Consensus Conference on Aspects of Cesarean Birth. Can Med Assoc J . 1986;;134:1348-1352.
57 +
Naylor CD, Baigrie RS, Goldman BS, et al.  Assessment of priority for coronary revascularization procedures. Lancet . 1990;;335:1070-1073.
58 +
Chassin M, Kosecoff J, Park RE, et al.  Does inappropriate use explain geographic variations in the use of health care services? JAMA . 1987;;258: 2533-2537.
59 +
Gray D, Hampton JR, Bernstein SJ, Kosecoff JB, Brook RH.  An audit of coronary angiography and coronary artery bypass surgery in the Trent region based on ratings of appropriateness. Lancet . 1990;;335:1317-1320.

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