Recent outcomes research in Britain

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OUTCOMES RESEARCH Nutrition Vol. 12, No. 2, 1996 GUEST EDITOR SIMON ALLISON, MD, MRCP Consultant Physician Department of Medicine Queens Medical Centre Nottingham, United Kingdom Recent Outcomes Research in Britain SIMON ALLISON, MD, MRCP From the Department of Medicine, Queens Medical Centre, Nottingham, United Kingdom I was pleased to be invited to be Eu- ropean Outcomes Research Editor for Nutrition. In Europe as in the United States the buzz phrase is “evidence- based medicine” and the caring profes- sions are being increasingly required to demonstrate that their activities are cost effective, that the benefits of treatment outweigh the risks, and that scarce re- sources are not wasted. I shall be invit- ing a succession of European authors to contribute columns on their own special areas of interest, but I begin this series with a brief account of some papers con- cerning outcome given at the annual meeting of the British Association of Parenteral and Enteral Nutrition (BA- PEN) held 5 -7 December 1995. The abstracts of these papers will be pub- lished in Proceedings of the Nutrition Society. McWhirter and Pennington from Dundee, following their paper which showed the high incidence and low rate of recognition of malnutrition in hospi- tal,’ described the first of a series of in- tervention studies in which they com- pared oral and nasogastric nutritional supplements in patients who were mal- nourished on admission by weight for height and by anthropometric criteria. Eighty-six patients were randomized to one of three groups: control, oral supple- ments, or nasogastric supplements. All subjects had access to ordinary hospital food and were supplemented for at least 7 days. More than 80% of energy re- quirements were achieved in only 4% of the controls, but in 71% of those receiv- Nutrition 12:133-134, 1996 OElsevier Science Inc. 1996 Printed in the USA. All rights reserved. ing oral supplements and 88% of those on nasogastric feeding. Seventy-three percent of the controls lost weight, but 64% of supplemented patients gained weight. There were few complications of nutritional support, and neither method of supplementation significantly reduced the normal oral intake. A randomized comparison of percuta- neous endoscopic gastrostomy feeding and nasogastric tube feeding, following acute dysphagic stroke, was described by Norton and colleagues from the Der- byshire Royal Infirmary and the Notting- ham City Hospital. This paper was sub- sequently published in the British Medi- cal JournaL2 Although it could be criticized for its small numbers (16 pa- tients received gastrostomy and 14 pa- tients nasogastric feeding), and the delay in introducing nutritional support (14 days following the stroke), there was a significant difference in discharge rates and mortality at 6 wk. Mortality was 12.5% in the gastrostomy group com- pared with 57% in the nasogastric group. At the very least, however, this was a useful pilot study, indicating that more extensive and detailed trials in this group of patients may be worthwhile. My own department presented a prospective study of nutritional changes and gastrostomy feeding in motor neuron disease, in which we followed up an unselected group of 84 patients referred sequentially to the neurology department with this disease between June 1989 and Decem- ber 1994, with review every 3 mo. The time from onset of symptoms to 50% of ELSEVIER the population developing dysphagia was 650 days, the time to 10% weight loss was 575 days, and the time to death was 870 days. If oral supplements proved un- successful and the patients developed ( 1) severe dysphagia, (2) loss of 10% of re- membered weight with mild dysphagia, and (3 ) oral energy intake below 1.5 x estimated metabolic rate, then they and their families were offered a percutane- ous endoscopic gastrostomy (PEG) to provide a route for food, fluid and drugs. Seventy-eight percent of the original pa- tients fulfilled these criteria and were of- fered a PEG. Only 32 accepted, of whom 2 did not use the PEG after insertion and 4 died during their admission for PEG insertion. Out of the original population, 21 patients benefited in either main- taining or gaining weight, or increasing their energy intake above 1.5 x resting metabolic rate. The amount administered and the rate of delivery above 120 mL/ h was limited by (a) the patient’s sensa- tion of reflux and (b) shortness of breath due to weak respiratory muscles and the increased demands for gas exchange as- sociated with diet-induced thermogene- sis. We concluded that approximately 25% of patients who develop motor neu- ron disease may benefit from PEG feed- ing. At worst, it may have a useful pallia- tive role in improving quality of life; at best it may prolong life in those patients where bulbar palsy is the main feature of their disease. One of the most exciting papers of the meeting was by Griffiths and colleagues from the Intensive Care Research Group, 0899-9007/96/$15.00 PI1 SOS99-9007(96)00022-6

Transcript of Recent outcomes research in Britain

Page 1: Recent outcomes research in Britain

OUTCOMES RESEARCH Nutrition Vol. 12, No. 2, 1996

GUEST EDITOR

SIMON ALLISON, MD, MRCP Consultant Physician

Department of Medicine Queens Medical Centre

Nottingham, United Kingdom

Recent Outcomes Research in Britain SIMON ALLISON, MD, MRCP

From the Department of Medicine, Queens Medical Centre, Nottingham, United Kingdom

I was pleased to be invited to be Eu- ropean Outcomes Research Editor for Nutrition. In Europe as in the United States the buzz phrase is “evidence- based medicine” and the caring profes- sions are being increasingly required to demonstrate that their activities are cost effective, that the benefits of treatment outweigh the risks, and that scarce re- sources are not wasted. I shall be invit- ing a succession of European authors to contribute columns on their own special areas of interest, but I begin this series with a brief account of some papers con- cerning outcome given at the annual meeting of the British Association of Parenteral and Enteral Nutrition (BA- PEN) held 5 -7 December 1995. The abstracts of these papers will be pub- lished in Proceedings of the Nutrition Society.

McWhirter and Pennington from Dundee, following their paper which showed the high incidence and low rate of recognition of malnutrition in hospi- tal,’ described the first of a series of in- tervention studies in which they com- pared oral and nasogastric nutritional supplements in patients who were mal- nourished on admission by weight for height and by anthropometric criteria. Eighty-six patients were randomized to one of three groups: control, oral supple- ments, or nasogastric supplements. All subjects had access to ordinary hospital food and were supplemented for at least 7 days. More than 80% of energy re- quirements were achieved in only 4% of the controls, but in 71% of those receiv-

Nutrition 12:133-134, 1996 OElsevier Science Inc. 1996 Printed in the USA. All rights reserved.

ing oral supplements and 88% of those on nasogastric feeding. Seventy-three percent of the controls lost weight, but 64% of supplemented patients gained weight. There were few complications of nutritional support, and neither method of supplementation significantly reduced the normal oral intake.

A randomized comparison of percuta- neous endoscopic gastrostomy feeding and nasogastric tube feeding, following acute dysphagic stroke, was described by Norton and colleagues from the Der- byshire Royal Infirmary and the Notting- ham City Hospital. This paper was sub- sequently published in the British Medi- cal JournaL2 Although it could be criticized for its small numbers (16 pa- tients received gastrostomy and 14 pa- tients nasogastric feeding), and the delay in introducing nutritional support (14 days following the stroke), there was a significant difference in discharge rates and mortality at 6 wk. Mortality was 12.5% in the gastrostomy group com- pared with 57% in the nasogastric group. At the very least, however, this was a useful pilot study, indicating that more extensive and detailed trials in this group of patients may be worthwhile. My own department presented a prospective study of nutritional changes and gastrostomy feeding in motor neuron disease, in which we followed up an unselected group of 84 patients referred sequentially to the neurology department with this disease between June 1989 and Decem- ber 1994, with review every 3 mo. The time from onset of symptoms to 50% of

ELSEVIER

the population developing dysphagia was 650 days, the time to 10% weight loss was 575 days, and the time to death was 870 days. If oral supplements proved un- successful and the patients developed ( 1) severe dysphagia, (2) loss of 10% of re- membered weight with mild dysphagia, and (3 ) oral energy intake below 1.5 x estimated metabolic rate, then they and their families were offered a percutane- ous endoscopic gastrostomy (PEG) to provide a route for food, fluid and drugs. Seventy-eight percent of the original pa- tients fulfilled these criteria and were of- fered a PEG. Only 32 accepted, of whom 2 did not use the PEG after insertion and 4 died during their admission for PEG insertion. Out of the original population, 21 patients benefited in either main- taining or gaining weight, or increasing their energy intake above 1.5 x resting metabolic rate. The amount administered and the rate of delivery above 120 mL/ h was limited by (a) the patient’s sensa- tion of reflux and (b) shortness of breath due to weak respiratory muscles and the increased demands for gas exchange as- sociated with diet-induced thermogene- sis. We concluded that approximately 25% of patients who develop motor neu- ron disease may benefit from PEG feed- ing. At worst, it may have a useful pallia- tive role in improving quality of life; at best it may prolong life in those patients where bulbar palsy is the main feature of their disease.

One of the most exciting papers of the meeting was by Griffiths and colleagues from the Intensive Care Research Group,

0899-9007/96/$15.00 PI1 SOS99-9007(96)00022-6

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University of Liverpool (unpublished observations). In a beautifully designed and conducted double-blind randomized study, they examined the survival of in- tensive care patients given glutamine- supplemented parenteral nutrition, com- pared with conventional parenteral nutri- tion. Patients were selected by the fact that they were unable to tolerate nasogas- tric feeding and were some of the most severely ill. Previous follow-up experi- ence showed that such severely ill pa- tients had a 6-mo mortality of 60%. Eighty-four patients were randomized into the two groups, which were compa- rable in terms of age, sex, APACHE and nutritional score, etc. Although the pat- tern of early deaths was similar in the two groups, the patients on conventional TPN had a significantly longer stay and increased late mortality. Mortality at 6 mo was 66.7% for conventional TPN and 42.9% with glutamine-supplemented TPN. This well-conducted study was not only remarkable for being one of the few successful studies of outcome research from nutritional pharmacology, but also in tackling the intensive care unit popula- tion, who are notoriously difficult to study in this manner.

One of my own interests has been in the role of TPN in the management of acute and chronic gastrointestinal failure. If survival with complete starvation is limited to between 50 and 70 days in the

absence of initial obesity, then gastroin- testinal failure which prevents normal in- take for that period of time is by defini- tion fatal and parenteral nutrition is life- saving in the same sense that ventilation is life-saving for ventilatory failure and dialysis allows survival in acute and in chronic kidney failure. At the BAPEN meeting, Richards and Irving from Sal- ford, Manchester, reported a cost utility analysis of home parenteral nutrition in 64 patients with benign intestinal dis- ease, mainly Crohn’s or ischemia. This group has previously shown a high qual- ity of life and good survival in over 80% of such patients.3 In this study the mar- ginal costs per quality-adjusted life year (QALY) were reported. Resource con- sumption was determined in three phases, enumeration, measurement and valuation. The marginal cost per QALY for an average patient was 268,975. If the patient survived for only 1 yr, this ratio was increased to &85,829, but sur- vival for 10 yr decreased the ratio to &54,734. In patients over 55 yr of age, the cost was &126,865, compared with &58,233 in those less than 44 yr of age. It was pointed out that treating such a patient in hospital rather than at home increased the cost to &I 89,45 1, and there- fore that the potential savings for a pa- tient on home parenteral nutrition for 4 yr were &170,506.

In an audit of 10 yr, parenteral nutri-

OUTCOME

tion carried out in hospital for acute but prolonged episodes of gastrointestinal failure; that is, in patients with benign disease who had already lost lo-20% of their body weight before nutritional support and who were fed for an average of 50 days by the parenteral route, there was a 75% lo-yr survival with a cost per year of life of &4,700. These costs are similar to other well-accepted technolo- gies and justify the resources needed to provide this form of treatment.4

In future columns I shall be ad- dressing these aspects of nutritional sup- port in more detail, with the help of ex- pert European colleagues.

REFERENCES

McWhirter JP, Penmngton CR. Incidence and recognition of malnutrition in hospital. Br Med J 1994;308:945 Norton B, Homer-Ward M, Donnelly MT, Long RG, Holmes GKT. A randomised prospective comparison of percutaneous endoscopic gastrostomy and nasogastric tube feeding after acute dysphagic stroke. Br Med J 1996;312:13 O’Hanrahan T, Irving MH. The role of home parenteral nutrition in the manage- ment of intestinal failure-report of 400 cases. Clin Nutr 1992; 11:33 1 _ Shields PL. Field J. Rawlinus J. Kendall J. Allison SP: Long-term outgome and cost: effectiveness of parenteral nutrition for acute gastrointestinal failure. Clin Nutr, in press